van Outryve M, Toussaint J
Department of Gastroenterology, University Hospital of Antwerp, Belgium.
J Int Med Res. 1995 Sep-Oct;23(5):335-41. doi: 10.1177/030006059502300503.
Loperamide oxide was compared with placebo for the treatment of chronic diarrhoea in patients with Crohn's disease. After initially receiving 2 mg loperamide oxide or placebo, hospital out-patients with Crohn's disease were instructed to take one tablet of loperamide oxide (1 mg) or placebo after passage of each unformed stool in a 1-week double-blind investigation. Patients who responded to this treatment by passing less than three unformed stools per 24 h continued to receive the drug, twice daily, for a further week. At the end of the initial 1-week treatment phase both the investigator's and the patients' global evaluations of efficacy were significantly in favour of the active treatment (P = 0.025 and P = 0.020, respectively). The investigator's assessment of the change in abdominal pain was significant for loperamide oxide (P = 0.020) but not for placebo. Improvements in patient-rated severity of diarrhoea were significantly greater for loperamide oxide than for placebo (P = 0.046). The mean daily dose of loperamide oxide was 2.7 mg. During the second week, both the investigator's and the patients' assessments of global efficacy and symptom improvement continued to favour loperamide oxide though the differences were not significant. Adverse events were rare. The results suggest that loperamide oxide (3 mg/per day) provides a safe and effective treatment for the chronic diarrhoea associated with Crohn's disease.
将氧化洛哌丁胺与安慰剂用于治疗克罗恩病患者的慢性腹泻进行了比较。在最初接受2毫克氧化洛哌丁胺或安慰剂后，克罗恩病门诊患者在为期1周的双盲研究中，被指示在每次排出不成形大便后服用1片氧化洛哌丁胺（1毫克）或安慰剂。对该治疗有反应（每24小时排出少于3次不成形大便）的患者继续接受该药物治疗，每日两次，持续一周。在最初1周的治疗阶段结束时，研究者和患者对疗效的总体评价均显著支持活性治疗（分别为P = 0.025和P = 0.020）。研究者对腹痛变化的评估显示氧化洛哌丁胺有显著效果（P = 0.020），而安慰剂则无。氧化洛哌丁胺使患者评定的腹泻严重程度改善明显大于安慰剂（P = 0.046）。氧化洛哌丁胺的平均日剂量为2.7毫克。在第二周，研究者和患者对总体疗效和症状改善的评估继续支持氧化洛哌丁胺，尽管差异不显著。不良事件很少见。结果表明，氧化洛哌丁胺（每日3毫克）为与克罗恩病相关的慢性腹泻提供了一种安全有效的治疗方法。
