Bariatric Surgery versus Intensive Medical Therapy for Diabetes - 5-Year Outcomes.
Bariatric Surgery versus Intensive Medical Therapy for Diabetes - 5-Year Outcomes.
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DOI：
10.1056/nejmoa1600869
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发表时间：
2017-02-16
期刊：
影响因子：
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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;Aminian A;Brethauer SA;Navaneethan SD;Singh RP;Pothier CE;Nissen SE;Kashyap SR;STAMPEDE Investigators
对2型糖尿病患者的内科治疗和手术治疗进行比较的随机对照试验的长期结果是有限的。我们评估了150名2型糖尿病患者的5年后的预后，这些患者的体重指数(BMI；体重除以身高的平方)在27到43之间，他们被随机分配到单独接受强化药物治疗或接受强化药物治疗加Roux-en-Y胃分流术或袖状胃切除术。主要结果是糖化血红蛋白水平在使用或不使用糖尿病药物的情况下为6.0%或以下。在接受随机分组的150名患者中，1名患者在5年随访期内死亡；其余149名患者中有134名(90%)完成了5年随访期。在基线时，134名患者的平均(±SD)年龄为49±8岁，其中66%为女性，平均糖化血红蛋白水平为9.2±1.5%，平均体重指数为37±3.5。5年时，单纯接受药物治疗的38例患者中有2例(5%)达到了主要终点的标准，而在意向治疗分析中，49例患者中有14例(未调整P=0.01，调整后P=0.03，P=0.08)和47例胃袖状切除术患者中有11例(23%)达到了主要终点的标准(在意向治疗分析中，未调整P=0.03，调整后P=0.07，P=0.17)。与单纯接受内科治疗的患者相比，接受外科手术的患者糖化血红蛋白水平的平均百分比下降幅度更大(2.1%比0.3%，P=0.003)。在5年后，胃旁路组和袖状胃切除术组在体重(胃旁路组、袖状胃切除术组和药物治疗组分别为−23%、−19%和−5%)、甘油三酯水平(−40%、−29%和−8%)、高密度脂蛋白胆固醇水平(32%、30%和7%)、胰岛素使用(−35%、−34%和−13%)、和生活质量测量(一般健康评分增加17，16和0.3；兰德36项健康调查的得分在0到100之间，得分越高表明健康状况越好(P<；所有比较都是0.05)。除了一次再次手术外，没有重大的晚期手术并发症的报道。五年的结果数据显示，在体重指数在27到43之间的2型糖尿病患者中，减肥手术加强化药物治疗在降低或在某些情况下解决高血糖方面比单独进行强化药物治疗更有效。
Long-term results from randomized, controlled trials that compare medical therapy with surgical therapy in patients with type 2 diabetes are limited. We assessed outcomes 5 years after 150 patients who had type 2 diabetes and a body-mass index (BMI; the weight in kilograms divided by the square of the height in meters) of 27 to 43 were randomly assigned to receive intensive medical therapy alone or intensive medical therapy plus Roux-en-Y gastric bypass or sleeve gastrectomy. The primary outcome was a glycated hemoglobin level of 6.0% or less with or without the use of diabetes medications. Of the 150 patients who underwent randomization, 1 patient died during the 5-year follow-up period; 134 of the remaining 149 patients (90%) completed 5 years of follow-up. At baseline, the mean (±SD) age of the 134 patients was 49±8 years, 66% were women, the mean glycated hemoglobin level was 9.2±1.5%, and the mean BMI was 37±3.5. At 5 years, the criterion for the primary end point was met by 2 of 38 patients (5%) who received medical therapy alone, as compared with 14 of 49 patients (29%) who underwent gastric bypass (unadjusted P = 0.01, adjusted P = 0.03, P = 0.08 in the intention-to-treat analysis) and 11 of 47 patients (23%) who underwent sleeve gastrectomy (unadjusted P = 0.03, adjusted P = 0.07, P = 0.17 in the intention-to-treat analysis). Patients who underwent surgical procedures had a greater mean percentage reduction from baseline in glycated hemoglobin level than did patients who received medical therapy alone (2.1% vs. 0.3%, P = 0.003). At 5 years, changes from baseline observed in the gastric-bypass and sleeve-gastrectomy groups were superior to the changes seen in the medical-therapy group with respect to body weight (−23%, −19%, and −5% in the gastric-bypass, sleeve-gastrectomy, and medical-therapy groups, respectively), triglyceride level (−40%, −29%, and −8%), high-density lipoprotein cholesterol level (32%, 30%, and 7%), use of insulin (−35%, −34%, and −13%), and quality-of-life measures (general health score increases of 17, 16, and 0.3; scores on the RAND 36-Item Health Survey ranged from 0 to 100, with higher scores indicating better health) (P<0.05 for all comparisons). No major late surgical complications were reported except for one reoperation. Five-year outcome data showed that, among patients with type 2 diabetes and a BMI of 27 to 43, bariatric surgery plus intensive medical therapy was more effective than intensive medical therapy alone in decreasing, or in some cases resolving, hyperglycemia.