Galmiche J P, Zerbib F, Ducrottè P, Fournet J, Rampal P, Avasthy N, Humphries T J
Centre Hospitalier Universitaire de Nantes, Nantes Cedex, France.
Aliment Pharmacol Ther. 2001 Sep;15(9):1343-50. doi: 10.1046/j.1365-2036.2001.01030.x.
Rabeprazole has been shown to be more potent and faster than other proton pump inhibitors in in vitro studies and highly effective in decreasing oesophageal acid exposure in patients with gastro-oesophageal reflux disease (GERD).
This study was a multicentre, double-blind, placebo-controlled, randomized, parallel-group comparison of three active treatment regimens utilizing two different proton pump inhibitors, or placebo, administered over 7 days in patients with GERD.
Eighty-two patients with symptomatic GERD were given placebo, rabeprazole 10 mg b.d., rabeprazole 20 mg o.m., or omeprazole 20 mg o.m. for 7 days. Twenty-four hour oesophageal pH monitoring was performed at baseline and repeated at the conclusion of the treatment period.
At the end of study, the percentage time (mean +/- s.d.) with pH < 4 over a 24-h period was significantly decreased by the three active regimens but without significant difference between them (9.27 +/- 4.77; 2.53 +/- 4.27; 2.02 +/- 1.71 and 2.91 +/- 4.06 for placebo, rabeprazole 10 mg b.d., rabeprazole 20 mg o.m. and omeprazole 20 mg o.m., respectively). Acid exposure was normalized in 90% of patients treated with rabeprazole 10 mg b.d., 95% treated with rabeprazole 20 mg o.m., 78% treated with omeprazole 20 mg o.m., and only 9.5% of patients treated with placebo. Both rabeprazole and omeprazole were well-tolerated.
Although rabeprazole 20 mg o.m. showed greater activity numerically, this study demonstrates that rabeprazole 10 mg b.d. and 20 mg o.m. are equivalent to omeprazole 20 mg o.m. in decreasing oesophageal acid exposure.
在体外研究中,雷贝拉唑已显示出比其他质子泵抑制剂更有效且起效更快,并且在降低胃食管反流病(GERD)患者的食管酸暴露方面非常有效。
本研究是一项多中心、双盲、安慰剂对照、随机、平行组比较研究,在GERD患者中使用两种不同的质子泵抑制剂或安慰剂进行三种活性治疗方案,为期7天。
82例有症状的GERD患者接受安慰剂、雷贝拉唑10mg每日两次、雷贝拉唑20mg每日一次或奥美拉唑20mg每日一次治疗7天。在基线时进行24小时食管pH监测,并在治疗期结束时重复进行。
在研究结束时,三种活性治疗方案均使24小时内pH<4的时间百分比(均值±标准差)显著降低,但它们之间无显著差异(安慰剂组、雷贝拉唑10mg每日两次组、雷贝拉唑20mg每日一次组和奥美拉唑20mg每日一次组分别为9.27±4.77、2.53±4.27、2.02±1.71和2.91±4.06)。接受雷贝拉唑10mg每日两次治疗的患者中90%的酸暴露恢复正常,接受雷贝拉唑20mg每日一次治疗的患者中95%恢复正常,接受奥美拉唑20mg每日一次治疗的患者中78%恢复正常,而接受安慰剂治疗的患者中仅9.5%恢复正常。雷贝拉唑和奥美拉唑的耐受性均良好。
尽管雷贝拉唑20mg每日一次在数值上显示出更大的活性,但本研究表明雷贝拉唑10mg每日两次和20mg每日一次在降低食管酸暴露方面与奥美拉唑20mg每日一次等效。