米卡芬净/氟康唑用于预防和治疗真菌感染的疗效与安全性的Meta分析

Efficacy and Safety of Micafungin Versus Fluconazole for Prophylaxis and Treatment of Fungal Infections:A Meta-analysis of Randomized Controlled Trials

目的系统评价米卡芬净与氟康唑预防和治疗真菌感染的疗效与安全性。方法计算机检索PubMed、EMbase、Cochrane图书馆、中国生物医学文献数据库(CBM)、中国期刊全文数据库(CNKI)、维普中文科技期刊全文数据库(VIP)和万方数字化期刊全文库,纳入米卡芬净对比氟康唑用于预防和治疗真菌感染的随机对照试验和前瞻性队列研究,对符合纳入标准的临床研究进行质量评价和资料提取后,采用Rev Man 5.1软件进行Meta分析。结果共纳入5个研究,合计1 759例患者。Meta分析结果为:1预防侵袭性真菌感染:米卡芬净比氟康唑的治疗成功率高,差异有统计学意义[OR=1.56,95%CI(1.16,2.10),P=0.004],米卡芬净的突破感染率、可疑真菌感染率较氟康唑低,差异有统计学意义[OR=0.42,95%CI(0.19,0.94),P=0.03]、[OR=0.61,95%CI(0.44,0.85),P=0.003]。2治疗念珠菌感染:米卡芬净与氟康唑的镜下治愈率、终点临床有效率、总体治疗有效率、复发率之间差异无统计学意义(P>0.05)。3总体药物相关不良事件:150 mg米卡芬净剂量组发生率高于氟康唑组,差异有统计学意义[OR=1.46,95%CI(1.00,2.13),P=0.05];4不良反应发生率:二者的皮疹、恶心、白细胞减少、血小板减少、发热及输液部位反应等6种不良反应的发生率差异均无统计学意义(P>0.05)。结论米卡芬净预防造血干细胞移植患者侵袭性真菌感染的疗效优于氟康唑,二者在治疗念珠菌感染疗效方面无显著性差异,150 mg剂量组的米卡芬净安全性低于氟康唑组。

OBJECTIVE To assess the efficacy and safety of micafungin versus fluconazole for prophylaxis and treatment of fun- gal infections. METHODS We searched PubMed, EMbase, Cochrane library, CBM, CNKI, VIP and Wanfang database, and col- lected the randomized controlled trials and prospective cohort studies of micafungin versus fluconazole for prophylaxis and treatment of fungal infections. Data were extracted and evaluated by two reviewers independently with a designed extraction form. The RevMan 5. 1 software was used to carry out statistical analysis. RESULTS Five studies involving 1 759 patients were included. The results of Me- ta-analysis showed the following facts ： ① For antifungal prophylaxis ： the treatment success rate of micafungin was significantly higher than fluconazole [ OR = 1.56,95% CI（ 1.16,2. 10） ,P =0. 0041. The breakthrough infections and frequency of possible fungal infec- tions of micafungin were significantly lower than fluconazole [ OR = 0. 42,95% CI （ 0. 19,0. 94 ） , P = 0. 03 1 , [ OR = 0. 61,95% C1 （0.44,0. 85 ） ,P = 0. 003 ].②For treatment of candida infections： there was no significant difference between the two groups of endo- scopic cure rates, clinical response at the end of treatment, overall therapeutic response, and incidence of relapse（ P 〉 0. 05 ）. ③The overall incidence of drug-related adverse events of 150 mg micafungin was significantly higher than that of fluconazole [ OR=1.46, 95% CI（ 1.00,2. 13） ,P=0.05 ]. ④There was no significant difference between the two groups about the incidence of adverse reac- tion, such as rash, nausea, leucopenia, thrombocytopenia, fever, and injection site reaction（P 〉 0. 05）. CONCLUSION Micafun- gin offers an appropriate alternative to fluconazole for antifungal prophylaxis rather than the treatment of invasive candida infection. U- sing micafungin with a dose of 150 mg is not safer than fluconazole.