Silver M T, Murdock R H, Morrill B B, Sue S O
Glaxo Research Institute, Research Triangle Park, North Carolina, USA.
Aliment Pharmacol Ther. 1996 Jun;10(3):373-80. doi: 10.1111/j.0953-0673.1996.00373.x.
Ranitidine 150 mg q.d.s. is the currently recommended dosage in the United States for the treatment of erosive oesophagitis. To determine whether a higher dose of ranitidine administered less frequently would also be effective in healing erosive oesophagitis, we compared ranitidine 300 mg b.d. with ranitidine 150 mg q.d.s. in the treatment of erosive oesophagitis.
This multicentre, double-blind, randomized, placebo-controlled study conducted in the United States compared two dosages of ranitidine in 772 patients with endoscopically diagnosed erosive oesophagitis. Patients were treated with ranitidine 300 mg b.d., ranitidine 150 mg q.d.s. or placebo for up to 12 weeks. Endoscopies were repeated after 4, 8 and 12 weeks of treatment.
Ranitidine 300 mg b.d. was significantly more effective than placebo in healing erosive oesophagitis at weeks 8 and 12 (51 vs. 36% and 66 vs. 52%, respectively; P < or = 0.004). Significantly higher healing rates were also achieved with ranitidine 150 mg q.d.s. compared with placebo at 4, 8 and 12 weeks (37 vs. 21%, 62 vs. 36% and 77 vs. 52%, respectively; P < 0.001). Healing rates were significantly higher with ranitidine 150 mg q.d.s. than with ranitidine 300 mg b.d. at all scheduled endoscopies (P < or = 0.041).
Ranitidine 300 mg b.d. is effective in healing erosive oesophagitis and may be appropriate as an alternative dosage regimen to ranitidine 150 mg q.d.s. in some patients with erosive oesophagitis.
在美国,雷尼替丁150毫克每日四次是目前推荐用于治疗糜烂性食管炎的剂量。为了确定较少给药次数但更高剂量的雷尼替丁治疗糜烂性食管炎是否同样有效,我们比较了雷尼替丁300毫克每日两次与雷尼替丁150毫克每日四次治疗糜烂性食管炎的效果。
这项在美国进行的多中心、双盲、随机、安慰剂对照研究,比较了772例经内镜诊断为糜烂性食管炎的患者使用两种剂量雷尼替丁的情况。患者接受雷尼替丁300毫克每日两次、雷尼替丁150毫克每日四次或安慰剂治疗长达12周。在治疗4周、8周和12周后重复进行内镜检查。
在第8周和第12周,雷尼替丁300毫克每日两次治疗糜烂性食管炎的效果显著优于安慰剂(分别为51%对36%和66%对52%;P≤0.004)。在第4周、8周和12周时,雷尼替丁150毫克每日四次的愈合率也显著高于安慰剂(分别为37%对21%、62%对36%和77%对52%;P<0.001)。在所有预定的内镜检查中,雷尼替丁150毫克每日四次的愈合率显著高于雷尼替丁300毫克每日两次(P≤0.041)。
雷尼替丁300毫克每日两次对糜烂性食管炎的愈合有效,对于一些糜烂性食管炎患者,可能是雷尼替丁150毫克每日四次的替代给药方案。