哌拉西林／他唑巴坦治疗医院获得性肺炎的多中心临床研究

A Multicenter Clinical Trial on the Efficacy and Safety of Piperacillin/tazobactam for the Treatment of Patients with Hospital Acquired Pneumonia

目的评价哌拉西彬他唑巴坦（特治星）治疗医院获得性肺炎的疗效与安全性。方法采用多中心、开放、非对照方法治疗医院获得性肺炎，给药方案为每次4．5g静脉注射，q8h，7～14d。结果共250例患者入选，符合方案分析246例，安全性分析250例。符合方案分析病例中，治疗结束时特治星治疗的总有效率为81．7％（201／246例），细菌清除率为74．1％（83／112株）。药物相关不良反应发生率为2．8％（7／250例），包括临床不良反应4例（1．6％，4／250例），主要为皮疹、胸闷、注射部位局部疼痛、排便次数增加；实验室检查异常3例，为肝功能损害、血嗜酸粒细胞增多，均系轻度，呈一过性改变，对症处理或停药后恢复正常。结论特治星治疗医院获得性肺炎疗效确切，不良反应少，推荐该药作为治疗医院获得性肺炎的首选药物之一。

Objective To evaluate the clinical efficacy and safety of piperaeillin/tazobaetam in the treatment of hospital acquired pneumonia（HAP）. Methods A multicenter, open-labeled, non-comparative clinical trial was conducted. Patients with HAP were administered intravenously with piperacillin/tazobaetam（4. 5 g） every 8 h for 7-14 days. Results A total of 250 patients were enrolled in this study and 246 subjects were clinical valuable. At the end point, the clinical efficacy rate was 81.7% （201/246） and the bacterial eradication rate was 74. 1% （83/112）. The rate of drug related adverse events was 2.8% （7/250）, in which 4 cases had clinical significance （rash,dyspnea, injection site pain and diarrhea, respectively） and 3 cases had abnormal laboratory findings （ hepatic dysfuction , eosinopbilia and so on ） . All events were mild and transient . Conclusions Piperacillin/tazobactam is effective and safe in the treatment of HAP, therefore, it is recommended as one of the first-line antibiotics to treat the patients with HAP.