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肥胖患者的减重手术与 2 型糖尿病的预防

Bariatric surgery and prevention of type 2 diabetes in Swedish obese subjects.

机构信息

Institute of Medicine, Sahlgrenska Academy at the University of Gothenburg, Gothenburg, Sweden.

出版信息

N Engl J Med. 2012 Aug 23;367(8):695-704. doi: 10.1056/NEJMoa1112082.

Abstract

BACKGROUND

Weight loss protects against type 2 diabetes but is hard to maintain with behavioral modification alone. In an analysis of data from a nonrandomized, prospective, controlled study, we examined the effects of bariatric surgery on the prevention of type 2 diabetes.

METHODS

In this analysis, we included 1658 patients who underwent bariatric surgery and 1771 obese matched controls (with matching performed on a group, rather than individual, level). None of the participants had diabetes at baseline. Patients in the bariatric-surgery cohort underwent banding (19%), vertical banded gastroplasty (69%), or gastric bypass (12%); nonrandomized, matched, prospective controls received usual care. Participants were 37 to 60 years of age, and the body-mass index (BMI; the weight in kilograms divided by the square of the height in meters) was 34 or more in men and 38 or more in women. This analysis focused on the rate of incident type 2 diabetes, which was a prespecified secondary end point in the main study. At the time of this analysis (January 1, 2012), participants had been followed for up to 15 years. Despite matching, some baseline characteristics differed significantly between the groups; the baseline body weight was higher and risk factors were more pronounced in the bariatric-surgery group than in the control group. At 15 years, 36.2% of the original participants had dropped out of the study, and 30.9% had not yet reached the time for their 15-year follow-up examination.

RESULTS

During the follow-up period, type 2 diabetes developed in 392 participants in the control group and in 110 in the bariatric-surgery group, corresponding to incidence rates of 28.4 cases per 1000 person-years and 6.8 cases per 1000 person-years, respectively (adjusted hazard ratio with bariatric surgery, 0.17; 95% confidence interval, 0.13 to 0.21; P<0.001). The effect of bariatric surgery was influenced by the presence or absence of impaired fasting glucose (P=0.002 for the interaction) but not by BMI (P=0.54). Sensitivity analyses, including end-point imputations, did not change the overall conclusions. The postoperative mortality was 0.2%, and 2.8% of patients who underwent bariatric surgery required reoperation within 90 days owing to complications.

CONCLUSIONS

Bariatric surgery appears to be markedly more efficient than usual care in the prevention of type 2 diabetes in obese persons. (Funded by the Swedish Research Council and others; ClinicalTrials.gov number, NCT01479452.).

摘要

背景

减肥可以预防 2 型糖尿病,但仅通过行为改变很难维持。在一项非随机、前瞻性、对照研究的数据分析中,我们研究了减重手术对预防 2 型糖尿病的效果。

方法

在这项分析中,我们纳入了 1658 名接受减重手术的患者和 1771 名肥胖匹配对照者(按组而非个体进行匹配)。所有参与者基线时均无糖尿病。减重手术组患者接受了束带术(19%)、垂直捆绑胃成形术(69%)或胃旁路术(12%);非随机、匹配、前瞻性对照者接受常规护理。参与者年龄在 37 至 60 岁之间,体重指数(BMI;体重千克数除以身高米数的平方)男性为 34 或以上,女性为 38 或以上。这项分析主要关注 2 型糖尿病的发病率,这是主要研究的一个预先规定的次要终点。在进行这项分析时(2012 年 1 月 1 日),参与者的随访时间最长达 15 年。尽管进行了匹配,但两组之间的一些基线特征仍存在显著差异;与对照组相比,减重手术组的基线体重更高,且危险因素更为明显。随访 15 年后,最初的参与者中有 36.2%退出了研究,30.9%尚未进行 15 年的随访检查。

结果

在随访期间,对照组中有 392 名参与者和减重手术组中有 110 名参与者发生了 2 型糖尿病,相应的发病率分别为每 1000 人年 28.4 例和 6.8 例(减重手术后的调整风险比为 0.17;95%置信区间为 0.13 至 0.21;P<0.001)。减重手术的效果受空腹血糖受损的存在与否影响(交互作用 P=0.002),但不受 BMI 影响(P=0.54)。敏感性分析包括终点推断,并未改变总体结论。术后死亡率为 0.2%,90 天内因并发症需要再次手术的患者中,有 2.8%接受了减重手术。

结论

与常规护理相比,减重手术在预防肥胖人群 2 型糖尿病方面似乎更为有效。(由瑞典研究理事会和其他机构资助;ClinicalTrials.gov 编号,NCT01479452。)

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