Yan Yong, Sha Yanhua, Yao Guoxiang, Wang Shiguang, Kong Fanzhi, Liu Haijun, Zhang Guangjun, Zhang Haiqing, Hu Cheng, Zhang Xueli
From the Department of General Surgery (YY, GY, SW, FK, HL, GZ, HZ, XZ), Fengxian Central Hospital, Affiliated Hospital of Southern Medical University, Shanghai; Laboratory Medicine Center (YS), Nanfang Hospital, Southern Medical University, Guangzhou; and Department of Endocrinology and Metabolism (CH), Shanghai Diabetes Institute, Shanghai Jiao Tong University Affiliated Sixth People's Hospital, Shanghai, China.
Medicine (Baltimore). 2016 Apr;95(17):e3462. doi: 10.1097/MD.0000000000003462.
The aim of the study is to compare Roux-en-Y gastric bypass (RYGB) surgery versus medical treatment for type 2 diabetes mellitus (T2DM) in obese patients.Bariatric surgery can achieve remission of T2DM in obese patients. RYGB surgery has been performed as one of the most common surgical treatment options for obese patients with T2DM, but the efficacy of RYGB surgery comparing with medical treatment alone has not been conclusively determined.A systematic literature search identified randomized controlled trials (RCTs) evaluating RYGB surgery versus medical treatment for T2DM in obese patients was conducted in PubMed, Embase, Cochrane Database, and Cochrane Clinical Trials Registry. This systematic review and meta-analysis were performed according to the preferred reporting items for systematic reviews and meta-analyses (PRISMA) guidelines. The primary outcome was T2DM remission. Additional analyses comprised hemoglobin A1c (HbA1c), fasting plasma glucose (FPG), body mass index (BMI), waist circumference, serum lipid level, blood pressure, medication use, and adverse events. Random-effects meta-analyses were calculated and presented as weighted odds ratio (OR) or mean difference (MD) with 95% confidence intervals (CI).Six RCTs concerning 410 total obese T2DM patients were included. Follow-up ranged from 12 to 60 months. RYGB surgery was associated with a higher T2DM remission rate (OR: 76.37, 95% CI: 20.70-281.73, P < 0.001) and serum level of high-density lipoprotein cholesterol (MD: 0.24 mmol/L, 95% CI 0.18-0.30 mmol/L, P < 0.001) than medical treatment alone. HbA1c (MD: -1.25%, 95% CI: -1.88% to -0.63%, P < 0.001), BMI (MD: -6.54 kg/m, 95% CI: -9.28 to -3.80 kg/m, P < 0.001), waist circumference (MD: -15.60 cm, 95% CI: -18.21 to -13.00 cm, P < 0.001), triglyceride (MD: -0.87 mmol/L, 95% CI: -1.17 to -0.57 mmol/L, P < 0.001), low-density lipoprotein cholesterol (MD: -0.32 mmol/L, 95% CI: -0.62 to -0.02 mmol/L, P = 0.04), systolic blood pressure (MD: -2.83 mm Hg, 95% CI: -4.88 to -0.78 mm Hg, P < 0.01) were lower after RYGB surgery. However, FPG (MD: -1.58 mmol/L, 95% CI: -3.58 to 0.41 mmol/L, P = 0.12), total cholesterol (MD: -0.40 mmol/L, 95% CI: -0.92 to 0.12 mmol/L, P = 0.13), and diastolic blood pressure (MD: 0.28 mm Hg, 95% CI: -1.89 to 2.45 mm Hg, P = 0.80) were not significantly different between the 2 treatment groups. The medicine use and quality of life were solely improved in the surgical group. Nutritional deficiencies and anemia were noted more frequently in the RYGB group.RYGB surgery is superior to medical treatment for short- to medium-term remission of T2DM, improvement of metabolic condition, and cardiovascular risk factors. Further RCTs should address the safety and long-term benefits of RYGB surgery on obese patients with T2DM.
本研究旨在比较肥胖患者中,Roux-en-Y胃旁路术(RYGB)与2型糖尿病(T2DM)药物治疗的效果。减肥手术可使肥胖患者的T2DM得到缓解。RYGB手术已成为肥胖T2DM患者最常用的手术治疗方法之一,但与单纯药物治疗相比,RYGB手术的疗效尚未最终确定。通过在PubMed、Embase、Cochrane数据库和Cochrane临床试验注册库中进行系统文献检索,确定了评估肥胖患者中RYGB手术与T2DM药物治疗的随机对照试验(RCT)。本系统评价和荟萃分析按照系统评价和荟萃分析的首选报告项目(PRISMA)指南进行。主要结局是T2DM缓解。额外分析包括糖化血红蛋白(HbA1c)、空腹血糖(FPG)、体重指数(BMI)、腰围、血脂水平、血压、药物使用和不良事件。计算随机效应荟萃分析,并以加权比值比(OR)或平均差(MD)及95%置信区间(CI)呈现。纳入了6项涉及410例肥胖T2DM患者的RCT。随访时间为12至60个月。与单纯药物治疗相比,RYGB手术的T2DM缓解率更高(OR:76.37,95%CI:20.70-281.73,P<0.001),血清高密度脂蛋白胆固醇水平更高(MD:0.24 mmol/L,95%CI 0.18-0.30 mmol/L,P<0.001)。RYGB手术后,HbA1c(MD:-1.25%,95%CI:-1.88%至-0.63%,P<0.001)、BMI(MD:-6.54 kg/m,95%CI:-9.28至-3.80 kg/m,P<0.001)、腰围(MD:-15.60 cm,95%CI:-18.2至-13.00 cm,P<0.001)、甘油三酯(MD:-0.87 mmol/L,95%CI:-1.17至-0.57 mmol/L,P<0.001)、低密度脂蛋白胆固醇(MD:-0.32 mmol/L,95%CI:-0.62至-0.02 mmol/L,P=0.04)、收缩压(MD:-2.83 mmHg,95%CI:-4.88至-0.78 mmHg,P<0.01)更低。然而,2个治疗组之间的FPG(MD:-1.58 mmol/L,95%CI:-3.58至0.41 mmol/L,P=0.12)、总胆固醇(MD:-0.40 mmol/L,95%CI:-0.92至0.12 mmol/L,P=0.13)和舒张压(MD:0.28 mmHg,95%CI:-1.89至2.45 mmHg,P=0.80)无显著差异。手术组的药物使用和生活质量仅得到改善。RYGB组更常出现营养缺乏和贫血。RYGB手术在T2DM的短期至中期缓解、代谢状况改善和心血管危险因素方面优于药物治疗。进一步的RCT应探讨RYGB手术对肥胖T2DM患者的安全性和长期益处。