Kuti Joseph L, Nightingale Charles H, Nicolau David P
Center for Anti-Infective Research and Development, Hartford Hospital, 80 Seymour St., P.O. Box 5037, Hartford, CT 06102, USA.
Antimicrob Agents Chemother. 2004 Jul;48(7):2464-70. doi: 10.1128/AAC.48.7.2464-2470.2004.
The OPTAMA Program is intended to examine typical antimicrobial regimens used in the treatment of common nosocomial pathogens and the likelihood of these regimens attaining appropriate pharmacodynamic exposure in different parts of the world. A 5,000-subject Monte Carlo simulation was used to estimate pharmacodynamic target attainment for meropenem, imipenem, ceftazidime, cefepime, piperacillin-tazobactam, and ciprofloxacin against Escherichia coli, Klebsiella pneumoniae, Acinetobacter baumannii, and Pseudomonas aeruginosa. Standard dosing regimens from North America were used. Pharmacokinetic parameter variability was derived from existing healthy volunteer data, and MIC data came from the 2002 MYSTIC Program. Ciprofloxacin displayed the lowest target attainment against all bacterial species (41 to 46% for A. baumannii, 53 to 59% for P. aeruginosa, and 80 to 85% for the Enterobacteriaceae). Increasing the dose to 400 mg every 8 h did not significantly increase target attainment against nonfermenters. Piperacillin-tazobactam target attainments were similar to that of ceftazidime against all pathogens. Higher doses of both compounds were needed to achieve better target attainments against P. aeruginosa. Overall, meropenem, imipenem, and cefepime attained the highest probabilities of attainment against the Enterobacteriaceae (99 to 100%). The carbapenems appear to be the most useful agents against A. baumannii (88 to 92%), and these agents, along with higher doses of any of the beta-lactams, would be the most appropriate choices for empirical therapy for P. aeruginosa infection. Given the lack of agreement between percent susceptibility and probability of target attainment for certain antimicrobial regimens, a methodology employing stochastic pharmacodynamic analyses may be a more useful tool for differentiating the most-optimal compounds and dosing regimens in the clinical setting of initial empirical therapy.
OPTAMA项目旨在研究治疗常见医院病原体所使用的典型抗菌方案,以及这些方案在世界不同地区实现适当药效学暴露的可能性。采用一项纳入5000名受试者的蒙特卡洛模拟,来估计美罗培南、亚胺培南、头孢他啶、头孢吡肟、哌拉西林-他唑巴坦和环丙沙星针对大肠埃希菌、肺炎克雷伯菌、鲍曼不动杆菌和铜绿假单胞菌的药效学目标达成率。使用了来自北美的标准给药方案。药代动力学参数变异性来自现有的健康志愿者数据,而MIC数据来自2002年的MYSTIC项目。环丙沙星对所有细菌种类的目标达成率最低(鲍曼不动杆菌为41%至46%,铜绿假单胞菌为53%至59%,肠杆菌科为80%至85%)。将剂量增加至每8小时400毫克,对非发酵菌的目标达成率没有显著提高。哌拉西林-他唑巴坦对所有病原体的目标达成率与头孢他啶相似。需要更高剂量的这两种化合物才能对铜绿假单胞菌实现更好的目标达成率。总体而言,美罗培南、亚胺培南和头孢吡肟对肠杆菌科的达成概率最高(99%至100%)。碳青霉烯类似乎是对抗鲍曼不动杆菌最有效的药物(88%至92%),并且这些药物以及更高剂量的任何β-内酰胺类药物,将是铜绿假单胞菌感染经验性治疗的最合适选择。鉴于某些抗菌方案的药敏率与目标达成概率之间缺乏一致性,采用随机药效学分析的方法可能是在初始经验性治疗的临床环境中区分最优化合物和给药方案的更有用工具。