Department of Statistics, Caisse Nationale d'Assurance Maladie, Paris, France; Department of General, Digestive and Metabolic Surgery, La Cavale Blanche University Hospital, Brest, France; Department of Thrombosis Study, University of Bretagne Occidentale, Brest, France.
Department of Statistics, Caisse Nationale d'Assurance Maladie, Paris, France.
Lancet Diabetes Endocrinol. 2019 Oct;7(10):786-795. doi: 10.1016/S2213-8587(19)30191-3. Epub 2019 Aug 2.
BACKGROUND: Concerns are rising about the late adverse events following gastric bypass and sleeve gastrectomy. We aimed to assess, over a 7-year period, the late adverse events after gastric bypass and sleeve gastrectomy compared with matched control groups. METHODS: In this nationwide, observational, population-based, cohort study, we used data extracted from the French National Health Insurance (Système National des Données de Santé) database. All patients undergoing gastric bypass or sleeve gastrectomy in France in 2009, except those who had undergone bariatric surgery in the previous 4 years before inclusion, were matched with control patients with obesity in terms of age, sex, BMI category, baseline antidiabetic therapy, and baseline insulin therapy. Exclusion criteria for the control group included cancer, pregnancy, chronic infectious disease, serious acute or chronic disease in 2008-09, or previous (2005-09) or forthcoming (2010-11) bariatric surgery. The incidence rate was calculated for each type of adverse event leading to inpatient hospital admission over a 7-year period; incidence rate ratios (with 95% CIs) were computed to compare the rate of complications among the bariatric surgery and control groups. Risks of complications during follow-up were compared using Cox proportional-hazards regression analyses. Data were analysed according to the intention-to-treat methodology. FINDINGS: From Jan 1, 2009, to Dec 31, 2009, 8966 patients who underwent bariatric surgery (7359 [82%] women; mean age 40·4 years [SD 11·3]) and 8966 matched controls (7359 [82%] women; mean age 40·9 years [11·4]) were included in analyses 4955 (55%) off 8966 patients in the bariatric surgery group had a primary gastric bypass and 4011 (45%) patients had sleeve gastrectomy. With a mean follow-up of 6·8 years (SD 0·2), mortality was lower in the gastric bypass group than in its control group (hazard ratio 0·64 [95% CI 0·52-0·78]; p<0·0001) and in the sleeve gastrectomy group than in its control group (0·38 [0·29-0·50]; p<0·0001). The gastric bypass and sleeve gastrectomy groups had higher risk than did their control groups for invasive gastrointestinal surgery or endoscopy (incidence rate ratio 2·4 [95% CI 2·1-2·7], p<0·0001, for gastric bypass vs control and 1·5 [1·3-1·7], p<0·0001, for sleeve gastrectomy vs control); for gastrointestinal disorders not leading to invasive procedures (1·9 [1·7-2·1]), p<0·0001, for gastric bypass vs control and 1·2 [1·1-1·4], p<0·0001, for sleeve gastrectomy vs control); and for nutritional disorders (4·9 [3·8-6·4], p<0·0001, for gastric bypass vs control and 1·8 [1·3-2·5], p<0·0001, for sleeve gastrectomy vs control). For psychiatric disorders, there was no significant association (1·1 [0·9-1·4], p=0·190, for gastric bypass vs control and 1·1 [0·8-1·3], p=0·645, for sleeve gastrectomy vs control), except for gastric bypass and alcohol dependence (1·8 [1·1-2·8], p=0·0124). INTERPRETATION: Despite lower 7-year mortality, patients undergoing gastric bypass or sleeve gastrectomy had higher risk of hospital admission at least once for late adverse events, except for psychiatric disorders, than did control patients, with a higher risk observed after gastric bypass than with sleeve gastrectomy. FUNDING: None.
背景:人们对胃旁路和袖状胃切除术的晚期不良事件越来越关注。我们旨在评估胃旁路和袖状胃切除术与匹配的对照组相比,在 7 年内的晚期不良事件。
方法:在这项全国性的、观察性的、基于人群的队列研究中,我们使用了从法国国家健康保险(国家健康数据系统)数据库中提取的数据。2009 年在法国接受胃旁路或袖状胃切除术的所有患者(除了在纳入前的前 4 年内接受过减重手术的患者),根据年龄、性别、BMI 类别、基线抗糖尿病治疗和基线胰岛素治疗与肥胖对照组进行匹配。对照组的排除标准包括癌症、怀孕、慢性传染病、2008-09 年的严重急性或慢性疾病,或之前(2005-09 年)或即将进行(2010-11 年)的减重手术。在 7 年内,每个导致住院的不良事件类型的发生率均进行了计算;计算了发病率比值(95%置信区间),以比较减重手术组和对照组的并发症发生率。使用 Cox 比例风险回归分析比较了随访期间并发症的风险。根据意向治疗方法进行了数据分析。
结果:从 2009 年 1 月 1 日至 2009 年 12 月 31 日,8966 名接受减重手术的患者(7359 名女性;平均年龄 40.4 岁[标准差 11.3])和 8966 名匹配的对照组患者(7359 名女性;平均年龄 40.9 岁[标准差 11.4])被纳入分析。在 8966 名患者中,有 4955 名(55%)患者进行了原发性胃旁路手术,4011 名(45%)患者进行了袖状胃切除术。平均随访 6.8 年(标准差 0.2 年),与对照组相比,胃旁路组的死亡率较低(风险比 0.64[95%置信区间 0.52-0.78];p<0.0001),袖状胃切除术组的死亡率也较低(0.38[0.29-0.50];p<0.0001)。与对照组相比,胃旁路组和袖状胃切除术组发生侵入性胃肠手术或内镜检查的风险更高(发病率比值 2.4[95%置信区间 2.1-2.7],p<0.0001,胃旁路组与对照组相比;1.5[1.3-1.7],p<0.0001,袖状胃切除术组与对照组相比);发生非侵入性胃肠疾病的风险更高(1.9[1.7-2.1]),p<0.0001,胃旁路组与对照组相比;1.2[1.1-1.4],p<0.0001,袖状胃切除术组与对照组相比);发生营养障碍的风险更高(4.9[3.8-6.4],p<0.0001,胃旁路组与对照组相比;1.8[1.3-2.5],p<0.0001,袖状胃切除术组与对照组相比)。对于精神障碍,没有显著关联(胃旁路组与对照组相比,1.1[0.9-1.4],p=0.190;袖状胃切除术组与对照组相比,1.1[0.8-1.3],p=0.645),除了胃旁路组和酒精依赖(1.8[1.1-2.8],p=0.0124)。
解释:尽管 7 年死亡率较低,但与对照组相比,接受胃旁路或袖状胃切除术的患者至少有一次因晚期不良事件而住院的风险更高,除了精神障碍,胃旁路术组的风险高于袖状胃切除术组。
资金:无。
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