摘要
目的 探索利巴韦林气雾剂在防治手足口病中的作用.方法 采用多中心、随机、双盲和安慰剂对照的设计方法,选择2011年7月至2013年6月在上海交通大学医学院附属上海儿童医学中心、新华医院和上海儿童医院感染门诊就诊的临床诊断为轻症手足口病患儿300例,年龄6个月～6岁,男女比例1.5∶1.按计算机随机分为2组各150例：试验组用利巴韦林气雾剂[每次3喷（1.5 mg）,开始第1小时内用药4次,以后每隔1h用药1次,2d后每日用药4次];对照组同法给予安慰剂.每例患儿均加抗病毒口服液,疗程7d.观察用药前后两组体温、口腔疱疹、皮疹等主要临床表现的变化,并采集患儿咽拭子标本,用实时荧光反转录-PCR技术检测肠道病毒71（EV71）、柯萨基病毒A16型（CA16）.结果 用药前两组患儿基本资料、体温、口腔疱疹、皮疹以及病毒学等各项观察指标差异均无统计学意义（均P＞0.05）,用药后5～7d试验组口腔病变治疗有效率和病毒阴转率均明显高于对照组[100.0％（147/147）比83.9％（120/143）,80.0％（102/110）比41.8％（41/98）,χ^2=109.21、37.06,均P＜0.01],皮肤丘疱疹有效率也高[100.0％（147/147）比95.7％（139/145）,χ^2=6.38,P＜0.05].两组各有1例发生病情加重,皆无严重不良事件发生.试验组综合疗效指标明显高于对照组[93.9％（122/130）比52.0％ （64/123）,χ^2=111.08,P＜0.01].结论 利巴韦林气雾剂治疗手足口病用药剂量小、起效快、局部浓度高、临床疗效好且不良反应小;可明显缩短口咽部、皮疹病变的时间,同时可减少口咽部排毒量和缩短排毒时间.
Objective To explore the roles of ribavirin aerosol in the prevention and treatment of hand-foot-mouth disease （HFMD）.Methods For this prospective,multicenter,randomized,double-blind and placebo-controlled trial,a total of 300 HFMD outpatients from 3 class 3A hospitals from July 2011 to June 2013 were divided into treatment （ribavirin aerosol） and control （placebo） groups （n =150 each）.The age range was 6 months to 6 years.The proportion of male and female was 1.5∶ 1.Temperature,herpes of mouth and skin rash were observed before and after treatments.Before treatment and 6-7 days after,their specimens of throat swab were collected and the levels of EV71 and CA16 detected with reverse transcription （RT）-PCR.The software SAS 9.2 was used for statistic data analyses.Results Before treatment,no significant statistical difference existed in parameters between treatment and control groups （all P 〉 0.05）.After treatment,the degree of herpes of mouth and papulovesicle of skin in treatment group was better than that in control group （100.0% （147/147） vs 83.9% （120/143）,χ^2 =109.21,P 〈 0.01） ; （100.0% （147/147） vs 95.9% （139/145）,χ^2 =6.38,P 〈 0.05）.The virus negative conversion rates had significant inter-group difference （80.0% （102/110） vs 41.8% （41/98）,χ^2 =37.06,P 〈 0.01）.The temperature,compliance and differences were not significant （all P 〉 0.05）.The effective rate of comprehensive efficacy in treatment group was higher than that in control group （93.9% （122/130） vs 52.0% （64/123）,χ^2 =111.08,P 〈 0.01）.No obvious adverse drug reaction was observed.Conclusions Ribavirin aerosol has multiple advantages of lower dose,quicker onset,higher local concentration,better clinical efficacy and fewer side-effects.Its therapeutic effect for local lesion is better than that for systemic lesion.Thus it may shorten the duration of oropharyngeal and skin lesions and lower the number and time of viral release.
出处
《中华医学杂志》
CAS
CSCD
北大核心
2014年第20期1563-1566,共4页
National Medical Journal of China
基金
上海市科委自然科学基金（10dz1920204）
关键词
手足口病
肠道病毒感染
疾病传播
利巴韦林
儿童
Hand,food and mouth disease
Entervirus infections
Disease transmission
Ribavirin
Child
