减重手术与强化药物治疗糖尿病——3 年结果。
Bariatric surgery versus intensive medical therapy for diabetes--3-year outcomes.
机构信息
From the Bariatric and Metabolic Institute (P.R.S., S.A.B., A.A.), Lerner Research Institute (J.P.K.), Heart and Vascular Institute (K.W., C.E.P., E.S.H.K., S.E.N.), Urological and Kidney Institute (S.D.N.), and Endocrinology Institute (S.R.K.), Cleveland Clinic, Cleveland; and Brigham and Women's Hospital Heart and Vascular Center and Harvard Medical School - both in Boston (D.L.B.).
出版信息
N Engl J Med. 2014 May 22;370(21):2002-13. doi: 10.1056/NEJMoa1401329. Epub 2014 Mar 31.
BACKGROUND
In short-term randomized trials (duration, 1 to 2 years), bariatric surgery has been associated with improvement in type 2 diabetes mellitus.
METHODS
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.
RESULTS
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.
CONCLUSIONS
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.).
背景
在为期 1 至 2 年的短期随机试验中，减重手术已被证明可改善 2 型糖尿病。
方法
我们评估了 150 名肥胖且未控制的 2 型糖尿病患者随机接受强化药物治疗（对照组）或强化药物治疗联合 Roux-en-Y 胃旁路术或袖状胃切除术 3 年后的结局。主要终点为糖化血红蛋白水平<6.0%。
结果
患者基线时的平均（±SD）年龄为 48±8 岁，68%为女性，基线时糖化血红蛋白水平为 9.3±1.5%，基线时体重指数（kg/㎡）为 36.0±3.5。共有 91%的患者完成了 36 个月的随访。3 年后，对照组有 5%的患者达到主要终点，而胃旁路术组为 38%（P<0.001），袖状胃切除术组为 24%（P=0.01）。手术组使用降糖药物（包括胰岛素）的比例低于对照组。手术组患者的体重较基线平均下降幅度更大，胃旁路术组下降 24.5±9.1%，袖状胃切除术组下降 21.1±8.9%，而对照组仅下降 4.2±8.3%（两者均 P<0.001）。两组手术组的生活质量评分均明显优于对照组。两组手术均无重大晚期手术并发症。
结论
在肥胖且未控制的 2 型糖尿病患者中，与单纯强化药物治疗相比，3 年强化药物治疗联合减重手术可使更多患者血糖得到控制。次要终点分析包括体重、降糖药物使用和生活质量，结果也显示手术组在 3 年内优于单纯药物治疗组。（由 Ethicon 等资助；STAMPEDE 临床试验注册编号，NCT00432809）。
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