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洛哌丁胺治疗慢性腹泻及回肠造口术后腹泻:一项安慰剂对照双盲交叉研究。

Loperamide in chronic diarrhea and after ileostomy: a placebo-controlled double-blind cross-over study.

作者信息

Tytgat G N, Huibregtse K, Meuwissen S G

出版信息

Arch Chir Neerl. 1976;28(1):13-20.

PMID:779663
Abstract

Fifteen patients (20 to 66 years) with long-standing chronic diarrhea of varying etiology were selected for an open trial of loperamide 2 mg capsules. The optimal daily dose for substantial reduction of the diarrhea ranged from two to seven capsules. Eleven patients showed a significant improvement in stool consistency and stool frequency, and a decrease of abdominal cramps. Loperamide appeared to be ineffective in two patients with cholerrheic diarrhea, and in one patient with laxative-induced diarrhea, and in one patient with diarrhea of unknown etiology. The eleven successfully treated patients then entered a double-blind placebo-controlled trial for ten days or until relapse, the daily dose being identical to the optimal one previously determined in the open phase. The investigator was able to guess the code correctly in ten out of eleven cases. Twenty ileostomy patients (ages 25 to 73 years) volunteered for the evaluation of the inhibitory activity on small intestinal peristalsis by loperamide in a double-blind placebo-controlled cross-over study. Mean daily ileostomy output decreased by 22% in the loperamide period, as compared with the drug-free study phase (P less than 0.001). Of the 20 patients, 16 were able to guess their code correctly, whereas four were uncertain, although their fecal weights were lower with loperamide. Many patients noticed an increased urinary production and experienced an improvement in their ileostomy care during loperamide treatment. Because of its effectiveness, its low side-effect liability and its lack of toxicity, loperamide is considered a promising drug in the symptomatic treatment of chronic diarrhea, and as a reliable agent in the treatment of ileostomy patients.

摘要

选取了15名年龄在20至66岁之间、病因各异且长期患有慢性腹泻的患者,进行洛哌丁胺2毫克胶囊的开放性试验。显著减少腹泻的最佳日剂量为2至7粒胶囊。11名患者的粪便稠度和排便次数有显著改善,腹部绞痛也有所减轻。洛哌丁胺对2名胆汁性腹泻患者、1名缓泻剂所致腹泻患者及1名病因不明的腹泻患者似乎无效。11名治疗成功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,日剂量与开放期预先确定的最佳剂量相同。在11例病例中,研究者有10例猜对了编码。20名回肠造口术患者(年龄在25至73岁之间)自愿参加一项双盲安慰剂对照交叉研究,以评估洛哌丁胺对小肠蠕动的抑制活性。与无药研究阶段相比,在服用洛哌丁胺期间,回肠造口术患者的日均排出量减少了22%(P小于0.001)。20名患者中,16名能够正确猜出自己的编码,4名不确定,尽管服用洛哌丁胺后他们的粪便重量较轻。许多患者注意到在服用洛哌丁胺治疗期间尿量增加,回肠造口术护理也有所改善。由于其有效性、低副作用发生率及无毒性,洛哌丁胺被认为是治疗慢性腹泻症状的一种有前景的药物,也是治疗回肠造口术患者的可靠药物。

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