Brown R B, Kruse J A, Counts G W, Russell J A, Christou N V, Sands M L
Infectious Disease Division, Baystate Medical Center, Springfield, Massachusetts 01199.
Antimicrob Agents Chemother. 1990 Feb;34(2):269-72. doi: 10.1128/AAC.34.2.269.
A prospective, double-blind, placebo-controlled study was conducted to determine the safety and efficacy of endotracheal tobramycin (ETT) for treatment of gram-negative bacterial pneumonia. Patients were randomized to either 40 mg of tobramycin or a placebo instilled endotracheally every 8 h. Patients also received intravenous tobramycin plus either cefazolin or piperacillin. Of 85 patients enrolled, 41 were assessable. Most microbiologic diagnoses were made by endotracheal aspiration with strict grading criteria. The clinical-radiographic responses of patients and standard demographic data were recorded. Pseudomonas aeruginosa, "multiple pathogens," and Klebsiella-Enterobacter-Serratia-Citrobacter species were isolated in 41, 32, and 15% of the instances, respectively. Causative pathogens were eradicated from sputum significantly more frequently by patients who received ETT (P less than 0.05). However, no significant differences were noted in the clinical outcomes of the two study groups. No local adverse reactions attributable to the administration of this agent were observed, but four patients had supraventricular tachycardia, compared with none who received the placebo (P = 0.053). ETT may be considered as adjunctive therapy for seriously ill individuals.
进行了一项前瞻性、双盲、安慰剂对照研究，以确定气管内给予妥布霉素（ETT）治疗革兰氏阴性菌肺炎的安全性和有效性。患者被随机分为两组，一组每8小时气管内滴注40毫克妥布霉素，另一组滴注安慰剂。患者还接受静脉注射妥布霉素加头孢唑林或哌拉西林。在85名入组患者中，41名可进行评估。大多数微生物诊断通过气管内抽吸并采用严格的分级标准做出。记录患者的临床影像学反应和标准人口统计学数据。铜绿假单胞菌、“多种病原体”以及克雷伯菌-肠杆菌-沙雷菌-柠檬酸杆菌属分别在41%、32%和15%的病例中分离出来。接受ETT的患者痰液中致病病原体的清除率明显更高（P<0.05）。然而，两个研究组的临床结局没有显著差异。未观察到因使用该药物引起的局部不良反应，但有4名患者出现室上性心动过速，而接受安慰剂的患者中无此情况（P = 0.053）。ETT可被视为重症患者的辅助治疗方法。
