On-demand treatment of gastro-oesophageal reflux symptoms: a comparison of ranitidine 75 mg with cimetidine 200 mg or placebo
On-demand treatment of gastro-oesophageal reflux symptoms: a comparison of ranitidine 75 mg with cimetidine 200 mg or placebo
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DOI：
10.1046/j.1365-2036.1998.00384.x
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发表时间：
1998-09-01
影响因子：
7.6
通讯作者：
Slama, A
中科院分区：
文献类型：
--
作者：
Galmiche, JP;Shi, G;Slama, A
目的：比较雷尼替丁 75 mg 与西咪替丁 200 mg 或安慰剂在 15 天期间缓解胃食管反流病典型症状的效果。方法：招募了 1336 名胃灼热发作患者（年龄大于或等于 18 岁），并随机分配到雷尼替丁 75 mg 组、西咪替丁 200 mg 组或安慰剂组，根据胃灼热的发生或持续情况，根据需要进行治疗，每天最多 3 次，两次给药之间至少间隔 2 小时。如果在任何一天第三次用药后症状持续至少 2 小时，则可以使用抗酸剂作为救援药物。主要终点定义为研究期间胃灼热发作缓解至少 75% 的患者比例（即药物摄入后 2 小时内缓解并持续至少 5 小时）。 结果：在意向治疗人群中进行分析，包括雷尼替丁组 504 名受试者、西咪替丁组 515 名受试者和安慰剂组 270 名受试者。三组的主要终点成功率分别为 41%、38% 和 28%（雷尼替丁与安慰剂相比，P < 0.001，雷尼替丁与西咪替丁相比，P = 0.274）。雷尼替丁 75 mg 在缓解胃灼热方面明显比安慰剂更有效（P < 0.001）。雷尼替丁组和西咪替丁组之间的差异并不显着，只是雷尼替丁组在研究结束时胃灼热频率显着降低（P < 0.05）。与安慰剂组相比，雷尼替丁组的药物剂量较低，使用的救援药物也较少。三个治疗组在耐受性方面没有差异。 结论：按需服用雷尼替丁 75 mg 或西咪替丁 200 mg 是治疗反流相关症状安全有效的方法。
Aim: To compare the effects of ranitidine 75 mg with those of either cimetidine 200 mg or placebo given on demand for relief of typical symptoms of gastro-oesophageal reflux disease during a 15-day period.Methods: A total of 1336 patients (aged greater than or equal to 18 years) with heartburn episodes were recruited and randomly assigned to a ranitidine 75 mg, cimetidine 200 mg or placebo group, Depending on the occurrence or persistence of heartburn, treatment was administered as required up to three times daily, with at least 2 h between drug doses. Antacids were allowed as rescue medication if symptoms persisted for at least 2 h after the third medication on any given day. The primary end-point was defined as the proportion of patients with relief of at least 75% of heartburn episodes during the study period (i.e. relief occurring within 2 h after drug ingestion and lasting for at least 5 h),Results: Analysis was performed in an intention-to-treat population comprising 504 subjects in the ranitidine group, 515 in the cimetidine group and 270 in the placebo group. Primary end-point success rates were 41, 38 and 28%, respectively, for the three groups (P < 0.001 for ranitidine vs, placebo, P = 0.274 for ranitidine vs. cimetidine). Ranitidine 75 mg was significantly more effective than placebo in providing overall heartburn relief (P < 0.001). The differences between the ranitidine and cimetidine groups were not significant, except for a greater reduction in heartburn frequency in the ranitidine group at the end of the study period (P < 0.05). Drug dose was lower and less rescue medication was used in the ranitidine group than the placebo group. The three treatment groups did not differ in terms of tolerability.Conclusion: On-demand ranitidine 75 mg or cimetidine 200 mg are safe and effective treatment for reflux-related symptoms.