Graham D Y, Evans D G
Department of Medicine, Veterans Administration Medical Center, Houston, Texas 77030.
Rev Infect Dis. 1990 Jan-Feb;12 Suppl 1:S68-72. doi: 10.1093/clinids/12.supplement_1.s68.
The effectiveness of bismuth subsalicylate in the prevention and treatment of diarrhea induced in volunteers by a single strain of enterotoxigenic Escherichia coli and a standard inoculum size was evaluated. Bismuth subsalicylate (500 mg in a solid dosage form) was administered 8 hours and 2 hours before and 2 hours and 4 hours after the E. coli challenge; treatment was continued four times a day for three additional days. Volunteers experiencing diarrhea were re-randomized to receive placebo or bismuth subsalicylate (300 mg every 30 minutes, for a total of 2.4 g of bismuth subsalicylate, in eight doses). Diarrhea occurred in nine (56%) of the 16 volunteers receiving placebo and in two (13%) of the 15 volunteers receiving bismuth subsalicylate (P less than .03). In vitro studies revealed that bismuth subsalicylate and its components each were bactericidal at concentrations possibly attained during the clinical trial. The effect of the dosage form (solid vs. liquid), the relation of drug administration to meals, and how these variables might greatly influence the effectiveness of bismuth subsalicylate prophylaxis for travelers' diarrhea were considered.
评估了碱式水杨酸铋对由单一菌株产肠毒素大肠杆菌及标准接种量诱发志愿者腹泻的预防和治疗效果。在大肠杆菌攻击前8小时、2小时以及攻击后2小时、4小时给予碱式水杨酸铋(500毫克固体剂型);治疗持续4次/天,共额外进行3天。出现腹泻的志愿者重新随机分组,接受安慰剂或碱式水杨酸铋(每30分钟300毫克,共2.4克碱式水杨酸铋,分8剂)。16名接受安慰剂的志愿者中有9名(56%)出现腹泻,15名接受碱式水杨酸铋的志愿者中有2名(13%)出现腹泻(P<0.03)。体外研究显示,碱式水杨酸铋及其成分在临床试验可能达到的浓度下均具有杀菌作用。考虑了剂型(固体与液体)、给药与进餐的关系以及这些变量如何可能极大地影响碱式水杨酸铋对旅行者腹泻的预防效果。