中国组织工程研究 ›› 2011, Vol. 15 ›› Issue (31): 5736-5760.doi: 10.3969/j.issn.1673-8225.2011.31.013

• 器官移植循证医学 evidence-based medicine of organ transplantation • 上一篇    下一篇

器官移植后环孢素A谷浓度和服药后2 h浓度监测有效性和安全性的Meta分析

李海菊1,平卫伟2   

  1. 1山西长治医学院附属和平医院药剂科,山西省长治市 046000
    2山西长治医学院预防医学教研室,山西省长治市 046000
  • 收稿日期:2011-04-25 修回日期:2011-07-04 出版日期:2011-07-30 发布日期:2011-07-30
  • 作者简介:李海菊★,女,1974年生,山西省长治人,汉族,2005年中南大学湘雅医学院毕业,硕士,讲师,主要从事临床药学研究。 li_haiju@126.com

Safety and efficacy of cyclosporine A trough level monitoring and 2 hours level post-administration monitoring in organ transplantation recipients: A Meta analysis

Li Hai-ju1, Ping Wei-wei2   

  1. 1Department of Pharmacy, Affiliated Heping Hospital of Changzhi Medical College, Changzhi 046000, Shanxi Province, China
    2Department of Preventive Medicine, Changzhi Medical College, Changzhi 046000, Shanxi Province, China
  • Received:2011-04-25 Revised:2011-07-04 Online:2011-07-30 Published:2011-07-30
  • About author:Li Hai-ju★, Master, Lecturer, Department of Pharmacy, Affiliated Heping Hospital of Changzhi Medical College, Changzhi 046000, Shanxi Province, China li_haiju@126.com

摘要:

背景:对环孢素A治疗药物监测目前常用的方法为监测环孢素A谷浓度和服药2 h后的血药浓度。
目的:基于国内报道的环孢素A监测研究,评价谷浓度和峰浓度监测在预测器官移植后急性排斥反应和药物不良反应中的有效性。
方法:计算机检索中国期刊全文数据库,万方数据库,中文科技期刊全文数据库,中国优秀硕士学位论文全文数据库、中国博士学位论文全文数据库,并辅以文献追溯的方法,收集国内公开发表的所有相关病例对照、队列研究。检索年限均为从建库到2010-12-31。按纳入排除标准筛选文献并评价纳入研究的质量后,采用RevMan 4.2软件进行Meta分析。
结果与结论:共纳入8篇文献,合计1 147例患者。统计结果表明,谷浓度和峰浓度监测均可以预测急性排斥反应的发生,但峰浓度监测更优越,峰浓度监测可以预测肝肾毒性的发生。总之,峰浓度监测对预测器官移植后急性排斥反应和药物不良反应更有效。

关键词: 环孢素A, 器官移植, 谷浓度, 服药后2 h浓度, Meta分析

Abstract:

BACKGROUND: Cyclosporine microemulsion (CsA-ME) is a drug with a narrow therapeutic window and highly variable pharmacokinetics. Therapeutic drug monitoring is essential and has been conventionally guided by trough levels (C0). Recent evidence indicates that a single blood concentration monitoring 2 hours after CsA administration (C2) is a more accurate predictor of the occurrence of the acute reject reaction and harmful reaction than monitoring of C0.
OBJECTIVE: To analyze the clinical benefits of cyclosporine C2-level monitoring and C0-level monitoring in solid organ transplantation recipients.
METHODS: Case-control studies and cohort studies were collected by searching the electronic bibliographic databases such as CBMdisc (1979 to 2010), Chinese Sci-tech Periodical Full-text Database (1989 to 2010), Wanfang (1982 to 2010), Chinese Journals Full-text Database (since 1994), China Master’s Theses Full-text Database (since 1999), and China Doctor Dissertations Full-text Database (since 1999). All the relevant studies were identified and the quality of the included studies was assessed. The RevMan 4.2 software was used for meta-analysis.
RESULTS AND CONCLUSION: Eight studies with 1 148 patients were included. Result of Meta analysis showed: the rate of acute rejection episodes in C2 was lower than that in C0 [OR = 1.64, 95%CI(1.15, 2.35)]; mean C0 level in the rejection group was lower than that in the no rejection group [SMD = -0.40, 95%CI(-0.68, -0.13)]; mean C2 level in the rejection group was lower than that in the no rejection group [SMD = -1.11, 95%CI(-1.64, -0.58)]; the difference between C2 group and C0 group in terms of the rate of harmful reaction was not significant [OR = 0.92, 95%CI(0.52,1.62)]; the difference between harmful reaction group and no harmful reaction group in terms of mean C0 level was not significant [SMD = 0.14, 95%CI(-0.28, 0.55)]; mean C2 level in the harmful reaction group was higher than that in the no harmful reaction group [SMD = 0.94, 95%CI(0.05,1.83)]; the current domestic evidence proves that both C2 and C0 monitoring can predict acute rejection episodes, C2 monitoring is better than C0 monitoring. C2 monitoring can predict harmful reaction. In conclusion, C2 is a more accurate predictor of the occurrence of the acute reject reaction and harmful reaction than C0.

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