Evaluation Of Clinical Efficacy Research Articles

Evaluation of Pain Reduction and Clinical Efficacy of Feedback-Controlled Ultrasonic Scaler

Evaluation of Pain Reduction and Clinical Efficacy of Feedback-Controlled Ultrasonic Scaler

Evaluation of Clinical Efficacy of Scalp Block with 0.25% Injection Bupivacaine and 0.25% Injection Levobupivacaine to Blunt the Hemodynamic Response to Skull Pin Insertion during Supratentorial Craniotomies - A Prospective Study

BACKGROUND
 Head fixation is necessary to maintain the desired head position. Application of skull pins in neurosurgery leads to hemodynamic changes and this sudden change can be prevented by combining general anaesthesia with scalp block which blocks supraorbital nerve, supratrochlear nerve, zygomaticotemporal nerve, auriculotemporal nerve, lesser occipital nerve and greater occipital nerve which are present in superficial and deep layers of the scalp. Several studies have been done to study the efficacy of Injection levobupivacaine and injection bupivacaine in 0.5 % concentrations for scalp block. However, the comparative efficacy of 0.25% injection levobupivacaine and injection bupivacaine for scalp block has not been determined by any study previously. We wanted to compare the efficacy of 0.25% injection levobupivacaine and 0.25% injection bupivacaine in scalp block on the haemodynamic response to head pinning, incision and during craniotomy.
 METHODS
 This prospective randomised study included 60 patients of ASA status I or II between age 18–60 years and of either sex who underwent supratentorial craniotomy under general anaesthesia followed by scalp block. Patients were randomly allocated into two groups of 30 each and before application of the Mayfield skull pin head holder, scalp block was given as per group distribution (Group A: 20 ml 0.25% injection bupivacaine and Group B: 20 ml of 0.25% injection levobupivacaine). The hemodynamic responses were recorded at baseline, during scalp block and after head pin insertion, incision and at craniotomy. The total analgesic requirement during intraoperative and post operative period was noted.
 RESULTS
 There were no clinically and statistically significant differences in values of heart rate and blood pressure after head pin insertion, skin incision and craniotomy in both the groups.
 CONCLUSIONS
 The study revealed that 0.25% injection levobupivacaine when used for scalp block was as efficacious as 0.25% injection bupivacaine. Both the drugs in low concentration of 0.25% were effective in minimizing pressor response to skull pin insertion, incision and craniotomy with less incidence of complication and reduced intraoperative requirement of analgesia.

Index Evaluation of Clinical Efficacy of Immunomodulatory and Osteotropic Therapy for Chronic Generalized Periodontitis of Varying Severity: A Prospective Cohort Study

Background. The significant prevalence of chronic generalized periodontitis, the severity of its course, the increase in the number of complicated forms and short-term remissions cause a constant search for new methods and means of its treatment. When choosing the most effective methods of therapy, specialists mostly prefer a complex effect on the main pathogenetic links of the disease, while often losing sight of the body's own defenses, especially in terms of pharmacotherapeutic support and immunity strengthening. This study presents the results of a study of the clinical efficacy of the treatment of chronic generalized periodontitis by means of the developed therapy complex, including the use of immunomodulatory and osteotropic drugs.Objective — to study clinical efficacy of the developed complex immunomodulatory and osteotropic treatment for chronic generalized periodontitis.Methods. A prospective cohort study was conducted in 154 patients aged 20 to 75 with periodontitis of varying severity. Conventional examination of patients was carried out in specialized dental clinics DentoProma (Krasnodar) and Dentalife (Stavropol) based at the Dentistry Department, Stavropol State Medical University (Russia). The study period was 24 months. The patients were divided into a main group of 118 participants and a control group of 36 participants. The comprehensive treatment plan, prescribed to all patients, included proper oral hygiene education, individual and professional dental hygiene, topical anti-inflammatory agents, Vector therapy, open flap debridement, flap surgery, relevant splinting prosthetics (if necessary). The authors developed a comprehensive therapy, which included administration of the immunomodulatory agent Hepon (Immapharma Company, Russia), glucosamine hydrochloride and chondroitin sulfate sodium. All patients of the main and control groups were additionally ranked into subgroups depending on the severity of diagnosed periodontitis: slight (subgroup 1), moderate (subgroup 2) and severe (subgroup 3). The major focus of the study was to establish efficacy of the developed therapy which was defined by the degree of resolution of the inflammatory process and increase in the period of remission. Reflecting the presence and degree of inflammation, dental plaque index and oral hygiene status were considered to be the target indicators. Analysis and statistical processing of the obtained data were carried out using Microsoft Excel (Microsoft, USA).Results. The analysis of the data revealed that the immediate clinical results of the developed complex therapy both in the main group and in the control group were approximately identical. According to the follow-up data obtained one month after the treatment, additional prescription of complex osteotropic treatment to the patients with chronic generalized periodontitis contributed to rapid resolution of infection in the gingival tissues and provided stable treatment results.Conclusion. Introduction of the complex clinical and hygienic treatment promoted resolution of the inflammatory process in the gingival tissues of all patients who received immunomodulatory and osteotropic therapy.

Clinical observation and mechanism of acupuncture on amnestic mild cognitive impairment based on the gut-brain axis: study protocol for a randomized controlled trial.

Amnestic mild cognitive impairment (aMCI) is a pre-dementia condition associated with declined cognitive function dominated by memory impairment. The occurrence of aMCI is associated with the gut-brain axis. Previous studies have shown cognitive improvements in MCI after acupuncture treatment. This study evaluates whether acupuncture can produce a therapeutic effect in patients with aMCI by modulating the gut-brain axis. This is a prospective, parallel, multicenter randomized controlled trial. A total of 40 patients with aMCI will be randomly assigned to an acupuncture group (AG) or a waiting-list group (WG), participants in both groups will receive health education on improving cognitive function at each visit, and acupuncture will be conducted twice a week for 12 weeks in the AG. Another 20 matched healthy volunteers will be enrolled as normal control. The primary outcome will be the change in Alzheimer's Disease Assessment Scale-cognitive scale score before and after treatment. Additionally, functional magnetic resonance imaging data, faeces, and blood will be collected from each participant to characterize the brain function, gut microbiota, and inflammatory cytokines, respectively. The differences between patients with aMCI and healthy participants, and the changes in the AG and WG groups before and after treatment will be observed. Ultimately, the correlation among brain function, gut microbiota, inflammatory cytokines, and clinical efficacy evaluation in patients with aMCI will be analyzed. This study will identify the efficacy and provide preliminary data on the possible mechanism of acupuncture in treating aMCI. Furthermore, it will also identify biomarkers of the gut microbiota, inflammatory cytokines, and brain function correlated with therapeutic effects. The results of this study will be published in peer-reviewed journals. http://www.chictr.org.cn, identifier ChiCTR2200062084.

A Split-Mouth Clinical Comparative Evaluation of the Anesthetic Efficacy of Articaine and Lignocaine for Maxillary Bicuspids Extraction.

Aim The study compared the anesthetic effectiveness of articaine and lignocaine when premolars are extracted bilaterally for orthodontic purposes. Material and methods This prospective split-mouth study was performed on 30 cases selected from orthodontic referral patients reporting to the Oral and Maxillofacial Surgery Department at Maharaja Ganga Singh Dental College and Research Center, Rajasthan, India, for bilateral extraction of premolars under local anesthesia. We used 4% articaine hydrochloride and adrenaline 1:100000 (AH) as group A and 2% lignocaine hydrochloride with adrenaline 1:100000 (LH) on the control side as group B. For premolar anesthetization, 0.6-1.6 ml of AH and 1-2 ml of LH were injected submucosally in the buccal vestibular area. The extraction procedure was then carried out after achieving adequate anesthesia. The pain was assessed with Visual Analog Scale. The average onset time and duration of anesthesia were recorded. Data collected were summarized with descriptive statistics.The SPSSversion 23.0 (IBM Corp., Armonk, New York) was used for data entry, validation, and analysis. Means of continuous variables were compared using the student t-test. All tests were 2-tailed and significant at equal or less than 0.05. (p≤0.05). Results When comparing the overall anesthetic efficiency, Group A had a lower overall pain score of 0.43 while Group B had a higher overall pain score of 2.9. The average onset time of anesthesia in Group A was 1.2 minutes and 2.55 minutes in Group B. In Group A, the average duration of anesthesia was 70 minutes, and 46.5 minutes in Group B. These parameters were statistically significant with a p-value of <0.05. Conclusion The study concluded that as an alternative to lignocaine, articaine could be used effectively for maxillary premolar extractions for orthodontic reasons obviating palatal injection which is very painful to the patient.

Targeted bile acids metabolomics in cholesterol gallbladder polyps and gallstones: From analytical method development towards application to clinical samples

Bile acids (BAs) are synthesized by the liver from cholesterol through several complementary pathways and aberrant cholesterol metabolism plays pivotal roles in the pathogeneses of cholesterol gallbladder polyps (CGP) and cholesterol gallstones (CGS). To date, there is neither systematic study on BAs profile of CGP or CGS, nor the relationship between them. To explore the metabolomics profile of plasma BAs in healthy volunteers, CGP and CGS patients, an ultra-performance liquid chromatography-tandem mass spectrometry (UPLC-MS/MS) method was developed and validated for simultaneous determination of 42 free and conjugated BAs in human plasma. The developed method was sensitive and reproducible to be applied for the quantification of BAs in the investigation of plasma samples. The results show that, compared to healthy volunteers, CGP and CGS were both characterized by the significant decrease in plasma BAs pool size, furthermore CGP and CGS shared aberrant BAs metabolic characteristics. Chenodeoxycholic acid, glycochenodeoxycholic acid, λ-muricholic acid, deoxycholic acid, and 7-ketolithocholic acid were shared potential markers of these two cholesterol gallbladder diseases. Subsequent analysis showed that clinical characteristics including cysteine, ornithine and body mass index might be closely related to metabolisms of certain BA modules. This work provides metabolomic information for the study of gallbladder diseases and analytical methodologies for clinical target analysis and efficacy evaluation related to BAs in medical institutions.

Evaluation methods of clinical efficacy of traditional Chinese medicine

Clinical efficacy is the basis for the development of traditional Chinese medicine(TCM), and the evaluation of clinical efficacy of TCM has always been the focus of attention. The technical and methodological difficulties in the evaluation process often restrict the generation of high-level evidence. Therefore, methodological research should be deepened and innovative practice should be carried out to study the application of scientific research methods in the evaluation of the advantages of TCM. After more than ten years of development, the clinical efficacy evaluation of TCM, on the basis of the initially classic placebo randomized controlled trials, has successively carried out a series of meaningful attempts and explorations in N-of-1 trials, cohort studies, case-control studies, cross-sectional studies, real world studies, narrative medicine studies, systematic evaluation, and other aspects, laying the foundation for the transformation of TCM from &quot;experience&quot; to &quot;evidence&quot;. This paper focused on the clinical efficacy evaluation of TCM, summarized the main connotation and development status of efficacy evaluation indicators, standards, and methods, and put forward corresponding countermeasures and suggestions for the problems of indicator selection, standard formulation, and methodology optimization in the research process. It is clear that scientific and objective evaluation of the efficacy of TCM is an urgent problem to be solved at present.

Evaluation of clinical efficacy of the Vigomax Forte Tablet in Male Sexual Dysfunction

Aim of the study: To study the effects of Vigomax Forte Tablet in male sexual dysfunction following certain physical and mental exhaustion states. Materials and Methods: Male patients complaining of sexual dysfunction as a result of stress, alcohol, diabetes or anti-hypertensive drugs were considered for the study. 64 patients satisfying the above-mentioned inclusion criteria were selected for the study. Patients of each group were randomly administered Vigomax Forte Tablet / Placebo Tablets in the dose of 1 Tablet twice a day. Each patient was asked to follow up every 4 weeks, when he was examined and the beneficial or adverse effects of the drug treatment were noted. Results: There was a statistically significant improvement in all the parameters evaluated. Conclusion: Thus, in this study, Vigomax Forte Tablet enhanced libido as well as erectile function in patient population with varied etiology of erectile dysfunction. Vigomax Forte Tablet was also well tolerated. Based on these data, Vigomax Forte Tablet may have the potential to become a safe &amp; effective treatment option for erectile dysfunction.

Evaluation of Clinical Efficacy of Extrammune Tablet in Recurrent Upper Respiratory Tract Infections (URTI)

Aim of the study: The objective of this clinical study was to evaluate the efficacy of Extrammune Tablets, a polyherbal preparation in recurrent URTI patients. Materials and Methods: A clinical trial was conducted on 60 patients, including both the sexes, and from the age group 10-60 years having low immunity and who were constantly suffering from various upper respiratory tract infections. The study drug was administered as 2 tablet twice a day for 3 months. Evaluation Parameters: 1) Incidence of participant-reported number of Infections (URTI- influenza-like syndrome). 2) Duration and severity of episodes. 3) Number of new antibiotics prescription for infections. Results: There was a statistically significant improvement in all the parameters evaluated. Conclusion: The above clinical trial shows that Extrammune tablet can be used to boost the immune system to fight against various infections especially upper respiratory tract infections.

Clinical Evaluation of Overall Efficacy and Pain Perception of Ultrasonic Oscillating Tips and Conventional High-speed Burs for Removal of Dental Caries in Children in Age-group of 6-8 Years.

To clinically evaluate the overall efficacy and pain perception of ultrasonic oscillating tips and conventional high-speed burs to remove enamel and dentinal caries in children of ages 6-8 years. Bilateral deciduous canines with caries involving enamel or enamel and dentin were excavated by using a high-speed airrotor on one tooth and ultrasonic oscillating tips on another tooth in the same appointment. The overall response of the patient, both ultrasonic oscillating tips and airrotor along was recorded by Wong-Baker's Facial Pain Rating Scale (WBFPS) along with time taken to make each cavity and noise level generated by high-speed and ultrasonic system. Evaluation of WBFPS after every method of caries excavation showed that 84% of subjects in the ultrasonic group reported score of 0 as compared to only 24% of subjects in the airrotor group. Score 2 was reported by 16% of the subjects in the ultrasonic group and 32% of the subjects in the airrotor group. Score 4 was reported by 44% of the subjects in the airrotor group. Ultrasonic groups reported more time to remove caries as compared to the airrotor group. The ultrasonic group reported less noise as compared to the airrotor group and the difference between the two was significant. Patients preferred the ultrasonic method for caries excavation because of less pain and noise. The use of ultrasonic oscillating tips is as effective in caries excavation, less painful, and more time-consuming than the conventional airrotor. Ultrasonic oscillating tips can be successfully used in pediatric dentistry to aid patient cooperation and reduce pain during caries excavation. Kenjale MA, Shah P, Desai S, et al. Clinical Evaluation of Overall Efficacy and Pain Perception of Ultrasonic Oscillating Tips and Conventional High-speed Burs for Removal of Dental Caries in Children in Age-group of 6-8 Years. Int J Clin Pediatr Dent 2023;16(2):251-258.

The Clinical Efficacy Evaluation of Thigh Liposuction Based on 3-Dimensional Digital Technology: A Quantitative Study.

There is a lack of convenient and accurate objective methods to evaluate the clinical efficacy of thigh liposuction. This retrospective study involved the 3-dimensional images of 19 patients who underwent bilateral thigh liposuction. Data such as volume change and volume change rate before and after surgery, circumference change, and circumference change rate of 3 planes (upper, middle, and lower) were analyzed. The correlation between body mass index and volume change rate and between preoperative circumference and circumference change rate of different planes were determined. There were significant differences between the preoperative and postoperative volume and circumference of 3 planes of 19 patients (38 thighs). The rate of change in total volume (16.90 ± 5.55%) correlated with the circumference change rate at the top of the thigh. There was also a linear relationship between body mass index and volume change rate, but not between preoperative circumference and circumference change rate. Three-dimensional imaging technology can accurately quantify the volume and circumference change of the thigh to objectively evaluate the clinical efficacy of thigh liposuction.

Implementation strategies and outcomes of school-based programs for adolescent suicide prevention: A scoping review protocol.

This scoping review aims to identify and map the empirical literature on the implementation strategies and outcomes of school-based programs for adolescent suicide prevention (SBASP). School-based programs are preferred interventions for preventing suicide in adolescents, and their effectiveness has been well-systematized in several reviews. Implementation research is a growing field for prevention programs, making it possible to understand the nature of success or failure outcomes and maximize intervention benefits. However, there is a knowledge gap in the implementation research applied to adolescent suicide prevention in the educational context. We conduct a scoping review to provide the first overview of the scope of implementation research applied to adolescent suicide prevention programs in the school setting to know what implementation strategies and outcomes are reported by these programs and how they are evaluated. The proposed scoping review will be conducted following six stages, including the definition of objectives. Studies must be empirical and address implementation strategies or implementation outcomes of school-based programs for adolescent suicide prevention. Studies that focused exclusively on clinical efficacy or effectiveness evaluation will be excluded. A preliminary search of PubMed was conducted to refine the initial search strings, followed by a final search of several other electronic databases. Finally, a gray literature search will identify unpublished literature and reduce location bias. There will be no limits to a specific date. Two independent reviewers will screen, select, and extract the retrieved records. The results will be presented using tabular forms and a narrative summary with attention to the review objectives and research questions and their implications for research and practice of school-based programs for adolescent suicide prevention.

Evaluation of Clinical Efficacy and Safety Following Kyungokgo-Gamibang Administration in Dogs with Skin and Joint Diseases

Evaluation of Clinical Efficacy and Safety Following Kyungokgo-Gamibang Administration in Dogs with Skin and Joint Diseases

Post-exposure prophylaxis of COVID-19: results of double-blind, placebo-controlled, multicenter clinical study evaluation of efficacy and safety of double-stranded sodium salt RNA drug

The aim of the study was to evaluate the efficacy and safety of an RNA double-stranded sodium salt drug, a lyophilisate for a solution preparation for an intramuscular and subcutaneous administration, as a means of post-exposure COVID-19 prophylaxis in comparison with placebo.Material and methods. A double-blind, placebo-controlled, multicenter, randomized phase III clinical trial was conducted to evaluate the efficacy and safety of a double-stranded sodium salt RNA drug (RADAMIN®VIRO), a lyophilisate for preparing a solution for intramuscular and subcutaneous administration as a means of post-exposure prophylaxis of COVID-19. The study was conducted in 10 research centers in the Russian Federation from May 31, 2022 to January 17, 2023. The study included men and women aged ≥18 years who cohabitate with a person with a documented COVID-19 diagnosis and do not have symptoms characteristic of COVID-19. At the randomization stage, the subjects were assigned to one of two groups: group 1 (n=400) received a study drug RADAMIN®VIRO 5 mg (1 vial) intramuscularly once a day; group 2 (n=400) received placebo 1 vial intramuscularly once a day. The total duration of the study for each subject was no more than 30 days.Results. By day 10-11, in the double-stranded sodium salt RNA preparation group, the proportion of the subjects with confirmed COVID-19 and at least 1 symptom characteristic of COVID-19 was 5.76% (23/399), and in the placebo group – 11. 03% (44/399). The difference in proportions between the study drug and placebo groups was 0.0526 (5.26%), the 95% confidence interval (CI) for the difference in proportions between the groups was -95% CI [0.0123;0.0937]). More than 94% of single-dose subjects did not become infected with COVID-19 with any symptoms during the 11 days of the follow-up. As a result of a comparative analysis, it was shown that the infection frequency in the study drug group was statistically significantly (almost twice) less than in the comparison group, which indicates a high efficiency and expediency of using the double-stranded sodium salt RNA preparation as a means of the post-exposure COVID-19 prophylaxis.Conclusion. Thus, regardless of the vaccination availability, the effectiveness and feasibility of using the study double-stranded sodium salt RNA preparation as a means of the post-exposure COVID-19 prophylaxis was demonstrated not only in medical institutions (outpatient clinics and hospitals), but also in caregivers and/or the persons in contact with COVID-19 patients. The situation was the same in the organizations and enterprises in case of evolution of a mass infection threat and the availability of appropriate medical personnels.

Establishment of Standardized Diagnostic System for Brucella Spondylitis in the Elderly and Clinical Application of Precise Treatment Strategy

Objectives Establish a clinical standardized diagnosis and treatment strategy system for senile brucellosis spondylitis, and evaluate the clinical effect of applying this diagnosis and treatment system in order to improve the diagnosis rate and cure rate of the disease. Methods A diagnostic system was established based on the medical history, clinical, imaging, laboratory, bacteriological and pathological examinations of 70 elderly patients with brucellosis spondylitis admitted from January 2002 to December 2017. All patients received standardized drug therapy, anti-osteoporosis therapy and adjuvant hyperbaric oxygen therapy. Forty-two patients with spinal nerve injury received surgical treatment. Follow-up and evaluation were conducted at 2 weeks, 1 month, 3 months, 6 months, and 12 months after treatment. Results All patients were diagnosed after admission according to the diagnostic system standard examination. In this group, 28 patients (40%) received standardized drug therapy for non-surgical indications (group A), and 42 patients (60%) received surgical treatment for surgical indications (group B). VAS scores were significantly different between the two groups (P<0.05), group B was better than group a. Imaging scores showed that in group B, the myelopathy segments were stable without abscess and inflammatory granuloma, except for slow bone repair in the debridement area of the original myelopathy. Group A had no obvious vertebral lesion infiltration and interstitial infection absorption after 3 months of treatment, and gradually absorbed vertebral inflammatory infiltration and interstitial infection after 6 months. Clinical efficacy evaluation showed that both groups achieved good cure rates over time, and group B was better than group A (P<0.05). Conclusion Elderly brucellosis spondylitis has characteristic manifestations, and the establishment of a standardized diagnosis system will help improve the diagnosis rate; Synchronous drug therapy for BS and osteoporosis according to the treatment strategy has a good effect, and for patients who meet the indications for surgery, timely surgery can relieve or relieve pain, maintain spinal stability, and promote rapid recovery of nerve and spinal functions. It has obvious advantages and can better improve the clinical cure rate.

The role of Real-World Data and evidence in oncology medicines approved in EU in 2018–2019

Use of Real-World Data (RWD) has gained the interest of different stakeholders in cancer care. The aim of this study was to identify and describe the use of RWD/RWE during the pre-authorization phase of products authorized by the EMA in 2018 and 2019 (n = 111), with the focus on oncology medicines (n = 24). Information was extracted from the European Public Assessment Report (EPAR) summaries and recorded for 5 stages (11 categories) of the drug development lifecycle (discovery, early development, clinical development, registration/market launch, lifecycle management). Specific chapters of full EPAR were reviewed to substantiate the findings on RWD/RWE use in clinical trial design, efficacy, safety, and effectiveness evaluation. RWD/RWE is present in all stages of the oncology drug development; 100.0 % in discovery, 37.5 % early development, 58.3 % in clinical development, 62.5 % in registration decision and 100.0 % in post-authorization lifecycle management. Examples showed that trial design supported by RWD/RWE included use of open label/single arm studies; efficacy was about using either comparison of results to historical controls, supplying survey data obtained outside the clinical trial or utilizing expert panel advice; safety about including literature findings in evidence; and effectiveness on comparison of trial results of the given product to historical data or existing standard of care. The findings of this study provide specific insights into how RWD/RWE is used in development of cancer therapeutics, how it contributes to regulatory decision making and can guide further policy developments in this field.

Evaluation of clinical efficacy of tumor necrosis factor‑α inhibitors in treatment of distal extremity swelling with pitting edema in psoriatic arthritis of inadequate response to conventional therapy: A 10‑year retrospective study.

Distal extremity swelling with pitting edema in psoriatic arthritis (PsA) is a rare rheumatological condition, whose management presents a challenge. The aim of the present study was to identify the clinical characteristics of, and formulate a standardized management strategy for, patients with distal extremity swelling with pitting edema in PsA. The medical records of consecutive patients with PsA, with or without distal extremity swelling with pitting edema, were systematically analyzed over a ~10-year period (between September 2008 and September 2018) in a single center and a comprehensive review (pathogenic mechanisms, clinical manifestations, and treatments) was undertaken. A total of 167 patients with PsA were evaluated, and distal extremity swelling with pitting edema was recorded in 16 of these patients. In three of the 16 patients, distal extremity swelling with pitting edema occurred as the first, isolated manifestation of PsA. The upper and lower extremities were affected, predominantly asymmetrically. Female patients with PsA were more likely to be affected with pitting edema and the blood test results revealed that the patients with PsA and pitting edema also presented with a significantly higher erythrocyte sedimentation rate and concentration of C-reactive protein. The onset of pitting edema was associated with the activity of the disease. Lymphoscintigraphy and magnetic resonance imaging (MRI) scans revealed that edema might have resulted from inflammation of the tenosynovial structures. Furthermore, treatment with tumor necrosis factor-α inhibitor (TNFi) elicited improvements in patients with pitting edema that were not responsive to conventional synthetic disease-modifying antirheumatic drug therapy. In conclusion, distal extremity swelling with pitting edema, also termed atypical remitting seronegative symmetrical synovitis with pitting edema (RS3PE) syndrome, may represent the initial isolated manifestation of PsA. The atypical RS3PE syndrome in PsA was attributable to inflammation of the tenosynovial structures, and TNFi may serve as a potential treatment.

Evaluation of clinical efficacy of Ginkgo biloba extract in the treatment of knee osteoarthritis: a randomized clinical trial

Background: Osteoarthritis (OA) is a degenerative joint disease characterized by deteriorating articular cartilage. Most patients may not get enough control of symptoms in spite of the availability of various treatment options. Because of the synergistic impact of flavonoids and ginkgolides, Ginkgo biloba (GB) has been shown to possess antioxidant and anti-inflammatory properties besides its generally safe profile. This study aims to assess the efficacy and safety of the Ginkgo biloba extract (GBE) in patient with Knee OA . Methods: This is a randomized double blinded clinical trial conducted in a private orthopaedic clinic in Al-Najaf Government-Iraq between 1st November 2021 to 1st June 2022. Patients were randomized into two groups; Group A administered the standard treatment (diclofenac capsule 100 milligram sustained released with paracetamol 1 gram twice daily) with GBE capsule 120 milligram twice daily, while Group B administered the standard treatment with placebo (starch) capsule only. The Knee injury and Osteoarthritis Outcome Score (KOOS) was performed to assess the efficacy of the GBE in patient with Knee OA for eight weeks.Results: 60 patients (Group A: mean age 54.2±8.6, male 24.24%, female 75.76%; Group B: mean age 58.0±8.4, male 22.22%, female 77.78%) successfully completed the eight weeks follow up. Pain, symptoms, sport, activity of daily living (ADL) scores showed significant improvement in Group A from the first two weeks after treatment with GB in comparison with group B. however, scores of quality of life (QOL) were not significantly improved in two group comparison at each assessment week. Only 10 patients (group A:8, group B:2) reported gastrointestinal adverse effects during the study which were all mild. Conclusions: GB may provide additional beneficial health effects to patients with knee OA based on KOOS scores when add to the standard treatment regime. Registration: ClincialTrials.gov (NCT05398874, https://clinicaltrials.gov/ct2/show/NCT05398874).

Effects of combined test dose and therapeutic drug monitoring strategy in exposure-directed busulfan.

Although exposure-directed busulfan (BU) dosing can improve allogeneic hematopoietic stem cell transplantation outcomes, there is still large variability in BU exposure with test dose alone due to changes in BU clearance caused by drug interactions. We conducted a single-arm phase II trial using the combined test dose and therapeutic drug monitoring strategy (PK-guided group) and compared the outcomes with an external historical cohort receiving a fixed-dose (fixed-dose group). The first eight and second eight doses were adjusted based on the area under the blood concentration-time curve (AUC) of the test and first doses, respectively, targeting a total AUC of 82.1mg·h/L. All patients received either BU and cyclophosphamide conditioning (BU/CY) or fludarabine (FLU)-containing conditioning. The BU clearance at the first dose decreased more in patients receiving FLU than in those receiving BU/CY; however, BU clearance also declined over time in patients who received BU/CY. The simulated total AUC (sAUC) with test dose only was significantly higher in patients who received FLU than in those who received BU/CY, but sAUC with the combined strategy was comparable. The 100-day progression-free survival was 85.5% (95% confidence interval [CI]: 71.9-92.8%), and was not inferior to that in the fixed-dose group. For the FLU-containing regimens, the PK-guided group showed decreased relapse (0.0% vs. 26.9%, p = 0.03), and favorable overall survival (75.1% vs. 57.0%, p = 0.07) at 1year. The combined strategy effectively controlled the BU exposure close to the target levels, potentially improving efficacy, especially in patients receiving the FLU-containing regimen. Clinical evaluation of efficacy of dose-modified intravenous busulfan in allogeneic hematopoietic stem cell transplantation for hematological malignancy (#UMIN000014077, June 15th, 2014).

A narrative review of identifying the culprit antibody in neuroimmune diseases: concept and clinical significance.

Neuroimmune disease is a group of autoimmune diseases that are directed against antigens of the nervous system. Autoantibody testing is of great significance in early diagnosis, clinical severity assessment, prognosis, and efficacy evaluation. With the discovery of new antibodies and the development of antibody detection techniques, multiple antibodies have been found to coexist in patients with neuroimmune diseases. In this narrative review, we aim to define the culprit antibody and discuss the correlation between culprit antibodies and the clinical phenotype of neuroimmune diseases. We searched Medline, Embase, Web of Science, and CNKI from inception to February 2021 to acquire references on the relationship between neuroimmune diseases and antibodies. Eligible articles were reviewed regarding the relationship between antibodies and phenotypes. By reviewing relevant references and discussion, we propose the concept of "culprit antibody", namely, the pathogenic antibody which has a corresponding causal relationship with one or more phenotypes during the course of a patient's neuroimmune disease. The proposal, significance, and relevant clinical research of culprit antibodies related to neuroimmune diseases are elaborated as the proposal of concept and determination points of casual relationship, association with clinical phenotypes and core phenotypes, the role in antibody overlapping syndrome in the same patient, and different stages. In the era of precision medicine, proposing the concept of culprit antibodies and clarifying relevant evidence chains are helpful for precise and effective immune intervention.