JAMA：胃旁路手术治疗2型糖尿病：风险与获益并存

　　美国和中国台湾联合研究表明，轻至中度肥胖的2型糖尿病患者，在改善生活方式和应用药物治疗的同时，行胃旁路手术，与较好的代谢转归相关。但临床应用时必须权衡附加胃旁路手术的潜在获益与严重不良事件风险。该论文6月5日发表于《美国医学会杂志》。

　　研究纳入120例糖尿病患者，所有患者糖化血红蛋白（HbA1c）≥8.0%，体质指数（BMI）为30.0～39.9，C肽＞1.0 ng/ml，病程≥6个月。所有患者均改善生活方式并接受强化药物治疗，其中60例患者随机接受Roux-en-Y胃旁路手术。研究主要复合终点为HbA1c＜7%、低密度脂蛋白胆固醇＜100 mg/dl且收缩压＜130 mmHg。

　　结果为，12个月后，手术组中28例（49%）患者和非手术组中11例（19%）患者达到主要终点[比值比（OR）=4.8]。手术组患者平均所需药物（1.7种）较非手术组（4.8种）减少3种，初始体重下降（26.1%）较非手术组（7.9%）多17.5%。回归分析表明，体重减轻是达到研究复合终点的主要原因。严重不良事件，手术组发生22例（包括1例心血管事件），非手术组发生15例。共发生4例围手术期并发症和6例术后晚期并发症。手术组患者营养不足现象较非手术组多见。

　　■ 同期述评

　　手术治疗糖尿病，可行吗？

　　美国俄勒冈健康与科学大学 沃尔夫（Wolfe）和珀内尔（Purnell） 美国匹兹堡大学公共卫生学院 贝尔（Belle）

　　减肥手术可在术后不久、体重下降之前缓解2级（BMI≥35）和3级（BMI≥40）肥胖的2型糖尿病患者病情，为糖尿病治疗提供了新思路。

　　本期JAMA发表的伊克拉姆丁（Ikramuddin）等的研究表明，与单纯改善生活方式及药物治疗相比，附加胃旁路手术具有更好的代谢转归，但同时，也具有较高的手术并发症风险。尽管2型糖尿病病情得到缓解就患者健康而言是件好事，但仍有几个问题亟待解决。首先，应权衡利弊，审慎考虑总体健康获益；其次，应明确手术长期安全性和长期并发症的患病率及严重程度；再次，Roux-en-Y胃旁路术后糖尿病的复发率，以及病情暂时缓解的糖尿病患者的远期获益，仍有待明确；最后，对这一人群进行减肥手术的经济学影响也有待评估。

　　近期，有关肥胖和糖尿病强化治疗的大规模试验结果均差强人意。减肥手术确实具有良好的减轻体重和控制糖尿病效果，但初始医疗花费高且有并发症风险。治疗肥胖和糖尿病的最佳方法究竟是什么？或许能够提供确切数据的、进一步精心设计的随机试验，可以回答这一问题。

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.