JAMA：胃分流术可帮助控制糖尿病风险因子

据6月5日发表在《美国医学会杂志》上的一则研究披露，对于罹患II型糖尿病且具有轻度与中度肥胖的病人，将胃分流术加到生活方式及内科方法处理之中更有可能使诸如血糖、低密度脂蛋白-胆固醇及收缩压等代谢性风险因子的水平得到改善。

根据文章的背景资料：“II型糖尿病的治疗基础是减肥，减肥可以通过生活方式的改变来减少能量的摄入及增加身体的活动来达到。来自Look AHEAD (AHEAD ：糖尿病的健康行动)试验的结果显示，通过生活方式改变来维持体重减轻可改善对糖尿病的控制，但随着时间的推移要做到并维持这一点却不容易。控制高血糖症、血压及胆固醇对糖尿病患者是重要的。但如何才能最有效地达到这一目标则是未知的。”

明尼阿波利斯明尼苏达大学的Sayeed Ikramuddin, M.D.及其同事开展了一项研究，旨在比较鲁氏Y形胃分流术与生活方式及强力内科方式处理在控制并存疾病（同时存在的）风险因子方面的功效。这一历时12个月、由2组参与者组成的随机化试验是在美国和台湾的4家教学医院中开展的，它包括了120名参与者，这些人的血红蛋白A1c (HbA1c) 浓度在8.0% 或以上、身体质量指数（BMI）在30.0至39.9之间、C肽浓度超过1.0 ng/mL（ng/mL：纳克/毫升）并患有II型糖尿病至少6个月。这项研究是在2008年4月开始的。该试验的干预手段为生活方式-强力内科处理干预及鲁氏Y形胃旁路手术。用于高血糖症、高血压及血脂异常的药物是根据标准化的方案及外科技术给予的。

本研究的综合目标是由美国糖尿病协会（ADA）为糖尿病治疗所设立的目标： HbA1c低于7.0%，低密度脂蛋白胆固醇低于100 mg/dL（mg/dL：毫克/分升）而收缩压低于130 mm Hg（mm Hg：毫米汞柱）。

所有120名患者都接受了Look AHEAD的强力生活方式-内科处理方案——这是在Look AHEAD研究中所用的方案，它被认为是在肥胖患者中治疗糖尿病最成功的方案；120名患者中有60人被随机指派接受鲁氏Y形胃分流术。研究人员发现，在第12个月时，生活方式-内科方式处理组有11位参与者（19%）及胃旁路手术组中有28位参与者（49%）达到了主要复合终点。

分析表明，达到该复合终点应主要归因于体重减轻。胃分流术小组的参与者比生活方式-内科处理小组的参与者有更多的营养缺乏症。总体而言，在胃分流术组发生了22起严重的不良反应事件，而在生活方式-内科方式处理组有15起这样的事件。

研究人员得出结论：“对罹患II型糖尿病的中度肥胖患者施行胃分流术治疗的优点取决于胃分流术带来的可能的裨益是否能让风险变得可以接受。在罹患II型糖尿病的具有中度肥胖程度的患者中，对于那些用改变生活方式或内科方式处理无法成功地减轻体重及控制糖尿病的人而言，减肥手术可使他们的体重明显减轻且糖尿病控制得到显著的改善。进行减肥手术的好处必须要与产生严重的不良反应事件的风险进行权衡。”

Roux-en-Y gastric bypass vs intensive medical management for the control of type 2 diabetes, hypertension, and hyperlipidemia: the Diabetes Surgery Study randomized clinical trial.
IMPORTANCE
Controlling glycemia, blood pressure, and cholesterol is important for patients with diabetes. How best to achieve this goal is unknown.
OBJECTIVE
To compare Roux-en-Y gastric bypass with lifestyle and intensive medical management to achieve control of comorbid risk factors.
DESIGN, SETTING, AND PARTICIPANTS
A 12-month, 2-group unblinded randomized trial at 4 teaching hospitals in the United States and Taiwan involving 120 participants who had a hemoglobin A1c (HbA1c) level of 8.0% or higher, body mass index (BMI) between 30.0 and 39.9, C peptide level of more than 1.0 ng/mL, and type 2 diabetes for at least 6 months. The study began in April 2008.
INTERVENTIONS
Lifestyle-intensive medical management intervention and Roux-en-Y gastric bypass surgery. Medications for hyperglycemia, hypertension, and dyslipidemia were prescribed according to protocol and surgical techniques that were standardized. MAIN OUTCOMES AND MEASURES: Composite goal of HbA1c less than 7.0%, low-density lipoprotein cholesterol less than 100 mg/dL, and systolic blood pressure less than 130 mm Hg.
RESULTS
All 120 patients received the intensive lifestyle-medical management protocol and 60 were randomly assigned to undergo Roux-en-Y gastric bypass. After 12-months, 28 participants (49%; 95% CI, 36%-63%) in the gastric bypass group and 11 (19%; 95% CI, 10%-32%) in the lifestyle-medical management group achieved the primary end points (odds ratio [OR], 4.8; 95% CI, 1.9-11.7). Participants in the gastric bypass group required 3.0 fewer medications (mean, 1.7 vs 4.8; 95% CI for the difference, 2.3-3.6) and lost 26.1% vs 7.9% of their initial body weigh compared with the lifestyle-medical management group (difference, 17.5%; 95% CI, 14.2%-20.7%). Regression analyses indicated that achieving the composite end point was primarily attributable to weight loss. There were 22 serious adverse events in the gastric bypass group, including 1 cardiovascular event, and 15 in the lifestyle-medical management group. There were 4 perioperative complications and 6 late postoperative complications. The gastric bypass group experienced more nutritional deficiency than the lifestyle-medical management group.
CONCLUSIONS AND RELEVANCE
In mild to moderately obese patients with type 2 diabetes, adding gastric bypass surgery to lifestyle and medical management was associated with a greater likelihood of achieving the composite goal. Potential benefits of adding gastric bypass surgery to the best lifestyle and medical management strategies of diabetes must be weighed against the risk of serious adverse events.