Steffen R, DuPont H L, Heusser R, Helminger A, Witassek F, Manhart M D, Schär M
Antimicrob Agents Chemother. 1986 Apr;29(4):625-7. doi: 10.1128/AAC.29.4.625.
In a randomized double-blind study, Swiss adults traveling to tropical countries for 12 to 28 days took a solid formulation of bismuth subsalicylate (1.05 or 2.1 g/day on a twice-daily regimen) or placebo. Efficacy was evaluated in 231 volunteers. Diarrheal incidence was reduced by 41% in persons taking the high dose (P = 0.007) and by 35% in those taking the low dose (P = 0.03) with excellent compliance. No serious adverse reactions occurred, but objectionable taste, constipation, and nausea were seen more frequently with active medication (P = 0.04). Twenty patients provided stool samples: no bacteria were detected in the 8 volunteers who were on active medication, but various bacteria were found in 5 of the 12 patients who had taken placebo (P = 0.04).
在一项随机双盲研究中,前往热带国家旅行12至28天的瑞士成年人服用了水杨酸铋固体制剂(每日两次,剂量为1.05或2.1克/天)或安慰剂。对231名志愿者的疗效进行了评估。高剂量组腹泻发生率降低了41%(P = 0.007),低剂量组降低了35%(P = 0.03),依从性良好。未发生严重不良反应,但服用活性药物的患者更常出现味觉不适、便秘和恶心(P = 0.04)。20名患者提供了粪便样本:服用活性药物的8名志愿者未检测到细菌,但服用安慰剂的12名患者中有5名发现了各种细菌(P = 0.04)。