2 型糖尿病的医学管理与减重手术的长期结果比较。
Long-Term Outcomes of Medical Management vs Bariatric Surgery in Type 2 Diabetes.
机构信息
Department of Surgery, University of Pittsburgh, Pittsburgh, Pennsylvania.
Research Division, Joslin Diabetes Center, and Harvard Medical School, Boston, Massachusetts.
出版信息
JAMA. 2024 Feb 27;331(8):654-664. doi: 10.1001/jama.2024.0318.
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.
重要性：减重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：确定与 2 型糖尿病的医学/生活方式管理相比，减重手术在长期血糖控制和安全性方面的效果。
设计、地点和参与者：ARMMS-T2D（2 型糖尿病药物与代谢手术的联盟随机试验）是一项汇总分析，来自美国的 4 项单中心随机试验，这些试验于 2007 年 5 月至 2013 年 8 月进行，观察性随访持续到 2022 年 7 月。
干预措施：参与者最初被随机分配接受医学/生活方式管理或以下 3 种减重手术之一：Roux-en-Y 胃旁路术、袖状胃切除术或可调胃束带术。
主要结果和测量：主要结局是所有参与者从基线到 7 年时的血红蛋白 A1c（HbA1c）变化。数据报告最多可达 12 年。
结果：共有 305 名符合条件的参与者中的 262 名（86%）参加了本次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）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，随机接受医学/生活方式管理的参与者中有 25%接受了减重手术。中位随访时间为 11 年。在 7 年时，医学/生活方式组的 HbA1c 降低了 0.2%（95%CI，-0.5%至 0.2%），从基线的 8.2%，而减重手术组的 HbA1c 降低了 1.6%（95%CI，-1.8%至-1.3%），从基线的 8.7%。两组之间的差异为-1.4%（95%CI，-1.8%至-1.0%；P < .001）在 7 年时和-1.1%（95%CI，-1.7%至-0.5%；P = .002）在 12 年时。减重手术组使用的抗糖尿病药物较少。糖尿病缓解率在减重手术后更高（医学/生活方式组为 6.2%，减重手术组为 18.2%；P = .02），在 7 年和 12 年时（医学/生活方式组为 0.0%，减重手术组为 12.7%；P < .001）。有 4 例死亡（2.2%），每组 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重手术后更为常见。
结论和相关性：在 7 至 12 年的随访后，与医学/生活方式干预相比，最初随机接受减重手术的个体在血糖控制方面更优，使用糖尿病药物的剂量更少，糖尿病缓解率更高。
试验注册：ClinicalTrials.gov 标识符：NCT02328599。
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