Dobrilla G
Hepatogastroenterology. 1985 Aug;32(4):195-7.
The author compares the efficacy of ranitidine 300 mg in a single bedtime dose, and ranitidine 150 mg twice daily, in 509 duodenal ulcer patients treated in two Italian multicentre trials. In the first of these trials the treatment period was 4 weeks plus a further 4 weeks in patients whose ulcers failed to heal, as against 2 plus 4 weeks in the other trial. Given the homogeneity of the patient entry and exclusion criteria, and the fact that identical clinical and endoscopic evaluation criteria were used in the two trials, the results are grouped together for analysis purposes. This permits detailed evaluation of the therapeutic effects of the two ranitidine regimens at two-weekly intervals over a total period of 8 weeks. With the single bedtime dose regimen, healing rates were 47.2% after 2 weeks, 81.7% after 4 weeks, 83.6% after 6 weeks and 94.8% after 8 weeks, while the corresponding rates for the twice-daily regimen were substantially similar (51.9%, 84.1%, 89.5% and 95.8%). The two regimens also produced comparable results in terms of relief of daytime and nocturnal ulcer pain. The Italian experience confirms, in a fairly large patient population, that the simpler ranitidine regimen represented by the single bedtime dose fully preserves its therapeutic efficacy in duodenal ulcer. Moreover, the fact that no differences were noted in responses of patients from the various different regions of Italy with their greatly differing constitutional, environmental and alimentary characteristics, appears to suggest that such factors are not sufficient in themselves to affect the therapeutic results obtained with the drug.
作者在两项意大利多中心试验中,对509例十二指肠溃疡患者比较了雷尼替丁300毫克单次睡前剂量与雷尼替丁150毫克每日两次的疗效。在其中第一项试验中,治疗期为4周,溃疡未愈合的患者再延长4周;而在另一项试验中,治疗期为2周加4周。鉴于患者入选和排除标准的一致性,以及两项试验使用了相同的临床和内镜评估标准,为分析目的将结果合并在一起。这使得能够在总共8周的时间里,每隔两周详细评估两种雷尼替丁治疗方案的治疗效果。采用单次睡前剂量方案时,2周后的愈合率为47.2%,4周后为81.7%,6周后为83.6%,8周后为94.8%;而每日两次方案的相应愈合率基本相似(分别为51.9%、84.1%、89.5%和95.8%)。两种方案在缓解白天和夜间溃疡疼痛方面也产生了相当的结果。意大利的经验在相当大的患者群体中证实,单次睡前剂量这种更简单的雷尼替丁治疗方案在十二指肠溃疡中完全保留了其治疗效果。此外,来自意大利不同地区、具有大不相同的体质、环境和饮食特征的患者在反应上未发现差异,这似乎表明这些因素本身不足以影响该药物获得的治疗结果。