Department of Kidney Transplantation, The 1st Affiliated Hospital of Zhengzhou University, Zhengzhou, China.
J Clin Pharm Ther. 2012 Dec;37(6):652-6. doi: 10.1111/j.1365-2710.2012.01362.x. Epub 2012 Jun 21.
Invasive fungal infections are a major threat to renal transplant recipients. Micafungin and voriconazole are two useful antifungal agents for treating such infections. Our objective is to evaluate the comparative efficacy and safety of micafungin and voriconazole in the initial treatment of such infections.
In this prospective, multicentre, open-labelled, randomized, controlled trial, renal transplant recipients with invasive fungal infections were assigned to receive either micafungin or voriconazole. The enrolled subjects received a kidney transplant between March 2008 and March 2010 at one of the two transplant centres in Henan Province, China. The efficacy and adverse effects of the two treatments were compared.
The clinical trial enrolled 65 patients, of whom 31 were treated with micafungin, and 34 with voriconazole. The rates of microbiological evidence of infection in the micafungin and voriconazole groups were 64.5% and 70.5%, respectively, whereas the rates of Candida as the major cultured fungus were 80.0% and 75.0%, respectively. Complicated bacterial infection rates in the two treatment groups were 38.7% and 32.4%, respectively, whereas complicated CMV viral infection occurred at a rate of 19.2% and 23.5%, respectively. Fungal infection within one to 3 months after transplant was 83.6% (26/31) and 85.3% (29/34) in the micafungin and voriconazole groups, respectively. There was no significant difference between the two groups in terms of efficacy, survival beyond 10 days and discontinuation of treatment because of lack of efficacy (P > 0.05). Mortality rates in the micafungin and voriconazole groups were 9.7% (3/31) and 12.1% (4/33), respectively. Rates of adverse effects in the two groups were 41.9% and 51.6% (P > 0.05), respectively.
This is the first comparison of micafungin and voriconazole in renal transplant patients. Our study shows that the effectiveness of micafungin was similar to that of voriconazole in such patients.
侵袭性真菌感染是肾移植受者的主要威胁。米卡芬净和伏立康唑是两种治疗此类感染的有效抗真菌药物。我们的目的是评估米卡芬净和伏立康唑在初始治疗此类感染中的疗效和安全性。
在这项前瞻性、多中心、开放标签、随机、对照试验中，患有侵袭性真菌感染的肾移植受者被分配接受米卡芬净或伏立康唑治疗。纳入的受试者于 2008 年 3 月至 2010 年 3 月在河南省的两个移植中心之一接受了肾移植。比较了两种治疗方法的疗效和不良反应。
临床试验共纳入 65 例患者，其中 31 例接受米卡芬净治疗，34 例接受伏立康唑治疗。米卡芬净组和伏立康唑组的微生物学证据感染率分别为 64.5%和 70.5%，而主要培养真菌为念珠菌的比例分别为 80.0%和 75.0%。两组复杂细菌感染率分别为 38.7%和 32.4%，而复杂 CMV 病毒感染率分别为 19.2%和 23.5%。移植后 1-3 个月内真菌感染分别为米卡芬净组 83.6%（26/31）和伏立康唑组 85.3%（29/34）。两组在疗效、10 天后的存活率和因疗效不佳而停止治疗方面无显著差异（P>0.05）。米卡芬净组和伏立康唑组的死亡率分别为 9.7%（3/31）和 12.1%（4/33）。两组不良反应发生率分别为 41.9%和 51.6%（P>0.05）。
这是首次比较米卡芬净和伏立康唑在肾移植患者中的应用。我们的研究表明，米卡芬净在这类患者中的疗效与伏立康唑相似。
