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肥胖合并高血压患者行减重手术的效果:GATEWAY 随机试验(胃旁路术治疗持续高血压肥胖患者)。

Effects of Bariatric Surgery in Obese Patients With Hypertension: The GATEWAY Randomized Trial (Gastric Bypass to Treat Obese Patients With Steady Hypertension).

机构信息

Research Institute (C.A.S., A.C.B.-F., E.V.S., J.D.O., C.R.T., P.T.B., J.C.F., R.N.F., L.P.D., A.B.C., O.B.)

Research Institute (C.A.S., A.C.B.-F., E.V.S., J.D.O., C.R.T., P.T.B., J.C.F., R.N.F., L.P.D., A.B.C., O.B.).

出版信息

Circulation. 2018 Mar 13;137(11):1132-1142. doi: 10.1161/CIRCULATIONAHA.117.032130. Epub 2017 Nov 13.

DOI:10.1161/CIRCULATIONAHA.117.032130
PMID:29133606
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC5865494/
Abstract

BACKGROUND

Recent research efforts on bariatric surgery have focused on metabolic and diabetes mellitus resolution. Randomized trials designed to assess the impact of bariatric surgery in patients with obesity and hypertension are needed.

METHODS

In this randomized, single-center, nonblinded trial, we included patients with hypertension (using ≥2 medications at maximum doses or >2 at moderate doses) and a body mass index between 30.0 and 39.9 kg/m. Patients were randomized to Roux-en-Y gastric bypass plus medical therapy or medical therapy alone. The primary end point was reduction of ≥30% of the total number of antihypertensive medications while maintaining systolic and diastolic blood pressure <140 mm Hg and 90 mm Hg, respectively, at 12 months.

RESULTS

We included 100 patients (70% female, mean age 43.8±9.2 years, mean body mass index 36.9±2.7 kg/m2), and 96% completed follow-up. Reduction of ≥30% of the total number of antihypertensive medications while maintaining controlled blood pressure occurred in 41 of 49 patients from the gastric bypass group (83.7%) compared with 6 of 47 patients (12.8%) from the control group with a rate ratio of 6.6 (95% confidence interval, 3.1-14.0; <0.001). Remission of hypertension was present in 25 of 49 (51%) and 22 of 48 (45.8%) patients randomized to gastric bypass, considering office and 24-hour ambulatory blood pressure monitoring, respectively, whereas no patient submitted to medical therapy was free of antihypertensive drugs at 12 months. A post hoc analysis for the primary end point considering the SPRINT (Systolic Blood Pressure Intervention Trial) target reached consistent results, with a rate ratio of 3.8 (95% confidence interval, 1.4-10.6; =0.005). Eleven patients (22.4%) from the gastric bypass group and none in the control group were able to achieve SPRINT levels without antihypertensives. Waist circumference, body mass index, fasting plasma glucose, glycohemoglobin, low-density lipoprotein cholesterol, triglycerides, high-sensitivity C-reactive protein, and 10-year Framingham risk score were lower in the gastric bypass than in the control group.

CONCLUSIONS

Bariatric surgery represents an effective strategy for blood pressure control in a broad population of patients with obesity and hypertension.

CLINICAL TRIAL REGISTRATION

URL: https://clinicaltrials.gov. Unique identifier: NCT01784848.

摘要

背景

最近的减重手术研究集中在代谢和糖尿病的改善上。需要进行随机试验来评估减重手术对肥胖合并高血压患者的影响。

方法

在这项随机、单中心、非盲的试验中,我们纳入了高血压患者(使用最大剂量≥2 种药物或中等剂量>2 种药物),且体重指数(BMI)在 30.0 至 39.9kg/m²之间。患者被随机分配至 Roux-en-Y 胃旁路术联合药物治疗或单纯药物治疗。主要终点是在 12 个月时,降压药物的使用数量减少≥30%,同时维持收缩压和舒张压分别<140mmHg 和 90mmHg。

结果

我们纳入了 100 名患者(70%为女性,平均年龄 43.8±9.2 岁,平均 BMI 36.9±2.7kg/m²),其中 96%完成了随访。与对照组(47 名患者中有 6 名,12.8%)相比,胃旁路组(49 名患者中有 41 名,83.7%)中有更多的患者达到了降压药物使用数量减少≥30%且血压控制良好的主要终点,其比值比为 6.6(95%置信区间,3.1-14.0;<0.001)。在考虑诊室和 24 小时动态血压监测时,分别有 25/49(51%)和 22/48(45.8%)名随机分配至胃旁路组的患者高血压得到缓解,而接受药物治疗的患者在 12 个月时无一例无降压药物。对主要终点进行事后分析时,考虑到 SPRINT(收缩压干预试验)目标,结果仍一致,比值比为 3.8(95%置信区间,1.4-10.6;=0.005)。胃旁路组有 11 名(22.4%)患者和对照组无一例患者能够达到无降压药物的 SPRINT 水平。胃旁路组的腰围、BMI、空腹血糖、糖化血红蛋白、低密度脂蛋白胆固醇、甘油三酯、高敏 C 反应蛋白和 10 年Framingham 风险评分均低于对照组。

结论

减重手术是肥胖合并高血压患者血压控制的有效策略。

临床试验注册

网址:https://clinicaltrials.gov。唯一标识符:NCT01784848。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/946c/5865494/f5d8de484f1d/cir-137-1132-g006.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/946c/5865494/282da7872602/cir-137-1132-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/946c/5865494/cbca6e85a280/cir-137-1132-g003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/946c/5865494/cc6f2b6520b2/cir-137-1132-g005.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/946c/5865494/f5d8de484f1d/cir-137-1132-g006.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/946c/5865494/282da7872602/cir-137-1132-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/946c/5865494/cbca6e85a280/cir-137-1132-g003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/946c/5865494/cc6f2b6520b2/cir-137-1132-g005.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/946c/5865494/f5d8de484f1d/cir-137-1132-g006.jpg

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