Torres A, Bauer T T, León-Gil C, Castillo F, Alvarez-Lerma F, Martínez-Pellús A, Leal-Noval S R, Nadal P, Palomar M, Blanquer J, Ros F
Institut Clinic de Pneumologia i Cirurgia Toràcica, Servei de Pneumologia, UVIR, Universitat de Barcelona, IDIBAPS, Barcelona, Spain.
Thorax. 2000 Dec;55(12):1033-9. doi: 10.1136/thorax.55.12.1033.
A prospective multicentre study was undertaken to compare the efficacy of intravenous ciprofloxacin or imipenem in the treatment of severe nosocomial pneumonia requiring mechanical ventilation.
Patients with a clinical suspicion of pneumonia were randomised to receive either ciprofloxacin (800-1200 mg/day) or imipenem (2-4 g/day) in doses adjusted for renal function and specimens of the lower respiratory tract were taken. Patients were included in the study when specimens showed significant growth for potentially pathogenic microorganisms in quantitative bacterial cultures (n = 75, ciprofloxacin 41/75 (55%); imipenem 34/75 (45%)). The clinical and bacteriological success rates were the primary and secondary efficacy variables. An intent-to-treat analysis was performed for all randomised patients who received at least one dose of the study medication (n = 149, ciprofloxacin 72/149 (48%), imipenem 77/149 (52%)).
The success rates were generally good, but neither the clinical success rates (ciprofloxacin, 29/41 (71%), imipenem, 27/34 (79%); 95% CI -10.8 to 28.1; p = 0.435) nor the bacteriological response rate (ciprofloxacin, 20/41 (49%), imipenem, 17/34 (50%); 95% CI -21.5 to 23.9; p = 1.0) were significantly different between the study arms. Pseudomonas aeruginosa was recovered in 26/75 patients (35%) and clinical (ciprofloxacin, 10/14 (71%), imipenem, 8/12 (67%); 95% CI -40.4 to 30.9; p = 1.0) and bacteriological response rates (ciprofloxacin, 7/14 (50%), imipenem, 3/12 (25%), 95% CI -60.9 to 10.9, p = 0.247) were not significantly different in this subgroup of patients. Resistance of Pseudomonas aeruginosa developed in 5/26 cases (19%), 1/14 (7%) to ciprofloxacin and 4/12 (33%) to imipenem (p = 0.147), and the mortality was 12/75 (16%) with no difference between treatment groups (ciprofloxacin, 8/41(24%), imipenem 4/34 (17%); p = 0.362). The clinical response was evaluable in 109/149 patients (73%) in the intent-to-treat analysis and was successful in 74/109 patients (68%). The clinical response rates were also not significantly different in the intent-to-treat analysis (ciprofloxacin, 34/52 (65%), imipenem, 40/57 (70%); 95% CI -12.8 to 22.3; p = 0.746).
Treatment with either ciprofloxacin or imipenem was effective in a selected group of patients with microbiologically confirmed, severe nosocomial pneumonia requiring mechanical ventilation. Although no differences between the study medication could be documented in this trial, smaller differences between treatment arms may have been missed because of sample size limitations.
开展了一项前瞻性多中心研究，以比较静脉注射环丙沙星或亚胺培南治疗需要机械通气的严重医院获得性肺炎的疗效。
临床怀疑患有肺炎的患者被随机分配接受根据肾功能调整剂量的环丙沙星（800 - 1200毫克/天）或亚胺培南（2 - 4克/天），并采集下呼吸道标本。当定量细菌培养中标本显示潜在致病微生物有显著生长时，患者被纳入研究（n = 75，环丙沙星组41/75（55%）；亚胺培南组34/75（45%））。临床和细菌学成功率是主要和次要疗效变量。对所有接受至少一剂研究药物的随机分组患者进行意向性分析（n = 149，环丙沙星组72/149（48%），亚胺培南组77/149（52%））。
成功率总体良好，但研究组之间的临床成功率（环丙沙星组，29/41（71%），亚胺培南组，27/34（79%）；95%可信区间 - 10.8至28.1；p = 0.435）和细菌学反应率（环丙沙星组，20/41（49%），亚胺培南组，17/34（50%）；95%可信区间 - 21.5至23.9；p = 1.0）均无显著差异。26/75例患者（35%）分离出铜绿假单胞菌，该亚组患者的临床（环丙沙星组，10/14（71%），亚胺培南组，8/12（67%）；95%可信区间 - 40.4至30.9；p = 1.0）和细菌学反应率（环丙沙星组，7/14（50%）；亚胺培南组，3/12（25%），95%可信区间 - 60.9至10.9，p = 0.247）也无显著差异。26例铜绿假单胞菌感染患者中有5例（19%）出现耐药，环丙沙星组1/14（7%），亚胺培南组4/12（33%）（p = 0.147），死亡率为12/75（16%），治疗组之间无差异（环丙沙星组，8/41（24%），亚胺培南组4/34（17%）；p = 0.362）。在意向性分析中，109/149例患者（73%）的临床反应可评估，其中74/1,09例患者（68%）治疗成功。在意向性分析中临床反应率也无显著差异（环丙沙星组，34/52（65%），亚胺培南组，40/57（70%）；95%可信区间 - ±12.8至22.3；p = 0.746）。
对于一组经微生物学确诊、需要机械通气的严重医院获得性肺炎患者，环丙沙星或亚胺培南治疗均有效。尽管本试验未发现研究药物之间存在差异，但由于样本量限制，可能遗漏了治疗组之间较小的差异。
