伏立康唑治疗药物监测有效性和安全性的系统评价

发布时间：2019-01-28 09:40

【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,P0.05)和儿童(RR=3.15,95%CI:0.80~12.42,P0.05)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,P0.05);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,P0.05),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(P0.05)。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。
[Abstract]:Objective to evaluate the efficacy and safety of therapeutic drug monitoring in patients with Volconazole. Methods Pub Med,Em Base,Cochrane Library,Clinicaltrials.gov,CNKI, Wanfang and CBM databases were searched systematically, and the retrieval date was as of January 26, 2016. A randomized controlled trial or an observational study was conducted to compare the efficacy of voriconazole in the treatment of patients with or without drug monitoring. The outcome indicators included fungal infection-related mortality, effective treatment rate, and incidence of adverse events. The incidence of drug withdrawal, hepatotoxicity, neurotoxicity and visual impairment due to adverse events. The two researchers independently extracted data and evaluated their quality and, if necessary, quantitatively analyzed the data by meta-analysis. Results one randomized controlled trial and one retrospective cohort study were conducted in 169 patients. The subjects were adults and children. The overall quality of the study was high. For effectiveness, no studies have been reported on fungal infection-related mortality. Therapeutic drug monitoring could improve the effective rate of treatment in patients with RR=1.38,95%CI:1.00~1.90,P0.05 and RR=3.15,95%CI:0.80~12.42,P0.05, but there was no significant difference between them. For safety, the incidence of drug withdrawal due to adverse events (RR=0.21,95%CI:0.05~0.95,P0.05) was significantly lower in adult patients than in non-therapeutic drug monitoring groups. The incidence of adverse events in the treatment drug monitoring group was significantly higher (RR=1.71,95%CI 1.08-2.71 P 0.05), which may be related to the longer course of treatment in the drug monitoring group. There was no significant difference in other safety indexes (P0.05). Conclusion although the pharmacokinetic monitoring of Volconazole can benefit patients more high quality clinical studies are needed.
【作者单位】：北京大学第三医院药剂科;北京大学药学院药事管理与临床药学系;
【分类号】：R978.5

【相似文献】