Basic Medication Research Articles

Selenium and Hashimoto disease

Selenium is one of the most important micronutrients affecting the human body. It plays a crucial role in the thyroid gland, where its concentration is the highest. This element has the ability to remove reactive oxygen species and deiodinate thyroid hormones. Balanced diet and supplements are basic for achieving proper concentration of selenium in human organism. Recently a number of studies have been conducted focusing on the effect of selenium on autoimmune thyroiditis - Hashimoto’s disease. In our study the oral supply of selenium was used, and then the levels of selected parameters were measured. It has been proved that Selenium lowers levels of antithyroglobulin and anti-thyroid peroxidase antibodies. Moreover the concentration of Thyroid Stimulating Hormone is also lowered by this micronutrient. In this review we draw attention to possible resources of delivery of this element to organisms and the impact it has on the course of the above-mentioned diseases. We come to conclusion that there is a strong correlation between Selenium and the functioning of thyroid gland. Doctor’s awareness and cooperation with the patient in order to establish proper doses of micro- and macronutrients which are taken with basic medications is very important for the therapeutic process. This article is a review of current medical knowledge about Selenium affecting a thyroid gland based on available publications in Pubmed and Google Scholar databases.

S1595 Misdiagnosis of Gastroparesis Is Common: A Retrospective Review of Patients Referred to a Tertiary Gastroenterology Practice for Gastroparesis

Introduction: Gastroparesis (GP) is a disorder defined by delayed gastric emptying, though diagnosing GP can be challenging for many clinicians. There is a paucity of data describing diagnostic outcomes of patients referred to a tertiary gastroenterology (GI) practice for GP. We hypothesize that the majority of patients referred for GP ultimately receive alternative diagnoses, namely functional dyspepsia (FD). Methods: A retrospective cohort population consisting of adult patients (18-90 years old) who were referred to Mayo Clinic Florida for the evaluation of GP between January 2019 and July 2021 was reviewed. Basic demographic information, medical comorbidities, medications, diagnostic tests, and labs were collected. A final diagnosis was determined by review of clinical notes and tests by experts in the field (BEL, DJC). Continuous variables were summarized with median and range, and categorical variables were summarized with frequency and percentage. Differences between misdiagnoses and correct diagnoses of GP were evaluated using the Kruskal-Wallis Rank Sum test for continuous measures and the Fisher Exact test for categorical measures. Results: 339 patients were evaluated; the mean age was 46 [range: 18-90]; 278 (82%) were female. Overall, 66 (19.5%) patients were diagnosed with GP after evaluation, whereas 273 (80.5%) patients received an alternative diagnosis (Figure); 151 (44.5%) were diagnosed with FD. Compared to GP patients, patients with alternative diagnoses were significantly younger [median age 44 vs 52, P=0.001] and had significantly lower median BMI [median 24.9 vs 28.5, P=0.017; Table]. Patients correctly diagnosed with GP were more often diabetic [40% vs 17.2%, P < 0.001), had Barrett’s esophagus [12.1% vs 4.8%, P=0.042], had undergone cholecystectomy [56.1% vs 37.7%, P=0.008], appendectomy [24.2% vs 13.6%, P=0.038] or fundoplication [13.6% vs 5.1%, P=0.025], were taking a PPI [71.2% vs 48.7%, P< 0.001], were less likely to use cannabis [9.1% vs 22.1%, P=0.034], and more often had retained food in the stomach on upper endoscopy [22.7% vs 8.8%, P=0.004]. There was no difference in GI symptoms on presentation between the patient groups. Conclusion: The vast majority of patients referred to a tertiary GI practice for evaluation of GP receive alternative diagnoses, most commonly FD. Presenting GI symptoms do not distinguish GP from alternative diagnoses, though a prior surgical history and findings of retained food on upper endoscopy may help predict a true diagnosis of GP.Figure 1.: Final Diagnoses Among Patients Referred for Evaluation of Gastroparesis Table 1. - Demographics and Relevant Historical Data of Patients Referred for Evaluation of Gastroparesis Misdiagnosis (N=273) Gastroparesis (N=66) Total (N=339) P-value Age 0.001 Median (Range) 44.00 (18-83) 52.00 (18-90) 46.00 (18-90) BMI 0.017 Median (Range) 24.89 (13.1-51.3) 28.52 (15.7-42.8) 25.34 (13.1-51.3) Sex 1.000 Female 224 (82.1%) 54 (81.8%) 278 (82.0%) Male 49 (17.9%) 12 (18.2%) 61 (18.0%) Race 0.842 White 231 (85.6%) 57 (87.7%) 288 (86.0%) Non-White 39 (14.4%) 8 (12.3%) 47 (14.0%) Diabetes < 0.001 Type I 18 (6.7%) 11 (16.9%) 29 (8.7%) Type II 28 (10.5%) 15 (23.1%) 43 (13.0%) GERD 195 (71.4%) 48 (72.7%) 243 (71.7%) 0.880 Barret's Esophagus 13 (4.8%) 8 (12.1%) 21 (6.2%) 0.042 H.pylori 17 (6.2%) 2 (3.0%) 19 (5.6%) 0.549 Depression 110 (40.4%) 21 (31.8%) 131 (38.8%) 0.208 Anxiety 157 (57.5%) 36 (54.5%) 193 (56.9%) 0.680 Cholecystectomy 103 (37.7%) 37 (56.1%) 140 (41.3%) 0.008 Fundoplication 14 (5.1%) 9 (13.6%) 23 (6.8%) 0.025 Appendectomy 37 (13.6%) 16 (24.2%) 53 (15.6%) 0.038 PPI 133 (48.7%) 47 (71.2%) 180 (53.1%) < 0.001 NSAIDs 50 (18.4%) 11 (16.7%) 61 (18.0%) 0.859 Opioids 41 (15.0%) 8 (12.1%) 49 (14.5%) 0.697 Cannabis use (current) 59 (21.7%) 6 (9.1%) 65 (19.2%) 0.034 Alcohol use (current) 103 (37.7%) 19 (28.8%) 122 (36.0%) 0.256 Tobacco use (current) 37 (13.6%) 4 (6.1%) 41 (12.1%) 0.241 Nausea 241 (88.3%) 61 (92.4%) 302 (89.1%) 0.388 Vomiting 174 (63.7%) 49 (74.2%) 223 (65.8%) 0.114 Satiety 98 (35.9%) 19 (28.8%) 117 (34.5%) 0.314 Abdominal pain 209 (76.6%) 50 (75.8%) 259 (76.4%) 0.873 Bloating 104 (38.1%) 23 (34.8%) 127 (37.5%) 0.672 Prior EGD Normal 107 (39.2%) 21 (31.8%) 128 (37.8%) 0.322 Retained Food on Prior EGD 24 (8.8%) 15 (22.7%) 39 (11.5%) 0.004

Longitudinal investigation of the factor structure of the Parkinson's disease activities of daily living, interference and dependence instrument.

The Parkinson's Disease Activities of Daily Living, Interference, and Dependence Instrument© (PD-AID) is a patient-reported outcome (PRO) instrument, recently developed to assess the clinical benefit of Parkinson's Disease (PD) treatment. The PD-AID consists of morning and evening assessments, administered daily. To benefit from the full set of the repeated observations over time, analytic approaches that account for both within- and between-individual variability are required. The current study aimed to employ the advantages of exploratory Multilevel Factor Analysis (MFA) on data collected from 93 participants with moderate to advanced PD, currently using and responding to Levodopa (L-Dopa), who completed the PD-AID twice daily as part of a prospective, non-intervention, observational study for ~28 days. Average daily completion rates were comparable for the Morning and the Evening PD-AID (78% and 74%, respectively). The intraclass correlation coefficients for the Morning and Evening PD-AID items were in the range of 0.70–0.90, with an average of 0.81 for the Morning PD-AID items and 0.83 for the Evening PD-AID items, suggesting that most variability (81%–83%) in responses was due to between-individual variability. For the Morning PD-AID, one factor (including nine out of 10 Morning PD-AID items) emerged at the between-individual level and four factors (core physical actions, basic self-care activities, feeding, and interference & dependence) at the within-individual level. For the Evening PD-AID, there were four between-individual factors (basic activities of daily living ADLs, life interference, impact on planning, and emotional consequences) and five within-individual factors (basic ADLs, toileting, life interference, medication planning, and emotional impact). The factors had high reliability.

Dialysis Service in the Embattled Tigray Region of Ethiopia: A Call to Action.

Haemodialysis is extremely limited in low-income countries. Access to haemodialysis is further curtailed in areas of active conflict and political instability. Haemodialysis in the Tigray region of Ethiopia has been dramatically affected by the ongoing civil war. Rapid assessment from the data available at Ayder Hospital's haemodialysis unit registry, 2015–2021, shows that enrollment of patients in the haemodialysis service has plummeted since the war broke out. Patient flow has decreased by 37.3% from the previous yearly average. This is in contrary to the assumption that enrollment would increase because patients could not travel to haemodialysis services in the rest of the country due to the complete blockade. Compared to the prewar period, the mortality rate has doubled in the first year after the war broke out, i.e., 28 deaths out of 110 haemodialysis recipients in 2020 vs. 43 deaths out of 81 haemodialysis recipients in the year 2021. These untoward outcomes reflect the persistent interruption of haemodialysis supplies, lack of transportation to the hospital, lack of financial resources, and the unavailability of basic medications due to the war and the ongoing economic and humanitarian blockade of Tigray in Northern Ethiopia. In the setting of this medical catastrophe, the international community should mobilize to advocate for resumption of life-saving haemodialysis treatment in Ethiopia's Tigray region and put pressure on the Ethiopian government to allow the passage of life-saving medicines, essential medical equipment, and consumables for haemodialysis into Tigray.

Bedside rationing and moral distress in nephrologists in sub- Saharan Africa

BackgroundKidney diseases constitute an important proportion of the non-communicable disease (NCD) burden in Sub-Saharan Africa (SSA), though prevention, diagnosis and treatment of kidney diseases are less prioritized in public health budgets than other high-burden NCDs. Dialysis is not considered cost-effective, and for those patients accessing the limited service available, high out-of-pocket expenses are common and few continue care over time. This study assessed challenges faced by nephrologists in SSA who manage patients needing dialysis. The specific focus was to investigate if and how physicians respond to bedside rationing situations.MethodsA survey was conducted among a randomly selected group of nephrologists from SSA. The questionnaire was based on a previously validated survey instrument. A descriptive and narrative approach was used for analysis.ResultsAmong 40 respondents, the majority saw patients weekly with acute kidney injury (AKI) or end-stage kidney failure (ESKF) in need of dialysis whom they could not dialyze. When dialysis was provided, clinical compromises were common, and 66% of nephrologists reported lack of basic diagnostics and medication and > 80% reported high out-of-pocket expenses for patients. Several patient-, disease- and institutional factors influenced who got access to dialysis. Patients’ financial constraints and poor chances of survival limited the likelihood of receiving dialysis (reported by 79 and 78% of nephrologists respectively), while a patient’s being the family bread-winner increased the likelihood (reported by 56%). Patient and institutional constraints resulted in most nephrologists (88%) frequently having to make difficult choices, sometimes having to choose between patients. Few reported existence of priority setting guidelines. Most nephrologists (74%) always, often or sometimes felt burdened by ethical dilemmas and worried about patients out of hospital hours. As a consequence, almost 46% of nephrologists reported frequently regretting their choice of profession and 26% had considered leaving the country.ConclusionNephrologists in SSA face harsh priority setting at the bedside without available guidance. The moral distress is high. While publicly funded dialysis treatment might not be prioritized in essential health care packages on the path to universal health coverage, the suffering of the patients, families and the providers must be acknowledged and addressed to increase fairness in these decisions.

PD05-02 ADHERENCE AND MEDICATION BELIEFS AMONGST PATIENTS PRESCRIBED THIAZIDES AND ALKALI FOR STONE PREVENTION AND THEIR ASSOCIATION WITH STONE RELATED QUALITY OF LIFE

You have accessJournal of UrologyCME1 May 2022PD05-02 ADHERENCE AND MEDICATION BELIEFS AMONGST PATIENTS PRESCRIBED THIAZIDES AND ALKALI FOR STONE PREVENTION AND THEIR ASSOCIATION WITH STONE RELATED QUALITY OF LIFE Christopher Haas, Shuang Li, Stephen Y. Nakada, and Kristina L. Pennniston Christopher HaasChristopher Haas More articles by this author , Shuang LiShuang Li More articles by this author , Stephen Y. NakadaStephen Y. Nakada More articles by this author , and Kristina L. PennnistonKristina L. Pennniston More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000002524.02AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: The primary objective of this study was to compare patient’s adherence and beliefs on the efficacy of thiazide diuretics and alkalizing agents used in the prevention of recurrent stone formation. Secondarily, we hypothesized that higher belief in their medication’s efficacy would be positively correlated with increased stone-related quality of life. METHODS: The Basic Medication Questionnaire (BMQ) is a validated tool for evaluating patients’ beliefs about medicines and to screen for adherence and adherence barriers. We mailed surveys of the BMQ and Wisconsin Stone Quality of Life Short Form (WISQOL-SF) to patients prescribed either a thiazide diuretic or an alkalizing agent within our metabolic stone clinic. A composite score of the questions on the BMQ relating to beliefs and bother from medication was created (range 0-10, 10 = highest positive belief). We generated descriptive statistics to compare BMQ questions between thiazide diuretics and alkali and created a scatter plot to assess correlation between belief scores of medication type and WISQOL-SF scores. RESULTS: Of surveys mailed (n=243), we received responses from 91 patients (response rate 37%). Of these, patients were 42% female, 66±8.6 years of age, had a median of 3 lifetime stone events (mean 13.5), and stone disease onset a median of 12 years ago (mean 17.8). Non-responders were not different for gender or age. Of patients taking a thiazide, 55% believed the drug worked moderately or very well compared to 68% taking alkali, with no notable differences between drugs’ bother scores (Figure 1A & B). Patients on alkali had a higher prevalence of less than perfect adherence vs. those on thiazides (Figure 1C). Positive beliefs about both medications were correlated with WISQOL-SF scores (Figure 1D). CONCLUSIONS: The majority of patients had moderate to strong beliefs about drug efficacy of thiazides and alkali. Adherence with the prescriptive alkali regimen tended to be lower than for thiazides. As higher belief scores in the efficacy of medications are associated with higher stone-related quality of life scores, providers should strive to educate patients on the benefits, mechanisms, and side effects of thiazide diuretics and alkalinizing agents in order to maximize patients’ stone related quality of life. Source of Funding: none © 2022 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 207Issue Supplement 5May 2022Page: e86 Advertisement Copyright & Permissions© 2022 by American Urological Association Education and Research, Inc.MetricsAuthor Information Christopher Haas More articles by this author Shuang Li More articles by this author Stephen Y. Nakada More articles by this author Kristina L. Pennniston More articles by this author Expand All Advertisement PDF DownloadLoading ...

Effect of Rehabilitation Robot Combined with Upper Limb Rehabilitation Training on Hemiplegic Patients in Recovery Stage of Stroke

<bold>Objective:</bold> To observe the effect of upper limb rehabilitation robot combined with upper limb rehabilitation training on motor function of upper extremity of hemiplegic patients in recovery stage of stroke. <bold>Methods</bold> A total of 40 hemiplegic patients in recovery stage of stroke who were treated in the Zhujiang Hospital of Southern Medical University from October 2018 to January 2020, which were randomly divided into the control group and the observation group according to the random number table method, with 20 cases in each group. Both groups received basic medication and conventional rehabilitation therapy (including good limb position, active and passive joint movement, sitting and standing balance training, walking function training, assistive device use training, speech and swallowing therapy, conventional physical therapy, etc.). The control group received upper limb rehabilitation training on the basis of basic medication and conventional rehabilitation therapy, 60 minutes a time, once a day, seven days a week, continuous treatment for two weeks. The observation group received upper limb rehabilitation robot training on the basis of the control group, upper limb rehabilitation training for 30 minutes a time, upper limb robot rehabilitation training for 30 minutes a time, once a day, seven days a week, continuous treatment for two weeks. Before and after treatment, the Fugl-Meyer assessment-upper limb (FMA-UL) was used to evaluate the motor function of upper extremity, including the FMA shoulder and elbow (FMA-SE) score and the FMA wrist and hand (FMA-WH) score; the Barthel index (BI) was used to evaluate activities of daily living; the root mean square (RMS) and integral electromyography (iEMG) values of the biceps, triceps, deltoid of anterior and middle fiber of the affected upper limbs of the subjects during maximal isometric contraction were measured by surface electromyography to assess muscle activation and synchronization of motor recruitment of the upper limbs. <bold>Results</bold> A total of 38 hemiplegia patients in the recovery stage of stroke completed the whole course of treatment. Compared with before treatment, FMA-UL score, FMA-SE score, FMA-WH score, BI score, RMS values of biceps, triceps, deltoid of anterior and middle fiber, and iEMG values of the both groups after treatment were significantly higher, with statistically significant differences (<italic>P</italic>&lt;0.05). Compared with the control group, the FMA-UL score, FMA-SE score, BI scores, triceps RMS value, deltoid of middle fiber RMS value and iEMG value of observation group were significantly higher, with statistically significant differences (<italic>P</italic>&lt;0.05). <bold>Conclusion</bold> Upper limb rehabilitation robot combined with upper limb rehabilitation training can effectively improve motor function of upper limb, muscle activation and motor unit recruitment synchronization of hemiplegic upper limb, and improve the activities of daily living of hemiplegic patients in recovery stage of stroke, which is worthy of clinical promotion.

Discovery of a Highly Selective β2-Adrenoceptor Agonist with a 2-Amino-2-phenylethanol Scaffold as an Oral Antiasthmatic Agent

Asthma patients in resource-poor countries cannot obtain adequate basic asthma medications because most asthma medications are supplied as inhalants. An alternative approach is to create oral antiasthmatic drugs with high β2/β1-selectivity, which should reduce treatment costs. In this study, we designed a cohort of compounds 1 using 2-(4-amino-3-chloro-5-(trifluoromethyl)phenyl)-2-(tert-butylamino)ethan-1-ol hydrogen chloride (1a) as the lead compound with an aim to expand the library of compounds possessing the 2-amino-2-phenylethanol scaffold. Structure-activity relationship studies on these compounds revealed that compounds created showed remarkable β2 selectivity compared to isoproterenol and gave additional insights on the rational design of β2-adrenoceptor agonists. Moreover, 1a was found as the best candidate compound showing the greatest potential for drug development. Cell-based assays showed that 1a was about 10 times more selective than salbutamol toward the β2-adrenoceptor. Moreover, 1a exhibited good oral bioavailability and low acute oral toxicity. These data reveal 1a as an oral antiasthmatic agent.

Clinical comprehensive evaluation of Qilong Capsules in treatment of ischemic stroke with Qi deficiency and blood stasis syndrome

The present study systematically sorted out the existing research on Qilong Capsules in the treatment of ischemic stroke with Qi deficiency and blood stasis syndrome and comprehensively evaluated its clinical evidence and value to highlight the advantages and characteristics of products and provide references for the decision-making of national pharmaceutical management departments. Based on the evidence-based medicine, epidemiology, clinical medicine, evidence-based pharmacy, and pharmacoeconomics, the qualitative and quantitative evaluation of &quot;6+1&quot; dimensions of safety, effectiveness, economy, innovation, suitability, and accessibility, as well as characteristics of traditional Chinese medicine(TCM) was performed with multi-criteria decision analysis(MCDA) mo-del using the information, such as public data, literature data, pharmaceutical research, and questionnaire survey, and CSC v2.0 was used to calculate the clinical value of Qilong Capsules. The evaluation results were grade A, B, C, or D. Spontaneous reporting system(SRS) monitoring data, literature reports, clinical trials, and other multi-source safety evidence showed that the main adverse reactions of this drug included dry mouth, nausea, and rash, and no severe adverse reactions was found. The evidence was sufficient with small and controllable known risks, and the safety was grade A. Meta-analysis showed that Qilong Capsules combined with conventional western medicine in the treatment of acute ischemic stroke was superior to the control group in improving neurological deficits, clinical total response rate, patients' activities of daily living, and hemorheological indexes. The level of evidence was high with manifest clinical significance, and the effectiveness was grade A. The results of pharmacoeconomic research showed that Qilong Capsules combined with conventional western medicine in the treatment of ischemic stroke were advantageous in cost-effectiveness as compared with conventional western medicine alone, but the incremental effect was not significant. The quality evaluation results of the economic report were comparatively clear, and the economy was grade B. Aiming at major cerebrovascular diseases in the society and giving full play to the advantages of TCM, Qilong Capsules focused on the inheritance of classics and scientific and technological innovation, and innovation was grade B. The results of the questionnaire survey showed that the technical characteristics and drug application could meet the medication needs of clinical doctors and patients, and the suitability was grade B. The price level of this drug was comparatively high and the affordability was good since the treatment cost accounted for a small proportion of disposable income. The drug accessibility was good with a wide range of drug sales, sufficient production capacity, and sustainable medicinal materials resources, and was grade B. This drug was derived from the classic prescription Buyang Huanwu Decoction with rich experience of human application, which could regulate Qi and blood circulation, and the section of TCM characteristics was grade B. Based on the evidence evaluation results of &quot;6+1&quot; dimensions of Qilong Capsules, the comprehensive evaluation of clinical value was class A. It is suggested that it can be transformed into relevant policy results of basic clinical medication management according to procedures.

Clinical comprehensive evaluation of Guanxin Shutong Capsules in treatment of coronary heart disease angina pectoris with heart blood stasis syndrome

This study aims to comprehensively summarize articles on the treatment of coronary heart disease angina pectoris with heart blood stasis syndrome(CHD-AP-HBSS) by Guanxin Shutong Capsules(GSC), and comprehensively evaluate the evidence and value of the formula in &quot;6+1&quot; dimensions based on multi-criteria decision analysis(MCDA) model and Guidelines for Management of Comprehensive Clinical Evaluation of Drugs(trial version 2021) with quantitative and qualitative methods, which is expected to highlight the clinical characteristics and advantages of the prescription and serve as a reference for medical and health departments. The dimensions are grade A, B, C, or D. In terms of safety, according to the reports from the spontaneous reporting system of National Center for ADR Monitoring, and literature analysis, GSC mainly results in the adverse reactions of mild or moderate nausea, diarrhea, rash, palpitation, and headache, with favorable prognosis in patients. Nevertheless, severe adverse reactions have been reported after marketing. Thus, additional evidence for its safety should be accumulated, and the current safety is grade B. Meta-analysis proves that GSC in combination with conventional treatment is superior to conventional treatment alone in alleviating AP and symptoms indicated by electrocardiogram(ECG). Therefore, the effectiveness of the medicine is grade A. As for the pharmacoeconomic value, based on the assumption that the per capita disposable income in 2020 is the willingness-to-pay threshold, it is more economical for CHD-AP patients to use GSC combined with conventional treatment than conventional treatment alone. However, as the currently available clinical parameters fail to support the difference in indirect cost between the two groups, the accuracy in the cost of intervention plan needs to be further improved. Therefore, the economy of the prescription is grade B. GSC has been awarded 13 national invention patents and 1 utility model patent, and won a lot of national and provincial patent awards, marking the enterprise service awareness and innovativeness. As a result, it is grade A in aspect of innovation. A questionnaire on the suitability of GSC suggests that publicity and promotion influence patients' choice and thus additional efforts should be made in this aspect. The suitability of this formula is grade B. Both rural and urban residents can afford the medicine for the whole course and the price is close to that of similar Chinese patent medicines. In addition, it is accessible regardless of season and place, so accessibility is grade A. As a Mongolian empirical formula destined to treat heart stabbing pain, it has the effects of activating blood and resolving stasis, dredging channels and activating collaterals, and moving Qi to relieve pain, and boasts the empirical evidence of more than 2 000 human cases. With prominent characteristics of traditional Chinese medicine, it is grade B. Based on the MCDA model and CSC v2.0, GSC is comprehensively class A in the treatment of CHD-AP-HBSS. The result can serve as a reference for basic clinical medication management.

Clinical comprehensive evaluation of Huangkui Capsules in treatment of chronic kidney diseases

Based on Guidelines for the Management of Clinical Comprehensive Evaluation of Drugs(trial version 2021), this study aims to sort out the clinical evidence of Huangkui Capsules(HC) in the treatment of chronic kidney diseases in aspects of safety, effectiveness, economy, innovation, suitability, accessibility, and characteristics of traditional Chinese medicine( &quot;6+1&quot; dimensions) from real-world data, secondary literature evaluations, questionnaires, and public data, with the methods in evidence-based medicine, epidemiology, pharmacoeconomics, and health technology. Furthermore, with multi-criteria decision analysis(MCDA) model and CSC v2.0, the clinical value of the medicine is comprehensively assessed. All the above are to highlight the advantages and characteristics of HC and lay a basis for scientific decision-making by the medical management department. The dimensions are graded A, B, C, or D. According to the conclusions from phase Ⅳ clinical trial, spontaneous reporting system(SRS), systematic review and Meta-analysis, acute toxicity and long-term toxicity tests, it mainly results in the adverse reactions of nausea, abdominal distension, vomiting, pruritus, rash, and good prognosis in patients. According to the available research, the safety evidence is sufficient and the risk is controllable, so the safety of this medicine is grade B. According to Meta-analysis, HC in combination with conventional drugs in the treatment of chronic kidney disease is superior to conventional drugs alone in reducing urinary protein, serum creatinine concentration, and blood urea nitrogen. In addition, HC combined angiotensin receptor blocker(ARB) or angiotensin converting enzyme inhibitor(ACEI) is outstanding in improving total clinical effective rate, reducing 24 h urinary protein quantity, urinary albumin excretion rate, serum creatinine concentration, triglyceride, and total cholesterol in the treatment of diabetic nephropathy as compared with ARB or ACEI alone. As for chronic nephritis, the application together with ARB or ACEI can raise the total effective rate, reduce 24 h urinary protein content, serum creatinine concentration, and blood urea nitrogen, and delay the progress of the disease. HC boasts high-quality evidence in treating chronic kidney disease, diabetic nephropathy, and chronic nephritis. It has obvious clinical significance in treating chronic kidney disease and thus its efficacy in this aspect is grade B. It has outstanding clinical significance for diabetic nephropathy and chronic nephritis and corresponding and the effectiveness is grade A. As for the pharmacoeconomic value, HC combined with ARB or ACEI is more economical in the treatment of chronic kidney disease than Bailing Capsules combined with ARB or ACEI, with high-quality evidence, and thus the economy of the formula is grade B. HC is a key solution to the high urinary protein in patients with hypotension and chronic kidney disease. The innovation is evidenced by the methods to ensuring drug supply, community-level supply, drug safety, effectiveness, and reasonable price, as wells as the aspects of enterprise philosophy, equipment management, research and development in process and technology, enterprise management and marketing. Thus, the prescription is grade A in innovation. The suitability, as evidenced in drug administration, technical management, drug storage, information service, and medication, is grade B. The course of the medicine is affordable, and it is accessible in a wide range of areas and hospitals. Thus, the accessibility is grade A. HC was developed from an in-hospital preparation, with application in numerous patients and thus large-scale real-world data. As a result, HC is grade B in terms of characteristics of traditional Chinese medicine. After comprehensive evaluation, the clinical value of HC in treating chronic kidney disease is class B, and that for diabetic nephropathy and chronic nephritis is class A. The result is of great reference value for the basic clinical medication management.

Clinical comprehensive evaluation of Reyanning Mixture in treatment of acute upper respiratory tract infection (heat-toxin attacking lung syndrome)

This study systematically sorted out the evidence data of the safety, effectiveness, economy, innovation, suitability, accessibility, and characteristics of traditional Chinese medicine(TCM) of Reyanning Mixture in the treatment of acute upper respiratory tract infection(heat-toxin attacking lung syndrome) with the qualitative and quantitative evaluation methods adopted. Based on evidence-based medicine, epidemiology, clinical medicine, evidence-based pharmacy, pharmacoeconomics, and health technology evalua-tion(HTA), the clinical value of Reyanning Mixture was evaluated using multi-criteria decision analysis(MCDA) model, Chinese patent medicine clinical evidence, and value evaluation software(CSC v2.0). The SRS monitoring data, Meta-analysis, and other safety evidence showed that the main adverse reactions of Reyanning Mixture were nausea, diarrhea, and rash, and no serious adverse reactions were found. The pharmacovigilance system was sound, and the system was perfect. There was no recall, notification, or interview for unqualified products. Based on the existing research, the evidence was sufficient, and the risk was controllable. Hence, its safety was grade A. Meta-analysis showed that in the treatment of acute upper respiratory tract infection, Reyanning Mixture combined with Amoxicillin Capsules was better than Amoxicillin Capsules alone in shortening the complete fever relief time and improving the cure rate. Besides, it was superior to Shuanghuanglian Granules in shortening the complete fever relief time, cough relief time, nasal congestion relief time, and pharyngeal congestion relief time. The Meta-analysis was conducted based on AMSTAR standard, and its ove-rall quality was proved good. The evidence quality in GRADE system evaluation was medium and low. The quality of evidence was medium, and the clinical value was obvious. Hence, its effectiveness was grade A. The results of pharmacoeconomic research showed that compared with Amoxicillin Capsules, Reyanning Mixture alone or in combination with Amoxicillin Capsules had cost-effectiveness advantages in the treatment of acute upper respiratory tract infection, and the results were stable in sensitivity analysis. According to the CASP economic evaluation checklist, the research problems were clear and the results were reliable. As revealed by the comprehensive evaluation, the evidence quality was sufficient and the result was clear. Its economy was grade B. Reyanning Mixture had multiple therapeutic targets like anti-virus, anti-bacteria, antipyresis, and anti-cough, with good clinical innovation. There were many innovative initiatives in ensuring drug supply, especially at the grass roots, drug safety, and effectiveness, and also multiple innovative contributions to production technology, quality control, scientific and technological research and development, and enterprise management and marketing. Therefore, its innovation was grade B. The dosage form of Reyanning was mixture, which made it convenient for storage and transportation. The usage was easy to be mastered and accepted by doctors and nurses, exhibiting good suitability for clinicians, nurses, pharmacists, and patients who received this drug and basically meeting the needs of clinical medication. The suitability was grade B. The average daily cost of this drug was 8.082 yuan, and the price was low. The treatment cost accounted for a small proportion of the annual disposable income of urban and rural residents, indicating that it was affordable. Reyanning Mixture was available in 31 provinces, cities and autonomous regions, covering 6 910 hospitals. The allocation of hospitals at all levels was more than 50%. There was no shortage or supply restriction of medicinal material resources. The annual production capacity was sufficient to meet the supply demand, so its accessibility was grade A. Reyanning Mixture, sourced from &quot;pneumonia Ⅲ&quot;, has been subjected to a real-world study of its clinical application, with 4 367 cases involved, and the characteristic of TCM was grade B. The comprehensive evaluation results demonstrated that the clinical value score of Reyanning Mixture in the treatment of acute upper respiratory tract infection(heat-toxin attacking lung syndrome) was 0.80, making it rated class A. According to the Guidelines for Management of Comprehensive Clinical Evaluation of Drugs(trial version 2021), it is recommended to convert it into the relevant policy results of basic clinical medication management according to the procedures.

Clinical comprehensive evaluation of Ginkgolide Injection in treatment of cerebral infarction

This clinical value-oriented comprehensive evaluation of drugs was carried out in accordance with Guidelines for Management of Comprehensive Clinical Evaluation of Drugs(trial version 2021), with the qualitative and quantitative evaluation methods adopted. Based on the evidence-based medicine, epidemiology, clinical medicine, pharmacoeconomics, mathematical statistics, and health technology evaluation(HTA), the clinical value of Ginkgolide Injection was evaluated from the &quot;6+1&quot; dimension by giving weight to the criterion level and index level and calculating with multi-criteria decision analysis(MCDA) model and CSC v2.0. After entering the market, Ginkgolide Injection has been subjected to phase Ⅳ clinical trial, spontaneous reporting system(SRS)-based data monitoring, systematic review and Meta-analysis, acute toxicity and long-term toxicity assays, active monitoring, and RCTs, and the evidence of safety was sufficient. The results of active monitoring showed that the incidence of adverse reactions was 0.09%(rare), mainly manifested as flushing, dizziness, rash, nausea, and vomiting. According to the nested case-control study, the adverse reactions of this drug had nothing to do with the product batch, implying that the drug quality was controllable. The adverse reactions mainly resulted from the pharmacodynamic reactions. Because the drug was effective in resisting platelet aggregation, the resulting adverse reactions such as flushing, dizziness, headache, and phlebitis were caused by vasodilation. Skin rash and gastrointestinal symptoms were mainly attributed to the patients' sensitivity to drugs and their own allergic constitution. According to the sufficiency of evidence and the incidence of adverse reactions in the safety research, the safety of Ginkgolide Injection was grade A. The results of Meta-analysis showed that Ginkgolide Injection combined with conventional western medicine was superior to conventional western medicine in improving the clinical effective rate, neurological function score, and activity of daily living score of patients with cerebral infarction. The validity evidence was evaluated according to the PICO principle to be high. According to the GREAD evaluation principle, the quality of such evidence as clinical effective rate, National Institute of Health stroke scale(NIHSS), and Barthel Index(BI) was evaluated, and the results demonstrated that the evidence quality of clinical effective rate and activity of daily living score was medium. The effectiveness of Ginkgolide Injection was grade A. According to the economic report of Ginkgolide Injection, it had short-term and long-term pharmacoeconomic advantages in the treatment of ischemic stroke, and the economic evidence value was good. According to the CASP economic evaluation checklist, the overall quality evaluation results of the economic report are basically clear. To be specific, the economic evidence quality was high. Based on the comprehensive economic evidence quality and economic value, the economy of this drug was grade A. The innovation of this product was evaluated from three aspects: clinical innovation, enterprise service system innovation, and industrial innovation. Ginkgolide Injection could be used 24 h after intravenous thrombolysis for improving patients' neurological function without increasing bleeding, indicating its important clinical innovation. There were many innovations in ensuring drug supply, especially at the grass roots, drug safety, effectiveness, and reasonable price, which has provided reference for establishing enterprise philosophy, managing drug resources, developing process and technology, and determining enterprise management and marketing. Therefore, its innovation was grade A. The drug had no special medication plan in use, exhibiting good suitability for doctors, nurses, and patients. The suitability was grade B. Compared with similar drugs, its price was at a medium level, meaning good affordability, sufficient production capacity, and easy accessibility. Its accessibility was therefore grade B. This drug belonged to Chinese medicinal injection. The large-sample real-world research revealed rich human use experience, so it was grade C for the traditional Chinese medicine characteristic. According to the comprehensive evaluation, the clinical value of Ginkgolide Injection in the treatment of cerebral infarction fell into class A. It is suggested that it can be transformed into the relevant policy results of basic clinical medication management according to the procedure.

Correlation of pharmacokinetic dispositionof methotrexate and serum cytokine levels in rheumatoid arthritis patients

Objective: Methotrexate is the principal basic anti-inflammatory medication used in the rheumatoid arthritis treatment.Therefore, research into its effect on cytokine concentrations may help improve the effectiveness of disease treatment. Study aim: was to investigate the neffect of methotrexate therapy on the blood content of proinflammatory cytokines in RA patients, as well as define the relation of proinflammatory cytokine blood concentration to clinical and laboratory disease features and methotrexate pharmacokinetics. Material and methods: Sixty-five patients with rheumatoid arthritis (46 women and 19 men; average age 50.83± 8.91 years) underwent an examination.Thirty-two patients (26 women and 6 men) participated in studyingmethotrexate pharmacokinetics. Results and Discussion: The course of rheumatoid arthritis is accompanied by a significant increase of TNF-α (40.36±4.01 pg/ml), IL-1β (17.68±1.74 pg/ml), andIL- 6(8.39±0.46pg/ml) in the blood.Oral administration of methotrexate (MT) for patients with rheumatoid arthritis promotes persistent elimination of clinical disease symptoms and reduced production of proinflammatory cytokines:TNF-α drops by 2.08 times (p&lt;0.05) compared to baseline, that of IL-1β and IL-6 – by 2.86 (p&lt;0.05) and2.84times(p&lt;0.05), correspondingly.Blood levels for TNF-α and IL-6 are consistent with clinical markers for rheumatoid arthritis, such as joint pain, joint swelling, and morning stiffness in extremities.Blood cytokine concentrations were not correlated with AUC, Cmax, and Tmax. There was an inverse correlation between the blood rates of TNF-α and the weekly dose of MT (r = -0.34, p&lt;0.05) and II-6 and the weekly dose of MT (r = -0.32, p&lt;0.05). Conclusion: Rheumatoid arthritis is closely associated with increaseing of proinflammatory cytokine blood levels, which affects the clinical course of the disease.The dosage of methotrexate applied affects the blood concentrations of IL-6 and TNF-α. Bangladesh Journal of Medical Science Vol. 21 No. 02 April’22 Page : 335-343

The role of systemic diseases and local conditions as risk factors.

The role of systemic diseases and local conditions as risk factors.

An overview on the various pricing policies of health-related products and incentivizing the innovation during the health emergency situations

Patents are often seen as legal monopolies that impose exorbitant pricing, particularly for innovations in the pharmaceutical and medical device sectors where the inventions are usually protected through the patents. Many have argued that patent protection should not be extended to sectors where the public interest in obtaining those products or services is important, such as health-related products, which also includes the medications. This paper provides an overview of different policy choices that national governments might employ to both promote innovation in health-related goods and ensure low consumer prices for the basic medicines. Special consideration is given to the current COVID-19 health emergency and highlights the solutions through the published reviews to make the basic medications freely accessible to all countries.

Assessment of medication adherence, medication safety awareness and medication practice among patients with lung cancer: A multicentre cross-sectional study.

ObjectivesWe aimed to explore the current status of medication adherence, safety awareness and practice among patients with lung cancer.MethodsWe conducted a questionnaire‐guided cross‐sectional study in Xi'an, Yulin, Hanzhong and Weinan in Shaanxi Province, China, from April to June 2021 for a period of 3 months. The study questionnaire was developed according to previous related studies reported in the literature, and includes basic demographic information and patients' medication safety questions. The data were double‐entered using EpiData 3.1 software; descriptive statistics, t‐test, analysis of variance, the Kruskal–Wallis test and the Mann–Whitney U‐test were performed to analyse the data.ResultsA total of 567 participants were included, and 409 valid questionnaires were finally completed, with an effective response rate of 72.13%. More than 80% of patients showed good medication adherence; the average adherence score was 22 ± 2.68 of 25. The average score for medication safety awareness was 16.40 ± 4.41, which was significantly lower than that of medication adherence (p < .001). Only 22.74% of patients always checked their medicines before a nurse administered them; 17.60% of patients never checked their medicines. Few patients actively consulted an health care professional to understand safety information before taking a medication. A significant difference existed in safety awareness scores among age groups (p = .039) and geographic regions (p < .001). Patients with three or more comorbidities had the lowest awareness scores (p = .027).ConclusionWe found that patients with lung cancer showed better medication adherence, but their awareness about medication safety was poor. Older patients, those with comorbidities and patients in regions with poor medical resources may have worse awareness about safety. Current medication education for patients should not only aim to improve adherence but should also encourage patients to take greater responsibility for their own safety and to actively participate in their medication safety. Greater systematic and individualized medication safety information is needed for older patients, those with more comorbidities and patients in areas with poor medical resources.Patient ContributionWe conducted a questionnaire‐guided cross‐sectional study on hospitalized lung cancer patients in Shaanxi Province to explore the patients' practices related to safety medication, including medication adherence and medication safety awareness.

De-Prescribing Proton Pump Inhibitors in Patients With End Stage Kidney Disease: A Quality Improvement Project.

Background:Proton pump inhibitors (PPIs) are widely prescribed and may be associated with harm; hypomagnesemia and reduced effectiveness of calcium carbonate phosphate binders may be important in end-stage kidney disease (ESKD).Objectives:Our objectives included (1) discontinuing PPIs and H2 blockers and (2) assessing the impact on serum magnesium and markers of mineral metabolism.Design:Prospective cohort.Setting:Satellite hemodialysis unit of a tertiary care hospital.Patients:Incident and prevalent patients with ESKD treated with hemodialysis.Measurements:We assessed the impact of stopping PPI/H2 blockers in patients who did not have an absolute indication as per guidelines in the general population; serum magnesium, calcium, and phosphate were measured before and approximately 8 weeks later. Analysis of variance (ANOVA) test and Kruskal-Wallis was used to describe the population. Wilcoxon signed rank test for the paired change scores (from pre to post)Methods:The electronic medical record (EMR) was extensively searched for absolute indications for a PPI. Results were reviewed with the primary nephrology team before approaching patients about stopping the PPI. Basic demographic information and select medications were also collected.Results:Electronic medical records were reviewed for 179 patients, 74 had a PPI or H2 antagonist or both on their medication list (43%); 23 (31%) were assessed as appropriate. After primary team and patient review, 29 patients agreed to a trial of PPI withdrawal. Fourteen patients restarted their PPI, most for gastroesophageal reflux disease. Three patients had a GI bleed, 1 fatally. Serum calcium (P = .17) and the dose of phosphate binders (P = .075) did not change but serum phosphate increased (1.55 [0.29] to 1.85 [0.34] mmol/L; P = .0005). Serum magnesium also increased (1.01 [0.16] to 1.06 [0.14] mmol/L; P = .01).Limitations:Small patient numbers and observational nature of the study does not establish causation in this population at high risk to experience a gastrointestinal bleed.Conclusions:Our results suggest that PPI deprescribing as recommended in the general population may be associated with harm in patients with ESKD and requires further study.Trial Registration:Not registered.

Effect of combining anticoagulant and glucocorticoid therapy on mortality in patients with severe COVID-19

IntroductionCoronavirus disease (COVID-19) has spread rapidly to more than 200 countries and regions worldwide. Although several options have been implemented in attempts to control the rate of COVID-19 infection, the mortality rates remain high. The aim of this study is to evaluate whether patients with severe COVID-19 will benefit from the combination of anticoagulant and glucocorticoid therapy.MethodsA single-center retrospective cohort study of patients with COVID-19 was performed. Several factors influencing patients with COVID-19 have been analyzed retrospectively, including basic conditions, inflammatory factors, coagulation parameters, medications, and outcomes. Continuous and categorical variables have been evaluated via binary logistic regression analysis to predict mortality. The association between anticoagulant treatment and outcomes has also been evaluated, stratifying patients according to glucocorticoid treatment.Results61 patients with severe COVID-19, including 23 critically ill patients have been enrolled in the study. In those with severe and critical illness COVID-19, mortality rate was lower in those who received combined anticoagulant and glucocorticoid with odds ratio of 0.003 (p = 0.042) and 0.031 (p = 0.046), respectively. In cases of severe COVID-19, those who were treated with both anticoagulant and glucocorticoid had lower mortality (17.6%) than those treated with glucocorticoid alone (31.8%), although this did not reach statistical significance (p = 0.321). In the critically ill COVID-19 patients who received both anticoagulant and glucocorticoid, there was significantly lower mortality (30%) than those who received glucocorticoid alone (77.8%) (p = 0.047). Seventy-five percent of non-survivors of COVID-19 met the International Society on Thrombosis and Haemostasis criteria of disseminated intravascular coagulation (total points ≥5).ConclusionPatients with severe COVID-19 or critically ill patients with COVID-19 may benefit from the combination therapy of anticoagulant and glucocorticoid. As the disease getting severe, more benefits may be obtained from the combination therapy.

Travelers with thyroid disorders.

Thyroid disorders account for a majority of endocrine diseases. The most frequent among them are Hashimoto's thyroiditis, thyroid nodules and cancer with hyperthyroidism or hypothyroidism. Many thyroid patients travel a lot and therefore require appropriate guidance from their doctor. The aim of the review article is to discuss various aspects of travel in order to determine the optimal travel conditions for thyroid patients. Thyroid travelers must be well prepared for their journey. They should put particular emphasis on the choice of destination, the season and iodine resources at the planned place of stay. Before going on a journey, they are advised to check their health insurance, buy enough medications, prepare a copy of prescriptions and all other necessary documents. Depending on the means of transport, a few precautions should be taken to avoid infections or worsening of thyroid symptoms during travel. To deal with unpredictable events which might occur at the place of stay, travelers are recommended to take a first-aid kit containing basic medications. It needs to be stressed that many drugs are responsible for thyroid function disruptions and should only be used after consultation with a healthcare professional. Avoiding stress, maintaining good night's rest, as well as following a healthy diet, are all of great importance in managing thyroid diseases. Observing a few simple rules can minimize the frequency of flare-ups and the occurrence of the life-threatening thyroid storm. Traveling is an inseparable element of life for many people. Therefore, ensuring that patients are well informed about how to travel safely may prevent unwanted health events during travel.