Tijtgat G N, Meuwissen S G, Huibregtse K
Ann Clin Res. 1975 Oct;7(5):325-30.
Fifteen patients (20-66 years) with persistent diarrhoea of varying aetiology were selected for an open trial of loperamide 2 mg capsules. The optimal daily dose for substantial reduction of the diarrhoea ranged from two to seven capsules. Eleven patients showed a significant improvement in stool consistency, a highly significant decrease in stool frequency and a decrease of abdominal cramps. One ileostomy patient with abundant ileostomy output and intermittent leaking of the ileosotmy appliance at night experienced a substantial reduction of the stoma output with virtual disappearance of soiling accidents as night. Loperamide appeared to be ineffective in two patients with cholerrhoeic diarrhoea; in one patient with laxative-induced diarrhoea and in one patient with probable nervous diarrhoea. The eleven successfully treated patients then entered a doubleblind placebo-controlled trial for ten days or util relaps, the daily dose being indentical to the optimal one previously determined in the open phase of the study. The investigator was able to guess the code correctly in ten out of eleven cases. The drug was well tolerated. Because of its considerable efficacy and low side-effect liability, loperamide has to be considered a promising drug in the treatment of chronic diarrhoea.
选择了15名病因各异的持续性腹泻患者（年龄20 - 66岁）进行洛哌丁胺2毫克胶囊的开放试验。显著减少腹泻的最佳日剂量为2至7粒胶囊。11名患者的大便稠度有显著改善，大便频率显著降低，腹部绞痛减轻。一名回肠造口术患者回肠造口排出物多，夜间回肠造口装置间歇性渗漏，其造口排出量大幅减少，夜间几乎没有弄脏事故。洛哌丁胺对两名胆汁性腹泻患者、一名缓泻剂引起腹泻的患者和一名可能为神经性腹泻的患者似乎无效。11名成功治疗的患者随后进入为期10天的双盲安慰剂对照试验或直至复发，日剂量与研究开放阶段先前确定的最佳剂量相同。在11例病例中，研究者有10次能够正确猜出编码。该药物耐受性良好。由于其显著疗效和低副作用发生率，洛哌丁胺在治疗慢性腹泻方面被认为是一种有前景的药物。
