重组人干扰素α-1b注射液雾化吸入辅助治疗手足口病疗效和安全性的系统评价  

Systematic Evaluation of Recombinant Human Interferon α-1b Injection in the Adjuvant Treatment of Hand-Foot-Mouth Disease

作　　者：王欣[1] 廖明[1] 柴中平 毛振[1] 李悦[1] 沈晨[1] Wang Xin;Liao Ming;Chai Zhongping;Mao Zhen;Li Yue;Shen Chen(Guiyang Maternal and Child Health Care Hospital,Guizhou Guiyang 550003,China)

机构地区：[1]贵阳市妇幼保健院,贵州贵阳5550003

出　　处：《儿科药学杂志》2018年第10期5-9,共5页Journal of Pediatric Pharmacy

摘　　要：目的:系统评价重组人干扰素α-1b注射液雾化吸入治疗手足口病的疗效,为临床治疗提供参考。方法:计算机检索Cochrane图书馆、Pub Med、EMBASE、Cochrane对照试验中心数据库、中国生物医学文献数据库、中国期刊全文数据库、中国科技期刊全文数据库、万方数据库,全面收集重组人干扰素α-1b注射液(试验组)对比常规治疗(对照组)治疗手足口病的随机临床对照试验,检索时限为各数据库建库起至2017年5月31日。提取符合纳入标准的研究资料并进行质量评价后,采用Cochrane Rev Man 5.3软件进行Meta分析。结果:本次统计共纳入13项研究,2 034例患儿。Meta分析结果显示,试验组总有效率[RR=1.23,95%CI(1.18,1.29),P<0.01]、退热时间[MD=-1.13,95%CI(-1.40,-0.87),P<0.001]、疱疹消退时间[MD=-1.32,95%CI(-1.68,-0.69),P<0.01]、治愈时间[MD=-1.28,95%CI(-1.55,-1.01),P<0.01]均优于对照组。13项研究中,1项报道了两组患儿在治疗前后及过程中的体温、心率、呼吸频率、血常规、血生化比较差异均无统计学意义,3项报道未观察到任何不良反应(如发热、疲劳、食欲不振、恶心等),其余9项未报道不良反应发生情况。结论:基于当前的研究证据,重组人干扰素α-1b注射液雾化吸入能有效辅助治疗手足口病,未发现明显不良反应,但因国内外均缺乏高质量的随机临床对照研究,故重组人干扰素α-1b注射液雾化吸入辅助治疗手足口病的疗效和安全性尚需进一步评价。Objective： To systematically review the efficacy of recombinant human interferon α-1 b injection in the treatment of hand-footmouth disease（HFMD）,so as to provide reference for the clinical treatment. Methods： Cochrane Library,Pub Med,EMBASE,Cochrane Controlled Trails Database,CBM,CNKI,VIP and Wanfang database were retrieved,randomized controlled trials（ RCT） about recombinant human interferon α-1 b injection（ experimental group） versus conventional treatment（ control group） in the treatment of HFMD were collected. Meta-analysis was performed by using Rev Man 5.3 software after quality assessment and data extraction. Results： A total of 13 RCT studies were involved,including 2,034 patients. Meta analysis showed that the total effective rate [RR = 1.23,95%CI（1.18,1.29）,P0.01],antipyretic time [MD =-1.13,95%CI,（-1.40,-0.87）,P0.001],herpes regression time [MD =-1.32,95%CI（-1.68,-0.69）,P0.001]and cure time [MD =-1.28,95%CI（-1.55,-1.01）,P0.001]of experimental group were better than those of control group（P0.01）. Of the 13 RCT studies,1 RCT reported that there was no significant difference in body temperature,heart rate,respiratory rate,blood routine,blood biochemistry between two groups before and after treatment,3 RCT reported that no adverse drug reactions（ADR）（such as fever,fatigue,anorexia,nausea,etc.） was observed,the remaining 8 RCT did not report the occurrence of ADR. Conclusion： Based on the current research evidence,recombinant human interferon α-1 b injection can effectively in the adjuvant treatment of HFMD with no significant ADR,but there is a lack of high quality RCT studies at home and abroad. Therefore,the efficacy and safety of recombinant human interferon α-1 b injection in the adjuvant treatment of HFMD still need further evaluation.

关 键 词：重组人干扰素α-1b注射液 手足口病 系统评价 疗效 安全性 

分 类 号：R725.1[医药卫生—儿科]