Bariatric surgery versus intensive medical therapy in obese patients with diabetes.
Bariatric surgery versus intensive medical therapy in obese patients with diabetes.
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DOI：
10.1056/nejmoa1200225
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发表时间：
2012-04-26
期刊：
影响因子：
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通讯作者：
Bhatt DL
中科院分区：
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作者：
Schauer PR;Kashyap SR;Wolski K;Brethauer SA;Kirwan JP;Pothier CE;Thomas S;Abood B;Nissen SE;Bhatt DL
观察性研究表明，2型糖尿病患者在减肥手术后情况有所改善。在这项随机、非盲单中心试验中，我们评估了150例肥胖型2型糖尿病患者的强化药物治疗与药物治疗加Roux-en-Y胃分流术或袖状胃切除术的疗效。患者平均年龄(±SD)为49±8岁，其中66%为女性。糖化血红蛋白平均水平为9.2±1.5%。主要终点是治疗12个月后糖化血红蛋白水平在6.0%或以下的患者的比例。在150名患者中，93%的患者完成了12个月的随访。内科治疗组主终点的比例为12%(5/41例)，胃旁路组为42%(21/50例)(P=0.002)，袖状胃切除组为37%(18/49例)(P=0.008)。3组血糖控制均有改善，内科治疗组平均糖化血红蛋白水平为7.5%±1.8%，胃旁路组为6.4%±0.9%(P<；0.001)，袖状胃切除组为6.6%±1.0%(P=0.003)。胃旁路组和袖状胃切除组体重下降(−29.4±9.0 kg和−25.1±8.5 kg)明显高于内科治疗组(−5.4±8.0 kg)(P<；0.001)。两种手术后，降低血糖、血脂和血压水平的药物使用显著减少，但只接受内科治疗的患者使用的药物增加。胰岛素抵抗的稳态模型评估指数(HOMA-IR)在减肥手术后显著改善。4例再次手术。没有死亡或危及生命的并发症。在患有未得到控制的2型糖尿病的肥胖患者中，与单纯药物治疗相比，12个月的药物治疗加减肥手术在更多的患者中实现了血糖控制。还需要进一步的研究来评估这些结果的持久性。(由ethicon Endo-Surgery和其他公司资助；ClinicalTrials.gov编号，NCT00432809。)
Observational studies have shown improvement in patients with type 2 diabetes mellitus after bariatric surgery. In this randomized, nonblinded, single-center trial, we evaluated the efficacy of intensive medical therapy alone versus medical therapy plus Roux-en-Y gastric bypass or sleeve gastrectomy in 150 obese patients with uncontrolled type 2 diabetes. The mean (±SD) age of the patients was 49 ± 8 years, and 66% were women. The average glycated hemoglobin level was 9.2 ± 1.5%. The primary end point was the proportion of patients with a glycated hemoglobin level of 6.0% or less 12 months after treatment. Of the 150 patients, 93% completed 12 months of follow-up. The proportion of patients with the primary end point was 12% (5 of 41 patients) in the medical-therapy group versus 42% (21 of 50 patients) in the gastric-bypass group (P = 0.002) and 37% (18 of 49 patients) in the sleeve-gastrectomy group (P = 0.008). Glycemic control improved in all three groups, with a mean glycated hemoglobin level of 7.5 ± 1.8% in the medical-therapy group, 6.4 ± 0.9% in the gastric-bypass group (P<0.001), and 6.6 ± 1.0% in the sleeve-gastrectomy group (P = 0.003). Weight loss was greater in the gastric-bypass group and sleeve-gastrectomy group (−29.4 ± 9.0 kg and −25.1 ± 8.5 kg, respectively) than in the medical-therapy group (−5.4 ± 8.0 kg) (P<0.001 for both comparisons). The use of drugs to lower glucose, lipid, and blood-pressure levels decreased significantly after both surgical procedures but increased in patients receiving medical therapy only. The index for homeostasis model assessment of insulin resistance (HOMA-IR) improved significantly after bariatric surgery. Four patients underwent reoperation. There were no deaths or life-threatening complications. In obese patients with uncontrolled type 2 diabetes, 12 months of medical therapy plus bariatric surgery achieved glycemic control in significantly more patients than medical therapy alone. Further study will be necessary to assess the durability of these results. (Funded by Ethicon Endo-Surgery and others; ClinicalTrials.gov number, NCT00432809.)