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替尔泊肽治疗成人2型糖尿病疗效和安全性的Meta分析OA

Efficacy and Safety of Tirzepatide in the Treatment of Type 2 Diabetes Mellitus in Adults:A Meta-analysis

中文摘要英文摘要

目的 系统性评价替尔泊肽相较于其他类型降糖药物治疗成人 2 型糖尿病(T2DM)的疗效和安全性.方法 计算机检索PubMed、Embase、Cochrane Library、Web of Science、ClinicalTrials.gov、中国期刊全文数据库、万方数据知识服务平台、中文期刊全文数据库和中国生物医学文献数据库(CBM),收集每周1 次5 mg、10 mg、15 mg替尔泊肽与安慰剂或其他降糖药物治疗T2DM的随机对照试验(RCT)研究,检索时限为建库至 2023 年 9 月.筛选文献、提取数据、评价质量后,采用RevMan 5.4 软件进行Meta分析.结果 共纳入10 项RCT研究,合计9 526 例患者.Meta分析结果显示,与安慰剂、基础胰岛素和胰高血糖素样肽-1 受体激动剂(GLP-1RA)相比,替尔泊肽能有效降低患者糖化血红蛋白(HbA1c),显著提高HbA1c达标率,明显降低体重,差异有统计学意义(P<0.05),疗效呈剂量依赖性.安全性方面,替尔泊肽不良事件(AE)发生率较高,主要是胃肠道不良反应较多,但低血糖发生率低于安慰剂[RR=0.65,95%CI(0.47,0.90),P<0.05]和基础胰岛素[RR=0.56,95%CI(0.43,0.72),P<0.05].剂量亚组分析显示,不良反应的发生会随剂量的增加而增多.结论 相比于安慰剂、基础胰岛素和GLP-1RA,替尔泊肽具有良好的降糖和减重效果,疗效呈剂量依赖性,且不会显著增加胃肠道反应和低血糖风险.

Objective To systematically evaluate the efficacy and safety of tirzepatide compared with other types of antidiabetic drugs in adults with type 2 diabetes mellitus(T2DM).Methods PubMed,Embase,Cochrane Library,Web of Science,ClinicalTrials.gov,CNKI,Wanfang Database,VIP database and China Biology Medicine Disc were searched by computer.The randomized controlled trials(RCT)of tirzepatide 5 mg,10 mg,15 mg versus placebo or other antidiabetic drugs in the treatment of T2DM were collected.The search time limit was from the establishment of the database to September 2023.After literature screening,data extraction and quality evaluation,RevMan 5.4 software was used for Meta-analysis.Results A total of 10 RCT studies were included,with a total of 9 526 patients.The results of meta-analysis showed that compared with placebo,basal insulin and glucagon-like peptide-1 receptor agonist(GLP-1RA),tirzepatide was more effective in reducing patients'HbA1c,significantly improving the HbA1c compliance rate,and significantly reducing body weight,with statistical significance(P<0.05).The effect was dose-dependent.In terms of safety,tirzepatide had a higher incidence of adverse events(AE),mainly gastrointestinal adverse events,but the incidence of hypoglycemia was lower than that of placebo[RR=0.65,95%CI(0.47,0.90),P<0.05]and basal insulin[RR=0.56,95%CI(0.43,0.72),P<0.05].Dose subgroup analysis showed that the occurrence of adverse reactions increased with the increase of dose.Conclusion Compared with placebo,basal insulin and GLP-1RA,tirzepatide has good hypoglycemic and weight loss effects in a dose-dependent manner,and does not significantly increase the risk of gastrointestinal reactions and hypoglycemia.

高宁;冯冰;高胜男;刘洋;牛梦娜;郭珊;刘国强

河北医科大学第三医院临床药学部,石家庄 050051河北医科大学第三医院临床药学部,石家庄 050051河北省药物与卫生技术综合评估学会,石家庄 050051河北医科大学第三医院药剂科,石家庄 050051河北医科大学第三医院临床药学部,石家庄 050051河北医科大学第三医院临床药学部,石家庄 050051河北医科大学第三医院临床药学部,石家庄 050051

临床医学

胰高血糖素样肽-1/葡萄糖依赖性促胰岛素多肽双受体激动剂替尔泊肽2型糖尿病有效性安全性Meta分析

Dual GLP-1/GIP receptor agonistTirzepatideType 2 diabetes mellitusEfficacySafetyMeta-analysis

《中国药物经济学》 2024 (11)

45-52,57,9

河北省自然科学基金项目(NH2021206407)

10.12010/j.issn.1673-5846.2024.11.009

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