伊曲康唑治疗口腔念珠菌病安全性与有效性的系统评价#br#

摘要：目的 系统评价伊曲康唑与其他抗真菌药(克霉唑、氟康唑、酮康唑及特比萘芬)相比治疗口腔念珠菌病的临床疗效与安全性，以期为临床提供循证参考。方法 计算机检索PubMed、EMbase、Medline、the Cochrane Library、中国生物医学文献数据库、中国知网、维普数据库和万方数据库。检索时间均从建库到2017年6月。搜集伊曲康唑治疗口腔念珠菌病的随机对照试验(randomized controlled trials, RCTs)，采用RevMan 5.3统计软件进行Meta分析。结果 共纳入8项RCT，共计892例患者。Meta分析结果显示：(1)临床治愈率：伊曲康唑组与氟康唑组[RR=0.82, 95%CI(0.62, 1.10), P=0.19]、克霉唑组[RR=1.05, 95%CI(0.87, 1.26), P=0.63]相比临床治愈率差异均无统计学意义；但伊曲康唑组临床治愈率(65.9%)显著高于特比萘芬组(33.3%)。(2)真菌学治愈率：伊曲康唑组与氟康唑组相比，真菌学治愈率差异无统计学意义[RR=0.87, 95%CI(0.75, 1.01), P=0.07]。(3)复发率：伊曲康唑组与氟康唑组相比，复发率差异无统计学意义[RR=0.85, 95%CI(0.51, 1.40), P=0.52]。(4)不良反应发生率：伊曲康唑并不会增加主要胃肠道不良反应[RR=1.10, 95%CI(0.59, 2.05), P=0.77]，其他不良反应发生率差异亦无统计学意义。结论 伊曲康唑治疗口腔念珠菌病的有效性和安全性与其他抗真菌药物无显著差异。然而，由于纳入文献质量偏低，提供的信息有限，尚需大规模和高质量的RCT进一步验证。

Efficacy and safety of itraconazole in the treatment of oral candidiasis: A systematic review#br#

Objective To evaluate the clinical efficacy and safety of itraconzole in comparison with other antifungal drugs (clotrimazole, fluconazole, ketoconazole and terbinafine) in the treatment of oral candidiasis and to provide an evidenced-base reference for clinical use. Methods The published studies for itraconazole in the treatment of oral candidiasis (up to June 2017) were retrieved from PubMed, EMbase, Medline, the Cochrane Library, and the Chinese literature databases (CBM, CNKI, VIP, and Wanfang Data). Relevant randomized controlled trials (RCTs) that compared itraconazole and other antifungal drugs were collected, followed by Meta-analysis using Rev Man 5.3 statistical software. Results A total of 8 RCTs were included, involving 892 patients. Meta-analysis showed that the effective rate of itraconazole group was equal to the fluconazole group [RR=0.82, 95%CI (0.62, 1.10), P=0.19] and clotrimazole group [RR=1.05, 95%CI (0.87, 1.26), P= 0.63]. However, the effective rate of the itraconazole group (65.9%) was significantly higher than that of the terbinafine group (33.3%). The microbiological cure rate ofitraconazole group was equal to that of the fluconazole group [RR=0.87, 95%CI (0.75, 1.01), P=0.07]. The recurrence rate of itraconazole group was equal to that of the fluconazole group [RR= 0.85, 95%CI (0.51, 1.40), P=0.52]. Itraconazole did not increase the gastrointestinal adverse reaction [RR=1.10, 95%CI (0.59, 2.05), P= 0.77]. The incidence of other adverse reactions was not statistically significant. Conclusion In the treatment of oral candidiasis, itraconzole appears to perform no better than other antifungal drugs in both effectiveness and safety. However, the observations need to be regarded cautiously due to the very limited literature information that provided only small-scale and low-quality studies. Further validation by large-scale and high-quality RCTs is