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糖尿病患者减肥手术与强化药物疗法的5年结局比较研究
Bariatric Surgery versus Intensive Medical Therapy for Diabetes — 5-Year Outcomes


Philip R. Schauer ... 糖尿病 • 2017.02.16
相关阅读
• 重度肥胖症胃旁路手术随访12年结局 • 胃旁路术12年后的体重和代谢结局 • 肥胖糖尿病患者的减肥手术和药物治疗之对比

摘要


背景

目前在2型糖尿病患者中,比较药物治疗和手术治疗的随机、对照试验的长期结果有限。

 

方法

我们将150例体质指数(BMI:体重[kg]除以身高[m]的平方)为27至43的2型糖尿病患者随机分成单纯药物强化治疗、药物强化治疗联合Roux-en-Y胃旁路术和药物强化治疗联合袖状胃切除术三组,并评估其随机分组后5年时的结局。主要结局为使用或不使用糖尿病药物的情况下糖化血红蛋白水平≤6.0%。

 

结果

接受随机化的150例患者中,5年随访期间1例患者死亡,其余149例患者中134例(90%)完成5年随访。基线时,134例患者的平均(±SD)年龄为49±8岁,66%为女性,糖化血红蛋白平均水平为9.2%±1.5%,平均BMI为37±3.5。5年时,与38例单纯药物治疗患者中有2例(5%)达到主要终点标准相比,49例胃旁路术患者中有14例(29%)达到主要终点标准(非校正P=0.01,校正P=0.03,意向治疗分析P=0.08),而47例袖状胃切除术患者中有11例(23%)达到主要终点标准(非校正P=0.03,校正P=0.07,意向治疗分析P=0.17)。手术治疗组患者糖化血红蛋白水平相对于基线的平均降低百分比大于单纯药物治疗组患者(2.1%对0.3%,P=0.003)。5年时,胃旁路术及袖状胃切除术患者相对于基线发生的变化优于药物治疗组,主要体现在以下指标(分别对应胃旁路术、袖状胃切除术及药物治疗组数值):体重(-23%、-19%及-5%)、三酰甘油水平(-40%、-29%及-8%)、高密度脂蛋白胆固醇水平(32%、30%及7%)、胰岛素的使用(-35%、-34%及-13%)、生活质量评估指标(一般健康评分提高17、16及0.3;RAND 36项健康调查[RAND 36-Item Health Survey]评分范围是0至100,较高评分表示较好的健康状况)(所有组间比较均为P<0.05)。除了1例患者再次行手术之外,没有重大后期手术并发症的报道。

 

结论

5年结局数据显示,在BMI为27至43的2型糖尿病患者中,减肥手术联合药物强化治疗在减轻或某些情况下缓解高血糖方面较单纯药物强化治疗更有效(该研究由Ethicon Endo-Surgery等资助;STAMPEDE在ClinicalTrials.gov注册号为NCT00432809)。





作者信息

Philip R. Schauer, M.D., Deepak L. Bhatt, M.D., M.P.H., John P. Kirwan, Ph.D., Kathy Wolski, M.P.H., Ali Aminian, M.D., Stacy A. Brethauer, M.D., Sankar D. Navaneethan, M.D., M.P.H., Rishi P. Singh, M.D., Claire E. Pothier, M.P.H., Steven E. Nissen, M.D., and Sangeeta R. Kashyap, M.D., for the STAMPEDE Investigators*
From the Bariatric and Metabolic Institute (P.R.S., A.A., S.A.B.), Lerner Research Institute (J.P.K.), Cleveland Clinic Coordinating Center for Clinical Research (K.W., C.E.P., S.E.N.), Cole Eye Institute (R.P.S.), and Endocrinology Institute (S.R.K.), Cleveland Clinic, Cleveland; Brigham and Women’s Hospital Heart and Vascular Center and Harvard Medical School, Boston (D.L.B.); and the Section of Nephrology, Baylor College of Medicine, Houston (S.D.N.). Address reprint requests to Dr. Schauer at the Bariatric and Metabolic Institute, Cleveland Clinic, M61, 9500 Euclid Ave., Cleveland, OH 44195, or at schauep@ccf.org. The contributions of the authors and committee members in the Surgical Treatment and Medications Potentially Eradicate Diabetes Efficiently (STAMPEDE) trial are listed in the Supplementary Appendix, available at NEJM.org.

 

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