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期刊来源：JAMA

原文链接：https://doi.org/10.1001/jama.2024.0318

摘要内容如下：

重要性

减肥手术的随机临床试验在规模、手术类型和随访时间方面受到限制。

目的

与2型糖尿病的药物/生活方式管理相比，确定减肥手术的长期血糖控制和安全性。

设计、设置和参与者

ARMMS-T2D（Alliance of Randomized Trials of Medicine vs Metabolic Surgery in Type 2 Diabetes）是对2007年5月至2013年8月期间进行的4项美国单中心随机试验的汇总分析，观察性随访至2022年7月。

干预

参与者最初被随机分为两组，一组接受药物/生活方式管理，另一组接受以下3种减肥手术中的一种：Roux-en-Y胃旁路术、袖状胃切除术或可调节胃束带术。

主要成果和措施

主要结果是所有参与者的糖化血红蛋白（HbA1c）从基线到7年的变化。数据报告长达12年。

结果

在305名符合条件的参与者中，共有262人（86%）参加了该汇总分析的长期随访。参与者的平均（SD）年龄为49.9（8.3）岁，平均（SD）身体质量指数为36.4（3.5），68.3%为女性，31%为黑人，67.2%为白人。在随访期间，随机接受药物/生活方式管理的参与者中有25%接受了减肥手术。中位随访时间为11年。7年时，医学/生活方式组的HbA1c从基线8.2%下降了0.2%（95%CI，-0.5%至0.2%），减肥手术组的HbA1c从基线8.7%下降了1.6%（95%CI，-1.8%至-1.3%）。组间差异为-1.4%（95%CI，-1.8%至-1.0%；P<.001）和-1.1%（95%CI，-1.7%至-0.5%；12岁时P=.002）。减肥手术组使用的抗糖尿病药物较少。减肥手术后糖尿病缓解率更高（药物/生活方式组为6.2%，减肥手术组为18.2%；P=0.02）（药物/生活方式组为0.0%，减肥手术组为12.7%；P<.001）。死亡4例（2.2%），每组各2例，主要心血管不良事件无差异。贫血、骨折和胃肠道不良事件在减肥手术后更为常见。

结论和相关性

经过7至12年的随访，与药物/生活方式干预相比，最初随机接受减肥手术的患者血糖控制更好，糖尿病药物使用更少，糖尿病缓解率更高。

试用注册

ClinicalTrials.gov标识符：NCT02328599。

英文原文如下：

Abstracts

Importance  Randomized clinical trials of bariatric surgery have been limited in size, type of surgical procedure, and follow-up duration.

Objective  To determine long-term glycemic control and safety of bariatric surgery compared with medical/lifestyle management of type 2 diabetes.

Design, Setting, and Participants  ARMMS-T2D (Alliance of Randomized Trials of Medicine vs Metabolic Surgery in Type 2 Diabetes) is a pooled analysis from 4 US single-center randomized trials conducted between May 2007 and August 2013, with observational follow-up through July 2022.

Intervention  Participants were originally randomized to undergo either medical/lifestyle management or 1 of the following 3 bariatric surgical procedures: Roux-en-Y gastric bypass, sleeve gastrectomy, or adjustable gastric banding.

Main Outcome and Measures  The primary outcome was change in hemoglobin A1c (HbA1c) from baseline to 7 years for all participants. Data are reported for up to 12 years.

Results  A total of 262 of 305 eligible participants (86%) enrolled in long-term follow-up for this pooled analysis. The mean (SD) age of participants was 49.9 (8.3) years, mean (SD) body mass index was 36.4 (3.5), 68.3% were women, 31% were Black, and 67.2% were White. During follow-up, 25% of participants randomized to undergo medical/lifestyle management underwent bariatric surgery. The median follow-up was 11 years. At 7 years, HbA1c decreased by 0.2% (95% CI, -0.5% to 0.2%), from a baseline of 8.2%, in the medical/lifestyle group and by 1.6% (95% CI, -1.8% to -1.3%), from a baseline of 8.7%, in the bariatric surgery group. The between-group difference was -1.4% (95% CI, -1.8% to -1.0%; P < .001) at 7 years and -1.1% (95% CI, -1.7% to -0.5%; P = .002) at 12 years. Fewer antidiabetes medications were used in the bariatric surgery group. Diabetes remission was greater after bariatric surgery (6.2% in the medical/lifestyle group vs 18.2% in the bariatric surgery group; P = .02) at 7 years and at 12 years (0.0% in the medical/lifestyle group vs 12.7% in the bariatric surgery group; P < .001). There were 4 deaths (2.2%), 2 in each group, and no differences in major cardiovascular adverse events. Anemia, fractures, and gastrointestinal adverse events were more common after bariatric surgery.

Conclusion and Relevance  After 7 to 12 years of follow-up, individuals originally randomized to undergo bariatric surgery compared with medical/lifestyle intervention had superior glycemic control with less diabetes medication use and higher rates of diabetes remission.

Trial Registration  ClinicalTrials.gov Identifier: NCT02328599.

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