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按需雷贝拉唑与雷尼替丁治疗非糜烂性反流病患者的随机开放标签试验。

A randomized open-label trial of on-demand rabeprazole vs ranitidine for patients with non-erosive reflux disease.

机构信息

Division of Gastroenterology, Department of Internal Medicine, American University of Beirut Medical Center, Hamra 11032090, Beirut, Lebanon.

出版信息

World J Gastroenterol. 2012 May 21;18(19):2390-5. doi: 10.3748/wjg.v18.i19.2390.

DOI:10.3748/wjg.v18.i19.2390
PMID:22654431
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC3353374/
Abstract

AIM

To compare the efficacy of the proton-pump inhibitor, rabeprazole, with that of the H₂-receptor antagonist, ranitidine, as on-demand therapy for relieving symptoms associated with non-erosive reflux disease (NERD).

METHODS

This is a single center, prospective, randomized, open-label trial of on-demand therapy with rabeprazole (group A) vs ranitidine (group B) for 4 wk. Eighty-three patients who presented to the American University of Beirut Medical Center with persistent gastroesophageal reflux disease (GERD) symptoms and a normal upper gastrointestinal endoscopy were eligible for the study. Patients in group A (n = 44) were allowed a maximum rabeprazole dose of 20 mg twice daily, while those in group B (n = 39) were allowed a maximum ranitidine dose of 300 mg twice daily. Efficacy was assessed by patient evaluation of global symptom relief, scores of the SF-36 quality of life (QoL) questionnaires, total number of pills used, and number of medication-free days.

RESULTS

Among the 83 patients who were enrolled in the study, 76 patients (40 in the rabeprazole group and 36 in the ranitidine group) completed the 4-wk trial. Baseline characteristics were comparable between both groups. After 4 wk, there was no significant difference in the subjective global symptom relief between the rabeprazole and the ranitidine groups (71.4% vs 65.4%, respectively; P = 0.9). There were no statistically significant differences between mean cumulative scores of the SF-36 QoL questionnaire for the two study groups (rabeprazole 22.40 ± 27.53 vs ranitidine 17.28 ± 37.06; P = 0.582). There was no significant difference in the mean number of pills used (rabeprazole 35.70 ± 29.75 vs ranitidine 32.86 ± 26.98; P = 0.66). There was also no statistically significant difference in the mean number of medication-free days between both groups.

CONCLUSION

Rabeprazole has a comparable efficacy compared to ranitidine when given on-demand for the treatment of NERD. Both medications were associated with improved quality of life.

摘要

目的

比较质子泵抑制剂雷贝拉唑与 H₂受体拮抗剂法莫替丁作为按需治疗非糜烂性反流病(NERD)相关症状的疗效。

方法

这是一项在贝鲁特美国大学医学中心进行的单中心、前瞻性、随机、开放标签的按需治疗试验,比较雷贝拉唑(A 组)与法莫替丁(B 组)治疗 4 周的疗效。共有 83 例因持续性胃食管反流病(GERD)症状和正常上消化道内镜而就诊于该中心的患者符合入组条件。A 组(n=44)患者允许最大雷贝拉唑剂量为每日 2 次,每次 20mg,B 组(n=39)患者允许最大法莫替丁剂量为每日 2 次,每次 300mg。通过患者对整体症状缓解的评估、SF-36 生活质量(QoL)问卷评分、所用药物总剂量和无药物天数来评估疗效。

结果

在纳入研究的 83 例患者中,76 例(雷贝拉唑组 40 例,法莫替丁组 36 例)完成了 4 周试验。两组基线特征相似。4 周后,雷贝拉唑组和法莫替丁组的主观整体症状缓解率无显著差异(分别为 71.4%和 65.4%;P=0.9)。两组研究的 SF-36 QoL 问卷的平均累积评分也无统计学差异(雷贝拉唑组 22.40±27.53,法莫替丁组 17.28±37.06;P=0.582)。使用的药物平均剂量也无显著差异(雷贝拉唑组 35.70±29.75,法莫替丁组 32.86±26.98;P=0.66)。两组之间无药物天数的平均差异也无统计学意义。

结论

雷贝拉唑按需治疗 NERD 的疗效与法莫替丁相当。两种药物均能改善生活质量。

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