Department of Surgery, Cedars-Sinai Medical Center, Los Angeles, CA, USA.
Clin Microbiol Infect. 2010 Aug;16(8):1274-81. doi: 10.1111/j.1469-0691.2010.03122.x.
Tigecycline (TGC) has demonstrated clinical efficacy and safety, in comparison with imipenem/cilastatin in phase 3 clinical trials, for complicated intra-abdominal infection (cIAI). The present study comprised a multicentre, open-label, randomized study of TGC vs. ceftriaxone plus metronidazole (CTX/MET) for the treatment of patients with cIAI. Eligible subjects were randomized (1:1) to receive either an initial dose of TGC (100 mg) followed by 50 mg every 12 h or CTX (2 g once daily) plus MET (1-2 g daily), for 4-14 days. The primary endpoint was the clinical response in the clinically evaluable (CE) population at the test of cure (TOC) assessment. Of 473 randomized subjects, 376 were CE. Among these, clinical cure rates were 70.4% (133/189) with TGC vs. 74.3% (139/187) with CTX/MET (95% CI -13.1 to 5.1; p 0.009 for non-inferiority). Clinical cure rates for subjects with Acute Physiological and Chronic Health Evaluation II scores > or =10 were 56.8% (21/37) with TGC vs. 58.3% (21/36) with CTX/MET. The microbiologic response was similar between the two treatment arms, with microbiological eradication at TOC achieved in 68.1% (94/138) of TGC-treated subjects and 71.5% (98/137) of CTX/MET-treated subjects. (The most frequently reported adverse events (AEs) for both treatment arms were nausea (TGC, 38.6% vs CTX/MET, 27.7%) and vomiting (TGC, 23.3% vs CTX/MET, 17.7%). Overall discontinuation rates as a result of an AE were 8.9% and 4.8% in TGC- and comparator-treated subjects, respectively. The results obtained in the present study demonstrate that TGC monotherapy is non-inferior to a combination regimen of CTX/MET with respect to treating subjects with cIAI.
替加环素（TGC）在 3 期临床试验中与亚胺培南/西司他丁相比显示出临床疗效和安全性，用于治疗复杂性腹腔内感染（cIAI）。本研究包括一项多中心、开放性、随机研究，比较 TGC 与头孢曲松加甲硝唑（CTX/MET）治疗 cIAI 患者。合格的受试者按 1:1 随机分为初始剂量 TGC（100mg），随后每 12 小时给予 50mg 或 CTX（每天 1 次 2g）加 MET（每天 1-2g），疗程 4-14 天。主要终点是在治愈测试（TOC）评估时，可评估人群的临床应答。在 473 名随机受试者中，376 名是可评估人群。其中，TGC 的临床治愈率为 70.4%（133/189），CTX/MET 为 74.3%（139/187）（95%CI-13.1 至 5.1；p=0.009 非劣效性）。急性生理学和慢性健康评估 II 评分≥10 的患者，TGC 的临床治愈率为 56.8%（21/37），CTX/MET 为 58.3%（21/36）。两种治疗方案的微生物学应答相似，TGC 治疗组在 TOC 时微生物学清除率为 68.1%（94/138），CTX/MET 治疗组为 71.5%（98/137）。（两种治疗方案中最常报告的不良事件（AE）是恶心（TGC 为 38.6%，CTX/MET 为 27.7%）和呕吐（TGC 为 23.3%，CTX/MET 为 17.7%）。TGC 组和对照组因 AE 导致停药的总发生率分别为 8.9%和 4.8%。本研究结果表明，替加环素单药治疗与头孢曲松/甲硝唑联合治疗相比，治疗复杂性腹腔内感染患者不劣效。
