Lazzaroni M, Petrillo M, Bianchi Porro G
Br J Clin Pract. 1989 Apr;43(4):151-5.
One hundred and twelve patients (80 males, 32 females) with endoscopically proven gastroduodenal ulcer participated in a clinical trial to compare the ulcer-healing effect of colloidal bismuth subcitrate (CBS) at standard dosage, administered either twice daily (Group A) or four times a day (Group B). Endoscopic control was programmed at Week 4 and Week 8, in case of delayed healing. With an 'intention to treat' analysis, the healing percentage at four weeks was 69.6 for Group A and 82.1 for Group B (IC95 of percentage difference: -0.049 to 2.29). At Week 8, the healing percentage for Groups A and B was 87.5 and 94.6 per cent respectively (IC95: -0.05 to 0.19). The mean steady-state values of bismuth levels in plasma were well below the threshold value of 50 micrograms/l. The data confirm the efficacy and acceptability of CBS swallowing formulation tablets and suggest that administration twice daily is an acceptable alternative to the qid schedule.
112例经内镜证实的胃十二指肠溃疡患者（80例男性，32例女性）参与了一项临床试验，以比较标准剂量的枸橼酸铋钾（CBS）的溃疡愈合效果，该药物分别每日服用两次（A组）或每日服用四次（B组）。若愈合延迟，计划在第4周和第8周进行内镜检查。采用“意向性治疗”分析，A组在4周时的愈合率为69.6%，B组为82.1%（百分比差异的95%置信区间：-0.049至2.29）。在第8周时，A组和B组的愈合率分别为87.5%和94.6%（95%置信区间：-0.05至0.19）。血浆中铋水平的平均稳态值远低于50微克/升的阈值。数据证实了CBS吞咽制剂片的疗效和可接受性，并表明每日服用两次是每日四次给药方案的可接受替代方案。
