
英国伦敦国王学院和意大利卡托利卡大学的课题组最近在一项研究中指出,在肥胖患者中,手术相比于传统的2型糖尿病的治疗方法可能更利于糖尿病的治疗。
这项发表在《Lancet》上的医学研究收集了过去五年内,2型糖尿病的手术治疗相比于标准的传统治疗方法的效果。他们的研究指出,在患有糖尿病的肥胖患者中,针对肥胖或者减肥的手术对于治疗2型糖尿病效果非常显着。作者指出,过去关于减肥手术治疗2型糖尿病的研究,随访时间都较短,而他们的随访则长达五年。
之前已经有些研究发现了,在肥胖人群中,进行过减肥相关的手术的患者,2型糖尿病患者的病情有很大的好转。这可能意味着,针对肥胖的手术,可能可以被用来作为糖尿病的治疗方法。这项研究则对比了不同方法对于糖尿病治疗的效果。这项研究中的一组参与者是介于30-60岁的意大利患者,他们的体质指数(BMI)均高于 35 kg/m2 。这些患者被随机分出三组,每组20人。一组患者接受传统的2型糖尿病治疗,一组接受胃旁路术(一组常用的减肥方法)治疗,还有一组人接受胆胰分流治疗。这后两组都是针对肥胖的手术治疗法。胃旁路术是一种手术将小肠和胃的结构进行改造来达到减肥的效果。这种手术会改变胃部的大小,同时会改变食物流经小肠的路径。而胆胰分流则是涉及到更加复杂的小肠的手术,来完成更彻底的食物分流。
这些患者中,有53人完成了为期五年的研究计划,定期进行糖尿病缓解的测试。这项测试中,如果糖化血红蛋白A1C在血液中的浓度小于等于6.5%,而且这期间有一年不需要药物维持,那么就可以认为是2型糖尿病情得到缓解。这五年的试验中,患者还被测试了很多其他指标,例如血糖浓度、体重变化、血压、血脂等等,同时还进行抗糖尿病的药物治疗、心血管药物治疗等。五年后,19位(约50%)手术治疗过的患者的糖尿病患者病情得到缓解,而传统方法治疗的20人中没有一人的2型糖尿病情得到缓解。不仅如此,手术治疗的患者更少地依赖药物,而且血糖浓度更低,生活质量更高。相比于胆胰分流,胆胰分流能够更好地减肥,在这个研究中也发现对糖尿病的缓解效果更好(胆胰分流67%,胆胰分流37%)。
考虑到这个研究涉及到的样本不大,手术治疗可能带来的很多其他的副作用也未知。然而,这项研究中发现手术减肥的方法能够明显改善心血管状况,对于药物依赖更低。大样本的深入研究仍然是有必要的。进一步大样本研究将确认,减肥相关的手术是否可以作为治疗2型糖尿病的理想方法。
DOI: http://dx.doi.org/10.1016/S0140-6736(15)00075-6
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Background
Randomised controlled trials have shown that bariatric surgery is more effective than conventional treatment for the short-term control of type-2 diabetes. However, published studies are characterised by a relatively short follow-up. We aimed to assess 5 year outcomes from our randomised trial designed to compare surgery with conventional medical treatment for the treatment of type 2 diabetes in obese patients.
Methods
We did our open-label, randomised controlled trial at one diabetes centre in Italy. Patients aged 30–60 years with a body-mass index of 35 kg/m2 or more and a history of type 2 diabetes lasting at least 5 years were randomly assigned (1:1:1), via a computer-generated randomisation procedure, to receive either medical treatment or surgery by Roux-en-Y gastric bypass or biliopancreatic diversion. Participants were aware of treatment allocation before the operation and study investigators were aware from the point of randomisation. The primary endpoint was the rate of diabetes remission at 2 years, defined as a glycated haemaglobin A1c (HbA1c) concentration of 6·5% or less (≤47·5 mmol/mol) and a fasting glucose concentration of 5·6 mmol/L or less without active pharmacological treatment for 1 year. Here we analyse glycaemic and metabolic control, cardiovascular risk, medication use, quality of life, and long-term complications 5 years after randomisation. Analysis was by intention to treat for the primary endpoint and by per protocol for the 5 year follow-up. This study is registered with ClinicalTrials.gov, number NCT00888836.
Findings
Between April 27, 2009, and Oct 31, 2009, we randomly assigned 60 patients to receive either medical treatment (n=20) or surgery by gastric bypass (n=20) or biliopancreatic diversion (n=20); 53 (88%) patients completed 5 years' follow-up. Overall, 19 (50%) of the 38 surgical patients (seven [37%] of 19 in the gastric bypass group and 12 [63%] of 19 in the bilipancreatic diversion group) maintained diabetes remission at 5 years, compared with none of the 15 medically treated patients (p=0·0007). We recorded relapse of hyperglycaemia in eight (53%) of the 15 patients who achieved 2 year remission in the gastric bypass group and seven (37%) of the 19 patients who achieved 2 year remission in the biliopancreatic diversion group. Eight (42%) patients who underwent gastric bypass and 13 (68%) patients who underwent biliopancreatic diversion had an HbA1c concentration of 6·5% or less (≤47·5 mmol/mol) with or without medication, compared with four (27%) medically treated patients (p=0·0457). Surgical patients lost more weight than medically treated patients, but weight changes did not predict diabetes remission or relapse after surgery. Both surgical procedures were associated with significantly lower plasma lipids, cardiovascular risk, and medication use. Five major complications of diabetes (including one fatal myocardial infarction) arose in four (27%) patients in the medical group compared with only one complication in the gastric bypass group and no complications in the biliopancreatic diversion group. No late complications or deaths occurred in the surgery groups. Nutritional side-effects were noted mainly after biliopancreatic diversion.
Interpretation
Surgery is more effective than medical treatment for the long-term control of obese patients with type 2 diabetes and should be considered in the treatment algorithm of this disease. However, continued monitoring of glycaemic control is warranted because of potential relapse of hyperglycaemia.
