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布拉酵母菌治疗急性轮状病毒腹泻的疗效与安全性:来自一个发展中国家的双盲随机对照试验

Efficacy and Safety of Saccharomyces boulardii in Acute Rotavirus Diarrhea: Double Blind Randomized Controlled Trial from a Developing Country.

作者信息

Das Susrut, Gupta Pradeep Kumar, Das Rashmi Ranjan

机构信息

Department of Pediatrics, Tata Main Hospital, Jamshedpur 831001, India

Department of Pediatrics, Tata Main Hospital, Jamshedpur 831001, India.

出版信息

J Trop Pediatr. 2016 Dec;62(6):464-470. doi: 10.1093/tropej/fmw032. Epub 2016 Jun 9.

Abstract

OBJECTIVE

To study the efficacy and safety of Saccharomyces boulardii (SB) in acute childhood rotavirus diarrhea.

METHODS

Children (3 months to 5 years) with WHO-defined acute watery diarrhea and stool rotavirus positive (n  =  60) were randomized into intervention (n  =  30) and control (n  =  30) groups. The intervention group received SB (500 mg/day) for 5 days.

RESULTS

The median duration (hours) of diarrhea was significantly shorter in the intervention group (60 vs. 89; 95% CI: -41.2 to - 16.8). A significantly shorter duration of hospitalization (74 vs. 91; 95% CI: -33.46 to - 0.54) was also seen in the intervention group, but no significant difference was seen for fever and vomiting. There was also no difference between the two groups in the proportion of children requiring parenteral rehydration and persistence of diarrhea lasting beyond day 7. There was no report of any adverse events.

CONCLUSIONS

The present trial showed that SB is effective and safe in acute rotavirus diarrhea.

摘要

目的

研究布拉氏酵母菌(SB)治疗儿童急性轮状病毒腹泻的疗效和安全性。

方法

将世界卫生组织定义的急性水样腹泻且粪便轮状病毒检测呈阳性的3个月至5岁儿童(n = 60)随机分为干预组(n = 30)和对照组(n = 30)。干预组接受SB(500毫克/天)治疗5天。

结果

干预组腹泻的中位持续时间(小时)显著缩短(60对89;95%可信区间:-41.2至-16.8)。干预组的住院时间也显著缩短(74对91;95%可信区间:-33.46至-0.54),但发热和呕吐方面无显著差异。两组在需要静脉补液的儿童比例以及腹泻持续超过7天的情况方面也无差异。未报告任何不良事件。

结论

本试验表明,SB治疗急性轮状病毒腹泻有效且安全。

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