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代谢手术对超重/肥胖2型糖尿病患者长期(5年)体重减轻和糖尿病缓解的益处与风险比较:一项随机试验的系统评价和网状Meta分析

Comparison of Benefits and Risks of Metabolic Surgery for Long-Term (5 Years) Weight Loss and Diabetes Remission in Overweight/Obese Patients With Type 2 Diabetes: A Systematic Review and Network Meta-Analysis of Randomized Trials.

作者信息

Zang Xiaoyu, Lin Tong, Ma Jing, Zhang Ying, Zhang Boxun, Huang Yishan, Zhou Danni, Ding Lu, Zhang Lili, Zhao Linhua

机构信息

Graduate College, Changchun University of Chinese Medicine, Changchun, China.

China Academy of Chinese Medical Sciences, Institute of Metabolic Diseases, Guang' Anmen Hospital, Beijing, China.

出版信息

Diabetes Metab Res Rev. 2025 Mar;41(3):e70033. doi: 10.1002/dmrr.70033.

DOI:10.1002/dmrr.70033
PMID:40121602
Abstract

BACKGROUND

While there have been studies comparing the efficiency of several metabolic operations in overweight or obese individuals with type 2 diabetes mellitus (T2DM), there is currently no comprehensive evidence about the complete remission of diabetes and its long-term safety.

METHODS

This comprehensive review and network meta-analysis encompassed searches of many databases including PubMed, Web of Science, Embase, the Cochrane Central Register of Controlled Trials (CENTRAL), Scopus, ClinicalTrials.gov, and Google Scholar. The search was conducted from the beginning of these databases' existence until 1 May 2024. The study selected randomized controlled trials (RCTs) with a 5-year follow-up period to compare the clinical benefits and evaluate the occurrence of side events. The network meta-analysis employed a random-effects model. The registration number for PROSPERO is CRD42023412536.

RESULTS

There was a total of 16 RCTs that included 1059 patients. A total of 897 patients, representing 84.7% of the entire sample, successfully completed the 5-year follow-up. Seven metabolic procedures were conducted. All ensuing estimates are to the comparison with a non-surgical treatment (NST). The evidence strongly supports that One-anastomosis gastric bypass (OAGB) is the most effective surgical procedure for achieving long-term complete remission of diabetes (relative risk [RR] 10.28, 95% CI 1.87 to 56.40). Additionally, Biliopancreatic diversion (BPD) is the most effective procedure for achieving long-term partial remission of diabetes (RR 16.74, 95% CI 4.66 to 60.12). The study found that BPD was the most successful method for long-term weight loss, with a mean difference of -11.68 in BMI decrease (95% CI -15.06 to -8.31) and a mean difference of -32.01 in weight change (95% CI -43.27 to -20.74). The evidence supporting this conclusion is of moderate quality. Regarding the occurrence of adverse events and complications related to surgery, gastrointestinal, macrovascular, and microvascular issues are not as frequent in BPD compared with NST (relative risk 0.29, 95% confidence interval 0.06 to 1.37). On the other hand, OAGB may have a higher occurrence of these difficulties, second only to BPD (relative risk 0.08, 95% confidence interval 0.2 to 3.29). Based on the findings on effectiveness and safety, it has been determined that OAGB (One Anastomosis Gastric Bypass) is more effective in obtaining long-term complete remission of diabetes and in assuring overall safety in diabetes management. However, BPD is superior to OAGB in terms of partial remission, weight loss and safety in diabetes management, ranking second in these aspects.

CONCLUSIONS

Both BPD and OAGB have been demonstrated superior efficacy in achieving long-term weight loss and diabetes remission in overweight/obese individuals with T2DM. OAGB is particularly advantageous for achieving long-term complete remission of diabetes mellitus and boasts a higher level of safety overall. The study found that BPD was the most efficacious treatment for achieving partial remission and weight loss in patients with long-term diabetes, while also having the lowest number of reported side events.

摘要

背景

虽然已有研究比较了超重或肥胖的2型糖尿病(T2DM)患者几种代谢手术的疗效,但目前尚无关于糖尿病完全缓解及其长期安全性的全面证据。

方法

本系统评价和网状Meta分析检索了多个数据库,包括PubMed、Web of Science、Embase、Cochrane对照试验中心注册库(CENTRAL)、Scopus、ClinicalTrials.gov和谷歌学术。检索从这些数据库建立之初至2024年5月1日。该研究选择了随访期为5年的随机对照试验(RCT),以比较临床获益并评估不良事件的发生情况。网状Meta分析采用随机效应模型。PROSPERO注册号为CRD42023412536。

结果

共有16项RCT,纳入1059例患者。共有897例患者(占整个样本的84.7%)成功完成了5年随访。进行了7种代谢手术。所有后续估计均为与非手术治疗(NST)的比较。证据有力地支持单吻合口胃旁路术(OAGB)是实现糖尿病长期完全缓解最有效的手术方法(相对危险度[RR]10.28,95%可信区间1.87至56.40)。此外,胆胰转流术(BPD)是实现糖尿病长期部分缓解最有效的手术方法(RR 16.74,95%可信区间4.66至60.12)。该研究发现,BPD是长期体重减轻最成功的方法,体重指数降低的平均差值为-11.68(95%可信区间-15.06至-8.31),体重变化的平均差值为-32.01(95%可信区间-43.27至-20.74)。支持这一结论的证据质量中等。关于与手术相关的不良事件和并发症的发生情况,与NST相比,BPD中胃肠道、大血管和微血管问题的发生频率较低(相对危险度0.29,95%可信区间0.06至1.37)。另一方面,OAGB可能有更高的此类困难发生率,仅次于BPD(相对危险度0.08,95%可信区间0.2至3.29)。基于有效性和安全性的研究结果,已确定OAGB(单吻合口胃旁路术)在实现糖尿病长期完全缓解和确保糖尿病管理的总体安全性方面更有效。然而,BPD在部分缓解、体重减轻和糖尿病管理安全性方面优于OAGB,在这些方面排名第二。

结论

BPD和OAGB在超重/肥胖的T2DM患者实现长期体重减轻和糖尿病缓解方面均显示出卓越疗效。OAGB在实现糖尿病长期完全缓解方面特别有利,总体安全性更高。该研究发现,BPD是实现长期糖尿病患者部分缓解和体重减轻最有效的治疗方法,同时报告的不良事件数量也最少。

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