米卡芬净与伊曲康唑预防造血干细胞移植患者早期真菌感染的效果及安全性比较

Comparison of efficacy and safety between micafungin and itraconazole for preventing early fungal infection in patients undergoing hematopoietic stem cell transplantation

目的比较米卡芬净注射液与伊曲康唑口服液预防造血干细胞移植(HSCT)患者早期真菌感染的效果和安全性。方法将44例拟行HSCT的患者随机分为米卡芬净组和伊曲康唑组各22例,从预处理开始分别使用米卡芬净注射液、伊曲康唑口服液预防真菌感染。比较两组患者真菌感染发生率和不良反应发生率。结果米卡芬净注射液组和伊曲康唑组侵袭性真菌感染发生率分别为9.1%和4.5%,差异无统计学意义(P>0.05)。伊曲康唑组呕吐的发生率高于米卡芬净组(P<0.05)。结论米卡芬净注射液和伊曲康唑口服液预防造HSCT患者早期真菌感染效果相近,伊曲康唑口服液的胃肠道不良反应发生率较高。

Objective To compare the efficacy and safety between micafungin injection and itraconazole oral solution for preventing early invasive fungal infection in patients undergoing hematopoietic stem cell transplantation（ HSCT）. Methods Forty-four patients who planned to receive HSCT were randomly divided into micafungin group and itraconazole group,with 22 cases in each group. The patients in the micafungin group and the itraconazole group were administered micafungin injection and itraconazole oral solution for preventing fungal infection when preconditioning,respectively. The incidence rates of invasive fungal infection and adverse reactions were compared between the two groups. Results The incidence rates of invasive fungal infection in the micafungin group and the itraconazole group were 9. 1%and 4. 5% respectively,but no statistical significance was observed（ P 〉 0. 05）. The incidence rate of vomiting in the itraconazole group was higher than that in the micafungin group（ P 〈 0. 05）. Conclusion The efficacy of micafungin injection is similar to that of itraconazole oral solution for preventing early invasive fungal infection in patients undergoing HSCT. However,itraconazole oral solution has a higher incidence rate of gastrointestinal adverse reaction.