胃旁路手术与最佳药物治疗对 2 型糖尿病合并肥胖的早期慢性肾脏病患者的影响：一项随机临床试验。
Effect of Gastric Bypass vs Best Medical Treatment on Early-Stage Chronic Kidney Disease in Patients With Type 2 Diabetes and Obesity: A Randomized Clinical Trial.
机构信息
The Center for Obesity and Diabetes, Oswaldo Cruz German Hospital, São Paulo, Brazil.
Applied Health Research Center, St Michael's Hospital, Toronto, Ontario, Canada.
出版信息
JAMA Surg. 2020 Aug 1;155(8):e200420. doi: 10.1001/jamasurg.2020.0420. Epub 2020 Aug 19.
IMPORTANCE
Early-stage chronic kidney disease (CKD) characterized by microalbuminuria is associated with future cardiovascular events, progression toward end-stage renal disease, and early mortality in patients with type 2 diabetes.
OBJECTIVE
To compare the albuminuria-lowering effects of Roux-en-Y gastric bypass (RYGB) surgery vs best medical treatment in patients with early-stage CKD, type 2 diabetes, and obesity.
DESIGN, SETTING, AND PARTICIPANTS: For this randomized clinical trial, patients with established type 2 diabetes and microalbuminuria were recruited from a single center from April 1, 2013, through March 31, 2016, with a 5-year follow-up, including prespecified intermediate analysis at 24-month follow-up.
INTERVENTION
A total of 100 patients with type 2 diabetes, obesity (body mass indexes of 30 to 35 [calculated as weight in kilograms divided by height in meters squared]), and stage G1 to G3 and A2 to A3 CKD (urinary albumin-creatinine ratio [uACR] >30 mg/g and estimated glomerular filtration rate >30 mL/min) were randomized 1:1 to receive best medical treatment (n = 49) or RYGB (n = 51).
MAIN OUTCOMES AND MEASURES
The primary outcome was remission of albuminuria (uACR <30 mg/g). Secondary outcomes were CKD remission rate, absolute change in uACR, metabolic control, other microvascular complications, quality of life, and safety.
RESULTS
A total of 100 patients (mean [SD] age, 51.4 [7.6] years; 55 [55%] male) were randomized: 51 to RYGB and 49 to best medical care. Remission of albuminuria occurred in 55% of patients (95% CI, 39%-70%) after best medical treatment and 82% of patients (95% CI, 72%-93%) after RYGB (P = .006), resulting in CKD remission rates of 48% (95% CI, 32%-64%) after best medical treatment and 82% (95% CI, 72%-92%) after RYGB (P = .002). The geometric mean uACRs were 55% lower after RYGB (10.7 mg/g of creatinine) than after best medical treatment (23.6 mg/g of creatinine) (P < .001). No difference in the rate of serious adverse events was observed.
CONCLUSIONS AND RELEVANCE
After 24 months, RYGB was more effective than best medical treatment for achieving remission of albuminuria and stage G1 to G3 and A2 to A3 CKD in patients with type 2 diabetes and obesity.
TRIAL REGISTRATION
ClinicalTrials.gov Identifier: NCT01821508.
背景： 早期伴有微量白蛋白尿的慢性肾脏病（CKD）与 2 型糖尿病患者的未来心血管事件、向终末期肾病进展和早期死亡有关。
目的：比较 Roux-en-Y 胃旁路（RYGB）手术与最佳药物治疗对早期 CKD、2 型糖尿病和肥胖患者的降蛋白尿作用。
设计、地点和参与者：这是一项随机临床试验，从 2013 年 4 月 1 日至 2016 年 3 月 31 日，在一个中心招募了患有 2 型糖尿病和微量白蛋白尿的患者，随访时间为 5 年，包括在 24 个月随访时进行预设的中期分析。
干预措施：共有 100 名患有 2 型糖尿病、肥胖症（体重指数为 30 至 35[按千克体重除以米平方计算]）和 G1 至 G3 期和 A2 至 A3 期 CKD（尿白蛋白-肌酐比[uACR]>30mg/g 和估计肾小球滤过率>30ml/min）的患者被随机分为 1:1 组，分别接受最佳药物治疗（n=49）或 RYGB（n=51）。
主要结果和测量：主要结局是白蛋白尿缓解（uACR<30mg/g）。次要结局包括 CKD 缓解率、uACR 的绝对变化、代谢控制、其他微血管并发症、生活质量和安全性。
结果：共有 100 名患者（平均[SD]年龄，51.4[7.6]岁；55[55%]男性）被随机分组：51 名接受 RYGB 治疗，49 名接受最佳药物治疗。最佳药物治疗后，55%（95%CI，39%-70%）的患者发生白蛋白尿缓解，RYGB 治疗后 82%（95%CI，72%-93%）的患者发生白蛋白尿缓解（P=0.006），因此，最佳药物治疗后 CKD 缓解率为 48%（95%CI，32%-64%），RYGB 治疗后为 82%（95%CI，72%-92%）（P=0.002）。RYGB 后尿白蛋白肌酐比（uACR）的几何平均值降低了 55%（10.7mg/g 肌酐），而最佳药物治疗后降低了 23.6mg/g 肌酐（P<0.001）。未观察到严重不良事件发生率的差异。
结论和相关性：在 24 个月时，RYGB 比最佳药物治疗更有效，可实现 2 型糖尿病和肥胖患者的白蛋白尿缓解以及 G1 至 G3 期和 A2 至 A3 期 CKD。
试验注册：ClinicalTrials.gov 标识符：NCT01821508。
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