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一种用于治疗急性腹泻的蒙脱石新混悬液剂型(液体“迪阿斯奥尔布”):一项随机对照研究。

A new suspension form of smectite (Liquid 'Diasorb') for the treatment of acute diarrhoea: a randomized comparative study.

作者信息

Leber W

出版信息

Pharmatherapeutica. 1988;5(4):256-60.

PMID:3174725
Abstract

An open, multi-centre, general practice study was carried out in 80 patients with acute diarrhoea to compare the effectiveness and tolerability of treatment with a liquid formulation of smectite, a hydrated aluminium-magnesium silicate (Liquid 'Diasorb'), and loperamide. Patients were allocated at random to receive one or other treatment for a maximum of 48 hours. Thirty-three of the patients on the smectite preparation and 30 of those on loperamide had acute diarrhoea of at least 24 hours but no longer than 48 hours in duration. Patients received a daily dose of 6 to 9 g smectite or 8 to 12 mg loperamide, depending on the symptoms. Details of red and white cell counts, serum electrolyte concentrations and stool culture for pathogens and parasites were recorded on entry and after 1 week. The results, judged in terms of resolution of symptoms after 2 and 7 days, doctor and patient assessment of response to therapy, and incidence of side-effects, showed that both treatments were equally effective and well-tolerated. Two patients were withdrawn, 1 patient (Liquid 'Diasorb') because of lack of response and the other (loperamide) because of dryness of the mouth and nausea. Laboratory parameters remained unchanged apart from a slight decrease in leucocytes in both groups.

摘要

一项开放性、多中心的全科医学研究在80例急性腹泻患者中开展,以比较蒙脱石(一种水合铝镁硅酸盐,商品名“Diasorb液剂”)液体制剂与洛哌丁胺治疗的有效性和耐受性。患者被随机分配接受其中一种治疗,最长治疗48小时。接受蒙脱石制剂治疗的33例患者和接受洛哌丁胺治疗的30例患者患有持续时间至少24小时但不超过48小时的急性腹泻。患者根据症状每日服用6至9克蒙脱石或8至12毫克洛哌丁胺。记录患者入组时及1周后的红细胞计数、白细胞计数、血清电解质浓度以及病原体和寄生虫的粪便培养结果。根据2天和7天后症状的缓解情况、医生和患者对治疗反应的评估以及副作用的发生率判断,结果显示两种治疗同样有效且耐受性良好。2例患者退出研究,1例(“Diasorb液剂”组)因无反应退出,另1例(洛哌丁胺组)因口干和恶心退出。除两组白细胞均略有减少外,实验室参数保持不变。

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