Galambos J T, Hersh T, Schroder S, Wenger J
Gastroenterology. 1976 Jun;70(6):1026-9.
Twenty-seven patients with chronic diarrhea due to Crohn's disease, ulcerative colitis, short bowel syndrome, and idiopathic (functional) causes participated in a multiphase study (open, double blind, and long term open) of loperamide HCl, a new single entity, oral antidiarrheal agent. In the open phase of the study, loperamide effectively relieved symptoms of diarrhea in 21 of 27 patients. The average number of stools dropped from eight in the initial relapse period to two stools after 1 month of treatment (P = 0.0001). Efficacy was confirmed in the double blind and long term open phases of the study. Four patients who were not relieved while on therapy had discontinued the drug because of abdominal cramping. No other side effects attributable to the drug were observed. Loperamide has been found to be a safe and effective agent for the treatment of chronic diarrhea.
27名患有因克罗恩病、溃疡性结肠炎、短肠综合征和特发性(功能性)病因导致的慢性腹泻患者参与了一项关于新型单一实体口服止泻药盐酸洛哌丁胺的多阶段研究(开放、双盲和长期开放)。在研究的开放阶段,洛哌丁胺有效缓解了27名患者中21人的腹泻症状。平均排便次数从初始复发期的每天8次降至治疗1个月后的每天2次(P = 0.0001)。该研究的双盲和长期开放阶段证实了其疗效。4名在治疗期间未缓解的患者因腹部绞痛而停药。未观察到其他可归因于该药物的副作用。已发现洛哌丁胺是一种治疗慢性腹泻的安全有效药物。