Explore the correlation between tacrolimus trough concentration (C₀) and clinical efficacy in children with lupus nephritis (LN), and identify key factors affecting the efficacy of tacrolimus treatment in LN patients..

A total of 120 children with LN who took tacrolimus in our hospital from March 2021 to December 2024 and were monitored for blood drug concentration were retrospectively selected. According to the treatment effect, they were divided into effective group (n=78) and ineffective group (n=42). The basic information, laboratory indicators and other data of the children were collected to explore the influencing factors of the efficacy of the children.

The daily dose of tacrolimus, trough concentration C₀, 24 h urinary protein and albumin in the effective group were higher than those in the ineffective group (all P<0.001), while the glomerular filtration rate was significantly lower than that in the ineffective group (P<0.001). After collinearity diagnosis, the indexes were included in Logistic regression analysis. The daily dose of tacrolimus, trough concentration C₀, glomerular filtration rate and albumin were all protective factors affecting the efficacy of children with LN (P<0.05), while 24 h urine protein quantification was a risk factor (P<0.05). The receiver operating characteristic curve was drawn. The AUC of glomerular filtration rate, 24-hour urinary protein quantification, and albumin in predicting the efficacy of children with LN was 0.882 [95% CI: 0.809-0.956], 0.861 [ 95 % CI: 0.790-0.932], 0.897 [95% CI: 0.837-0.956]. The AUC and optimal cut-off value of tacrolimus daily dose and trough concentration C₀ in predicting the efficacy of children with LN were 0.750 [95% CI : 0.649-0.851 ], 1.45 mg and 0.772 [ 95 % CI: 0.691-0.853 ], 4.05 ng·mL^-1.

The trough concentration of tacrolimus (C₀) is significantly correlated with the clinical efficacy of LN in children, and the daily dose and trough concentration C₀ are key factors affecting the efficacy.

To establish a population pharmacokinetic (PPK) model of duloxetine (DLXT) in hospitalized patients with depression, to investigate its influencing factors, and to provide reference for individualized medication.

A total of 325 patients who were hospitalized and received oral DLXT treatment at Shenzhen Kangning Hospital from January 2022 to October 2025 were retrospectively included, and their medication information, plasma concentrations, and other clinically relevant data were collected. Nonlinear mixed-effects modeling (NONMEM) was used to establish a PPK model of DLXT concentrations. Goodness-of-fit (GOF) plots, visual predictive check (VPC) and Bootstrap were used to evaluate the stability and predictive performance of the model, respectively. Based on the significant covariates identified in the final model, the steady-state plasma concentrations (C_ss) of DLXT over time were simulated under different dosage regimens in various populations.

A one-compartment model with first-order absorption and elimination was developed using 450 plasma concentration data points from 325 inpatients. The inter-individual variability of apparent clearance (CL/F) was 42.2%, and the proportional residual variability was 27.1%. Gender was identified as a significant covariate affecting CL/F. The final model was expressed as: CL/F(L·h^-1)=64.6×(1-0.25×Gender), where Gender is an indicator variable (male=0, female=1). The apparent volume of distribution was 1 530 L, and the absorption rate constant was fixed at 0.168 h^-1. Monte Carlo simulations showed that the C_ss in females was higher than that in males at the same doses.

A PPK model for DLXT in hospitalized patients with depression was successfully established. The final model is stable and reliable, and it can be used for individualized dosing regimens in clinical practice.

Against the backdrop of the comprehensive promotion of the policy of centralized bulk procurement of drugs (referred to as "centralized procurement"), this study aims to systematically review and integrate relevant evidence on the effectiveness, safety, and cost-effectiveness of cephalosporin injectables under centralized procurement as presented in real-world studies, and compare their clinical performance with that of original research drugs/imported generic drugs. The goal is to provide an evidence-based basis for the rational use, clinical evaluation, and policy optimization of selected generic drugs in centralized procurement.

Retrieval of real-world research literature on centralized collection cephalosporin injections published from April 2021 to February 2026, comprehensive analysis was conducted from the dimensions of clinical efficacy, safety, and economy, and QATSM-RWS was used to evaluate the quality of the included studies.

After screening, a total of 17 studies were included. The investigated medications primarily comprised cefuroxime, ceftriaxone, and cefoperazone-sulbactam sodium, covering diverse infectious populations in both adults and children, as well as two key clinical scenarios: perioperative infection prevention and therapeutic anti-infective treatment. The results demonstrated that, in terms of efficacy, most studies indicated comparable overall effectiveness between centrally procured cephalosporin injections and original/imported generic drugs for perioperative infection prevention and therapeutic anti-infective therapy, with only individual studies showing differences in secondary endpoints. Regarding safety, no significant differences were observed between the two groups for perioperative prophylaxis; in therapeutic applications, most studies confirmed equivalent safety profiles across both groups, with only certain safety indicators differing in specific studies. In terms of economy, centrally procured medications significantly reduced treatment-related expenses, demonstrating notable economic advantages.

Overall, centrally procured cephalosporin injections are basically consistent with original drugs/imported generic drugs in terms of clinical effectiveness and safety, while also offering superior cost-effectiveness, which can reduce patients’ medical burden. Limited by factors such as the limited coverage of included research varieties, mostly single-center studies, and small sample sizes, relevant research evidence still needs to be improved. Large-sample, multi-center clinical studies need to be conducted in the future to further consolidate the evidence-based basis.

To analyze the characteristics of adverse drug reactions (adverse drug reaction, ADRs) of oral riluzole in patients with amyotrophic lateral sclerosis (amyotrophic lateral sclerosis, ALS), and to provide references for clinical safe medication.

Data of ALS patients treated with riluzole at Peking Union Medical College Hospital from May 2018 to August 2023 were collected. Patients with ADRs were retrospectively analyzed regarding demographic information, medication details, clinical manifestations, time of onset, management, and outcomes. Causality assessment was performed according to China’s Measures for Reporting and Monitoring of Adverse Drug Reactions, severity was evaluated using CTCAE V5.0, and ADRs were coded using MedDRA terms.

A total of 67 ALS patients were included, among whom 22 experienced ADRs (32.8%). The incidence of ADRs was higher in females (44.0%) than in males (26.2%). A total of 54 ADR episodes were recorded. The most common ADRs involved the nervous system (20 cases/54 cases, 37.0%), followed by gastrointestinal system disorders (13 cases/54 cases, 24.1%), general disorders and administration site conditions (7 cases/54 cases, 13.0%), and various laboratory investigations (6 cases/54 cases, 11.1%). One patient (1.5%) experienced a grade 3 serious ADR (interstitial lung disease). Seventeen patients (77.3%) developed ADRs within the first three months of treatment. Sixteen patients (72.7%) tolerated the ADRs without specific intervention, while six (27.3%) improved after drug discontinuation, dose reduction, or symptomatic treatment.

The most common ADRs of riluzole in ALS patients involve the nervous system, gastrointestinal tract, and elevated liver enzymes (all not higher than twice the normal value), mostly occurring early in the treatment course. Clinicians should remain vigilant for respiratory ADRs and potential heightened inflammatory responses, with close monitoring recommended during the first six months of treatment.

To investigate the current status of safety review by institutional review boards (IRBs) for clinical drug trials in China, analyze existing issues and needs for improvement, and provide a basis for enhancing the quality and efficiency of ethical review.

An online questionnaire survey was conducted from May 2025 to March 2026, targeting 391 IRBs for clinical drug trials across 29 provinces, municipalities, and autonomous regions nationwide. The questionnaire covered the basic profile of the ethics committees, requirements for submitting safety reports and review processes, as well as attitudes toward the need for improvements in the review process. SPSS AU was used to perform descriptive statistics, analysis of variance (ANOVA), correlation analysis, and post-hoc analysis. The results showed that the questionnaire had good reliability and validity (Cronbach’s α=0.932, KMO=0.946).

86.7% of the drug clinical trial ethics committees explicitly stipulated in their SOPs the selection criteria and decision-makers for the review method of safety reports; however, implementation was inconsistent at critical stages, with a portion (46.04%) of the committees not having the chairperson decide on the selection of the lead reviewer. Regarding serious adverse events (SAEs), 94.63% of drug clinical trial ethics committees required the principal investigator to submit reports; however, there were discrepancies in the interpretation of the provisions of the "Good Clinical Practice for Drug Clinical Trials" (2020) (48.85% believed that only suspected and unexpected adverse reactions needed to be reviewed). 59.34% of ethics committees updated the types of review conclusions in a timely manner to be consistent with the "Measures for Ethical Review of Life Sciences and Medical Research Involving Humans" (2023). The results showed that there was no significant difference in the recognition of all improvement suggestions among the levels of different health institutions, investigators’ working years, professional backgrounds and technical titles, proving that the industry has a common and consistent demand for improving ethical standardization review. Correlation analysis shows that various improvement measures are closely related. Among them, the "Standard Operating Procedures for the Establishment and Review of Ethics Committees" and the "Application Guidelines for Institutional Establishment" showed a strong positive correlation (r=0.716, P<0.01), and various measures were positively correlated with "supervision by superior authorities" (r=0.407~0.705, P<0.01), highlighting the need for systematic optimization.

Our country’s ethical review system for drug clinical trial safety reports has been initially established, but it needs to be strengthened in terms of uniformity of review standards, timely implementation of regulations and standardization of process operations. This survey results show that in the future, efforts should be made to build a four-in-one systematic optimization plan of "regulations-standards-capabilities-supervision" to unify industry standards, improve review efficiency, and effectively protect the rights and interests of research participants.

To analyze the characteristics of patient subgroups and temporal patterns of adverse events (AE) associated with efgartigimod treatment for generalized myasthenia gravis (gMG), based on the U.S. FDA Adverse Event Reporting System (FAERS) database, providing evidence for personalized clinical use and long-term drug safety monitoring.

Individual case safety reports (ICSRs) in which efgartigimod was the primary suspect drug were extracted from the FAERS database covering Q1 2020 to Q4 2023. After deduplication and MedDRA standardization, binary logistic regression was used to assess the impact of age, sex, and body weight on symptom recurrence risk; K-means clustering identified high-risk patient subgroups; and descriptive analysis characterized the distribution of AE onset times (TTO).

A total of 788 ICSRs were included, of which 321 had complete time information. Logistic regression revealed that low body weight (OR=0.97, P=0.021) and younger age (OR=0.96, P=0.014) were risk factors for symptom recurrence. Clustering analysis divided patients into three groups: older and heavier individuals (mainly cardiovascular or procedure related AEs), younger and lighter individuals (primarily immune or hypersensitivity related AEs), and a heterogeneous group. The overall TTO distribution of AEs was right-skewed, with 68% occurring within 30 days. Median TTO for serious AEs (73 days) was longer than for non-serious AEs (54 days), indicating a clear delayed risk (>180 days).

Efgartigimod related AE risks exhibit heterogeneity across populations and time dependency. Younger, lower weight patients require close monitoring for immune related AEs, while older, higher weight patients should be monitored for cardiovascular risks. A comprehensive, long-term monitoring strategy throughout the treatment cycle is warranted clinically. The integrated framework proposed here "risk stratification-subgroup identification-temporal monitoring" can be directly applied to other neonatal Fc receptor (FcRn) targeted drugs, offering an innovative model for post-marketing evaluation of biologics in China.