肾移植后西罗莫司致不良反应的文献分析

Sirolimus-induced adverse reactions following kidney transplantation

背景:西罗莫司是一新型免疫抑制剂,肾毒性小,已在中国用于防治肾移植后排斥反应。目的:分析肾移植后应用免疫抑制剂西罗莫司所致不良反应的临床特征和相关因素。方法:计算机检索2002/2009中国知网数据库、万方数据资源的中国期刊全文数据库国内文献收载的西罗莫司不良反应报道资料,检索词"西罗莫司、肾移植",采用文献计量学方法进行统计、分析。纳入近年中国国内报道的西罗莫司临床应用及安全性方面的研究论文,要求其中不良反应报告的病例在性别、年龄、不良反应表现等方面详细具体。排除综述类文献及不良反应报告过于简单的病例资料。结果与结论:共选入文献15篇,患者500例,其中发生不良反应病例合计468例次。468例不良反应中高脂血症发生最多(182例,占38.9%),其次为感染和发热(62例,占13.2%),肝功能异常(54例,占11.5%)等。提示西罗莫司主要不良反应为高脂血症、感染和肝功能异常等,不良反应发生与血药浓度等因素相关,定期监测血药浓度,合理调整用量,可增加西罗莫司应用的有效性及安全性。

BACKGROUND： Sirolimus is a new generation of immunosuppressive agent with little renal toxicity, and it has been used effectively in Chinese kidney transplantation recipient patients to prevent acute rejection. OBJECTIVE： To analyze the clinical characteristics and related factors of adverse drug reaction （ADRs） induced by immunosuppressive agent sirolimus following kidney transplantation. METHODS： Retrieval-related contents were collected by computer from Chinese Journal Full-text Database in CNKI and Wanfang database with the of sirolimus and kidney transplantation during 2000 and 2009. ADRs cases induced by sirolimus reported in domestic medical journals were analyzed statistically by methods of bibliometries. The research thesis of sirolimus in clinical application and security were brought into the study, all ADRs cases must have detailed report in sex, age and ADRs syndromes. Reviews and simply reported literatures were excluded. RESULTS AND CONCLUSION： A total of 15 literatures were selected and 500 patients were included. Of all the 468 ADRs cases, hyperlipidemia （182 cases, 38.9%） were the most frequent adverse reactions, other ADRs were infection and fever （62 cases, 13.2%）, liver dysfunction （54 cases, 11.5%）, etc. The most frequent adverse reactions were hyperlipidemia, infection and liver dysfunction. Regular drug monitoring and reasonably dose modulation may increase the validity and security of sirolimus