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中国药学(英文版) ›› 2016, Vol. 25 ›› Issue (3): 215-223.DOI: 10.5246/jcps.2016.03.026

• 【临床药学专栏】 • 上一篇    下一篇

替拉万星疗效及安全性的系统评价和Meta分析

董悦1,2, 赵明1, 胡欣1*   

  1. 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
  • 收稿日期:2015-12-14 修回日期:2016-02-18 出版日期:2016-03-29 发布日期:2016-02-28
  • 通讯作者: Tel.: 86-10-85133636, E-mail: huxinbjyy@126.com

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

Yue Dong1,2, Ming Zhao1, Xin Hu1*   

  1. 1. Department of Pharmacy, Beijing Hospital, Beijing 100730, China;
    2. Department of Administration and Clinical Pharmacy, Peking University School of Pharmaceutical Sciences, Beijing 100191, China 
  • Received:2015-12-14 Revised:2016-02-18 Online:2016-03-29 Published:2016-02-28
  • Contact: Tel.: 86-10-85133636, E-mail: huxinbjyy@126.com

摘要:

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PubMed, 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)95%置信区间。本文共纳入7RCT研究,包括4(2229)复杂性皮肤软组织感染(cSSTIs)RCT研究, 2(1503)医院获得性肺炎(HAP)RCT研究, 1(31)金黄色葡萄球菌菌血症(SAB)RCT研究。Meta分析结果显示,对于cSSTIs, 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cSSTIs, HAPSAB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: 替拉万星, 耐甲氧西林金黄色葡萄球菌, 系统评价

Abstract:

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 PubMed, 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 cSSTIs, 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 cSSTIs, 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, P<0.00001; FEM)than vancomycin or standard therapy.Telavancin and vancomycin or standard therapy are equally effective for the treatment of cSSTIs, 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.

Key words: Telavancin, MRSA, Systematic review

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