Heredia Díaz J G, Alcántara I, Solís A
Rev Gastroenterol Mex. 1979 Oct-Dec;44(4):167-73.
A randomized double-blind placebo controlled trial of the safety and efficacy of lidamidine hydrochloride (WHR-1142A) in thirty patients with acute nonspecific diarrhea was conducted. During their 29-hour hospital treatment period, the average number of bowel movements for each ten patient treatment group was: placebo, 5.1: lidamidine hydrochloride (10 mg), 2.4; lidamidine hydrochloride (18 mg), 2.5. The average weight of the feces of the patients in each treatment group was: placebo, 576 grams; lidamidine hydrochloride (10 mg), 364 grams; lidamidine hydrochloride (18 mg), 435 grams. Time intervals between each of the first two doses were greater for those patients in the active treatment groups (lidamidine hydrochloride) when compared to the placebo group. Overall evaluation of therapy was rated by physician and patient at end of study: placebo, 10 of 10, not effective; lidamidine hydrochloride (10 mg), 10 of 10 (100%) effective; lidamidine hydrochloride (18 mg), 10 of 10 (100%) effective. Vital signs and laboratory values remained within normal ranges throughout the duration of study, and no clinically significant adverse effects were reported.
开展了一项关于盐酸利达脒(WHR - 1142A)对30例急性非特异性腹泻患者安全性和有效性的随机双盲安慰剂对照试验。在29小时的住院治疗期间,每个十名患者治疗组的平均排便次数为:安慰剂组5.1次;盐酸利达脒(10毫克)组2.4次;盐酸利达脒(18毫克)组2.5次。每个治疗组患者粪便的平均重量为:安慰剂组576克;盐酸利达脒(10毫克)组364克;盐酸利达脒(18毫克)组435克。与安慰剂组相比,活性治疗组(盐酸利达脒)患者前两剂之间的时间间隔更长。在研究结束时,医生和患者对治疗的总体评价为:安慰剂组10人中10人评价为无效;盐酸利达脒(10毫克)组10人中10人(100%)评价为有效;盐酸利达脒(18毫克)组10人中10人(100%)评价为有效。在整个研究期间,生命体征和实验室值均保持在正常范围内,且未报告有临床显著的不良反应。