[Safety of umeclidinium/vilanterol in Chinese patients in a real-world setting: a prospective, multicenter, single-arm, observational study].

Objective: To evaluate the safety of umeclidinium/vilanterol in Chinese participants in a real-world setting. Methods: This was a 24-week, prospective, multicenter, single-arm, observational study that enrolled participants treated with umeclidinium/vilanterol in real-world settings from 14 sites in China from 14 December 2020 to 30 January 2022. The primary outcomes were the incidence of adverse events (AEs) and serious adverse events (SAEs) at week 24. Results: A total of 887 participants on umeclidinium/vilanterol were enrolled. The mean (±SD) age of these participants was 67.5 (±9.6) years, with more men (77.7%) enrolled. The majority of the participants (98.1%) had been diagnosed with chronic obstructive pulmonary disease, and 67.6% of them reported comorbidities. More than half of the participants (52.8%) were taking concomitant medication in addition to the study treatment. AEs were reported in 59 (6.7%) participants and were predominantly mild to moderate in severity. SAEs were reported in 21 (2.4%) participants, including 9 fatal SAEs, 10 reported non-fatal SAEs, and 2 reported both non-fatal and fatal SAEs. None of the SAEs, including the fatal events, were considered by the investigators to be related to umeclidinium/vilanterol. Adverse drug reactions (ADRs) were reported in 6 (0.7%) participants with 4 preferred terms (PTs), all of which were considered mild in severity. Of these PTs, 2 were known ADRs of umeclidinium/vilanterol. Three participants (0.3%) reported AEs that were part of serious identified/potential hazards, all of which were considered by the investigators to be unrelated to umeclidinium/vilanterol. Conclusion: The results of this study showed that umeclidinium/vilanterol was well tolerated in Chinese participants in a real-world setting and no new drug-related safety signals were observed.

Fruit Intake and Alzheimer's Disease: Results from Mendelian Randomization.

Alzheimer's disease (AD) is the leading cause of dementia in old age, recognized as a global health priority. To explore causal effects of fresh fruit intake and dried fruit intake on AD liability, this study utilized GWAS from the UK Biobank and FinnGen to conduct Mendelian randomization (MR) analysis, and used inverse variance weighted (IVW), MR-Egger, and weighted median approaches for MR estimates, and visual inspections judged result stability. Results suggested little evidence of a potential causal relationship between fresh fruit intake and AD (OR=0.97, 95%CI=0.50-1.91, P=0.939), while significant, robust causality was indicated between dried fruit intake and AD (OR=4.09, 95%CI=2.07-8.10, P<0.001). Stability evaluations showed no heterogeneity or pleiotropy affecting interpretability and credibility of primary analyses. In conclusion, we strengthened evidence for positive causality from dried fruit intake to AD liability, with causality from fresh fruit intake on AD risk was not demonstrated.

Comparison of outcomes between preservation or division of the uterine round ligament in laparoscopic groin hernia repair in females: a meta-analysis and trial sequential analysis.

PURPOSE: The purpose of this study was to perform a meta-analysis comparing the short-term and long-term outcomes in laparoscopic groin hernia repair with or without preservation of the uterine round ligament (URL) in females. METHODS: We searched several databases including PubMed, Web of Science, Cochrane Library, and and CNKI databases. This meta-analysis included randomized clinical trials, and retrospective comparative studies regarding preservation or division of the URL in laparoscopic groin hernia repair in females. Outcomes of interest were age, BMI, type of hernia, type of surgery, operating time, estimated blood loss, time of hospitalization, seroma, concomitant injury, mesh infection, recurrence, uterine prolapse, foreign body sensation, chronic pain, and pregnancy. Meta-analyses and trial sequential analysis were performed with Review Manager v5.3 and TSA software, respectively. RESULTS: Of 192 potentially eligible articles, 9 studies with 1104 participants met the eligibility criteria and were included in the meta-analysis. There were no significant difference in age (MD-6.58, 95% CI - 13.41 to 0.24; P = 0.06), BMI (MD 0.05, 95%CI - 0.31 to 0.40; P = 0.81), blood loss (MD-0.04, 95% CI - 0.75 to 0.66; P = 0.90), time of hospitalization (MD-0.22, 95% CI-1.13 to 0.69; P = 0.64), seroma (OR 0.71, 95% CI 0.41 to 1.24; P = 0.23), concomitant injury (OR 0.32, 95% CI 0.01 to 8.24; P = 0.68), mesh infection (OR 0.13, 95% CI 0.01 to 2.61; P = 0.18), recurrence (OR 1.13, 95% CI 0.18 to 7.25; P = 0.90), uterine prolapse(OR 0.71, 95% CI 0.07 to 6.94; P = 0.77), foreign body sensation (OR 1.95, 95% CI 0.53 to 7.23; P = 0.32) and chronic pain(OR 1.03 95% CI 0.4 to 2.69; P = 0.95). However, this meta-analysis demonstrated a statistically significant difference in operating time (MD 6.62, 95% CI 2.20 to 11.04; P = 0.0003) between the preservation group and division group. Trial sequential analysis showed that the cumulative Z value of the operating time crossed the traditional boundary value and the TSA boundary value in the third study, and the cumulative sample size had reached the required information size (RIS), indicating that the current conclusion was stable. CONCLUSION: In summary, laparoscopic groin hernia repair in women with the preservation of the round uterine ligament requires a longer operating time, but there was no advantage in short-term or long-term complications, and there was no clear evidence on whether it causes infertility and uterine prolapse.