Post-marketing surveillance for the safety of the quadrivalent human papillomavirus vaccine: a retrospective real-world study in China.

Background: The potential occurrence of autoimmune- and pregnancy-related adverse events with the quadrivalent human papillomavirus (4vHPV) vaccine has previously not been assessed in the real-world setting in China.

Research Design And Methods: A retrospective active post-marketing surveillance of the 4vHPV vaccine has been conducted among Chinese women aged 20-45 years between January 2018 and March 2021 in the Ningbo city. Incidences of seven pre-specified autoimmune diseases diagnosed within 6 months after the 4vHPV vaccination were calculated.

Post-marketing study design to evaluate the effectiveness of the 9-valent and 4-valent HPV vaccines on serious HPV-related cervical disease in China.

The 4-valent (4 v) and 9-valent (9 v) human papillomavirus (HPV) vaccines are approved in China for females aged 9-45 years. However, the real-world impact of 4vHPV or 9vHPV vaccination for the prevention of high-grade cervical disease in Chinese women is lacking. Two post-marketing surveillance studies will be conducted to measure the occurrence of high-grade cervical lesions in Chinese women who had received ≥1 dose of the 4vHPV (aged 20-45 years) or 9vHPV (aged 16-26 years) vaccine in Ningbo, China.

Efficacy and dose-response relationships of antidepressants in the acute treatment of major depressive disorders: a systematic review and network meta-analysis.

Background: The optimal antidepressant dosages remain controversial. This study aimed to analyze the efficacy of antidepressants and characterize their dose-response relationships in the treatments of major depressive disorders (MDD).

Methods: We searched multiple databases, including the Embase, Cochrane Central Register of Controlled Trials, PubMed, and Web of Science, for the studies that were conducted between January 8, 2016, and April 30, 2023.

[Cardiovascular safety of sitagliptin added to metformin in real world patients with type 2 diabetes].

Objective: To assess the safety of sitagliptin added to metformin on cardiovascular adverse events in real world patients with type 2 diabetes mellitus (T2DM).

Methods: Real world data from Yinzhou Regional Health Care Database were used to select T2DM patients with diagnosis and treatment records in the platform from January 1, 2017 to December 31, 2022. According to drug prescription records, the patients were divided into metformin plus sitagliptin group (combination group) and metformin monotherapy group(monotherapy group).

Post-marketing surveillance for the safety of the 9-valent human papillomavirus vaccine: a retrospective real-world study in China.

Background: The 9-valent human papillomavirus (9vHPV) vaccine was introduced in China in 2018. This study was conducted to monitor the occurrence of new-onset autoimmune diseases (AIs) in Chinese women vaccinated with the 9vHPV vaccine and adverse pregnancy outcomes in infants born to mothers with inadvertent pregnancy exposure.

Research Design And Methods: Women who received the first dose of the 9vHPV vaccine at age 16-26 years in Ningbo between January 2019 and March 2021 were monitored in the Ningbo Regional Health Information Platform.

Adverse effects of 21 antidepressants on sleep during acute-phase treatment in major depressive disorder: a systemic review and dose-effect network meta-analysis.

Study Objectives: Sleep-related adverse effects during acute treatment with antidepressants undermine adherence and impede remission. We aimed to address subtypes of sleep-related adverse effects and depict the relationship between dose and sleep-related adverse events.

Methods: We searched PubMed, Embase, Cochrane Central Register of Controlled Trials, and Web of Science for double-blind randomized controlled trials of depression published before April 30th, 2023.

Risk of Fracture With Dipeptidyl Peptidase-4 Inhibitors, Glucagon-like Peptide-1 Receptor Agonists, or Sodium-Glucose Cotransporter-2 Inhibitors in Patients With Type 2 Diabetes Mellitus: A Systematic Review and Network Meta-analysis Combining 177 Randomized Controlled Trials With a Median Follow-Up of 26 weeks.

This study aims to investigate the association between the use of dipeptidyl peptidase-4 inhibitors (DPP-4i), glucagon-like peptide-1 receptor agonists (GLP-1 RAs), or sodium-glucose cotransporter-2 inhibitors (SGLT-2i) and the risk of fracture among patients with type 2 diabetes mellitus. Medline, Embase, Cochrane Library, and Clinical-Trials.gov databases were searched for randomized controlled trials (RCTs).

Serum Cortisol, 25 (OH)D, and Cardiovascular Risk Factors in Patients with Type 2 Diabetes Mellitus.

Background And Aims: The effects of cortisol on cardiovascular diseases (CVD) and CVD risk are unknown, especially in patients with type 2 diabetes mellitus (T2DM). Furthermore, it is unclear whether 25 (OH)D can alter the associations of cortisol with CVD and CVD risk factors. Thus, the present study was to investigate the associations of serum cortisol with CVD and CVD risk factors and whether 25 (OH)D altered these associations among patients with T2DM.

Pharmacovigilance in China: Evolution and future challenges.

Drug-related adverse reactions are among the main reasons for harm to patients under care worldwide and even their deaths. The pharmacovigilance system has been proven to be an effective method of avoiding or alleviating such adverse events. In 2019, after two decades of implementation of the drug-related adverse reaction reporting system, China formally implemented a pharmacovigilance system with the Pharmacovigilance Quality Management Standards and a series of supporting technical documents created to improve the safety of medication given to patients.

Self-controlled case series design in vaccine safety: a systematic review.

Background: There is limited comprehensive evaluation of the methodology and reporting quality of observational studies of vaccine safety.

Methods: Databases including Medline, Embase, Web of Science, Scopus, and Chinese databases were searched from inception to 31 May 2021. All observational studies regarding vaccine safety using an SCCS design were selected.