特比萘芬和伊曲康唑治療甲真菌病療效和安全性的Meta分析
本文選題:特比萘芬 切入點(diǎn):伊曲康唑 出處:《中國(guó)醫(yī)院用藥評(píng)價(jià)與分析》2016年02期
【摘要】:目的:系統(tǒng)評(píng)價(jià)特比萘芬和伊曲康唑治療甲真菌病的有效性及安全性,為甲真菌病治療中抗菌藥物的選擇提供參考。方法:使用計(jì)算機(jī)檢索Cochrane臨床對(duì)照試驗(yàn)數(shù)據(jù)庫(kù)、EMbase、Pub Med、中國(guó)生物醫(yī)學(xué)文獻(xiàn)數(shù)據(jù)庫(kù)、萬(wàn)方數(shù)據(jù)庫(kù)及手工檢索相關(guān)文獻(xiàn)等,檢索時(shí)間段為建庫(kù)至2014年11月。查找用英文或中文發(fā)表的比較特比萘芬和伊曲康唑治療甲真菌病有效性和安全性的隨機(jī)對(duì)照試驗(yàn),提取數(shù)據(jù)并進(jìn)行方法學(xué)質(zhì)量評(píng)價(jià)后,用Rev Man 5.1軟件進(jìn)行Meta分析。結(jié)果:總共納入10個(gè)隨機(jī)對(duì)照試驗(yàn)(1 839例患者)進(jìn)行Meta分析,其中對(duì)10個(gè)研究(1 839例患者)進(jìn)行了有效性(真菌治愈率)的評(píng)價(jià),特比萘芬組的真菌治愈率優(yōu)于伊曲康唑組,差異具有統(tǒng)計(jì)學(xué)意義[RR=1.29,95%CI=(1.13,1.46),P0.000 1];9個(gè)研究(1 711例患者)報(bào)告了不良反應(yīng)的發(fā)生情況,2組不良反應(yīng)發(fā)生率無(wú)統(tǒng)計(jì)學(xué)意義[RR=1.04,95%CI=(0.84,1.29),P=0.72];特比萘芬組的胃痛的發(fā)生率顯著高于伊曲康唑組(P=0.05),而肝功異常的發(fā)生率明顯低于伊曲康唑組(P≤0.05)。所有試驗(yàn)中均未觀察到嚴(yán)重不良反應(yīng)。結(jié)論:現(xiàn)有的臨床研究證據(jù)顯示,特比萘芬治療甲真菌病的療效優(yōu)于伊曲康唑,且無(wú)嚴(yán)重不良反應(yīng)。
[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.
【作者單位】: 北京大學(xué)首鋼醫(yī)院藥劑科;
【分類號(hào)】:R756.4
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