Okhuysen P C, DuPont H L, Ericsson C D, Marani S, Martinez-Sandoval F G, Olesen M A, Ravelli G P
Center for Infectious Diseases, University of Texas-Houston Medical School 77030, USA.
Clin Infect Dis. 1995 Aug;21(2):341-4. doi: 10.1093/clinids/21.2.341.
The present study was undertaken to compare the efficacy of a new calmodulin antagonist, zaldaride maleate, with that of placebo or loperamide in persons with traveler's diarrhea. One hundred seventy-nine patients were randomized to receive loperamide (4 mg followed by 2 mg after each unformed stool), zaldaride maleate (20 mg four times per day), or placebo. During the initial 48 hours of therapy, zaldaride maleate decreased the number of unformed stools by 30% and the duration of illness by 23% when compared with placebo. Loperamide was superior to both zaldaride maleate and placebo during the initial hours of treatment. However, after 48 hours of treatment, loperamide and zaldaride maleate were equally efficacious, decreasing by > 50% the number of unformed stools passed in a 24-hour interval (P, not significant), and were both superior when compared with placebo (P < .0001 and P = .0048, respectively). The apparent superiority of loperamide early in the course of therapy appeared to be related to a loading-dose effect and not to any differences in antidiarrheal properties.
本研究旨在比较新型钙调蛋白拮抗剂马来酸扎尔达利德与安慰剂或洛哌丁胺对旅行者腹泻患者的疗效。179名患者被随机分为三组，分别接受洛哌丁胺（首剂4 mg，此后每次不成形大便后服用2 mg）、马来酸扎尔达利德（每日4次，每次20 mg）或安慰剂治疗。在治疗的最初48小时内，与安慰剂相比，马来酸扎尔达利德可使不成形大便次数减少30%，病程缩短23%。在治疗的最初数小时内，洛哌丁胺的疗效优于马来酸扎尔达利德和安慰剂。然而，治疗48小时后，洛哌丁胺和马来酸扎尔达利德的疗效相当，均可使24小时内的不成形大便次数减少> 50%（P值无统计学意义），且二者均优于安慰剂（P值分别为< .0001和= .0048）。治疗早期洛哌丁胺的明显优势似乎与负荷剂量效应有关，而非止泻特性存在差异。
