Rate Of Adverse Reactions Research Articles

Efficacy and Mechanism of Alprostadil in Diabetes Mellitus Combined with Peripheral Atherosclerosis.

The aim is to investigate the clinical efficacy of Alprostadil in diabetes mellitus (DM) combined with peripheral atherosclerosis and to investigate the molecular mechanisms. Patients included 154 cases with DM combined with peripheral atherosclerosis and were divided into the conventional group (77 cases) and the Alprostadil group (77 cases). Both groups of patients were given conventional treatment, and the Alprostadil group was given Alprostadil treatment on the basis of the conventional group. The therapeutic efficacy and clinical symptom improvement were compared, and the adverse reactions were observed. An in vitro cell model was constructed using high glucose (HG) (50 mM) and oxidized low-density lipoprotein (50 μg/mL) treatment. The total effective rate of treatment in the Alprostadil group was higher than that in the conventional group. The biochemical indices of whole blood viscosity, plasma viscosity, erythrocyte pressure volume, and fibrinogen, as well as the level of inflammatory factors in the Alprostadil group were lower than those in the conventional group. The incidence rate of adverse reactions of Alprostadil administration was lower than that in the conventional group (P = .030). Alprostadil inhibited platelet aggregation and promoted platelet spreading. Alprostadil had an ameliorative effect on HG- and oxidized low-density lipoprotein cholesterol (ox-LDL)-induced human umbilical vascular endothelial cells (HUVECs), and promoted apoptosis and inflammatory response of HUVECs. Clinically, the use of Alprostadil as an adjunct to conventional therapy for the treatment of DM combined with peripheral atherosclerosis has high clinical efficacy. In addition, Alprostadil has a significant ameliorative effect on high glucose- and ox-LDL-induced HUVECs.

Effects of sufentanil in combination with dexmedetomidine for patient-controlled intravenous analgesia after renal transplantation

Background/Aim. Nowadays, the most convenient analgesic method is patient-controlled intravenous injection of one or more adjuvant drugs. The aim of our study was to evaluate the effects of sufentanil plus dexmedetomidine for patient-controlled intravenous analgesia (PCIA) after renal transplantation. Methods. Seventy-eight patients receiving living-related renal transplantation under general anesthesia were selected. Radioisotope scanning was performed, and the single glomerular filtration rate of the unilateral kidney was ? 40 mL/min/1.73 m2. The control group (CG) and observation group (OG) (39 patients in each group) were analgesic with sufentanil and sufentanil plus dexmedetomidine, respectively. When the Visual Analogue Scale (VAS) score exceeded 4 points, 0.05 mg/kg oxycodone was intravenously injected for remedial analgesia. Plasma levels of endothelin, urea nitrogen, and creatinine were measured by radioimmunoassay. Heart rate (HR), mean arterial pressure, oxygen saturation, VAS score, and sedation score were recorded before anesthesia and after surgery. Analgesic remediation rate, number of effectively pressing the PCIA pump, and incidence rate of adverse reactions within 48 hrs after surgery were recorded. Results. HR of OG was significantly lower than that of CG 6 and 12 hrs after surgery (p < 0.05). VAS score of OG was lower than that of CG 6, 12, and 24 hrs after surgery (p < 0.05). OG had a lower postoperative remedial rate, number of effectively pressing the PCIA pump, and incidence rates of nausea and vomiting (p < 0.05) compared to CG. Endothelin, urea nitrogen, and creatinine levels significantly decreased after surgery compared with those before anesthesia (p < 0.05). The levels of OG were lower than those of CG at each time point after surgery (p < 0.05). Conclusion. Sufentanil plus dexmedetomidine can be safely and effectively used for PCIA after renal transplantation, with superior outcomes to those of sufentanil alone.

Influence of propranolol plus methimazole on curative efficacy and thyroid function of patients with hyperthyroidism.

To analyze the influence of propranolol (Prop) plus methimazole (MMI) on curative efficacy and thyroid function (TF) of patients with hyperthyroidism (HT). In this retrospective study, 107 cases of HT presented between August 2019 and August 2021 were grouped according to different therapeutic regimens: a control group (the Con) with 53 cases treated with MMI, and a research group (the Res) with 54 cases treated with Prop + MMI. Inter-group comparisons were performed in terms of the following domains: heart rate (HR), efficacy, adverse reactions (ARs), TF parameters (free triiodothyronine, FT3; free thyroxine, FT4; thyroid stimulating hormone, TSH), hepatic function indicators (alanine aminotransferase, ALT; aspartate aminotransferase, AST), and quality of life (Short-Form 36 Item Health Survey, SF-36). Finally, multivariate analysis was performed by Logistic regression to determine the risk factors leading to the ineffectiveness of treatment. The analysis showed an obviously higher total effective rate and an evidently lower AR rate in the Res compared with the Con group. Besides, the Res group had notably lower FT3, FT4, ALT and AST and statistically higher TSH after treatment compared with the baseline (before treatment) and the Con group. Higher SF-36 scores were also determined in the Res group. Finally, the results of Logistic regression analysis revealed that AST was an independent risk factor for ineffective treatment. Prop plus MMI is effective in the treatment of HT, which can effectively improve the HR, thyroid hormone levels, hepatic function, and quality of life of patients, with a lower incidence of ARs.

Comprehensive Analysis of Factors Influencing Endometrial Polyps Incidence and Evaluation of Hysteroscopy Treatment Efficacy

Objective: To analyze the factors related to the incidence of endometrial polyps and assess the value of hysteroscopic treatment. Methods: Fifty women with endometrial polyps admitted to the gynecology department of Xinghua People’s Hospital between January 2020 and June 2021 participated in the study. They were categorized into two groups using numerical expressions, and their uteri were analyzed. Causes and related factors of endometrial polyps were assessed. The study included 25 patients undergoing dilation and curettage (control group) and 25 patients undergoing hysteroscopy (observation group). Clinical surgical indicators, endometrial indicators, adverse reactions, and recurrence rates were compared between the two groups. Results: The observation group exhibited lower intraoperative and postoperative bleeding volumes, as well as significantly shorter operation time and hospitalization time compared to the control group (P < 0.05). The incidence rate of adverse reactions was 4.0% in the observation group, significantly lower than the 24.0% in the control group (P < 0.05). After 1 year of follow-up, the recurrence rate in the observation group was 4.0%, considerably lower than the 20.0% in the control group (P < 0.05). Conclusion: Endometrial polyps have various causes, including endometritis and long-term use of contraceptive pills use. Hysteroscopic treatment proves effective, with minimal adverse reactions and a low recurrence rate, making it a commendable surgical option for promotion.

Effect of Magnesium Sulfate Combined with Labetalol in the Treatment of Pregnancy-Induced Hypertension and Its Impact on Adverse Pregnancy Outcomes

Objective: To investigate the effect of magnesium sulfate combined with labetalol in treating hypertension in pregnancy (HIP) and its impact on adverse pregnancy outcomes. Methods: A total of 150 HIP patients treated at the Qujing Maternal and Child Healthcare Hospital from June 2020 to June 2023 were randomly assigned using the lottery method. They were divided into the control group (treated with magnesium sulfate alone, 75 cases), and the intervention group (magnesium sulfate + labetalol combined treatment, 75 cases). Blood pressure levels, total adverse reaction rates, total adverse pregnancy outcome rates, and total adverse fetal outcome rates were compared between the two groups. Results: Compared to the control group’s diastolic (87.94 ± 4.86 mmHg) and systolic (138.52 ± 9.23 mmHg) blood pressures, the intervention group showed lower levels of diastolic (78.95 ± 3.57 mmHg) and systolic (129.88 ± 7.47 mmHg) blood pressures (P < 0.05). The intervention group exhibited a lower total adverse reaction rate (4.00%) compared to the control group (14.67%; P < 0.05). Similarly, the total adverse pregnancy outcome rate in the intervention group (4.00%) was significantly lower than that in the control group (18.67%; P < 0.05). Furthermore, the total adverse fetal outcome rate in the intervention group (6.67%) was lower than that in the control group (22.67%; P < 0.05). Conclusion: The combination of magnesium sulfate and labetalol demonstrates significant efficacy in treating HIP. It effectively lowers blood pressure, improves pregnancy and fetal outcomes, is highly safe, and deserves promotion and application.

Evaluating the Efficacy of Interventional Approaches for Cardiac Arrhythmias in Acute Myocardial Infarction

Objective: To assess the effectiveness of interventional treatments for cardiac arrhythmias in acute myocardial infarction (AMI). Methods: Eighty AMI patients admitted between August 2022 and August 2023 were selected and randomly assigned into groups using the random number table method. The control group (n = 40) received conventional thrombolytic treatment, while the observation group (n = 40) underwent percutaneous coronary intervention (PCI). Clinical effects were compared between the two groups. Results: Before treatment, there were no significant differences in heart rate indicators, cardiac function indicators, and physiological indicators between the two groups (P > 0.05). After treatment, the observation group showed significantly improved heart rate indicators, cardiac function indicators, and physiological indicators compared to the control group (P < 0.05). The adverse reaction rates in the observation group were lower than in the control group (P < 0.05). Conclusion: PCI treatment demonstrated significant improvements in heart rate, cardiac function, and physiological indicators among AMI patients, leading to a reduced incidence of adverse reactions such as arrhythmia. The overall effect is deemed significant.

Time series analysis of using the PDCA method combined with the Teach-back method to improve spontaneous reports of adverse drug reactions in a grade IIIA hospital in China.

Spontaneous reporting of adverse drug reactions (ADRs) is essential for the post-marketing safety evaluation of drugs. Therefore, good monitoring of ADRs is vital for strengthening drug supervision, management, and guiding rational drug use. Chinese medical institutions are the primary source of ADR case reports, but the proportion of the reports in grade IIIA hospitals is still low due to serious under-reporting. The 3rd Affiliated Hospital of Chengdu Medical College, Chengdu Pidu District People's Hospital, also has such a problem. To improve the quantity and quality of ADR reports and enhance the level of pharmacovigilance in hospitals, the Third Affiliated Hospital of Chengdu Medical College, People's Hospital of Chengdu Pidu District experienced 10years to gradually establish a management model to improve the medical staff's reporting rate of spontaneous reporting of ADRs. The management model is led by clinical pharmacists and combines the PDCA with Teach-back methods. The purpose of this paper is to introduce the management model and discuss its advantages and shortcomings of this model. This study was conducted at the Third Affiliated Hospital of Chengdu Medical College-Chengdu Pidu District People's Hospital. From 2016, the daily management of reporting, auditing, and data improvement of adverse drug reactions in the hospital was carried out by clinical pharmacists, who used the PDCA method combined with the Teach-back method to continuously improve the reporting program of ADRs in the hospital during 2016-2021. Then, the proportion of spontaneous reports of total, new, and serious ADRs was compared before and after the intervention. Also, we performed a time series analysis using an autoregressive moving average model to assess changes in the total number of spontaneous ADR reports before the intervention (2013-2015), the first intervention (2016-2018), and the second intervention (2019-2021). After the combined PDCA and Teach-back method intervention, the median number of reported ADRs per year increased from 50 (range 37-55) in the pre-intervention period to 88 (range 83-162) in the first intervention period and to 374 in the second (range 312-566). Breakpoint regression analysis of the spontaneous reporting rate of ADRs showed that the instantaneous increase after the first intervention was not statistically significant (P = 0.526). However, the reporting rate of ADRs increased at a month-by-month growth rate during the second intervention compared to the first intervention. Its spontaneous reporting rate improved 1.034 times (P = 0.002). After the second intervention, the spontaneous reporting rate of ADRs transiently increased 6.111-fold (P < 0.001), and the month-to-month growth rate increased 1.024-fold (P < 0.001) again. The management model that combines the PDCA and the Teach-back method significantly improves the reporting rate of adverse drug reactions.

Efficacy and safety of pulsed radiofrequency combined with gabapentin in the treatment of acute herpetic neuralgia

Objective: To explore the clinical efficacy and safety of pulsed radiofrequency (PRF) combined with gabapentin in the treatment of acute herpetic neuralgia (AHN). Methods: A total of 123 AHN patients were retrospectively selected in Henan Provincial People's Hospital from November 2019 to July 2022, who were divided into two groups based on treatment methods: control group (treated with gabapentin, n=61) and study group (treated with gabapentin and PRF, n=62). The visual analog scale (VAS) was utilized for pain severity assessment and the self-rating scale for sleep (SRSS) was utilized for sleep quality evaluation. The differences in serum levels of interleukin (IL)-10, chemokine ligand 10 (CXCL-10), prostaglandin E2 (PGE2), cyclooxygenase-2 (COX-2), IL-2 and IL-6 before and after treatment were compared between the two groups. The overall treatment effectiveness and the occurrence rates of postherpetic neuralgia and adverse reactions were evaluated in both groups. Results: Among the study group patients, 28 were male and 34 were female, and the age was (62.8±8.5) years. Among the control group patients, 35 were male and 26 were female, and the age was (64.0±7.8) years. The VAS scores of the study group before and after treatment were 7.96±1.33 and 1.52±0.60, respectively, while the control group were 7.68±1.52 and 2.70±0.64. The SRSS scores before and after treatment in the study group were 31.74±5.90 and 12.06±2.81, respectively, while those in the control group were 33.10±5.54 and 14.14±2.96, respectively. Before treatment, there were no statistically differences of the VAS scores and SRSS scores in both groups (all P>0.05). After treatment, the VAS scores and SRSS scores in both groups decreased compared with before treatment (all P<0.05), the study group's VAS scores and SRSS scores were lower than those in the control group (all P<0.05). Before treatment, there were no statistically differences of the serum levels of IL-10, CXCL-10, PGE2, COX-2, IL-2 and IL-6 in both groups (all P>0.05). After treatment, the serum levels of IL-10, CXCL-10, PGE2, COX-2 and IL-6 in both groups decreased compared with before treatment, while the IL-2 level increased. Additionally, the study group had lower serum levels of IL-10, PGE2, COX-2 and IL-6 compared with the control group (all P<0.05). After treatment, the study group had 35 cases of cure, 26 cases of effectiveness, and 1 case of ineffectiveness, while the control group had 22 cases of cure, 31 cases of effectiveness, and 8 cases of ineffectiveness. The overall treatment efficacy of the study group was better than that of the control group (P=0.012). The incidence of postherpetic neuralgia in the study group after treatment was 16.1% (10/62), which was lower than that in the control group, which was 37.7% (23/61) (P<0.05). There were no statistically differences of the occurrence rates of adverse reactions in both groups (all P>0.05). Conclusion: Combining PRF with gabapentin for the treatment of AHN demonstrates better overall efficacy and safety, which can more effectively alleviate pain, improve sleep, and reduce inflammatory cytokine levels.

EVALUATION OF CONTINUOUS GLUCOSE MONITORING (isCGM) ON TYPE 2 DIABETES PATIENTS TREATED WITH BASAL – BOLUS INSULIN THERAPY

SUMMARY&#x0D; Objective: Evaluate effectiveness of continuous glucose monitoring (isCGM) on type 2 diabetes patients treated with basal – bolus insulin therapy. Method: Descriptive and interventional study on 29 type 2 diabetes patients treated with basal – bolus insulin therapy at Department of Endocrinology and Diabetes, Bachmai Hospital from 1/2023 to 7/2023. Results: Average age is 61.4 ± 17.4. The majority oral antidiabetic drug is Metformin combined with Anti DDP4 (37%), bolus insulin is Regular (73%), basal insulin is Glargine U100 (97%). Average HbA1c is 10,8 ± 2,8 %, average serum glucose on arrival is 17.2 ± 11.6 mmol/L. Time in range on 14th day 66,2 ± 16.9% higher than the 1st day 55.1 ± 29.0% (p=0.03). CGM can detect more hypoglycemia events than point-of-care capillary blood glucose (34.2% versus 17.2%). Adverse reaction rate is 3.4% only. Conclusion: Continuous glucose monitoring is not only useful in controlling blood glucose level but also in detecting more hypoglycemia events than point-of-care capillary blood glucose.

Effect of AGEs-RAGE system on the efficacy of PD-1 inhibitors in the treatment of driver-gene mutation negative advanced non-squamous non-small cell lung cancer.

To observe the therapeutic effect of PD-1 inhibitors on driver-gene mutation negative advanced non-squamous non-small cell lung cancer (nsNSCLC) and the role of the AGEs-RAGE system in the disease, provide more reliable treatment for future nsNSCLC patients. In this study, we selected 130 nsNSCLC patients admitted between January 2021 and April 2022 were selected as the study subjects, 61 of whom received pemetrexed plus carboplatin (control group) and 69 received PD-1 inhibitors, pemetrexed and carboplatin (research group). The clinical efficacy and adverse reactions of the two groups were compared, and the prognostic survival time was calculated. The results show that two groups were not statistically different in objective response rate (ORR) and incidence of adverse reactions, but the disease control rate (DCR) was higher in the research group (P<0.05). Besides, the median progression-free survival (PFS) was prolonged in the research group compared with the control group (P<0.05). In addition, changes in the levels of T lymphocyte subsets, AGEs and RAGE before and after treatment were detected, and the relationship between AGEs-RAGE and the therapeutic effect of PD-1 inhibitors was analyzed. The research group also showed higher CD3+, CD4+ and lower CD8+, AGEs and RAGE levels than the control group after treatment (P<0.05). Finally, we found that in addition, the efficacy of the study group was inversely related to AGEs and RAGE levels (P<0.05). With these results, we concluded that PD-1 inhibitors are effective in the treatment of driver-gene mutation negative advanced nsNSCLC, and the AGEs-RAGE system may provide a more reliable guarantee for the treatment outcomes of patients in the future.

Study protocol of a randomized controlled trial to assess safety of teleconsultation compared with face-to-face consultation: the ECASeT study

BackgroundThe use of remote consultation modalities has exponentially grown in the past few years, particularly since the onset of the COVID-19 pandemic. Although a huge body of the literature has described the use of phone (tele) and video consultations, very few of the studies correspond to randomized controlled trials, and none of them has assessed the safety of these consultation modalities as the primary objective. The primary objective of this trial was to assess the safety of remote consultations (both video and teleconsultation) in the follow-up of patients in the hospital setting.MethodsMulticenter, randomized controlled trial being conducted in four centers of an administrative healthcare area in Catalonia (North-East Spain). Participants will be screened from all individuals, irrespective of age and sex, who require follow-up in outpatient consultations of any of the departments involved in the study. Eligibility criteria have been established based on the local guidelines for screening patients for remote consultation. Participants will be randomly allocated into one of the two study arms: conventional face-to-face consultation (control) and remote consultation, either teleconsultation or video consultation (intervention). Routine follow-up visits will be scheduled at a frequency determined by the physician based on the diagnostic and therapy of the baseline disease (the one triggering enrollment). The primary outcome will be the number of adverse reactions and complications related to the baseline disease. Secondary outcomes will include non-scheduled visits and hospitalizations, as well as usability features of remote consultations. All data will either be recorded in an electronic clinical report form or retrieved from local electronic health records. Based on the complications and adverse reaction rates reported in the literature, we established a target sample size of 1068 participants per arm. Recruitment started in May 2022 and is expected to end in May 2024.DiscussionThe scarcity of precedents on the assessment of remote consultation modalities using randomized controlled designs challenges making design decisions, including recruitment, selection criteria, and outcome definition, which are discussed in the manuscript.Trial registrationNCT05094180. The items of the WHO checklist for trial registration are available in Additional file 1. Registered on 24 November 2021.

Let go of the myth: safety of indocyanine green for sentinel lymph node mapping in endometrial cancer

ObjectiveSentinel lymph node mapping by intracervical indocyanine green injection is the preferred method for surgical staging in endometrial cancer. Adverse reactions to indocyanine green are extremely rare, and information about...

A comparative study of treatment of cervical low-grade squamous intraepithelial lesions (LSIL)

Background and AimsLow-grade squamous intraepithelial lesion (LSIL) is one of two categories of cervical intraepithelial lesions. Given that controversy exists regarding its management, this comparative study aimed to evaluate the effect of 5-aminolevulinic acid photodynamic therapy (ALA-PDT) in treating LSIL of the high-risk human papillomavirus (HR-HPV)-infected cervix. MethodsA total of 218 patients (25–45 years old) with cervical LSIL associated with HR-HPV who underwent ALA-PDT, loop electrosurgical excision procedure (LEEP), or observation only were included. The clearance rates of cervical LSIL and HR-HPV between the ALA-PDT, LEEP, and observation groups were compared at 6 and 12 months follow-up. Adverse reactions were also compared. The factors affecting the clearance on ALA-PDT of cervical LSIL were evaluated. ResultsThere were no statistically significant differences in lesion and HR-HPV clearance rates between the ALA-PDT and LEEP groups at 6 and 12 months. However, the lesion and HR-HPV clearance rates were significantly higher in the ALA-PDT group than that in the observation group. The adverse reaction rate was significantly lower in the ALA-PDT group than in the LEEP group. ConclusionFor patients with cervical LSIL, the lesion and HR-HPV clearance rates after ALA-PDT were close to those after LEEP and significantly higher than in the observation group. Moreover, the adverse reaction rate for ALA-PDT was much lower than that for LEEP. Therefore, ALA-PDT provides a new option for the minimally invasive treatment of cervical LSIL.

Analysis of the Efficacy of Triamcinolone Acetonide Combined with Ranibizumab in the Treatment of Fundus Diseases

Objective: To analyze the effect of triamcinolone acetonide combined with ranibizumab in patients with fundus diseases. Methods: 100 patients with fundus diseases admitted from January 2018 to January 2023 were selected. The patients were separated into two groups according to the random number table method, with 50 cases in the control group (treated with ranibizumab), and 50 cases in the observation group (treated with triamcinolone acetonide combined with ranibizumab). The clinical effects of both treatment regimens were compared. Results: The time taken for symptom disappearance of the observation group was shorter than that of the control group (P &lt; 0.05). The observation group had higher naked-eye visual acuity (4.18 ± 0.89) compared to the control group. Besides, the observation group also had lower intraocular pressure (14.19 ± 1.33 mmHg) and retinal thickness (283.14 ± 3.29 μm), with (P &lt; 0.05) compared to the control group. Moreover, the observation group had a lower adverse reaction rate and a higher quality of life (P &lt; 0.05). Conclusion: The application of triamcinolone acetonide combined with ranibizumab treatment can quickly relieve the clinical symptoms of patients with fundus disease, improve visual acuity, intraocular pressure, and retinal thickness, with low adverse reaction rate and better prognosis and quality of life.

The association between levosimendan and mortality in patients with sepsis or septic shock: a systematic review and meta-analysis.

Levosimendan is increasingly being used in patients with sepsis or septic shock because of its potential to improve organ function and reduce mortality. We aimed to determine if levosimendan can reduce mortality in patients with sepsis or septic shock via meta-analysis. We comprehensively searched the PubMed, Embase, Web of Science, and Cochrane Library databases from inception through 1 October 2022. Literature evaluating the efficacy of levosimendan in patients with sepsis or septic shock was included. Two reviewers extracted data and assessed study quality. A meta-analysis was performed to calculate an odds ratio (OR), 95% confidence intervals (CI), and P -values for 28-day mortality (primary outcome). Secondary outcomes included changes in indexes reflecting cardiac function before and after treatment, changes in serum lactate levels in the first 24 h of treatment, and the mean SOFA score during the study period. Safety outcomes included rates of tachyarrhythmias and total adverse reactions encountered with levosimendan. Eleven randomized controlled trials were identified, encompassing a total of 1044 patients. After using levosimendan, there was no statistical difference between groups for 28-day mortality (34.9% and 36.2%; OR: 0.93; 95% CI [0.72-1.2]; P = 0.57; I 2 = 0%; trial sequential analysis-adjusted CI [0.6-1.42]) and sequential organ failure assessment (SOFA) score, and more adverse reactions seemed to occur in the levosimendan group, although the septic shock patient's heart function and serum lactate level improved. There was no association between the use of levosimendan and 28-day mortality and SOFA scores in patients with septic shock, though there was statistically significant improvement in cardiac function and serum lactate.

A real-world study and network pharmacology analysis of EGFR-TKIs combined with ZLJT to delay drug resistance in advanced lung adenocarcinoma

ObjectiveThis study aimed to explore the efficacy and safety of combining epidermal growth factor receptor tyrosine kinase inhibitors (EGFR-TKIs) with ZiLongJin Tablet (ZLJT) in delaying acquired resistance in advanced EGFR-mutant lung adenocarcinoma (LUAD) patients. Furthermore, we employed network pharmacology and molecular docking techniques to investigate the underlying mechanisms.MethodsA retrospective comparative study was conducted on stage IIIc/IV LUAD patients treated with EGFR-TKIs alone or in combination with ZLJT at the Second Affiliated Hospital of the Air Force Medical University between January 1, 2017, and May 1, 2023. The study evaluated the onset of TKI resistance, adverse reaction rates, safety indicators (such as aspartate aminotransferase, alanine aminotransferase, and creatinine), and inflammatory markers (neutrophil-to-lymphocyte ratio and platelet-to-lymphocyte ratio) to investigate the impact of EGFR-TKI combined with ZLJT on acquired resistance and prognostic indicators. Additionally, we utilized the Traditional Chinese Medicine Systems Pharmacology Database and Analysis Platform, the Bioinformatics Analysis Tool for Molecular Mechanism of Traditional Chinese Medicine, PubChem, UniProt, and Swiss Target Prediction databases to identify the active ingredients and targets of ZLJT. We obtained differentially expressed genes related to EGFR-TKI sensitivity and resistance from the Gene Expression Omnibus database using the GSE34228 dataset, which included sensitive (n = 26) and resistant (n = 26) PC9 cell lines. The "limma" package in R software was employed to detect DEGs. Based on this, we constructed a protein‒protein interaction network, performed gene ontology and KEGG enrichment analyses, and conducted pathway network analysis to elucidate the correlation between the active ingredients in ZLJT and signaling pathways. Finally, molecular docking was performed using AutoDockVina, PYMOL 2.2.0, and Discovery Studio Client v19.1.0 software to simulate spatial and energy matching during the recognition process between predicted targets and their corresponding compounds.Results(1) A total of 89 patients were included, with 40 patients in the EGFR-TKI combined with ZLJT group (combination group) and 49 patients in the EGFR-TKI alone group (monotherapy group). The baseline characteristics of the two groups were comparable. There was a significant difference in the onset of resistance between the combination group and the monotherapy group (P < 0.01). Compared to the monotherapy group, the combination group showed a prolongation of 3.27 months in delayed acquired resistance. There was also a statistically significant difference in the onset of resistance to first-generation TKIs between the two groups (P < 0.05). (2) In terms of safety analysis, the incidence of adverse reactions related to EGFR-TKIs was 12.5% in the combination group and 14.3% in the monotherapy group, but this difference was not statistically significant (P > 0.05). There were no statistically significant differences in serum AST, ALT, CREA, TBIL, ALB and BUN levels between the two groups after medication (P > 0.05). (3) Regarding inflammatory markers, there were no statistically significant differences in the changes in neutrophil-to-lymphocyte Ratio(NLR) and Platelet-to-lymphocyte Ratio(PLR) values before and after treatment between the two groups (P > 0.05). (4) Network pharmacology analysis identified 112 active ingredients and 290 target genes for ZLJT. From the GEO database, 2035 differentially expressed genes related to resistant LUAD were selected, and 39 target genes were obtained by taking the intersection. A "ZLJT-compound-target-disease" network was successfully constructed using Cytoscape 3.7.0. GO enrichment analysis revealed that ZLJT mainly affected biological processes such as adenylate cyclase-modulating G protein-coupled receptor. In terms of cellular components, ZLJT was associated with the cell projection membrane. The molecular function primarily focused on protein heterodimerization activity. KEGG enrichment analysis indicated that ZLJT exerted its antitumor and anti-drug resistance effects through pathways such as the PI3K-Akt pathway. Molecular docking showed that luteolin had good binding activity with FOS (-9.8 kJ/mol), as did tanshinone IIA with FOS (-9.8 kJ/mol) and quercetin with FOS (-8.7 kJ/mol).ConclusionZLJT has potential antitumor progression effects. For patients with EGFR gene-mutated non-small cell LUAD, combining ZLJT with EGFR-TKI treatment can delay the occurrence of acquired resistance. The underlying mechanisms may involve altering signal transduction pathways, blocking the tumor cell cycle, inhibiting tumor activity, enhancing cellular vitality, and improving the bioavailability of combination therapy. The combination of EGFR-TKI and ZLJT represents an effective approach for the treatment of tumors using both Chinese and Western medicine.

Therapeutic effect of mycophenolate mofetil or cyclophosphamide in children with Henoch-Schönlein purpura nephritis of different age groups

To investigate the difference in the therapeutic effect of mycophenolate mofetil (MMF) or cyclophosphamide (CTX) in children with Henoch-Schönlein purpura nephritis (HSPN) of different age groups. A retrospective analysis was conducted on the clinical data of 135 children with HSPN who were treated with MMF or CTX in the Department of Nephrology, Children's Hospital Affiliated to Capital Institute of Pediatrics, from October 2018 to October 2020. According to the immunosuppressant used, they were divided into two groups: MMF group and CTX group, and according to the age, each group was further divided into two subgroups: ≤12 years and >12 years, producing four groups, i.e, the ≤12 years MMF subgroup (n=30), the >12 years MMF subgroup (n=15), the ≤12 years CTX subgroup (n=71), and the >12 years CTX subgroup (n=19). All children were followed up for at least 12 months, and the above groups were compared in terms of clinical outcomes and the incidence rate of adverse reactions. There was no significant difference in the complete response rate between the MMF group and the CTX group after 3, 6, and 12 months of treatment (P>0.05). There were no significant difference in the complete response rate and the incidence rate of adverse reactions between the >12 years MMF subgroup and the ≤12 years MMF subgroup at 3, 6, and 12 months of treatment (P>0.05). The >12 years CTX subgroup had a significantly lower complete response rate than the ≤12 years CTX subgroup at 6 and 12 months of treatment (P<0.05). The >12 years CTX subgroup had a significantly higher incidence rate of adverse reactions than the >12 years MMF subgroup (P<0.05). The efficacy and adverse reactions of MMF are not associated with age, but the efficacy of CTX is affected by age, with a higher incidence rate of adverse reactions. CTX should be selected with caution for children with HSPN aged >12 years.

Denosumab Combined with Alendronate and Nutritional Intervention Improves Bone Metabolism and Density in Postmenopausal Osteoporosis

This study aimed to investigate the efficacy of denosumab combined with alendronate and nutritional intervention on bone metabolism and density in postmenopausal patients with osteoporosis. We randomly divided 120 patients with osteoporosis into two groups: an observation group and a control group. The patients in the control group received sodium phosphate and nutrition intervention therapy, while those in the observation group received denosumab combined with sodium phosphate and nutrition intervention therapy. Osteocalcin, procollagen type I N-terminal propeptide, and beta-C-terminal telopeptide levels were lower among patients in the observation group than among those in the control group. The bone densities of the lumbar and femoral neck among patients in the observation group were higher than those among patients in the control group. The visual analog scale scores of patients in the observation group were lower than those of patients in the control group. The fracture rate of patients in the observation group was lower than that of patients in the control group. The adverse reaction rate was similar in both groups. Denosumab combined with alendronate and nutritional intervention is a safe and efficacious approach to improving bone metabolism and bone density in postmenopausal patients, relieving bone pain, and preventing fractures.

Abstract 15929: Safety Profile of Ultrasound Enhancing Agents in Echocardiography Across Yale New Haven Health System

Background: Ultrasound Enhancing Agents (UEAs) are increasingly used in echocardiography for delineation of endocardial border and detection of left ventricular (LV) thrombus with reported rate of serious adverse reactions from 0 to 0.029%. Contemporary utilization and safety data of UEA in echocardiography are scarce. Aims: We aimed to obtain contemporary data on comparative safety of UEA Lumason and Definity in inpatient and outpatient settings across large academic healthcare system. Methods: A retrospective database analysis of all echocardiograms performed within Yale New Haven Health System (YNHHS) between January 1, 2019 to December 31, 2022 was done. Echocardiography reporting software captured type of UEA as well as any observed adverse reaction. All reported adverse events were manually chart reviewed through electronic medical record for confirmation and grading severity. American College of Radiology (ACR) criteria for contrast agent reaction were used for grading to mild, moderate, or severe reaction. Adverse reactions differences were analyzed with Pearson’s chi-square and predictors were identified by Logistic regression. Results: Out of 305,749 echocardiograms 91,215 (29.83%) required UEAs. In total, 430 (0.47%) adverse events were reported. Lumason (49216, 54.42%) and Definity (41077, 45.42%) were mainly used agents with 158 (0.32%) and 270 (0.66%) reactions recorded, respectively (p&lt;0.001). There were more mild reactions with Definity (245, 0.6%) Vs Lumason (124, 0.25%) (p &lt;0.001), and more severe reaction with Lumason (13, 0.026%) Vs Definity (3, 0.007%) (p=0.0322). Females had higher chance of having any form of contrast reaction (OR 1.707; 95% CI: 1.412-2.065). Older age (OR 0.984 per 1 year; p &lt;0.0001) and higher heart rate (OR 0.993 per 1 bpm; P = 0.050) were associated with a decreased chance of reaction. Ejection fraction and body mass index were not associated with adverse events. Conclusion: UEAs are frequently used in routine echocardiography studies. Adverse reactions to UEA were rare and mostly mild. Severe reactions were more frequent with Lumason than Definity. Female sex, younger age and lower heart rate were associated with increased incidence of adverse reactions.

Adverse Events Following mRNA COVID-19 Vaccine in 2021 and 2022: A Retrospective Analysis in Costa Rica and Italy.

Introduction Pharmacovigilance plays a crucial role in evaluating and monitoring the safety of medicines, which is essential for preventing harm to patients and improving public health. This study aims to compare the pharmacovigilance systems of Costa Rica and Italy and assess the safety profile of coronavirus disease 2019 (COVID-19) vaccines in both countries. Methods Data were collected from the official pharmacovigilance platforms in Costa Rica and Italy. Adverse events following immunization (AEFIs) were categorized by system organ class. Reports of suspected AEFIs associated with COVID-19 vaccines were analyzed for the period from January 1, 2021, to December 31, 2022. Results Both countries achieved high vaccination rates, with 84.9% in Italy and 92.9% in Costa Rica. A higher proportion of AEFIs occurred in females in both countries, with 53% and 65% in Naples and Costa Rica, respectively. Most AEFIs were observed in individuals aged 18-64 years. The rate of serious adverse reactions was lower in both countries than the international average. However, Naples reported a higher incidence of serious events per 100,000 inhabitants. Discussion The study sheds light on the importance of vaccine safety profiling and the significance of a comprehensive understanding of vaccine safety and effectiveness, specific population data, and collaborative strategies to mitigate and improve safety. Additionally, the study highlighted the significance of considering sex and gender when evaluating vaccine safety and efficacy, as sex-specific differences may impact vaccine outcomes. Conclusion Continuous pharmacovigilance efforts, collaborative approaches, and comprehensive data analysis are critical in ensuring vaccine safety and efficacy and safeguarding global public health. Lessons learned from the COVID-19 pandemic highlight the importance of proactive measures in addressing emerging challenges in vaccine safety and rollout programs worldwide.