Bariatric surgery versus intensive medical therapy for diabetes--3-year outcomes.
Bariatric surgery versus intensive medical therapy for diabetes--3-year outcomes.
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DOI：
10.1056/nejmoa1401329
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发表时间：
2014-05-22
期刊：
影响因子：
--
通讯作者：
STAMPEDE Investigators
中科院分区：
文献类型：
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作者：
Schauer PR;Bhatt DL;Kirwan JP;Wolski K;Brethauer SA;Navaneethan SD;Aminian A;Pothier CE;Kim ES;Nissen SE;Kashyap SR;STAMPEDE Investigators
在短期随机试验（持续时间 1 至 2 年）中，减肥手术与 2 型糖尿病的改善相关。我们对 150 名患有未控制的 2 型糖尿病的肥胖患者进行随机分组，接受单独强化药物治疗或强化药物治疗加 Roux-en-Y 胃绕道手术或袖状胃切除术 3 年后的结果进行评估。主要终点是糖化血红蛋白水平为 6.0% 或更低。患者基线时的平均 (±SD) 年龄为 48±8 岁，68% 为女性，平均基线糖化血红蛋白水平为 9.3±1.5%，平均基线体重指数（公斤体重除以米身高的平方）为 36.0±3.5。总共91%的患者完成了36个月的随访。 3 年时，药物治疗组有 5% 的患者达到主要终点标准，而胃绕道手术组为 38%（P<0.001），袖状胃切除组为 24%（P = 0.01）。手术组中降糖药物（包括胰岛素）的使用率低于药物治疗组。手术组患者体重较基线平均下降百分比更大，胃绕道组患者体重下降24.5±9.1%，袖状胃切除术组患者体重下降21.1±8.9%，而药物治疗组患者体重下降4.2±8.3%（两项比较P<0.001）。两个手术组的生活质量指标明显优于药物治疗组。没有出现重大的晚期手术并发症。在患有未控制的 2 型糖尿病的肥胖患者中，经过 3 年的强化药物治疗加减肥手术，与单独药物治疗相比，明显有更多患者的血糖得以控制。对次要终点（包括体重、降糖药物的使用和生活质量）的分析也显示，与仅接受药物治疗的组相比，手术组在 3 年时取得了良好的结果。 （由 Ethicon 等资助；STAMPEDE ClinicalTrials.gov 编号，NCT00432809。）
In short-term randomized trials (duration, 1 to 2 years), bariatric surgery has been associated with improvement in type 2 diabetes mellitus. We assessed outcomes 3 years after the randomization of 150 obese patients with uncontrolled type 2 diabetes to receive either intensive medical therapy alone or intensive medical therapy plus Roux-en-Y gastric bypass or sleeve gastrectomy. The primary end point was a glycated hemoglobin level of 6.0% or less. The mean (±SD) age of the patients at baseline was 48±8 years, 68% were women, the mean baseline glycated hemoglobin level was 9.3±1.5%, and the mean baseline body-mass index (the weight in kilograms divided by the square of the height in meters) was 36.0±3.5. A total of 91% of the patients completed 36 months of follow-up. At 3 years, the criterion for the primary end point was met by 5% of the patients in the medical-therapy group, as compared with 38% of those in the gastric-bypass group (P<0.001) and 24% of those in the sleeve-gastrectomy group (P = 0.01). The use of glucose-lowering medications, including insulin, was lower in the surgical groups than in the medical-therapy group. Patients in the surgical groups had greater mean percentage reductions in weight from baseline, with reductions of 24.5±9.1% in the gastric-bypass group and 21.1±8.9% in the sleeve-gastrectomy group, as compared with a reduction of 4.2±8.3% in the medical-therapy group (P<0.001 for both comparisons). Quality-of-life measures were significantly better in the two surgical groups than in the medical-therapy group. There were no major late surgical complications. Among obese patients with uncontrolled type 2 diabetes, 3 years of intensive medical therapy plus bariatric surgery resulted in glycemic control in significantly more patients than did medical therapy alone. Analyses of secondary end points, including body weight, use of glucose-lowering medications, and quality of life, also showed favorable results at 3 years in the surgical groups, as compared with the group receiving medical therapy alone. (Funded by Ethicon and others; STAMPEDE ClinicalTrials.gov number, NCT00432809.)