Lilly Research Laboratories, Lilly Corporate Center, Eli Lilly and Company, Indianapolis, Indiana 46285, USA.
Drug Saf. 2011 Jan 1;34(1):73-82. doi: 10.2165/11539560-000000000-00000.
Routine surveillance of spontaneous reporting data and subsequent disproportionality analyses have indicated that the use of vancomycin might be associated with an increased risk of hepatic events.
To conduct a meta-analysis of published randomized controlled clinical trials (RCTs) to better understand if the use of vancomycin is potentially associated with an increased risk of hepatic events.
A comprehensive search and review of published clinical studies indexed in MEDLINE, PubMed, International Pharmaceutical Abstracts and the Cochrane Library from 1950 to June 2010 was conducted.
The inclusion criteria consisted of (i) published RCTs comparing vancomycin with/without other additional treatments to other comparators; and (ii) studies that reported hepatic events.
The data related to any hepatic events reported in RCTs were extracted and examined. The quality of selected studies was assessed based on the Jadad scale. The effect size was presented as a risk ratio (RR) with a 95% CI and number needed to harm. The pooled RRs were calculated by using both fixed-effects and random-effects models. The impact of publication bias was assessed by funnel plot and the Egger's test.
A total of 20 RCTs, including 7419 patients, met the study inclusion criteria and were selected. An increased incidence of hepatic events, specifically elevated serum aminotransferase levels, was observed in patients receiving vancomycin, when compared with other comparators (pooled RR=1.95; 95% CI 1.62, 2.36; p<0.001), but the majority of the events were mild to moderate in nature. No evidence is currently available suggesting that the use of vancomcycin confers a risk of progressive or severe drug-induced liver injury.
Continuous monitoring of hepatic events on a routine basis among patients with the use of vancomycin is suggested.
常规监测自发报告数据和随后的不稳定性分析表明，万古霉素的使用可能与肝事件风险增加有关。
进行已发表的随机对照临床试验（RCT）的荟萃分析，以更好地了解万古霉素的使用是否可能与肝事件风险增加相关。
对 MEDLINE、PubMed、国际药学文摘和 Cochrane 图书馆从 1950 年到 2010 年 6 月发表的临床研究进行了全面搜索和综述。
纳入标准包括：（i）比较万古霉素与/或其他附加治疗与其他对照的 RCT；（ii）报告肝事件的研究。
提取并检查 RCT 报告的任何肝事件相关数据。根据 Jadad 量表评估所选研究的质量。效应大小以风险比（RR）和 95%置信区间（CI）和需要治疗的人数表示。使用固定效应和随机效应模型计算汇总 RR。通过漏斗图和 Egger 检验评估发表偏倚的影响。
共有 20 项 RCT，包括 7419 名患者，符合研究纳入标准。与其他对照相比，接受万古霉素治疗的患者肝事件发生率升高，特别是血清转氨酶水平升高（汇总 RR=1.95；95%CI 1.62，2.36；p<0.001），但大多数事件为轻度至中度。目前尚无证据表明万古霉素的使用会导致进行性或严重的药物性肝损伤。
建议常规监测万古霉素治疗患者的肝事件。
