van Loon F P, Bennish M L, Speelman P, Butler C
International Centre for Diarrhoeal Disease Research, Bangladesh.
Gut. 1989 Apr;30(4):492-5. doi: 10.1136/gut.30.4.492.
To determine if loperamide is effective and safe in treating watery diarrhoea, we randomly assigned 50 adult expatriates in Bangladesh with more than three unformed stools in the previous 24 hours and illness of less than 72 hours to receive loperamide or a placebo. On entry into the five day study patients took two capsules (one loperamide capsule = 2 mg) and one after each unformed stool up to a maximum of eight per day. The groups did not significantly differ in pretreatment features or pathogens identified. Mean number of stools on study day 1 was 2.6 in the loperamide group and 4.0 in the placebo group (p = 0.035); on day 2 it was 1.3 versus 3.4 (p less than 0.001). Differences in stool frequencies during the final three study days, or proportion of patients with cramps, nausea, or vomiting on any study day, were not significant. No serious side effects occurred in either group. We conclude that loperamide, by decreasing stool frequency during the early part of illness, may have a role in the symptomatic treatment of this self-limiting disease.
为确定洛哌丁胺治疗水样腹泻是否有效且安全,我们将孟加拉国50名成年侨民随机分组,这些人在过去24小时内有超过3次不成形大便且患病时间少于72小时,让他们接受洛哌丁胺或安慰剂治疗。进入为期五天的研究时,患者服用两粒胶囊(一粒洛哌丁胺胶囊 = 2毫克),此后每次不成形大便后服用一粒,每日最多服用8粒。两组在预处理特征或鉴定出的病原体方面无显著差异。在研究第1天,洛哌丁胺组的平均大便次数为2.6次,安慰剂组为4.0次(p = 0.035);在第2天,分别为1.3次和3.4次(p小于0.001)。在研究最后三天的大便频率差异,或在任何研究日出现痉挛、恶心或呕吐的患者比例,均无显著差异。两组均未出现严重副作用。我们得出结论,洛哌丁胺通过在疾病早期减少大便频率,可能在这种自限性疾病的对症治疗中发挥作用。