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PCORnet 减重研究队列中不同种族和族裔人群中 Roux-en-Y 胃旁路术和袖状胃切除术治疗体重和 2 型糖尿病的安全性和有效性比较。

Comparative Safety and Effectiveness of Roux-en-Y Gastric Bypass and Sleeve Gastrectomy for Weight Loss and Type 2 Diabetes Across Race and Ethnicity in the PCORnet Bariatric Study Cohort.

机构信息

Kaiser Permanente Southern California, Department of Research and Evaluation, Pasadena.

Kaiser Permanente Washington Health Research Institute, Seattle.

出版信息

JAMA Surg. 2022 Oct 1;157(10):897-906. doi: 10.1001/jamasurg.2022.3714.

Abstract

IMPORTANCE

Bariatric surgery is the most effective treatment for severe obesity; yet it is unclear whether the long-term safety and comparative effectiveness of these operations differ across racial and ethnic groups.

OBJECTIVE

To compare outcomes of Roux-en-Y gastric bypass (RYGB) and sleeve gastrectomy (SG) across racial and ethnic groups in the National Patient-Centered Clinical Research Network (PCORnet) Bariatric Study.

DESIGN, SETTING, AND PARTICIPANTS: This was a retrospective, observational, comparative effectiveness cohort study that comprised 25 health care systems in the PCORnet Bariatric Study. Patients were adults and adolescents aged 12 to 79 years who underwent a primary (first nonrevisional) RYGB or SG operation between January 1, 2005, and September 30, 2015, at participating health systems. Patient race and ethnicity included Black, Hispanic, White, other, and unrecorded. Data were analyzed from July 1, 2021, to January 17, 2022.

EXPOSURE

RYGB or SG.

OUTCOMES

Percentage total weight loss (%TWL); type 2 diabetes remission, relapse, and change in hemoglobin A1c (HbA1c) level; and postsurgical safety and utilization outcomes (operations, interventions, revisions/conversions, endoscopy, hospitalizations, mortality, 30-day major adverse events) at 1, 3, and 5 years after surgery.

RESULTS

A total of 36 871 patients (mean [SE] age, 45.0 [11.7] years; 29 746 female patients [81%]) were included in the weight analysis. Patients identified with the following race and ethnic categories: 6891 Black (19%), 8756 Hispanic (24%), 19 645 White (53%), 826 other (2%), and 783 unrecorded (2%). Weight loss and mean reductions in HbA1c level were larger for RYGB than SG in all years for Black, Hispanic, and White patients (difference in 5-year weight loss: Black, -7.6%; 95% CI, -8.0 to -7.1; P < .001; Hispanic, -6.2%; 95% CI, -6.6 to -5.9; P < .001; White, -5.9%; 95% CI, -6.3 to -5.7; P < .001; difference in change in year 5 HbA1c level: Black, -0.29; 95% CI, -0.51 to -0.08; P = .009; Hispanic, -0.45; 95% CI, -0.61 to -0.29; P < .001; and White, -0.25; 95% CI, -0.40 to -0.11; P = .001.) The magnitude of these differences was small among racial and ethnic groups (1%-3% of %TWL). Black and Hispanic patients had higher risk of hospitalization when they had RYGB compared with SG (hazard ratio [HR], 1.45; 95% CI, 1.17-1.79; P = .001 and 1.48; 95% CI, 1.22-1.79; P < .001, respectively). Hispanic patients had greater risk of all-cause mortality (HR, 2.41; 95% CI, 1.24-4.70; P = .01) and higher odds of a 30-day major adverse event (odds ratio, 1.92; 95% CI, 1.38-2.68; P < .001) for RYGB compared with SG. There was no interaction between race and ethnicity and operation type for diabetes remission and relapse.

CONCLUSIONS AND RELEVANCE

Variability of the comparative effectiveness of operations for %TWL and HbA1c level across race and ethnicity was clinically small; however, differences in safety and utilization outcomes were clinically and statistically significant for Black and Hispanic patients who had RYGB compared with SG. These findings can inform shared decision-making regarding bariatric operation choice for different racial and ethnic groups of patients.

摘要

重要性:减重手术是治疗严重肥胖症最有效的方法;然而,不同种族和族裔群体接受这些手术的长期安全性和相对有效性尚不清楚。

目的:在全国患者中心临床研究网络(PCORnet)减重研究中,比较 Roux-en-Y 胃旁路术(RYGB)和袖状胃切除术(SG)在不同种族和族裔群体中的结果。

设计、地点和参与者:这是一项回顾性、观察性、比较有效性队列研究,纳入了 PCORnet 减重研究中的 25 个医疗保健系统。患者为年龄在 12 岁至 79 岁之间的成年人和青少年,在参与的医疗系统中接受了原发性(第一次非修正)RYGB 或 SG 手术。患者的种族和族裔包括黑人、西班牙裔、白人、其他和未记录。数据于 2021 年 7 月 1 日至 2022 年 1 月 17 日进行分析。

暴露:RYGB 或 SG。

结果:体重减轻百分比(%TWL);2 型糖尿病缓解、复发和糖化血红蛋白(HbA1c)水平变化;以及手术后 1、3 和 5 年的手术安全性和利用结果(手术、干预、修订/转换、内镜、住院、死亡率、30 天主要不良事件)。

结论:在黑人、西班牙裔和白人群体中,与 SG 相比,RYGB 的体重减轻和 HbA1c 水平平均降低幅度更大,在所有年份中差异均有统计学意义(5 年体重减轻差异:黑人,-7.6%;95%CI,-8.0 至-7.1;P<0.001;西班牙裔,-6.2%;95%CI,-6.6 至-5.9;P<0.001;白人,-5.9%;95%CI,-6.3 至-5.7;P<0.001;第 5 年 HbA1c 水平变化差异:黑人,-0.29;95%CI,-0.51 至-0.08;P=0.009;西班牙裔,-0.45;95%CI,-0.61 至-0.29;P<0.001;和白人,-0.25;95%CI,-0.40 至-0.11;P=0.001。)这些差异在种族和族裔群体中幅度较小(体重减轻百分比的 1%-3%)。与 SG 相比,RYGB 使黑人和西班牙裔患者的住院风险更高(风险比[HR],1.45;95%CI,1.17-1.79;P=0.001 和 1.48;95%CI,1.22-1.79;P<0.001,分别)。西班牙裔患者的全因死亡率(HR,2.41;95%CI,1.24-4.70;P=0.01)和 30 天主要不良事件(OR,1.92;95%CI,1.38-2.68;P<0.001)的风险更高。在糖尿病缓解和复发方面,种族和族裔与手术类型之间没有交互作用。

结论:在种族和族裔群体中,手术对 %TWL 和 HbA1c 水平的相对有效性的差异在临床上较小;然而,对于接受 RYGB 的黑人和西班牙裔患者,安全性和利用结果的差异在临床上和统计学上均具有显著意义,与 SG 相比。这些发现可以为不同种族和族裔群体的患者提供有关减重手术选择的信息。

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