1.Signal mining and analysis of adverse drug events of tirzepatide
Zeyu XIE ; Zhuoru LIANG ; Guimei ZHENG ; Weiling CAO ; Jisheng CHEN
China Pharmacy 2025;36(8):956-960
OBJECTIVE To identify and analyze adverse drug event (ADE) signals associated with tirzepatide based on the FDA Adverse Event Reporting System (FAERS) database, providing a reference for clinical medication safety. METHODS ADE reports from January 1, 2022, to June 30, 2024, with tirzepatide as the primary suspected drug, were extracted from the FAERS database. Medical Dictionary for Regulatory Activities was used to systematically categorize the selected system organ class (SOC) and preferred term of ADE. Signal mining and analysis were performed using the reporting odds ratio method and the proportional reporting ratio method. RESULTS A total of 39 229 ADE reports related to tirzepatide were obtained, including 3 934 severe ADE reports (10.03%). The majority of severe ADE reports were related to hospitalization or prolonged hospitalization (3.82%), involving 131 positive ADE signals. Among the reports with documented patient gender and age, 26 195 were female (66.77%), 7 869 were male (20.06%), and the majority of patients were aged 18-64 years (54.26%). The top three most frequently reported ADE were injection site pain, nausea, and injection site hemorrhage. Strong ADE signals not mentioned in the tirzepatide instruction included injection site coldness, starvation ketoacidosis, injection site hemorrhage, hunger, elevated adrenaline, injection site skin cracking, binge eating, skin laxity, intestinal sepsis, lack of satiety, and dysesthesia. Subgroup analysis for patient’s gender and age showed differences in the proportion of ADE reports across different SOC. Male patients or those aged≥65 years had a higher risk of gastrointestinal system disorders compared to female patients or those aged <65 years. CONCLUSIONS In clinical use of tirzepatide, in addition to monitoring ADE listed in the instruction, attention should also be paid to ADE not mentioned in the instruction, such as injection site coldness, starvation ketoacidosis, injection site hemorrhage, elevated adrenaline, and intestinal sepsis, to ensure patient safety.
2.Rapid health technology assessment of tirzepatide for diabetes mellitus type 2 and long-term weight management
Zeyu XIE ; Yinuo LIU ; Zhuoru LIANG ; Yaohua CAO ; Guimei ZHENG ; Weiling CAO
China Pharmacy 2025;36(9):1141-1146
OBJECTIVE To evaluate the efficacy, safety and cost-effectiveness of tirzepatide for diabetes mellitus type 2 (T2DM) and long-term weight management, and provide evidence-based basis for clinical drug treatment and health insurance policy formulation. METHODS Computer searches were conducted in Embase, PubMed, the Cochrane Library, CNKI and health technology assessment (HTA) official website from their inception to October 1st 2024 to collect HTA report, systematic review/ meta-analysis and pharmacoeconomic study on tirzepatide for the treatment of T2DM or for weight management. After data extraction and quality evaluation, descriptive analysis was performed on the research results. RESULTS Totally 18 papers were included, including 14 systematic reviews/meta-analyses and 4 pharmacoeconomics studies, and no HTA report was retrieved. In terms of efficacy, most results showed that the tirzepatide 10 mg and 15 mg were significantly better than other glucagon-like peptide-1 (GLP-1) receptor agonists in reducing glycosylated hemoglobin, body weight, and waist circumference (P<0.05). In terms of safety, compared with other GLP-1 receptor agonists, tirzepatide did not increase the incidence of gastrointestinal-related adverse events (AE), the incidence of AE of grade ≥3, or the incidence of severe hypoglycemia (P>0.05). However, tirzepatide 15 mg may significantly increased the incidence of hypoglycemia and the rate of discontinuation due to adverse reactions (P< 0.05). In terms of cost-effectiveness, based on the background of foreign pharmacoeconomic studies, tirzepatide was more cost- effective compared to semaglutide and liraglutide in the treatment of T2DM or for weight management. CONCLUSIONS Tirzepatide at doses of 10 mg and 15 mg has good efficacy and safety for the treatment of T2DM and for long-term weight management. However, when using the 15 mg dose of tirzepatide, close monitoring is required due to the risk of hypoglycemia and discontinuation due to adverse reactions it may pose. Based on pharmacoeconomic studies conducted abroad results, tirzepatide exhibits economic advantages.
3.Surgical treatment of 655 patients with deep chest wall infection: A single-center retrospective analysis
Wenzhang WANG ; Qing FENG ; Zhuoru LIANG ; Xiangyi CHENG ; Jing WANG ; Bowen LI ; Xiaofang WANG ; Xiaohong WANG
Chinese Journal of Clinical Thoracic and Cardiovascular Surgery 2022;29(07):904-908
Objective To explore the surgical treatment of deep chest wall infection, improve the cure rate and reduce the recurrence rate. Methods The clinical data of 655 patients with deep chest wall infection treated in Yanda Hospital and Beijing Royal Integrative Medicine Hospital from June 2015 to June 2020 were retrospectively analyzed. There were 450 males and 205 females, aged 55.6±12.8 years. There were 8 patients with chest wall infection after tumor necrosis, 15 patients after radiotherapy and 632 patients after thoracotomy (612 patients after cardiovascular surgery and 20 patients after general thoracic surgery). Among them, 649 patients underwent debridement and reconstruction of chest wall defect with muscle flap. Results The average operation time was 95±65 min, the average intraoperative blood loss was 180±100 mL, and the average postoperative hospital stay was 13±6 d. Of the 649 patients who underwent muscle flap reconstruction after debridement, 597 patients recovered within 2 weeks, and the primary wound healing rate was 94.4%. Twenty-three (3.5%) patients died. The median follow-up time was 25 (2-40) months. Among the remaining 632 patients, 20 recurred, with a recurrence rate of 3.1% (20/632). Conclusion Pedicled muscle flap after thorough debridement of deep chest wall infection is one of the best methods to repair chest wall defect with pedicled muscle flap.