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纳曲酮-安非他酮疗法在中国肥胖患者中的真实世界疗效与安全性:单中心经验

Real-world efficacy and safety of naltrexone-bupropion therapy in Chinese patients with obesity: A single-centre experience.

作者信息

Lui David Tak Wai, Tsoi Kimberly Hang, Fong Carol Ho Yi, Jiang Nancy Su, Chow Wing Sun, Yuen Michele Mae Ann

机构信息

Department of Medicine, School of Clinical Medicine, Li Ka Shing Faculty of Medicine, The University of Hong Kong, Hong Kong, Hong Kong.

出版信息

Endocrine. 2025 Feb;87(2):522-529. doi: 10.1007/s12020-024-04029-2. Epub 2024 Oct 5.

Abstract

PURPOSE

Naltrexone-bupropion (Contrave®) has shown efficacy and safety in large randomised controlled trials, predominantly comprising Caucasians. Data are limited in Asian populations. We carried out a retrospective matched cohort study of Chinese patients with obesity to evaluate the efficacy and safety of naltrexone-bupropion in real-world clinical practice.

METHODS

We performed a retrospective matched cohort study of Chinese patients with obesity managed in the Obesity Clinic of Queen Mary Hospital in Hong Kong between 1 January 2016 and 31 December 2020. Electronic health records of patients treated with naltrexone-bupropion were retrieved for body weight and height, obesity-related metabolic parameters, and adverse events over a 12-month period. Age- and sex-matched controls from the Obesity Clinic who were only on self-directed lifestyle management were identified for comparison of weight changes. General linear models were used to analyse the change in body weight over 12 months.

RESULTS

Thirty-seven patients treated with naltrexone-bupropion were included (mean age 42.2 ± 8.4 years, 54.1% men, baseline body mass index 37.3 ± 4.6 kg/m), and 37 age- and sex-matched controls were included. Among the 37 naltrexone-bupropion-treated patients, the mean weight loss was 9.2 ± 5.2% at 6 months and 9.7 ± 8.1% at 12 months, which were significantly more than in controls (p < 0.001). Improvements in the obesity-related parameters were observed in association with weight loss over 12 months. Ten patients (27.0%) discontinued naltrexone-bupropion due to side effects, mainly neurological and gastrointestinal manifestations, within the first 12 months.

CONCLUSION

We demonstrated real-world efficacy and safety of naltrexone-bupropion among Chinese patients with obesity.

摘要

目的

纳曲酮-安非他酮(Contrave®)在主要纳入高加索人的大型随机对照试验中已显示出疗效和安全性。亚洲人群的数据有限。我们对中国肥胖患者进行了一项回顾性匹配队列研究,以评估纳曲酮-安非他酮在实际临床实践中的疗效和安全性。

方法

我们对2016年1月1日至2020年12月31日期间在香港玛丽医院肥胖诊所接受治疗的中国肥胖患者进行了一项回顾性匹配队列研究。检索接受纳曲酮-安非他酮治疗患者的电子健康记录,以获取12个月期间的体重、身高、肥胖相关代谢参数和不良事件。从肥胖诊所中识别出仅进行自我指导生活方式管理的年龄和性别匹配的对照,以比较体重变化。使用一般线性模型分析12个月内体重的变化。

结果

纳入了37例接受纳曲酮-安非他酮治疗的患者(平均年龄42.2±8.4岁,男性占54.1%,基线体重指数37.3±4.6kg/m²),并纳入了37例年龄和性别匹配的对照。在37例接受纳曲酮-安非他酮治疗的患者中,6个月时平均体重减轻9.2±5.2%,12个月时平均体重减轻9.7±8.1%,显著高于对照组(p<0.001)。在12个月的体重减轻过程中,观察到肥胖相关参数有所改善。10例患者(27.0%)在最初12个月内由于副作用(主要是神经和胃肠道表现)而停用纳曲酮-安非他酮。

结论

我们证明了纳曲酮-安非他酮在中国肥胖患者中的实际疗效和安全性。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/affe/11811244/2237659820c8/12020_2024_4029_Fig1_HTML.jpg

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