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racecadotril in the Treatment of Acute Diarrhoea in Adults. An Individual Patient Data Based Meta-Analysis

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International Journal of Clinical Medicine 2014年第7期5卷 345-360页

作者： Benoit Coffin Habib Hamza Jean-Marie Vetel Philippe Lehert Hepatogastroenterology Department Louis-Mourier HospitalColombesFrance Clinique Taoufik TunisTunisia Geriatric Department Centre Hospitalier du MansLe MansFrance Faculty of Economics UCL MonsLouvainBelgium Faculty of Medicine The University of MelbourneMelbourneAustralia

racecadotril is an antidiarrhoeal drug with a pure intestinal antisecretory mechanism of action. Aim: To assess racecadotril efficacy, whatever its dose, versus placebo in adult acute diarrhoea. Methods: Individual Patient Data meta-analysis following multilevel mixed models testing of the significance of the treatment effect adjusted for baseline covariates. Diarrhoea duration was the common main criteria. Results: Four randomized clinical trials (n = 669) were identified with raw data. The clinical global impression evaluated at baseline by the physician was found to be the essential predictor influencing the outcome. As compared to placebo, the 100 mg dose, the minimum effective dose, induced a 80% increase of the recovered patient proportion at anytime (Hazard Ratio = 1.8 [1.3, 2.5], p racecadotril induced several significant effects, such as reducing the diarrhoea duration, the number of stools and associated symptoms, leading to less lost productivity.

关键词： Acute Diarrhoea racecadotril Meta-Analysis

racecadotril Efficacy in the Symptomatic Treatment of Adult Acute Diarrhoea: A Systematic Review and Meta-Analysis

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International Journal of Clinical Medicine 2014年第7期5卷 361-375页

作者： Jean-Marie Vetel Habib Hamza Benoit Coffin Philippe Lehert Geriatric Department Centre Hospitalier du MansLe MansFrance Clinique Taoufik TunisTunisia Hepatogastroenterology Department Louis-Mourier HospitalColombesFrance Faculty of Economics UCL MonsLouvainBelgium Faculty of Medicine The University of MelbourneMelbourneAustralia

The efficacy of racecadotril (RC), an intestinal antisecretory drug acting via an enkephalinase inhibition, was reviewed in paediatric acute diarrhoea but not yet in adults. Objective: To estimate the effectiveness of RC in the symptomatic treatment of acute diarrhoea in adults. Data Sources: A systematic review of MedLine, Cochrane Controlled Trials Register, DARE, and Embase (up to November 2013). Additional studies were identified by contacting clinical experts and the manufacturer. Study Selection and Appraisal: Randomized Controlled Trials performed in adults suffering from acute diarrhoea using RC in one treatment arm. Independent extraction of articles using predefined data fields, and methodological quality measurement assessment. All randomised trials performed in adults suffering from acute diarrhoea with RC as the studied group. Statistics: The main efficacy endpoint was diarrhoea duration defined as time to recovery compared between groups by survival techniques and converted into hazard ratio (HR). We exclusively used a random-effect meta-analytic model. Constipation proportion was the main safety endpoint, evaluated between treatments by the Relative Risks (RR). Results: Twelve randomised trials (2619 patients) met inclusion criteria. Duration of diarrhoea was much shorter in the RC group, the proportion of patients having recovered at any time of the treatment period was 65% higher in the RC group, compared with placebo (HR = 1.65 [1.38-1.97], p < 0.00001, n= 1001). Duration of diarrhoea was similar in the RC and loperamide groups (HR = 1.08 [0.95-1.22], p = 0.24, n = 1618). The proportions of constipated patients were similar in the RC and placebo groups 0.95 [0.24-3.68], p = 0.97), however, about 3 times more constipated patients were found in the loperamide group compared with the RC group (RR = 0.34 [0.22-0.51], p to placebo, RC is characterized by a clinically relevant earlier remission of diarrhoea. When compared to loperamide, diarrhoea duratio

关键词： Acute Diarrhoea Meta-Analysis racecadotril

racecadotril治疗儿童急性腹泻的效果和耐受性

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国外医学（消化系疾病分册） 2001年第4期21卷 252-253页

作者：徐正婕

抗分泌药物因其副反应一般不用于治疗急性腹泻,但racccadotril是例外,它是脑啡肽酶的特异性抑制剂,治疗成人腹泻的效果和安全性均高。此研究旨在明确racecadotril对儿童严重急性腹泻的疗效和耐受性。方法:此研究为随机、双盲。

关键词：急性腹泻 racecadotril 儿童抑制剂药物疗法腹泻

racecadotril治疗儿童急性水样腹泻

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国际流行病学传染病学杂志 2001年第3期 144-145页

作者：李春元

腹泻是儿童发生疾病与死亡的主要原因之一。racecadotril(醋托泛,Acetorphan)是一种脑啡肽酶抑制剂,可降低腹泻中的肠液

关键词：水样腹泻对照组 racecadotril 儿童

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止泻药—racecadotril

国外新药介绍 2001年第1期 8-12页

作者：朱晓红

racecadotril在急性水样腹泻中的应用

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德国临床用药 2001年第2期4卷 44-44页

Focus on acute diarrhoeal disease

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World Journal of Gastroenterology 2009年第27期15卷 3341-3348页

作者： Fabio Baldi Maria Antonia Bianco Gerardo Nardone Alberto Pilotto Emanuela Zamparo Gastroenterology Unit S. Orsola-Malpighi HospitalVia Massarenti 9 40138 Bologna Italy

Diarrhoea is an alteration of normal bowel movement characterized by an increase in the water content, volume, or frequency of stools. Diarrhoea needs to be classified according to the trends over time （acute or chronic） and to the characteristics of the stools （watery, fatty, inflammatory）. Secretory diarrhoeas, mostly acute and of viral aetiology in more than 70% of cases, are by far the most important subtype of diarrhoeas in terms of frequency, incidence and mortality （over 2.5 million deaths/year in developing countries）. Natural and synthetic opiates such as morphine, codeine, and Ioperamide which react with endogenous opiates （enkephalins, beta-endorphins, dynorphins） mainly act on intestinal motility and slow down transit. An antidiarrhoeal drug developed in recent years, racecadotril, acts as an enkephalinase inhibitor. Clinical studies have shown that it is just as effective as ioperamide in resolving acute diarrhoea but with greater reduction in pain and abdominal distension. Some studies have explored the prevalence of diarrhoea in old age. An epidemiological study carried out in Italy by 133 General Practitioners on 5515 elderly outpatients reported a prevalence of diarrhoea, defined according to the Rome criteria, of 9.1%. Infectious diseases （19%） and drug use （16%） were the most common causes of diarrhoea in old age. Regardless of the cause, the treatment of elderly patients with diarrhoea must include rehydration and nutritional support. Every year, more than 50 million tourists travel from industrialized countries to places where hygiene levels are pool. At least 75% of those travelling for short periods mention health problems, and in particular traveller＇s diarrhoea.

关键词： Diarrhoea Secretory diarrhoeas Elderly patients Traveller's diarrhoea Antidiarrhoeal drugs Enkephalinase inhibitor racecadotril Efficacy Tolerability