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重组人干扰素a1b注射液与利巴韦林治疗手足口病疗效和安全性的系统评价
申天甜1,高向东1,蒋荣猛2
0
(1. 中国药科大学生命科学和技术学院,江苏南京 210009;2. 首都医科大学附属北京地坛医院,北京 100015)
摘要:
目的:评价重组人干扰素 a1b 注射液和利巴韦林治疗手足口病的有效性和安全性。 方法:通过 PubMed、Cochrane 图书馆、中国知网、万方数据库及中国生物医学文献数据库检索重组人干扰素 a1b 注射液治疗手足口病的随机对照研究文献,提取文献信息并进行方法学质量评价,应用 RevMan 5.3 软件进行 Meta 分析。 结果:最终纳入 14 篇研究,干扰素组 913 例,利巴韦林组 901 例,共计 1 814 例患儿。 干扰素组治疗总有效率、退热时间、皮疹消退时间和疱疹溃疡愈合时间均优于利巴韦林组,差异具有统计学意义[OR=6.86,95%CI(4.97,9.46);MD=-1.55,95% CI(-2.13,-0.96);MD= -1.71,95% CI(-2.31,-1.11);MD=-1.13,95%CI(-1.38,-0.88),P<0.05]。 干扰素组不良反应发生率低于利巴韦林组。 结论:重组人干扰素 a1b 注射液联合常规治疗用于小儿手足口病较利巴韦林联合常规治疗有更好的疗效及安全性,但限于纳入研究质量总体不高,需更多高质量、多中心临床研究进一步验证。
关键词:  重组人干扰素 a1b  利巴韦林  手足口病  系统评价  随机对照研究
DOI:10.13407/j.cnki.jpp.1672-108X.2018.05.002
基金项目:
Recombinant Human Interferon a1b Injection and Ribavirin in the Treatment of Hand-Foot-Mouth Disease: a Meta-Analysis
Shen Tiantian 1 , Gao Xiangdong 1 , Jiang Rongmeng 2
(1. College of Life Science and Technology, China Pharmaceutical University,Jiangsu Nanjing 210009, China; 2. Beijing Ditan Hospital Affiliated to the Capital Medical University, Beijing 100015, China)
Abstract:
Objective: To systematically assess the effectiveness and safety of recombinant human interferon a1b injection (rhIFN-a1b) and ribavirin in the treatment of hand-foot-mouth disease (HFMD). Methods: PubMed, Cochrane library, CNKI, WanFang Database and CBM databases were searched from inception to Sep. 2016 to collect the randomized controlled trails (RCTs) of rhIFN-a1b in the treatment of HFMD. Related data were extracted, and the methodological qualities of included studies were also assessed. Meta-analysis was performed by using RevMan 5.3 software. Results: Fourteen RCTs were involved, with 913 cases of the rhIFN-a1b group, 901 cases of the ribavirin group and with 1,814 cases of children in total. The results of Meta-analysis showed that, compared with ribavirin group, rhIFN-a1b group had higher total efficiency ((OR=6.86, 95% CI(4.97, 9.46)), defervescence time [(MD=-1.55, 95% CI (-2.13, -0.96)], skin rash disappeared time [(MD=-1.71, 95% CI (-2.31, -1.11)], oral ulcer concrescence time [(MD=-1.13, 95% CI (-1.38, -0.88)] (P<0.05). rhIFN-a1b group had less adverse drug reactions than ribavirin group.Conclusion: The study shows that rhIFN-a1b may have better treatment effects and safety for HFMD than ribavirin. However, with limitations of quality of the included studies, the results need to be further verified by high quality and multiple center RCTs.
Key words:  recombinant human interferon a1b  ribavirin  hand-foot-mouth disease  systematically assessment  randomized controlled trails

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