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体质量指数(BMI)是否影响质子泵抑制剂(PPI)治疗 GERD 的临床疗效?以雷贝拉唑为例。

Does BMI affect the clinical efficacy of proton pump inhibitor therapy in GERD? The case for rabeprazole.

机构信息

Department and Chair of Gastroenterology, University of Milan, Italy.

出版信息

Eur J Gastroenterol Hepatol. 2011 Oct;23(10):845-51. doi: 10.1097/MEG.0b013e32834991b7.

DOI:10.1097/MEG.0b013e32834991b7
PMID:21900784
Abstract

BACKGROUND

Increased BMI is associated with a higher risk of gastroesophageal reflux disease.

AIMS

To investigate whether overweight/obesity (BMI≥25 kg/m(2)) affects rabeprazole clinical efficacy versus omeprazole in patients with erosive esophagitis (EE).

PATIENTS AND METHODS

Post-hoc analysis of EE healing rate and symptom response stratified by patient BMI was performed on data from a multicenter, double-blind, randomized, 4-to-8-week trial comparing EE healing with rabeprazole (20 mg daily) and omeprazole (20 mg daily). Analysis of variance, two-sample t-test, Blackwelder's test for equivalence, log-rank, and Cochran-Mantel-Haenszel tests were used to analyze comparisons.

RESULTS

In the two BMI groups (<25 kg/m(2) and ≥25 kg/m(2) respectively), rabeprazole and omeprazole were equally effective for mucosal healing regardless of patient's BMI (N=542, P>0.05). However, in overweight/obese patients, rabeprazole was significantly faster than omeprazole in inducing heartburn relief during the first treatment week (P<0.0001).

CONCLUSIONS

Results of this study show that the clinical efficacy of rabeprazole is maintained in overweight/obese patients with gastroesophageal reflux disease and suggest that this subgroup of patients may derive, from rabeprazole, even greater benefit than lean patients.

摘要

背景

BMI 增加与胃食管反流病风险增加相关。

目的

研究超重/肥胖(BMI≥25kg/m2)是否影响雷贝拉唑相对于奥美拉唑治疗糜烂性食管炎(EE)患者的临床疗效。

患者和方法

对一项多中心、双盲、随机、4-8 周的临床试验数据进行了 EE 愈合率和症状缓解的事后分析,该试验比较了雷贝拉唑(每日 20mg)和奥美拉唑(每日 20mg)治疗 EE 的疗效。采用方差分析、两样本 t 检验、Blackwelder 等效性检验、对数秩检验和 Cochran-Mantel-Haenszel 检验对比较进行分析。

结果

在两个 BMI 组(<25kg/m2 和≥25kg/m2)中,雷贝拉唑和奥美拉唑对黏膜愈合的疗效在患者 BMI 不同的情况下相当(N=542,P>0.05)。然而,在超重/肥胖患者中,雷贝拉唑在治疗的第一周内缓解烧心的速度明显快于奥美拉唑(P<0.0001)。

结论

本研究结果表明,雷贝拉唑在超重/肥胖的胃食管反流病患者中的临床疗效得到维持,并提示该亚组患者可能比瘦患者获得更大的益处。

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