Department of Clinical Pharmacology, the PLA General Hospital, 28 Fu Xing Road, Beijing 100853, People's Republic of China.
Antimicrob Agents Chemother. 2011 Mar;55(3):1162-72. doi: 10.1128/AAC.01402-10. Epub 2010 Dec 20.
The aim of this study was to compare the efficacy and safety of tigecycline, a newly developed glycylcycline antibiotic, with those of empirical antibiotic regimens which have been reported to possess good efficacy for complicated skin and skin structure infections (cSSSIs), complicated intra-abdominal infections (cIAIs), community-acquired pneumonia (CAP), and other infections caused by methicillin-resistant Staphylococcus aureus (MRSA) or vancomycin-resistant Enterococcus (VRE). A meta-analysis of randomized controlled trials (RCTs) identified in PubMed, the Cochrane Library, and Embase was performed. Eight RCTs involving 4,651 patients were included in the meta-analysis. Compared with therapy with empirical antibiotic regimens, tigecycline monotherapy was associated with similar clinical treatment success rates (for the clinically evaluable [CE] population, odds ratio [OR] = 0.92, 95% confidence interval [CI] = 0.76 to 1.12, P = 0.42; for the clinical modified intent-to-treat [c-mITT] population, OR = 0.86, 95% CI = 0.74 to 1.01, P = 0.06) and similar microbiological treatment success rates (for the microbiologically evaluable [ME] population, OR = 0.86, 95% CI = 0.69 to 1.07, P = 0.19). The incidence of adverse events in the tigecycline group was significantly higher than that in the other therapy groups with a statistical margin (for the modified intent-to-treat [mITT] population, OR = 1.33, 95% CI = 1.17 to 1.52, P < 0.0001), especially in the digestive system (mITT population, OR = 2.41, 95% CI = 1.67 to 3.46, P < 0.00001). No difference regarding all-cause mortality and drug-related mortality between tigecycline and the other regimens was found, although numerically higher mortality was found in the tigecycline group. This meta-analysis provides evidence that tigecycline monotherapy may be used as effectively as the comparison therapy for cSSSI, cIAIs, CAP, and infections caused by MRSA/VRE. However, because of the high risk of mortality, AEs, and emergence of resistant isolates, prudence with the clinical use of tigecycline monotherapy in infections is required.
本研究旨在比较替加环素（一种新型甘氨酰环素抗生素）与已报道对复杂性皮肤和皮肤结构感染（cSSSIs）、复杂性腹腔内感染（cIAIs）、社区获得性肺炎（CAP）和耐甲氧西林金黄色葡萄球菌（MRSA）或万古霉素耐药肠球菌（VRE）引起的其他感染具有良好疗效的经验性抗生素治疗方案的疗效和安全性。对 PubMed、Cochrane 图书馆和 Embase 中确定的随机对照试验（RCT）进行了荟萃分析。荟萃分析纳入了 8 项 RCT 共 4651 例患者。与经验性抗生素治疗相比，替加环素单药治疗的临床治疗成功率相似（对于临床可评估人群，比值比 [OR] = 0.92，95%置信区间 [CI] = 0.76 至 1.12，P = 0.42；对于临床改良意向治疗 [c-mITT] 人群，OR = 0.86，95%CI = 0.74 至 1.01，P = 0.06），微生物学治疗成功率也相似（对于微生物可评估人群，OR = 0.86，95%CI = 0.69 至 1.07，P = 0.19）。替加环素组不良反应的发生率显著高于其他治疗组，且具有统计学意义（对于改良意向治疗 [mITT] 人群，OR = 1.33，95%CI = 1.17 至 1.52，P < 0.0001），尤其是消化系统（mITT 人群，OR = 2.41，95%CI = 1.67 至 3.46，P < 0.00001）。替加环素与其他方案相比，全因死亡率和与药物相关的死亡率无差异，但替加环素组死亡率数值较高。这项荟萃分析提供的证据表明，替加环素单药治疗可能与比较治疗方案一样有效治疗 cSSSI、cIAIs、CAP 和由 MRSA/VRE 引起的感染。然而，由于死亡率、不良反应和耐药分离株的发生率较高，在感染中谨慎使用替加环素单药治疗是必要的。
