Standard care versus protocol based therapy for new onset Pseudomonas aeruginosa in cystic fibrosis.
Standard care versus protocol based therapy for new onset Pseudomonas aeruginosa in cystic fibrosis.
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DOI：
10.1002/ppul.22693
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发表时间：
2013-10
影响因子：
3.1
通讯作者：
Ramsey, Bonnie W.
中科院分区：
文献类型：
--
作者：
Mayer-Hamblett, Nicole;Rosenfeld, Margaret;Treggiari, Miriam M.;Konstan, Michael W.;Retsch-Bogart, George;Morgan, Wayne;Wagener, Jeff;Gibson, Ronald L.;Khan, Umer;Emerson, Julia;Thompson, Valeria;Elkin, Eric P.;Ramsey, Bonnie W.
早期假单胞菌感染控制 (EPIC) 随机试验严格评估了不同抗生素治疗方案对根除囊性纤维化 (CF) 儿童中新发现的假单胞菌 (Pa) 的功效。试验中基于方案的治疗是基于独立于症状的培养阳性而提供的。目前尚不清楚临床试验中观察到的结果是否与历史标准护理中观察到的结果不同，呼吸道症状比单独培养阳性更严重地驱动。我们假设，与历史对照相比，试验参与者中 Pa 复发和住院的发生率将显着降低，历史对照的护理标准早于广泛采用妥布霉素吸入溶液 (TIS) 作为新分离 Pa 时的初始根除治疗。试验的资格标准用于从 CF 流行病学研究 (ESCF) 中得出历史对照，这些历史对照在 TIS 广泛使用之前于 1995 年至 1998 年接受标准护理治疗。对 15 个月内的 PA 复发和住院结果进行了评估。与 304 名试验参与者中的 100% 相比，只有 296/608 (49%) 的历史对照在新发 Pa 后平均 20 周内接受了抗生素治疗。104/298 (35%) 的试验参与者中发生 Pa 复发，而历史对照的比例为 295/549 (54%)（差异 19%，95% CI：12%、26%， p<0.001）。各队列之间的住院发生率没有观察到显着差异。与新发 Pa 的抗生素治疗不太积极的历史对照队列相比，针对新发 Pa 的基于方案的抗菌治疗导致 Pa 复发率较低，但住院率相当。
The Early Pseudomonal Infection Control (EPIC) randomized trial rigorously evaluated the efficacy of different antibiotic regimens for eradication of newly identified Pseudomonas (Pa) in children with cystic fibrosis (CF). Protocol based therapy in the trial was provided based on culture positivity independent of symptoms. It is unclear whether outcomes observed in the clinical trial were different than those that would have been observed with historical standard of care driven more heavily by respiratory symptoms than culture positivity alone. We hypothesized that the incidence of Pa recurrence and hospitalizations would be significantly reduced among trial participants as compared to historical controls whose standard of care preceded the widespread adoption of tobramycin inhalation solution (TIS) as initial eradication therapy at the time of new isolation of Pa. Eligibility criteria from the trial were used to derive historical controls from the Epidemiologic Study of CF (ESCF) who received standard of care treatment from 1995 to 1998, before widespread availability of TIS. Pa recurrence and hospitalization outcomes were assessed over a 15-month time period. As compared to 100% of the 304 trial participants, only 296/608 (49%) historical controls received antibiotics within an average of 20 weeks after new onset Pa. Pa recurrence occurred among 104/298 (35%) of the trial participants as compared to 295/549 (54%) of historical controls (19% difference, 95% CI: 12%, 26%, p<0.001). No significant differences in the incidence of hospitalization were observed between cohorts. Protocol-based antimicrobial therapy for newly acquired Pa resulted in a lower rate of Pa recurrence but comparable hospitalization rates as compared to a historical control cohort less aggressively treated with antibiotics for new onset Pa.
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影响因子：
158.5
作者：
Ramsey, BW;Pepe, MS;Smith, AL
通讯作者：
Smith, AL
影响因子：
2.2
作者：
Treggiari, Miriam M.;Rosenfeld, Margaret;Ramsey, Bonnie W.
通讯作者：
Ramsey, Bonnie W.
影响因子：
3.1
作者：
PAMUKCU, A;BUSH, A;BUCHDAHL, R
通讯作者：
BUCHDAHL, R
影响因子：
10
作者：
Ratjen, Felix;Munck, Anne;Angyalosi, Gerhild
通讯作者：
Angyalosi, Gerhild
影响因子：
3.1
作者：
HENRY, RL;MELLIS, CM;PETROVIC, L
通讯作者：
PETROVIC, L