Babinchak Timothy, Ellis-Grosse Evelyn, Dartois Nathalie, Rose Gilbert M, Loh Evan
Medical Research Group, Wyeth Research, Collegeville, PA 19426, USA.
Clin Infect Dis. 2005 Sep 1;41 Suppl 5:S354-67. doi: 10.1086/431676.
This pooled analysis includes 2 phase 3, double-blind trials designed to evaluate the safety and efficacy of tigecycline, versus that of imipenem-cilastatin, in 1642 adults with complicated intra-abdominal infections. Patients were randomized to receive either tigecycline (initial dose of 100 mg, followed by 50 mg intravenously every 12 h) or imipenem-cilastatin (500/500 mg intravenously every 6 h) for 5-14 days. The primary end point was the clinical response at the test-of-cure visit (12-42 days after therapy) in the co-primary end point microbiologically evaluable and microbiological modified intent-to-treat populations. For the microbiologically evaluable group, clinical cure rates were 86.1% (441/512) for tigecycline, versus 86.2% (442/513) for imipenem-cilastatin (95% confidence interval for the difference, -4.5% to 4.4%; P < .0001 for noninferiority). Clinical cure rates in the microbiological modified intent-to-treat population were 80.2% (506/631) for tigecycline, versus 81.5% (514/631) for imipenem-cilastatin (95% confidence interval for the difference, -5.8% to 3.2%; P < .0001 for noninferiority). Nausea (24.4% tigecycline, 19.0% imipenem-cilastatin [P = .01]), vomiting (19.2% tigecycline, 14.3% imipenem-cilastatin [P = .008]), and diarrhea (13.8% tigecycline, 13.2% imipenem-cilastatin [P = .719]) were the most frequently reported adverse events. This pooled analysis demonstrates that tigecycline was efficacious and well tolerated in the treatment of patients with complicated intra-abdominal infections.
这项汇总分析纳入了2项3期双盲试验，旨在评估替加环素与亚胺培南-西司他丁相比，在1642例患有复杂性腹腔内感染的成人患者中的安全性和疗效。患者被随机分配接受替加环素（初始剂量100mg，随后每12小时静脉注射50mg）或亚胺培南-西司他丁（每6小时静脉注射500/500mg）治疗5至14天。主要终点是在共同主要终点的微生物学可评估和微生物学改良意向性治疗人群中，治疗结束访视（治疗后12 - 42天）时的临床反应。对于微生物学可评估组，替加环素的临床治愈率为86.1%（441/512），亚胺培南-西司他丁为86.2%（442/513）（差异的95%置信区间为-4.5%至4.4%；非劣效性检验P<0.0001）。微生物学改良意向性治疗人群中，替加环素的临床治愈率为80.2%（506/631），亚胺培南-西司他丁为81.5%（514/631）（差异的95%置信区间为-5.8%至3.2%；非劣效性检验P<0.0001）。恶心（替加环素24.4%，亚胺培南-西司他丁19.0%[P = 0.01]）、呕吐（替加环素19.2%，亚胺培南-西司他丁14.3%[P = 0.008]）和腹泻（替加环素13.8%，亚胺培南-西司他丁13.2%[P = 0.719]）是最常报告的不良事件。这项汇总分析表明，替加环素在治疗复杂性腹腔内感染患者中有效且耐受性良好。
