泮托拉唑与雷尼替丁治疗有症状的胃食管反流病患者的疗效和安全性比较

Efficacy and safety of pantoprazole versus ranitidine in the treatment of patients with symptomatic gastroesophageal reflux disease.

作者信息

van Zyl J, van Rensburg C, Vieweg W, Fischer R

机构信息

University Hospital, Bloemfontein, Germany.

出版信息

Digestion. 2004;70(1):61-9. doi: 10.1159/000080130. Epub 2004 Aug 5.

DOI:10.1159/000080130

PMID:15297779

Abstract

BACKGROUND/AIM: Gastroesophageal reflux disease (GERD) is a prevalent disease associated with a high symptom burden and a reduced quality of life. This multicenter, randomized, double-blind study compared relief from key GERD symptoms (heartburn, acid eructation, and pain on swallowing) and from other gastrointestinal symptoms (epigastric pain, vomiting, nausea, flatulence, retching, and retrosternal feeling of tightness) and safety profiles of the proton pump inhibitor pantoprazole and the H2 antagonist ranitidine in patients suffering from symptomatic GERD.

METHODS

The patients [338 intention-to-treat (ITT) population; 284 per-protocol (PP) population] received 20 mg pantoprazole (once daily in the morning) plus ranitidine placebo (once daily in the evening; ITT n = 167, PP n = 136) or pantoprazole placebo (once daily in the morning) plus 300 mg ranitidine (once daily in the evening; ITT n = 171, PP n = 148) for 28 days. The primary efficacy criterion (ITT and PP populations) was relief from key GERD symptoms (heartburn, acid eructation, and pain on swallowing) after 28 days of treatment. Secondary criteria (PP) included relief from key GERD symptoms on day 14, relief from all gastrointestinal symptoms on days 14 and 28, and relief from key GERD symptoms on days 14 and 28. Safety evaluations included adverse events and laboratory assessments.

RESULTS

Significantly more pantoprazole-treated patients were free from key GERD symptoms at day 28 (68.3%, n = 114) as compared with ranitidine-treated patients (43.3%, n = 74; 95% confidence interval for odds ratio 1.84-4.51). Pantoprazole was also significantly more efficacious in controlling all gastrointestinal symptoms of GERD. By day 28, 51.5% (n = 70) of the pantoprazole-treated patients were completely symptom free versus 31.1% (n = 46) of the ranitidine-treated patients (95% confidence interval for odds ratio 1.45-3.83). Both treatments were well tolerated.

CONCLUSION

Pantoprazole is significantly superior to ranitidine in the treatment of key and associated gastrointestinal symptoms of GERD and is well tolerated.

摘要

背景/目的：胃食管反流病（GERD）是一种常见疾病，症状负担重，生活质量下降。这项多中心、随机、双盲研究比较了质子泵抑制剂泮托拉唑和H2拮抗剂雷尼替丁对有症状GERD患者关键GERD症状（烧心、反酸和吞咽疼痛）、其他胃肠道症状（上腹痛、呕吐、恶心、腹胀、干呕和胸骨后紧迫感）的缓解情况以及安全性。

方法

患者[338例意向性治疗（ITT）人群；284例符合方案（PP）人群]接受20mg泮托拉唑（每天早晨一次）加雷尼替丁安慰剂（每天晚上一次；ITT n = 167，PP n = 136）或泮托拉唑安慰剂（每天早晨一次）加300mg雷尼替丁（每天晚上一次；ITT n = 171，PP n = 148），治疗28天。主要疗效标准（ITT和PP人群）是治疗28天后关键GERD症状（烧心、反酸和吞咽疼痛）的缓解情况。次要标准（PP）包括第14天关键GERD症状的缓解情况、第14天和第28天所有胃肠道症状的缓解情况以及第14天和第28天关键GERD症状的缓解情况。安全性评估包括不良事件和实验室评估。

结果

与雷尼替丁治疗的患者相比，泮托拉唑治疗的患者在第28天无关键GERD症状的比例显著更高（68.3%，n = 114）（43.3%，n = 74；优势比的95%置信区间为1.84 - 4.51）。泮托拉唑在控制GERD的所有胃肠道症状方面也显著更有效。到第28天，泮托拉唑治疗的患者中有51.5%（n = 70）完全无症状，而雷尼替丁治疗的患者中这一比例为31.1%（n = 46）（优势比的95%置信区间为1.45 - 3.83）。两种治疗的耐受性都良好。