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肥胖症患者 2 型糖尿病与大血管疾病结局的关联:减肥手术的影响。

Association Between Bariatric Surgery and Macrovascular Disease Outcomes in Patients With Type 2 Diabetes and Severe Obesity.

机构信息

The Permanente Medical Group, Kaiser Permanente Northern California, Oakland.

Kaiser Permanente Washington Health Research Institute, Seattle.

出版信息

JAMA. 2018 Oct 16;320(15):1570-1582. doi: 10.1001/jama.2018.14619.

Abstract

IMPORTANCE

Macrovascular disease is a leading cause of morbidity and mortality for patients with type 2 diabetes, and medical management, including lifestyle changes, may not be successful at lowering risk.

OBJECTIVE

To investigate the relationship between bariatric surgery and incident macrovascular (coronary artery disease and cerebrovascular diseases) events in patients with severe obesity and type 2 diabetes.

DESIGN, SETTING, AND PARTICIPANTS: In this retrospective, matched cohort study, patients with severe obesity (body mass index ≥35) aged 19 to 79 years with diabetes who underwent bariatric surgery from 2005 to 2011 in 4 integrated health systems in the United States (n = 5301) were matched to 14 934 control patients on site, age, sex, body mass index, hemoglobin A1c, insulin use, observed diabetes duration, and prior health care utilization, with follow-up through September 2015.

EXPOSURES

Bariatric procedures (76% Roux-en-Y gastric bypass, 17% sleeve gastrectomy, and 7% adjustable gastric banding) were compared with usual care for diabetes.

MAIN OUTCOMES AND MEASURES

Multivariable-adjusted Cox regression analysis investigated time to incident macrovascular disease (defined as first occurrence of coronary artery disease [acute myocardial infarction, unstable angina, percutaneous coronary intervention, or coronary artery bypass grafting] or cerebrovascular events [ischemic stroke, hemorrhagic stroke, carotid stenting, or carotid endarterectomy]). Secondary outcomes included coronary artery disease and cerebrovascular outcomes separately.

RESULTS

Among a combined 20 235 surgical and nonsurgical patients, the mean (SD) age was 50 (10) years; 76% of the surgical and 75% of the nonsurgical patients were female; and the baseline mean (SD) body mass index was 44.7 (6.9) and 43.8 (6.7) in the surgical and nonsurgical groups, respectively. At the end of the study period, there were 106 macrovascular events in surgical patients (including 37 cerebrovascular and 78 coronary artery events over a median of 4.7 years; interquartile range, 3.2-6.2 years) and 596 events in the matched control patients (including 227 cerebrovascular and 398 coronary artery events over a median of 4.6 years; interquartile range, 3.1-6.1 years). Bariatric surgery was associated with a lower composite incidence of macrovascular events at 5 years (2.1% in the surgical group vs 4.3% in the nonsurgical group; hazard ratio, 0.60 [95% CI, 0.42-0.86]), as well as a lower incidence of coronary artery disease (1.6% in the surgical group vs 2.8% in the nonsurgical group; hazard ratio, 0.64 [95% CI, 0.42-0.99]). The incidence of cerebrovascular disease was not significantly different between groups at 5 years (0.7% in the surgical group vs 1.7% in the nonsurgical group; hazard ratio, 0.69 [95% CI, 0.38-1.25]).

CONCLUSIONS AND RELEVANCE

In this observational study of patients with type 2 diabetes and severe obesity who underwent surgery, compared with those who did not undergo surgery, bariatric surgery was associated with a lower risk of macrovascular outcomes. The findings require confirmation in randomized clinical trials. Health care professionals should engage patients with severe obesity and type 2 diabetes in a shared decision making conversation about the potential role of bariatric surgery in the prevention of macrovascular events.

摘要

重要提示:大血管疾病是 2 型糖尿病患者发病率和死亡率的主要原因,包括生活方式改变在内的医学治疗可能无法降低风险。

目的:研究肥胖症和 2 型糖尿病患者的减重手术与大血管(冠心病和脑血管疾病)事件的关系。

设计、地点和参与者:在这项回顾性、匹配队列研究中,在美国的 4 个综合医疗系统中,2005 年至 2011 年间,5301 名患有严重肥胖症(体重指数≥35)且患有糖尿病的患者接受了减重手术,与 14934 名现场匹配的对照患者相匹配,年龄、性别、体重指数、糖化血红蛋白、胰岛素使用、观察到的糖尿病持续时间和之前的医疗保健使用情况,随访至 2015 年 9 月。

暴露:(76%的 Roux-en-Y 胃旁路手术、17%的袖状胃切除术和 7%的可调胃束带)与糖尿病的常规治疗相比。

主要结果和措施:多变量调整后的 Cox 回归分析研究了大血管疾病(首次发生冠心病[急性心肌梗死、不稳定型心绞痛、经皮冠状动脉介入治疗或冠状动脉旁路移植术]或脑血管事件[缺血性中风、出血性中风、颈动脉支架置入术或颈动脉内膜切除术])的时间。次要结局包括冠心病和脑血管结局。

结果:在 20235 例手术和非手术患者中,平均(SD)年龄为 50(10)岁;76%的手术患者和 75%的非手术患者为女性;手术组和非手术组的基线平均(SD)体重指数分别为 44.7(6.9)和 43.8(6.7)。在研究期末,手术组中有 106 例大血管事件(包括 37 例脑血管事件和 78 例冠心病事件,中位数随访时间为 4.7 年;四分位距,3.2-6.2 年),而匹配的对照组中有 596 例事件(包括 227 例脑血管事件和 398 例冠心病事件,中位数随访时间为 4.6 年;四分位距,3.1-6.1 年)。5 年内,减重手术与复合大血管事件发生率降低相关(手术组为 2.1%,非手术组为 4.3%;风险比,0.60[95%置信区间,0.42-0.86]),冠心病发生率降低(手术组为 1.6%,非手术组为 2.8%;风险比,0.64[95%置信区间,0.42-0.99])。5 年内脑血管疾病的发生率在两组之间无显著差异(手术组为 0.7%,非手术组为 1.7%;风险比,0.69[95%置信区间,0.38-1.25])。

结论和相关性:在这项对接受手术和未接受手术的 2 型糖尿病和严重肥胖症患者的观察性研究中,与未接受手术的患者相比,减重手术与大血管结局风险降低相关。这些发现需要在随机临床试验中得到证实。医疗保健专业人员应与患有严重肥胖症和 2 型糖尿病的患者进行共同决策对话,探讨减重手术在预防大血管事件中的潜在作用。

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