Department of Medicine, Washington University School of Medicine, 660 South Euclid Avenue, St Louis, Missouri 63110, USA.
Crit Care. 2010;14(3):R84. doi: 10.1186/cc9012. Epub 2010 May 10.
Ventilator-associated pneumonia (VAP) is associated with increased medical resource utilization, but few randomized studies have been conducted to evaluate the effect of initial antibiotic therapy. To assess medical resource utilization in patients with VAP, we conducted a pooled analysis of two prospective, randomized, open-label, multicenter, phase III studies, which also showed that doripenem was clinically noninferior to comparators.
We assessed durations of mechanical ventilation, intensive care unit (ICU) stay, and hospitalization in patients with VAP who received at least 1 dose of doripenem or a comparator in the phase III studies. Comparators were piperacillin/tazobactam (study 1) and imipenem (study 2). We analyzed between-group differences in medical resource utilization endpoints by comparison of Kaplan-Meier curves with generalized Wilcoxon test and in microbiologic eradication rates by two-sided Fisher's exact test.
625 patients with VAP were evaluated and received at least 1 dose of doripenem (n = 312) or a comparator (n = 313). Median durations of mechanical ventilation (7 versus 10 days; P = 0.008) and hospitalization (22 versus 26 days; P = 0.010) were shorter for doripenem than comparators; corresponding ICU stays were 12 and 13 days (P = 0.065). All-cause, overall mortality rates were similar (51/312 [16%] versus 47/313 [15%]; P = 0.648). MIC90 values against Pseudomonas aeruginosa for doripenem versus imipenem were 4 versus 16 microg/mL in study 2. P. aeruginosa was eradicated from 16/24 (67%) doripenem recipients and 10/24 (42%) comparator recipients (P = 0.147). In patients with P. aeruginosa at baseline, median durations of mechanical ventilation (7 versus 13 days; P = 0.031) and ICU stay (13 versus 21 days; P = 0.027) were shorter for doripenem; corresponding hospital stays were 24 and 35 days (P = 0.129).
Doripenem was associated with lower medical resource utilization than comparators. Differences in antipseudomonal activity may have contributed to these findings.
ClinicalTrials.gov number NCT00211003 (study 1) and NCT00211016 (study 2).
呼吸机相关性肺炎（VAP）与医疗资源利用增加有关，但很少有随机研究评估初始抗生素治疗的效果。为了评估 VAP 患者的医疗资源利用情况，我们对两项前瞻性、随机、开放标签、多中心 III 期研究进行了汇总分析，这些研究还表明，多利培南在临床疗效上不劣于对照药物。
我们评估了 VAP 患者的机械通气时间、重症监护病房（ICU）入住时间和住院时间，这些患者在 III 期研究中至少接受了 1 剂多利培南或对照药物。对照药物为哌拉西林/他唑巴坦（研究 1）和亚胺培南（研究 2）。我们通过比较 Kaplan-Meier 曲线和广义 Wilcoxon 检验，分析了两组间医疗资源利用终点的差异，并通过双侧 Fisher 精确检验分析了微生物清除率。
625 例 VAP 患者接受了至少 1 剂多利培南（n=312）或对照药物（n=313）治疗。与对照药物相比，多利培南组的机械通气时间（7 天 vs. 10 天；P=0.008）和住院时间（22 天 vs. 26 天；P=0.010）更短；相应的 ICU 入住时间分别为 12 天和 13 天（P=0.065）。全因死亡率相似（51/312[16%] vs. 47/313[15%]；P=0.648）。多利培南对铜绿假单胞菌的 MIC90 值与亚胺培南相比为 4μg/ml 对 16μg/ml，这在研究 2 中有所体现。在基线时存在铜绿假单胞菌的患者中，多利培南组的机械通气时间（7 天 vs. 13 天；P=0.031）和 ICU 入住时间（13 天 vs. 21 天；P=0.027）更短；相应的住院时间分别为 24 天和 35 天（P=0.129）。
多利培南与对照药物相比，可降低医疗资源利用。抗假单胞菌活性的差异可能导致了这些发现。
ClinicalTrials.gov 编号 NCT00211003（研究 1）和 NCT00211016（研究 2）。
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