Lancet Diab & Endo:Roux-en-Y胃旁路术治疗T2DM

2015-05-31 沐晴 MedSci原创

背景:治疗T2DM的传统方法疗效有限,本研究旨在评估除了强化生活方式干预和药物治疗外,Roux-en-Y胃旁路术治疗T2DM的疗效与风险。 <span style="font-size:12.0pt;mso-bidi-font-family: Helvetica;color:#2F2F33;text-transform:uppercase;font-weight:normal">方法:研究

背景:治疗T2DM的传统方法疗效有限,本研究旨在评估除了强化生活方式干预和药物治疗外,Roux-en-Y胃旁路术治疗T2DM的疗效与风险。

方法:研究者报道了这项5年随机对照研究(糖尿病外科治疗研究)的,术后2年的治疗效果,受试者分别来自四家教学医院(3家来自美国,1家来自台湾)。受试者入组标准:HbA1c≥8.0%(64
mmol/mol), BMI在30.0-30.9 kg/m2之间,T2DM病史至少6个月,年龄在30-67岁之间。随机安排受试者分为两组:强化生活方式干预和药物治疗组,强化生活方式干预和药物治疗+ 标准Roux-en-Y胃旁路术组。所有患者的降压药、降糖药和降脂药按照规定给予。主要的治疗终点是:HbA1c≤7.0%,LDL-c≤2.59 mmol/L,收缩压在12个月内≤130mmHg。在此,研究者报道了术后2年的复合治疗终点和其他预期结果。以意向性治疗为基础分析数据,使用多重填补法分析缺失数据。

结果:在2008.04.21至2011.11.21之间,一共随机挑选120名合格的受试者入组,强化生活方式干预和药物治疗组60人,手术治疗组60人。其中药物治疗组有1人死于胰腺癌,所有最终119名入组。很明显地,在术后24个月,手术治疗组比药物治疗组,有更多的患者达到三项复合治疗终点(26 [43%]
vs 8[14%]; OR 5.1 [95% CI 2.0-12.6], p=0.0004),提示血糖情况改善的主要终点HbA1c <7.0% ,手术组vs 药物组是45 [75%] vs 14 [24%]。其中有手术组有46人,药物组有25人,发生重要的临床不良事件(主要不良事件之一是感染,手术组8人,药物组4人)。利用负二项回归模型进行评估发现,手术组不良事件发生率是药物治疗组的1.67倍,不存在显著性差异(95% CI 0.98-2.87, p=0.06)。在随访的2年内,手术组共有7人发生严重跌倒,其中5人发生骨折;药物组共3人发生跌倒,其中1人骨折。所有骨折患者均为女性。尽管协议中给予受试者补充营养元素,术后许多受试者仍存在营养元素缺乏,主要是缺铁、白蛋白、钙和维生素D。


结论:在强化生活方式干预和药物治疗的基础上,进行胃旁路术治疗2型糖尿病,可以改善患者的血糖代谢。但是,不良事件和营养物质缺乏在手术组更常见。目前需要规模更大随访时间更久的研究来评估胃转流术治疗T2DM的风险与受益。

原始出处:




Ikramuddin S1, Billington CJ2, Lee WJ3, Bantle JP4, Thomas AJ5, Connett JE5, Leslie DB1, Inabnet WB 3rd6, Jeffery RW7, Chong K8, Chuang LM9, Sarr MG10, Jensen MD11, Vella A11, Ahmed L12, Belani K13, Schone JL14, Olofson AE10, Bainbridge HA15, Laqua PS7, Wang Q5, Korner J15.Roux-en-Y gastric bypass for diabetes (the Diabetes Surgery Study): 2-year outcomes of a 5-year, randomised, controlled trial.Lancet Diabetes Endocrinol. 2015 Jun;3(6):413-22. doi: 10.1016/S2213-8587(15)00089-3. Epub 2015 May 12.


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    2015-06-09 ljjj1053

    认真学习了

    0

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