美国路易斯安那州彭宁顿生物医学研究中心John P. Kirwan团队比较了内科治疗与减肥手术治疗2型糖尿病长期疗效。2024年2月27日，《美国医学会杂志》发表了这一成果。

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。该研究旨在确定与2型糖尿病的医疗/生活方式管理相比，减肥手术的长期血糖控制和安全性。ARMMS-T2D（2型糖尿病药物与代谢外科随机试验联盟）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，观察随访至2022年7月。

参与者最初被随机分配接受医疗/生活方式管理或以下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。主要结局是所有参与者的血红蛋白A_1c（HbA_1c）从基线到7年的变化。报告的数据长达12年。

305名符合条件的参与者中，共有262名（86%）参加了该汇总分析的长期随访。参与者的平均年龄为49.9（8.3）岁，平均体重指数为36.4（3.5），68.3%为女性，31%为黑人，67.2%为白人。在随访期间，25%随机接受医疗/生活方式管理的参与者接受了减肥手术。中位随访时间为11年。在第7年时，医疗/生活方式组的HbA_1c从基线的8.2%下降了0.2%（95%CI，-0.5%至0.2%），减肥手术组从基线的8.7%下降了1.6%（95%CI，-1.8%至-1.3%）。在第7年和第12年时组间差异为-1.4%（95%CI，-1.8%至-1.0%；P < .001）和−1.1%（95%CI，−1.7%至−0.5%；P = .002）。

减肥手术组使用的抗糖尿病药物较少。在第7年（医疗/生活方式组为6.2%，减肥手术组为18.2%；P = .02）和第12年时（医学/生活方式组为0.0%，减肥手术组为12.7%；P < .001），减肥手术后糖尿病缓解率均更高。共有4例死亡（2.2%），每组2例，重大心血管不良事件无差异。减肥手术后贫血、骨折和胃肠道不良事件更为常见。

研究结果表明，经过7至12年的随访，与医疗/生活方式干预相比，最初随机接受减肥手术的个体血糖控制更好，糖尿病药物使用更少，糖尿病缓解率更高。

附：英文原文

Title: Long-Term Outcomes of Medical Management vs Bariatric Surgery in Type 2 Diabetes

Author: Anita P. Courcoulas, Mary Elizabeth Patti, Bo Hu, David E. Arterburn, Donald C. Simonson, William F. Gourash, John M. Jakicic, Ashley H. Vernon, Gerald J. Beck, Philip R. Schauer, Sangeeta R. Kashyap, Ali Aminian, David E. Cummings, John P. Kirwan

Issue&Volume: 2024/02/27

Abstract:

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.

DOI: 10.1001/jama.2024.0318

Source: https://jamanetwork.com/journals/jama/fullarticle/2815401