特比萘芬和伊曲康唑治疗甲真菌病疗效和安全性的Meta分析
本文选题:特比萘芬 切入点:伊曲康唑 出处:《中国医院用药评价与分析》2016年02期
【摘要】:目的:系统评价特比萘芬和伊曲康唑治疗甲真菌病的有效性及安全性,为甲真菌病治疗中抗菌药物的选择提供参考。方法:使用计算机检索Cochrane临床对照试验数据库、EMbase、Pub Med、中国生物医学文献数据库、万方数据库及手工检索相关文献等,检索时间段为建库至2014年11月。查找用英文或中文发表的比较特比萘芬和伊曲康唑治疗甲真菌病有效性和安全性的随机对照试验,提取数据并进行方法学质量评价后,用Rev Man 5.1软件进行Meta分析。结果:总共纳入10个随机对照试验(1 839例患者)进行Meta分析,其中对10个研究(1 839例患者)进行了有效性(真菌治愈率)的评价,特比萘芬组的真菌治愈率优于伊曲康唑组,差异具有统计学意义[RR=1.29,95%CI=(1.13,1.46),P0.000 1];9个研究(1 711例患者)报告了不良反应的发生情况,2组不良反应发生率无统计学意义[RR=1.04,95%CI=(0.84,1.29),P=0.72];特比萘芬组的胃痛的发生率显著高于伊曲康唑组(P=0.05),而肝功异常的发生率明显低于伊曲康唑组(P≤0.05)。所有试验中均未观察到严重不良反应。结论:现有的临床研究证据显示,特比萘芬治疗甲真菌病的疗效优于伊曲康唑,且无严重不良反应。
[Abstract]:Objective: To evaluate the efficacy and safety of terbinafine and itraconazole in the treatment of onychomycosis, provide a reference for the selection of antibacterial drugs in the treatment of onychomycosis. Methods: using computer controlled trials database, Cochrane EMbase Pub Med, clinical retrieval, Chinese biomedical literature database, Wanfang database and manual search of relevant documents, retrieval time up to November 2014. English Chinese published or search by comparison of terbinafine and itraconazole in the treatment of onychomycosis of the efficacy and safety of randomized controlled trials, method of data extraction and quality evaluation, Meta analysis was carried out using Rev Man 5.1 software. Results: a total of a total of 10 randomized controlled trials (1839 patients) were analyzed by Meta. One of 10 studies (1839 patients) were effective (cure rate of fungi) evaluation, fungi group cure rate naphthalenophane tebi. In the itraconazole group, the difference was statistically significant ([RR=1.29,95%CI= 1.13,1.46, P0.000 1]); 9 studies (1711 patients) had reported adverse reactions, adverse reactions of 2 groups were not statistically significant ([RR=1.04,95%CI= 0.84,1.29), P=0.72]; the incidence rate in group stomach naphthalenophane was significantly higher than that of itraconazole group (P=0.05) however, abnormal liver function was significantly lower than the itraconazole group (P = 0.05). All the tests had no serious adverse events were observed. Conclusion: the clinical study of existing evidence shows that terbinafine is more effective than itraconazole in the treatment of onychomycosis, and no serious adverse reactions.
【作者单位】: 北京大学首钢医院药剂科;
【分类号】:R756.4
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