Efficacy and safety of telavancin: a systematic review and meta-analysis  

替拉万星疗效及安全性的系统评价和Meta分析(英文)

作　　者：董悦[1,2] 赵明[1] 胡欣[1] 

机构地区：[1]北京医院药学部,北京100730 [2]北京大学医学部药事管理与临床药学系,北京100191

出　　处：《Journal of Chinese Pharmaceutical Sciences》2016年第3期215-223,共9页中国药学（英文版）

摘　　要：The emergence and rapid spread of multidrug-resistant gram-positive bacteria has become a vital and serious medical problem. A literature search was conducted in Pub Med, EMBASE, and Elsevier databases to identify relevant publications. To calculate the risk ratios（RRs） with 95% confidential intervals（CIs）, a fixed- or random-effects model was applied based on the heterogeneity across studies. Five studies containing seven RCTs were included in this meta-analysis. Regarding c SSTIs, HAP, SAB, there was no statistically significant difference in the rate of clinical cure between telavancin and vancomycin or standard therapy in intention-to-treat population（ITT）（RR 1.01, 95% CI 0.97–1.05, P = 0.72; FEM） and clinically evaluable population（CE）（RR 1.01, 95% CI 0.98–1.04, P = 0.41; FEM）. However, telavancin was more effective than vancomycin or standard therapy in MRSA eradication rate（RR 1.08, 95% CI 1.02–1.14, P = 0.009; FEM）. Regarding the safety profile, no statistically significant differences were found in all-cause mortality（9.0% vs. 8.4%; RR 1.07, 95% CI 0.88–1.31, P = 0.49; FEM） and overall adverse events（77.0% vs. 72.3%; RR 1.08, 95% CI 0.98–1.20, P = 0.12; FEM） between telavancin and vancomycin or standard therapy. Pooled data from c SSTIs, HAP and SAB studies on telavancin indicated higher rates of adverse-event related withdrawals（7.7% vs. 5.4%; RR 1.43, 95% CI 1.12–1.83, P = 0.05; FEM） and creatinine elevation（10.0% vs. 5.1%; RR 1.95, 95% CI 1.53–2.48, P0.00001; FEM） than vancomycin or standard therapy. Telavancin and vancomycin or standard therapy are equally effective for the treatment of c SSTIs, HAP and SAB, and telavancin might be an option for the treatment of difficult-to-treat serious infections caused by MRSA. However, telavancin is associated a higher incidence of creatinine elevation and adverse-event related withdrawals.耐药革兰氏阳性球菌的出现和传播已成为一个严重的临床问题。我们通过检索Pub Med,EMBASE,Elsevier数据库,纳入相关随机对照试验(RCT)。采用固定效应模型或随机效应模型对数据进行分析,计算风险比(RR)和95%置信区间。本文共纳入7个RCT研究,包括4个(2229例)复杂性皮肤软组织感染(c SSTIs)RCT研究,2个(1503例)医院获得性肺炎(HAP)RCT研究,1个(31例)金黄色葡萄球菌菌血症(SAB)RCT研究。Meta分析结果显示,对于c SSTIs,HAP,SAB,替拉万星与万古霉素或标准治疗方法相比,在意向治疗人群(RR 1.01,95%CI 0.97–1.05,P=0.72;FEM)及临床评估人群(RR 1.01,95%CI 0.98–1.04,P=0.41;FEM)中治愈率并无显著差异。然而,与万古霉素或标准治疗方法相比,替拉万星在耐甲氧西林金黄色葡萄球菌(MRSA)清除率方面具有显著优势(RR 1.08,95%CI 1.02–1.14,P=0.009;FEM)。替拉万星与与万古霉素或标准治疗方法相比,全因死亡率(9.0%vs.8.4%;RR 1.07,95%CI 0.88–1.31,P=0.49;FEM)及总体不良反应发生率(77.0%vs.72.3%;RR 1.08,95%CI 0.98–1.20,P=0.12;FEM)并无显著性差异;替拉万星与万古霉素或标准治疗方法相比,不良反应导致的患者退出发生率(7.7%vs.5.4%;RR 1.43,95%CI 1.12–1.83,P=0.05;FEM)和肌酐升高发生率(10.0%vs.5.1%;RR 1.95,95%CI 1.53–2.48,P<0.00001;FEM)较高,差异有统计学意义。因此,可以发现对于c SSTIs,HAP和SAB的治疗,替拉万星与万古霉素或标准治疗方法的治疗效果并无显著性差异,提示替拉万星可以作为万古霉素用于难治性MRSA感染的替代疗法。然而,替拉万星不良反应导致的患者退出发生率及肌酐升高发生率较高。

关 键 词：TELAVANCIN MRSA Systematic review 

分 类 号：R969[医药卫生—药理学]