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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
王欣,廖明,柴中平,毛振,李悦,沈晨
0
(贵阳市妇幼保健院,贵州贵阳 5550003)
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、PubMed、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Cochran RevMan 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<0.01]、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。
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
DOI:10.13407/j.cnki.jpp.1672-108X.2018.10.002
基金项目:
Systematic Evaluation of Recombinant Human Interferon α-1b Injection in the Adjuvant Treatment of Hand-Foot-Mouth Disease
Wang Xin, Liao Ming, Chai Zhongping, Mao Zhen, Li Yue, Shen Chen
(Guiyang Maternal and Child Health Care Hospital, Guizhou Guiyang 550003, China)
Abstract:
Objective: To systematically review the efficacy of recombinant human interferon α-1b injection in the treatment of hand-foot- mouth disease (HFMD), so as to provide reference for the clinical treatment. Methods: Cochrane Library, PubMed, EMBASE, Cochrane Controlled Trails Database, CBM, CNKI, VIP and Wanfang database were retrieved, randomized controlled trials ( RCT) about recombinant human interferon α-1b injection (experimental group) versus conventional treatment (control group) in the treatment of HFMD were collected. Meta-analysis was performed by using RevMan 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), P<0.01], antipyretic time [MD =-1.13, 95%CI, (-1.40, -0.87), P<0.01], herpes regression time [MD =-1.32, 95%CI (-1.68, -0.69), P<0.001] and cure time [MD =-1. 28, 95% CI (-1.55, -1.01), P<0.01] of experimental group were better than those of control group (P<0. 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-1b 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-1b injection in the adjuvant treatment of HFMD still need further evaluation.
Key words:  recombinant human interferon α-1b injection  hand-foot-mouth disease  systematic review  efficacy  safety

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