Single-dose ciprofloxacin versus 12-dose erythromycin for childhood cholera: a randomised controlled trial.
Single-dose ciprofloxacin versus 12-dose erythromycin for childhood cholera: a randomised controlled trial.
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单剂量环丙沙星与 12 剂量红霉素治疗儿童霍乱：一项随机对照试验。
DOI：
10.1016/s0140-6736(05)67290-x
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发表时间：
2005
期刊：
影响因子：
--
通讯作者：
Bennish,MichaelL
中科院分区：
文献类型：
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作者：
Saha,Debasish;Khan,WasifA;Karim,MohammadM;Chowdhury,HafizurR;Salam,MohammedA;Bennish,MichaelL
研究背景单剂量环丙沙星治疗成人重症霍乱有效。我们评估了是否单剂量环丙沙星将是有效的3天，12剂量红霉素在实现临床治愈儿童严重cholerae.MethodsWe做了一个随机，开放标签，对照试验在2-15岁的儿童与V choleraeO 1或O 139存在于粪便中的暗视野显微镜。分别给予环丙沙星20 mg/kg（n=90）或红霉素12.5 mg/kg（n=90），每6 h 1次，共3 d，住院5 d。主要结局是治疗的临床成功，定义为药物治疗开始后48小时内停止水样便。分析符合方案。这项研究被注册为国际标准随机对照试验，编号ISRCTN 00142272。60%（47/78）接受环丙沙星治疗的儿童和55%（46/84）接受红霉素治疗的儿童临床治疗成功（差异5% [95%CI −10至21]）。接受环丙沙星治疗的儿童与接受红霉素治疗的儿童相比，呕吐次数较少（58%vs74%;差异16% [2 - 30]），排便次数较少（15 vs 21; 6 [0 - 9]），粪便量较少（152 vs 196 mL/kg; 43 mL/kg [13 - 87]）。细菌学失败在环丙沙星治疗的患者中比红霉素治疗的患者更常见（58%vs30%; 28% [13 - 43]）。
BackgroundSingle-dose ciprofloxacin is effective for the treatment of severe cholera in adults. We assessed whether single-dose ciprofloxacin would be as effective as 3-day, 12-dose erythromycin in achieving clinical cure in children with severe cholera.MethodsWe did a randomised, open label, controlled trial in children age 2–15 years withV choleraeO1 or O139 present in stool on dark-field microscopy. Children received either a single 20 mg/kg dose of ciprofloxacin (n=90) or 12·5 mg/kg of erythromycin (n=90) every 6 h for 3 days, and remained in hospital for 5 days. The primary outcome was clinical success of treatment, defined as cessation of watery stools within 48 h of start of drug treatment. Analysis was per protocol. This study is registered as an International Standard Randomised Controlled Trial, number ISRCTN00142272.FindingsOf 180 children randomised 162 completed the study. Treatment was clinically successful in 60% (47/78) of children treated with ciprofloxacin and in 55% (46/84) of those treated with erythromycin (difference 5% [95% CI −10 to 21]). Children receiving ciprofloxacin vomited less often (58%vs74%; difference 16% [2 to 30]), had fewer stools (15vs21; 6 [0 to 9]), and less stool volume (152vs196 mL/kg; 43 mL/kg [13 to 87]) than those receiving erythromycin. Bacteriological failure was more common in ciprofloxacin-treated patients (58%vs30%; 28% [13 to 43]) than erythromycin-treated patients.InterpretationSingle-dose ciprofloxacin achieves clinical outcomes similar to, or better than, those achieved with 12-dose erythromycin treatment in childhood cholera, but is less effective in eradicatingV choleraefrom stool.