利巴韦林气雾剂治疗小儿手足口病的有效性和安全性研究
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钱继红,女,主任医师。

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上海市科委基金项目(10dz1920205 )。


Efficacy and safety of ribavirin aerosol in children with hand-foot-mouth disease
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    摘要:

    目的 评价利巴韦林气雾剂治疗手足口病(HFMD)患儿的有效性和安全性。方法 采用随机、双盲、对照研究方法。119 例轻症HFMD 患儿随机分为试验组(59 例)和对照组(60 例)。试验组应用利巴韦林气雾剂治疗,首次使用1 h 内喷4 次,以后每隔1 h 喷1 次;2 日以后,一日4 次,每次2~3 揿,连续用药7 d。对照组采用安慰剂,用法同试验组。两组均加用“抗病毒口服液”口服。记录治疗前和治疗后口腔溃疡、皮疹、鼻塞、流涕、喷嚏、咳嗽、发热等临床症状评分,评价治疗效果;分别于治疗前、治疗后5~7 d 取咽拭子,用RT-PCR 法检测病毒载量以评价两组阴转率。结果 完成研究报告表规定内容的受试者试验组有57 例,对照组56 例。用药5~7 d 后,试验组肠道病毒总阴转率高于对照组(P<0.01);试验组和对照组的综合疗效评价总显效率分别为89%、29%,总有效率分别为89%、43%,试验组的总显效率和总有效率均高于对照组。用药后两组均无头晕、呕吐等不良反应发生,外周血三系指标均无明显下降。结论 利巴韦林气雾剂治疗轻症HFMD 疗效确切,用药剂量小、不良反应轻,值得临床推广应用。

    Abstract:

    Objective To evaluate the efficacy and safety of ribavirin aerosol in children with hand-foot-mouth disease (HFMD). Methods A randomized, double-blind, placebo-controlled trial was performed. A total of 119 children with mild HFMD were randomly divided into an observed group (n=59) and a control group (n=60). In the observed group, ribavirin aerosol was given four times within the first hour, followed by once every other hour for the remaining time of the day and day 2; from days 3 to 7, it was given 4 times per day, with 2-3 sprays every time, for 7 days. In the control group, placebo was given in the same way as in the observed group. Additionally, both groups used oral antiviral liquid. The scores of clinical symptoms including oral ulcer, skin rash, nasal congestion, runny nose, sneezing, cough, and fever before and after treatment were recorded to evaluate treatment outcomes. Throat swabs were taken before treatment and 5-7 days after treatment to measure viral load by RT-PCR and to compare the negative conversion rate between the two groups. Results Fifty-seven patients in the observed group and 56 patients in the control group were tested according to the original research design. After 5-7 days of treatment, the observed group had a significantly higher overall negative conversion rate of enterovirus than the control group (P<0.01). The overall marked response rate and overall response rate of the observed group were 89% and 89%, respectively, significantly higher than those of the control group (29% and 43%). During treatment, there were no adverse reactions such as dizziness, vomiting, and notable decreases in hemoglobin, white blood cells, and platelets in the two groups. Conclusions Ribavirin aerosol can be effectively and safely used for treating mild HFMD. With low dosage and few adverse reactions, it holds promise for clinical application.

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张会平, 王丽, 钱继红, 蔡康, 陈颖虹, 张庆立, 俞慧菊.利巴韦林气雾剂治疗小儿手足口病的有效性和安全性研究[J].中国当代儿科杂志,2014,16(3):272-276

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  • 收稿日期:2013-07-22
  • 最后修改日期:2013-12-10
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  • 在线发布日期: 2014-03-15
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