摘要
目的:使用Meta分析的方法系统比较达利珠单抗联用传统三联免疫疗法与仅用传统三联免疫疗法诱导预防肾移植后急性免疫排斥反应的有效性和安全性。方法:在维普数据库,万方数据库和中国期刊全文数据库中检索从2001年1月1日到2016年7月13日之间发表的相关文献,搜索词为"达利珠单抗"或"Daclizumab","肾移植"或"Renal transplant"和"急性排斥反应"或"acute rejection"或"赛尼哌"或"Zenapax"。全文阅读后纳入最终有效文献进行质量评估、提取数据,使用Rev Man5.2软件进行Meta分析。结果:初步筛选纳入63篇文献,阅读全文后最终纳入8篇文献。Meta分析结果显示,试验组与对照组的有效率相比有显著差异[OR=0.41,95%CI(0.29,0.59),P<0.00001],药物不良反应(机会感染)发生率无统计学上的显著差异[OR=1.01,95%CI(0.68,1.52)]。结论:与仅使用传统三联免疫疗法治疗相比,使用1剂或2剂达利珠单抗加三联免疫疗法可有效降低肾移植后6个月内急性免疫排斥反应的发生,且对肾移植后感染的发生率没有显著影响。
Objective: To systematically evaluate the efficacy and safety of daclizumab on post-renal-transplant patients. Methods:Chinese databases including VIP,WANFANG and CNKI were searched by words‘daclizumab'and‘renal transplant'and ‘acute rejection'or‘Zenapax'in both Chinese and English for relevant literatures published from Jan 1,2001 to July 13,2016. After unqualified articles being eliminated,quality assessment,data extraction and Meta-analysis using Rev Man 5. 2 software were implemented. Results: After eliminating and retrieving,63 studies were preliminary selected and 8 of them were finally involved. Meta-analysis results show that the effective rates of treatments between experimental group and control group were statistically different[OR = 0. 41,95% CI( 0. 29,0. 59),P 0. 00001 ],while the adverse reaction rates( opportunistic infection) have no statistically significant difference [OR = 1. 01,95% CI( 0. 68,1. 52) ]. Conclusion: Treatments of 1-dose or 2-dose daclizumab combined with conditional triple immune-suppressive therapy can efficiently reduce the rate of acute rejection and has no significant effects on opportunistic infection rates on post-renal-transplant patients for 6 months.
出处
《中国药物评价》
2016年第4期239-245,共7页
Chinese Journal of Drug Evaluation