摘要
目的对使用伏立康唑的患者进行治疗药物监测的有效性和安全性进行评价。方法系统检索Pub Med、Em Base、Cochrane Library、Clinicaltrials.gov、CNKI、万方和CBM数据库,检索日期截至2016年1月26日。纳入比较伏立康唑进行治疗药物监测与不进行治疗药物监测患者的随机对照试验或观察性研究,结局指标包括真菌感染相关病死率、治疗有效率、不良事件发生率、因不良事件停药发生率、肝毒性发生率、神经毒性发生率和视觉障碍发生率。两位研究者独立提取数据和进行质量评价,必要时采用荟萃分析对数据进行定量分析。结果共纳入1篇随机对照试验和1篇回顾性队列研究,共计169名患者,研究对象分别为成人和儿童,研究总体质量较高。对于有效性,没有研究报道真菌感染相关病死率。治疗药物监测能提高成人(RR=1.38,95%CI:1.00~1.90,P<0.05)和儿童(RR=3.15,95%CI:0.80~12.42,P>0.05)患者治疗有效率,但儿童患者差异无统计学意义;对于安全性,相比于非治疗药物监测组,成人患者治疗药物监测组有显著更低的因不良事件而停药的发生率(RR=0.21,95%CI:0.05~0.95,P<0.05);儿童患者治疗药物监测组有显著更高的不良事件发生率(RR=1.71,95%CI 1.08-2.71,P<0.05),该结果可能与治疗药物监测组疗程更长有关。其余安全性指标差异均无统计学意义(P>0.05)。结论伏立康唑治疗药物监测虽然从药代动力学理论上能使患者获益,但仍需更多高质量的临床研究证实。
Objective To systematically review the efficacy and safety of voriconazole therapeutic drug monitoring（ TDM） in patients using voriconazole. Methods Pubmed,Em Base,Cochrane Library,Clinicaltrials. gov and 3 Chinese Data Bases（ CNKI,Wanfang and CBM） were systematically searched until Jan 26,2016. Randomized controlled trials（ RCTs） and observational studies comparing voriconazole TDM with non- TDM were identified. Outcomes included fungal infections- related mortality,treatment response,adverse events,discontinuation due to adverse events,hepatotoxicity,neurotoxicity and visual disturbance. Two reviewers performed the quality assessment and extracted data independently. Quantitative analysis was conducted through Meta- analysis if necessary. Results One RCT and a retrospective cohort study involving169 patients were included. Studying population were adults and children,respectively. The overall quality of included studies was high. Regarding efficacy,No studies reported fungal infections- related mortality.TDM could improve treatment response rate of both adults（ RR = 1. 38,95%CI： 1. 00- 1. 90,P〈0. 05） and children（ RR = 3. 15,95% CI： 0. 80- 12. 42,P〈0. 05）,yet result for children was not statistically significant. For safety outcomes,compared with non- TDM group,adults TDM group presented a significantly lower rate of discontinuation due to adverse events（ RR = 0. 21,95% CI： 0. 05- 0. 95,P〈0. 05）. Children TDM group presents a significantly higher rate of adverse events（ RR = 1. 71,95% CI： 1. 08- 2. 71,P〈0. 05）,which might probably be due to a longer duration of voriconazole treatment in children TDM group. Differences of other safety outcomes were not statistically significant. Conclusion Although patients can benefit from voriconazole TDM based on pharmacokinetic theory,more high quality studies are still required to validate the benefit of voriconazole TDM.
出处
《中国临床药理学杂志》
CAS
CSCD
北大核心
2017年第1期80-83,共4页
The Chinese Journal of Clinical Pharmacology
关键词
伏立康唑
治疗药物监测
系统评价
voriconazole
therapeutic drug monitoring
systematic review
