摘要
目的:采用间接比较的方法综合评价特比萘芬仿制药与原研药治疗甲真菌病的临床疗效和安全性。方法:检索PubMed、EMbase、Cochrane Library、中国知网(CNKI)、万方和维普数据库中收录的特比萘芬仿制药及原研药分别与伊曲康唑比较治疗甲真菌病的随机对照试验(RCT),检索时限从建库至2018年6月。在提取资料和质量评价后,采用RevMan5.2和ITC软件对纳入的研究分别进行Meta分析和间接比较,并用GRADEpro软件评价证据质量。结果:共纳入8个RCT,合计914例患者。分析结果显示疗效方面,特比萘芬仿制药对比原研药治疗甲癣的有效率[RR=0.95,95%CI(0.84,1.07),P=0.96,证据质量:极低]、痊愈率[RR=1.06,95%CI(0.81,1.38),P=0.77,证据质量:极低]差异均无统计学意义;安全性方面,两者比较不良反应发生率[RR=1.58,95%CI(0.77,3.26),P=0.83,证据质量:极低]差异无统计学意义。结论:目前的研究在实施、报道方面存在诸多问题,结合证据质量,尚不能确定特比萘芬仿制药和原研药在治疗甲真菌的疗效和安全性方面存在差异。
Objective:To systematically review the efficacy and safety of the generic and original preparation of Terbinafin.Methods:The studies involving randomized controlled trials(RCTs)were collected from the database,including PubMed,EMbase,Cochrane Libraries,CNKI,VIP database and Wanfang database from the year of database creation to June 2018.Statistical analysis was performed with RevMan5.2 and ITC software.Results:Totally 8 RCTs were included,involving 914 patients.In indirect comparisons,by using Itraconazole as common comparators,there was no significant difference in effective rate[RR=0.95,95%CI(0.84,1.07),P=0.96]or cure rate[RR=1.06,95%CI(0.81,1.38),P=0.77]between the original and generic preparation group,there was no significant difference between original and generic preparation group in rates of adverse events[RR=1.58,95%CI(0.77,3.26),P=0.83]either.Conclusions:The efficacy and safety of the generic preparation of Terbinafin are as good as original one.
作者
竺佳
黄巧玲
胡玉平
宋晓炎
ZHU Jia;HUANG Qiao-ling;HU Yu-ping;SONG Xiao-yan(Department of Pharmaceutical,Hangzhou Third People’s Hospital,Hangzhou 310009,China)
出处
《临床皮肤科杂志》
CAS
CSCD
北大核心
2020年第4期228-233,共6页
Journal of Clinical Dermatology
