米卡芬净预防血液系统恶性肿瘤患者侵袭性真菌感染有效性和安全性的Meta分析

目的系统评价米卡芬净预防血液系统恶性肿瘤患者侵袭性真菌感染(IFIs)的有效性及安全性,为临床治疗提供循证参考。方法计算机检索PubMed、Embase、Cochrane图书馆、中国知网(CNKI)、万方数据,检索时限为建库起至2021年1月,收集米卡芬净(试验组)对比常规抗真菌药物(两性霉素B及三唑类抗真菌药,对照组)的随机对照试验(RCT),对符合纳入标准的临床研究进行资料提取并采用Cochrane系统评价员手册5.0.2进行质量评价后,采用Rev Man 5.3统计软件对突破性IFIs、真菌感染死亡率、全因死亡率及因不良反应停药的发生率进行Meta分析。结果共纳入9项RCT,合计2 479例患者。Meta分析结果显示,试验组患者突破性IFIs发生率[OR=0.74,95%CI(0.50,1.07),P=0.11]、真菌感染死亡率[OR=0.73,95%CI(0.46,1.17),P=0.19]和全因死亡率[OR=0.94,95%CI(0.69,1.28),P=0.7]与对照组相比,差异无统计学意义;因不良反应停药的发生率[OR=0.46,95%CI(0.32,0.66),P<0.0001]显著低于对照组,差异有统计学意义。结论米卡芬净用于预防血液系统恶性肿瘤患者IFIs的效果与两性霉素B及三唑类抗真菌药物相当,且安全性更高。

Efficacy and safety of micafungin in preventing invasive fungal infection in patients with hematological malignancies:a Meta-analysis

Objective To systematically evaluate the effectiveness and safety of micafungin in preventing invasive fungal infections(IFIs)in patients with hematological malignancies,and to provide evidence-based reference for clinical treatment.Methods Computer searching of PubMed,Embase,Cochrane Library,China Knowledge Network(CNKI),Wanfang data from the establishment of the database to January 2021,randomized controlled trials(RCTs)of micafungin(experimental group)compared with conventional antifungal drugs(amphotericin B and triazole antifungal drugs,control group)were collected.After data extraction and quality evaluation with Cochrane system reviewer's manual 5.0.2,Meta analysis was performed on breakthrough IFIs,fungal infection mortality,all-cause mortality and the incidence of drug withdrawal due to adverse reactions with Rev man 5.3 statistical software.Results Nine RCTs involving 2479 patients were included.Meta analysis showed that the incidence of breakthrough IFIs[OR=0.74,95%CI(0.50,1.07),P=0.11],mortality of fungal infection[OR=0.73,95%CI(0.46,1.17),P=0.19]and all-cause mortality[OR=0.94,95%CI(0.69,1.28),P=0.7]in the experimental group were not significantly different from those in the control group;The incidence of drug withdrawal due to adverse reactions[OR=0.46,95%CI(0.32,0.66),P<0.0001]was significantly lower than that in the control group,the difference was statistically significant.Conclusion The effect of micafungin in preventing IFIs in patients with hematological malignancies is equivalent to that of amphotericin B and triazole antifungal drugs,and the safety is higher.