英国伦敦国王学院Geltrude Mingrone团队比较了代谢手术和传统药物治疗2型糖尿病的长期随访疗效。2021年1月23日，该研究发表在《柳叶刀》杂志上。

糖尿病代谢手术的随机对照试验尚无超过五年的随访数据。为了评估术后10年随访与2型糖尿病药物治疗的效果，研究组对一项开放性、单中心（意大利罗马三级医院）的随机对照试验进行了10年的随访研究。

研究组招募2型糖尿病患者，其基线持续时间>5年，糖化血红蛋白（HbA1c）>7.0%，体重指数<35 kg/m²。将其按1：1随机分组，分别接受药物治疗、Roux-en-Y胃分流术（RYGB）或胰胆分流术（BPD）。研究的主要终点是2年后的糖尿病缓解（HbA1c<6.5%，空腹血糖<5.55 mmol/L，且至少1年没有持续用药）。在10年的分析中，通过意向治疗（ITT）来分析糖尿病缓解的持久性。

2009年4月30日至2011年10月31日，研究组共纳入60名合格患者。10年随访率为95.0%（57/60）。在所有接受手术治疗的患者中，有15例（37.5%）在整个10年期间维持糖尿病缓解。具体而言，ITT人群中药物治疗的10年缓解率为5.5%，BPD为50.0%，RYGB为25.0%。

随访期间，研究组观察到2年后病情缓解的34名参与者中有20名（58.8%）出现高血糖复发（BPD组52.6%，RYGB组66.7%）。然而，所有复发患者在10年时都维持了足够的血糖控制（平均HbA1c 6%）。与药物治疗组相比，RYGB组和BPD组的参与者糖尿病相关并发症较少。BPD组的参与者发生严重不良事件的频率更高。

研究结果表明，在2型糖尿病的长期控制中，代谢手术比传统的药物治疗更有效。

附：英文原文

Title: Metabolic surgery versus conventional medical therapy in patients with type 2 diabetes: 10-year follow-up of an open-label, single-centre, randomised controlled trial

Author: Geltrude Mingrone, Simona Panunzi, Andrea De Gaetano, Caterina Guidone, Amerigo Iaconelli, Esmeralda Capristo, Ghassan Chamseddine, Stefan R Bornstein, Francesco Rubino

Issue&Volume: 2021/01/23

Abstract:

Background

No data from randomised controlled trials of metabolic surgery for diabetes are available beyond 5 years of follow-up. We aimed to assess 10-year follow-up after surgery compared with medical therapy for the treatment of type 2 diabetes.

Methods

We did a 10-year follow-up study of an open-label, single-centre (tertiary hospital in Rome, Italy), randomised controlled trial, in which patients with type 2 diabetes (baseline duration >5 years; glycated haemoglobin [HbA 1c] >7·0%, and body-mass index ≥35 kg/m 2) were randomly assigned (1:1:1) to medical therapy, Roux-en-Y gastric bypass (RYGB), or biliopancreatic diversion (BPD) by a computerised system. The primary endpoint of the study was diabetes remission at 2 years (HbA 1c <6·5% and fasting glycaemia <5·55 mmol/L without ongoing medication for at least 1 year). In the 10-year analysis, durability of diabetes remission was analysed by intention to treat (ITT). This study is registered with ClinicalTrials.gov, NCT00888836.

Findings

Between April 30, 2009, and Oct 31, 2011, of 72 patients assessed for eligibility, 60 were included. The 10-year follow-up rate was 95·0% (57 of 60). Of all patients who were surgically treated, 15 (37·5%) maintained diabetes remission throughout the 10-year period. Specifically, 10-year remission rates in the ITT population were 5·5% for medical therapy (95% CI 1·0–25·7; one participant went into remission after crossover to surgery), 50·0% for BPD (29·9–70·1), and 25·0% for RYGB (11·2–46·9; p=0·0082). 20 (58·8%) of 34 participants who were observed to be in remission at 2 years had a relapse of hyperglycaemia during the follow-up period (BPD 52·6% [95% CI 31·7–72·7]; RYGB 66·7% [41·7–84·8]). All individuals with relapse, however, maintained adequate glycaemic control at 10 years (mean HbA 1c 6·7% [SD 0·2]). Participants in the RYGB and BPD groups had fewer diabetes-related complications than those in the medical therapy group (relative risk 0·07 [95% CI 0·01–0·48] for both comparisons). Serious adverse events occurred more frequently among participants in the BPD group (odds ratio [OR] for BPD vs medical therapy 2·7 [95% CI 1·3–5·6]; OR for RYGB vs medical therapy 0·7 [0·3–1·9]).

Interpretation

Metabolic surgery is more effective than conventional medical therapy in the long-term control of type 2 diabetes. Clinicians and policy makers should ensure that metabolic surgery is appropriately considered in the management of patients with obesity and type 2 diabetes.

DOI: 10.1016/S0140-6736(20)32649-0

Source: https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(20)32649-0/fulltext