JAMA Intern Med:GLP-1RA与胆囊或胆道事件相关

2022-06-10 MedSci原创 MedSci原创

GLP-1RA单独使用低血糖风险小,同时兼具减重、降压、改善血脂等作用。因此已被2017版《中国2型糖尿病防治指南》纳入作为二甲双胍之后的二联治疗选择之一。近年来,多个GLP-1RA在我国获批,同时多

GLP-1RA单独使用低血糖风险小,同时兼具减重、降压、改善血脂等作用。因此已被2017版《中国2型糖尿病防治指南》纳入作为二甲双胍之后的二联治疗选择之一。近年来,多个GLP-1RA在我国获批,同时多项心血管结局研究证明部分GLP-1RA具有心肾保护作用,众多国际和中国指南中GLP-1RA 在2型糖尿病(T2DM)合并动脉粥样硬化性心血管疾病(ASCVD)或心血管高风险患者中已被推荐为首选联合用药之一。例如,在2020版《中国2型糖尿病防治指南》中,推荐合并动脉粥样硬化性心血管疾病(ASCVD)或心血管风险高危的2型糖尿病(T2DM)患者,不论其糖化血红蛋白(HbA1c)是否达标,只要没有禁忌证都应在二甲双胍的基础上应用有ASCVD获益证据的GLP-1RA或SGLT-2i。 截止到2021年,已获批在我国上市的GLP-1RA包括艾塞那肽、利拉鲁肽、艾塞那肽微球、度拉糖肽等。不过,GLP-1 RA与胆囊、胆道疾病之间的关联一直存在争议。

2022年5月,北京协和医院内分泌科张化冰、何丽云等人的研究成果发表在国际著名医学期刊JAMA Internal Medicine上。

研究团队在MEDLINE/PubMed、EMBASE、Web of Science、Cochrane Library、临床试验注册网站上对相关随机对照试验进行检索,共纳入76项随机临床试验进行荟萃分析,对应用新型降糖药物胰高血糖素样肽-1受体激动剂(GLP-1RA)与胆道疾病发生的关系进行了评估。

研究显示,GLP-1RA与胆囊或胆道事件相关。

图片

新型降糖药物胰高血糖素样肽-1受体激动剂(GLP-1RA)可降低血糖,同时改善代谢。大规模随机对照研究证实,部分GLP-1RA可以减少心梗、脑卒中事件发生,甚至降低死亡。现行国内外糖尿病管理指南建议在心血管疾病高风险或确诊心血管疾病的2型糖尿病患者中优先使用GLP-1RA。部分GLP-1RA已在国外获批用于减重治疗,成为非常有前途的减重药物。对GLP-1RA进行全面评估具有非常重要的实践意义。

本研究从7214项初始研究中最终筛选出76项对比使用GLP-1RA药物和安慰剂,或非GLP-1RA药物的随机对照研究,总计纳入103 371例患者(平均年龄,57.8岁;女性占比40.5%),系统评估了GLP-1RA与胆道疾病发生的关系。研究还对GLP-1RA的剂量、用药时长和治疗目的是否对胆囊或胆道疾病发生存在影响进行了评估。

分析发现,随机分配至GLP-1RA治疗与胆囊或胆道疾病风险增加相关(RR,1.37;95% CI,1.23-1.52),具体而言:胆石症风险增加27%(RR,1.27;95% CI,1.10-1.47);胆囊炎风险增加36%(RR,1.36;95% CI,1.14-1.62);胆道疾病风险增加55%(RR,1.55;95% CI,1.08-2.22)。
 
图片

▲GLP-1RA治疗的患者与对照组胆系事件发生的比较

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▲GLP-1RA剂量、用药时长和治疗目的对胆系事件发生的影响

本研究提示GLP-1RA与胆囊或胆道事件相关,尤其是在更高剂量、更长用药时间和以减重为目的的人群中。

在以“减肥”为目的的试验中,GLP-1 RAs的使用同样也与胆囊或胆道疾病的风险增加相关(n=13;RR,2.29;95%CI,1.64-3.18)。

药物剂量方面,在所有纳入的试验中,与低剂量(RR, 0.99; 95% CI, 0.73-1.33; 交互作用P=0.006)相比,高剂量(RR,1.56;95% CI,1.36-1.78)使用GLP-1 RA与更高的胆囊或胆道疾病风险相关。

在用药时长方面,相比短期使用(RR, 0.79;95% CI, 0.48-1.31; 交互作用P=0.03),更长的使用时间(RR, 1.40; 95% CI, 1.26-1.56)与更高的胆囊或胆道疾病风险相关。

但需要指出的是:体重减少本身会增加胆系疾病的发生风险,目前尚不清楚胆囊和胆道事件增加的原因是GLP-1RA使用相关的体重减轻还是其他机制。

在有明确心血管疾病的患者中,估算1000人接受GLP-1RA治疗5年中可以绝对降低心血管事件37起,而这1000人在5年中GLP-1RA的使用仅与增加6.5起胆囊或胆道事件相关,GLP-1RA增加胆系疾病的绝对风险并不高,我们需要根据这一绝对风险对治疗决策进行评估,合理使用GLP-1RA。

原始出处:

He L, Wang J, Ping F, et al. Association of Glucagon-Like Peptide-1 Receptor Agonist Use With Risk of Gallbladder and Biliary Diseases: A Systematic Review and Meta-analysis of Randomized Clinical Trials. JAMA Intern Med. 2022;182(5):513–519. doi:10.1001/jamainternmed.2022.0338
 

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    2022-11-28 ms2000001381106517 来自山东省

    学习中

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    2022-11-07 360611848
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    2022-06-11 yibei
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    2022-06-10 肿瘤克星

    JAMA上文章都是顶级的,谢谢梅斯及时上新

    0

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