Euler A R, Murdock R H, Wilson T H, Silver M T, Parker S E, Powers L
Glaxo Inc., Research Triangle Park, North Carolina.
Am J Gastroenterol. 1993 Apr;88(4):520-4.
Two ranitidine dosages were compared for the treatment of erosive esophagitis in a multicenter, double-blind, randomized, parallel-group, placebo-controlled study. Adults with endoscopically verified erosive esophagitis were treated with either ranitidine 150 mg four times daily (n = 106), ranitidine 300 mg four times daily (n = 106), or placebo (n = 116) for up to 12 wk. Patients were also encouraged to adhere to lifestyle modifications (e.g., to elevate the head of bed, etc). Erosive esophagitis healing, determined by endoscopy, was achieved in 69% and 62% of ranitidine-treated patients by 8 wk and in 79% and 74% by 12 wk (150 mg and 300 mg, respectively) compared with 28% of placebo-treated patients by 8 wk and 40% by 12 wk (p < 0.001 ranitidine vs. placebo). Onset of heartburn relief occurred within 24 h of initiating either ranitidine dosage, and relief was maintained throughout the 12-wk study. Both ranitidine dosages displayed safety profiles similar to that of placebo. We conclude that ranitidine 150 mg or 300 mg administered four times daily is effective for healing erosive esophagitis and relieving its symptoms.
在一项多中心、双盲、随机、平行组、安慰剂对照研究中,比较了两种雷尼替丁剂量治疗糜烂性食管炎的效果。经内镜证实为糜烂性食管炎的成年人,分别接受每日4次、每次150 mg雷尼替丁治疗(n = 106)、每日4次、每次300 mg雷尼替丁治疗(n = 106)或安慰剂治疗(n = 116),疗程长达12周。还鼓励患者坚持生活方式改变(如抬高床头等)。通过内镜检查确定,接受雷尼替丁治疗的患者在8周时糜烂性食管炎愈合率分别为69%和62%,12周时分别为79%和74%(分别为150 mg和300 mg组),而接受安慰剂治疗的患者在8周时为28%,12周时为40%(雷尼替丁与安慰剂相比,p < 0.001)。两种雷尼替丁剂量在开始用药24小时内均出现烧心缓解,且在整个12周研究期间症状持续缓解。两种雷尼替丁剂量的安全性与安慰剂相似。我们得出结论,每日4次给予150 mg或300 mg雷尼替丁对愈合糜烂性食管炎和缓解其症状有效。