摘要
背景:卡泊芬净是新型棘白菌素类全身抗真菌药物,研究表明其对深部真菌感染有广谱抗菌作用,疗效优于或与两性霉素B的作用相当,但目前尚无肾移植术后应用卡泊芬净预防真菌感染的报道。目的:分析公民逝世后器官捐献供肾肾移植与亲属活体肾移植术后真菌感染高危因素的差异,探讨应用卡泊芬净预防公民逝世后器官捐献供肾肾移植术后真菌感染的可行性和安全性。方法:试验为前瞻性单中心临床试验,在中国河南省,郑州大学第一附属肾移植中心完成。选择2012年1月至2013年8月收治,移植前无明确真菌感染证据及无应用抗真菌类药物史的首次肾移植患者,其中公民逝世后器官捐献供肾肾移植102例为试验组,对照组为同期亲属活体肾移植86例。术前测定受者CYP3A5基因型,所有患者移植术后均采用他克莫司+吗替麦考酚酯+泼尼松三联免疫抑制方案。试验组术后采用卡泊芬净预防性抗真菌治疗2周,比较两组真菌感染的高危因素以及相同CYP3A5基因型受者术后1、2周及1,3,6个月卡泊芬净对他克莫司谷浓度、他克莫司谷浓度/剂量比值的影响,检测各随访时间点肝肾功能、记录不良事件及真菌感染情况。试验于2017年11月在中国临床试验注册中心注册(Chi CTR-OON-17013342)。结果与结论:(1)受者随访6个月人/肾存活率分别为98.4%,97.3%,其中试验组102例,入组97例;对照组86例全部随访;(2)术前透析时间、血红蛋白值、冷缺血时间、热缺血时间、术中输血量、中心静脉导管留置时间、甲强龙用量、ATG用量、1周时血肌酐下降幅度、血小板减少症和术后体温>38℃持续时间是试验组相对对照组术后真菌感染的极高危因素;(3)随访6个月时,试验组、对照组真菌感染率分别为0%、2.3%;(4)术后1周试验组血肌酐值高于对照组(P<0.05),其他时间点两组无差异(P>0.05);(5)移植术后应用卡泊芬净2周,对不�
BACKGROUND： Caspofungin, a novel echinocandins systemic antifungal agent, has been shown to exertbroad-spectrum antibacterial effect on deep fungal infections, which is superior to or equivalent with the role ofamphotericin B, but there is no report on its application for preventing fungal infection after renal transplantation.OBJECTIVE： To analyze the difference in high risk factors of fungal infection after kidney transplantation using donationafter cardiac death donors and living-related donor kidney transplantations, and to explore the feasibility and safety ofcaspofungin to prevent fungal infection after kidney transplantation using donation after cardiac death donors.METHODS： This was a prospective, single-center, controlled trial finished at the Department of Kidney Transplantation,the First Affiliated Hospital of Zhengzhou University, Henan Province, China. Totally 188 patients undergoing primarykidney transplantation without history of fungal infection and use of antifungal drugs between January 2012 and August2013 were enrolled, including kidney transplantation with donation after cardiac death donors （n=102, trail group）, andkidney transplantation with living-related donors （n=86, control group）. The CYP3A5 genotype was determinedpreoperatively. All patients received tacrolimus＋mycophenolate mofetil＋prednisone triple immunosuppression aftertransplantation. The trial group was subjected to caspofungin therapy for 2 weeks. The risk factors for fungal infection inthe two groups were compared, and the effects of caspofungin on the tacrolimus concentration, tacrolimusconcentration/dose were detected in the recipients with same CYP3A5 genotype recipients at 1 and 2 weeks, and 1, 3and 6 months postoperatively. The liver and kidney function, adverse events and fungal infections were recorded atdifferent time points. This trial was registered with the Chinese Clinial Trial Registry （Regitration number：ChiCTR-OON-17013342）.RESULTS AND CONCLUSION： The survival rate of patient/kidney was
出处
《中国组织工程研究》
CAS
北大核心
2017年第32期5189-5196,共8页
Chinese Journal of Tissue Engineering Research
