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替尔泊肽用于肥胖或2型糖尿病患者减肥的疗效和安全性:一项系统评价和荟萃分析

Efficacy and safety of tirzepatide for weight loss in patients with obesity or type 2 diabetes: a systematic review and meta-analysis.

作者信息

Tian Qiru, Song Yi, Deng Yan, Lin Shike

机构信息

School of Basic Medical Sciences, Hainan Vocational University of Science and Technology, Haikou, China.

Faculty of Medicine, Chinese University of Hong Kong, Hong Kong, Hong Kong SAR, China.

出版信息

Front Endocrinol (Lausanne). 2025 Jul 17;16:1593134. doi: 10.3389/fendo.2025.1593134. eCollection 2025.

DOI:10.3389/fendo.2025.1593134
PMID:40747302
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC12310450/
Abstract

BACKGROUND

This meta-analysis aims to evaluate efficacy and safety of tirzepatide for weight loss, including its dose-response relationship and adverse event profile.

METHODS

Studies were retrieved from high-impact journals and included phase 1 to phase 3 trials. Participants received tirzepatide at 5,10, or 15 mg doses or a placebo control. Weighted mean differences (WMD) and odds ratios (OR) with 95% confidence intervals (CIs) were used to evaluate treatment effects, and heterogeneity was assessed using I² statistic.

RESULTS

Tirzepatide induced a mean weight reduction of -10.39 kg versus placebo (95% CI: -10.80 to -9.99; p < 0.00001). Subgroup analyses by diabetes status showed that patients with type 2 diabetes lost -6.17 kg (95% CI: -7.16 to -5.17; p < 0.00001) at 5 mg, -8.57 kg (95% CI: -9.41 to -7.74; p < 0.00001) at 10 mg, and -9.60 kg (95% CI: -10.32 to -8.89; p < 0.00001) at 15 mg. Non-diabetic participants experienced greater absolute losses of -12.10 kg (95% CI: -13.47 to -10.72; p < 0.00001), -15.94 kg (95% CI: -17.25 to -14.62; p < 0.00001), and -17.86 kg (95% CI: -19.19 to -16.54; p < 0.00001) at the respective doses. Tirzepatide also markedly increased the odds of achieving clinically meaningful weight loss: ≥ 5% (OR=11.32; p < 0.0001), ≥ 10% (OR=14.77; p < 0.0001), and ≥ 15% (OR=18.07; p < 0.0001. Adverse events were more frequent with tirzepatide than placebo (OR=1.34; p < 0.0001), largely driven by gastrointestinal symptoms, whereas serious adverse events did not differ. Discontinuations due to side effects increased at higher doses (OR=2.31; p < 0.0001).

CONCLUSIONS

Tirzepatide induces significant, dose-dependent weight loss, with higher doses yielding greater reductions. While gastrointestinal side effects were common, they were generally mild to moderate and did not increase serious adverse events. These findings support tirzepatide as an effective weight management therapy, though strategies to mitigate gastrointestinal symptoms may improve adherence.

摘要

背景

本荟萃分析旨在评估替尔泊肽减肥的疗效和安全性,包括其剂量反应关系和不良事件谱。

方法

从高影响力期刊中检索研究,纳入1期至3期试验。参与者接受5毫克、10毫克或15毫克剂量的替尔泊肽或安慰剂对照。采用加权平均差(WMD)和95%置信区间(CI)的比值比(OR)来评估治疗效果,并使用I²统计量评估异质性。

结果

与安慰剂相比,替尔泊肽导致平均体重减轻-10.39千克(95%CI:-10.80至-9.99;p<0.00001)。按糖尿病状态进行的亚组分析显示,2型糖尿病患者在5毫克剂量时体重减轻-6.17千克(95%CI:-7.16至-5.17;p<0.00001),10毫克剂量时体重减轻-8.57千克(95%CI:-9.41至-7.74;p<0.00001),15毫克剂量时体重减轻-9.60千克(95%CI:-10.32至-8.89;p<0.00001)。非糖尿病参与者在相应剂量下体重绝对减轻更多,分别为-12.10千克(95%CI:-13.47至-10.72;p<0.00001)、-15.94千克(95%CI:-17.25至-14.62;p<0.00001)和-17.86千克(95%CI:-19.19至-16.54;p<0.00001)。替尔泊肽还显著增加了实现具有临床意义的体重减轻的几率:体重减轻≥5%(OR=11.32;p<0.0001)、≥10%(OR=14.77;p<0.0001)和≥15%(OR=18.07;p<0.0001)。替尔泊肽组的不良事件比安慰剂组更频繁(OR=1.34;p<0.0001),主要由胃肠道症状引起,而严重不良事件无差异。因副作用导致的停药率在较高剂量时增加(OR=2.31;p<0.0001)。

结论

替尔泊肽可导致显著的、剂量依赖性体重减轻,剂量越高减重越多。虽然胃肠道副作用常见,但一般为轻至中度,且未增加严重不良事件。这些发现支持替尔泊肽作为一种有效的体重管理疗法,不过减轻胃肠道症状的策略可能会提高依从性。

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本文引用的文献

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2
Incidence of new onset type 2 diabetes in adults living with obesity treated with tirzepatide or semaglutide: real world evidence from an international retrospective cohort study.使用替尔泊肽或司美格鲁肽治疗的肥胖成年患者新发2型糖尿病的发病率:一项国际回顾性队列研究的真实世界证据
EClinicalMedicine. 2024 Aug 15;75:102777. doi: 10.1016/j.eclinm.2024.102777. eCollection 2024 Sep.
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A review of serious adverse events linked with GLP-1 agonists in type 2 diabetes mellitus and obesity treatment.
GLP-1 激动剂在 2 型糖尿病和肥胖症治疗中与严重不良事件相关的综述。
Pharmacol Rep. 2024 Oct;76(5):981-990. doi: 10.1007/s43440-024-00629-x. Epub 2024 Aug 2.
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Understanding the cause of type 2 diabetes.了解2型糖尿病的病因。
Lancet Diabetes Endocrinol. 2024 Sep;12(9):664-673. doi: 10.1016/S2213-8587(24)00157-8. Epub 2024 Jul 19.
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Tirzepatide for Weight Reduction in Chinese Adults With Obesity: The SURMOUNT-CN Randomized Clinical Trial.司美格鲁肽在中国肥胖成人中的体重减轻作用:SURMOUNT-CN 随机临床试验。
JAMA. 2024 Aug 20;332(7):551-560. doi: 10.1001/jama.2024.9217.
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Long-Term Efficacy and Safety of Once-Weekly Semaglutide for Weight Loss in Patients Without Diabetes: A Systematic Review and Meta-Analysis of Randomized Controlled Trials.长期每周一次司美格鲁肽治疗无糖尿病患者的体重减轻的疗效和安全性:系统评价和随机对照试验的荟萃分析。
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