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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

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【作者】 董卫华邹雅敏董亚琳黄泰康

【Author】 DONG Wei-hua;ZOU Ya-min;DONG Ya-lin;HUANG Tai-kang;Research Center of Modern Social Pharmacy,Shenyang Pharmaceutical University;The First Affiliated Hospital of Xi’an Jiaotong University;State Food and Drug Administration;

【机构】 沈阳药科大学现代社会药学研究中心西安交通大学第一附属医院国家食品药品监督管理总局

【摘要】 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。

【Abstract】 OBJECTIVE To assess the efficacy and safety of micafungin versus fluconazole for prophylaxis and treatment of fungal infections. METHODS We searched PubMed,EMbase,Cochrane library,CBM,CNKI,VIP and Wanfang database,and collected 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. 1software was used to carry out statistical analysis. RESULTS Five studies involving 1 759 patients were included. The results of Meta-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. 004]. The breakthrough infections and frequency of possible fungal infections of micafungin were significantly lower than fluconazole[OR = 0. 42,95% CI(0. 19,0. 94),P = 0. 03]、[OR = 0. 61,95% CI(0.44,0.85),P =0.003]. 2For treatment of candida infections: there was no significant difference between the two groups of endoscopic 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 reaction,such as rash,nausea,leucopenia,thrombocytopenia,fever,and injection site reaction(P > 0. 05). CONCLUSION Micafungin offers an appropriate alternative to fluconazole for antifungal prophylaxis rather than the treatment of invasive candida infection. Using micafungin with a dose of 150 mg is not safer than fluconazole.

【关键词】 米卡芬净氟康唑Meta分析真菌感染
【Key words】 micafunginfluconazolemeta-analysisfungal infection
  • 【文献出处】 中国药学杂志 ,Chinese Pharmaceutical Journal , 编辑部邮箱 ,2014年16期
  • 【分类号】R519
  • 【被引频次】9
  • 【下载频次】595
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