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首页> 外文期刊>Clinical microbiology and infection: European Society of Clinical Microbiology and Infectious Diseases >Clinafloxacin monotherapy (CI-960) versus ceftazidime plus amikacin for empirical treatment of febrile neutropenic cancer patients.
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Clinafloxacin monotherapy (CI-960) versus ceftazidime plus amikacin for empirical treatment of febrile neutropenic cancer patients.

机译：克林沙星单药治疗（CI-960）与头孢他啶加丁胺卡那霉素用于高热性中性粒细胞减少癌患者的经验治疗。

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OBJECTIVE: To assess the efficacy and safety of clinafloxacin as a single agent for the empirical treatment of febrile episodes and bacterial infections in neutropenic cancer patients. METHODS: An open label, active-controlled, randomized, parallel treatment, multicenter study was conducted where clinafloxacin monotherapy was compared to the combination of ceftazidime plus amikacin (plus optional vancomycin or teicoplanin). Four hundred and nineteen patients were randomized to receive either intravenous clinafloxacin 200 mg every 12 h or intravenous ceftazidime (2 g) iv every 8 h plus intravenous amikacin (15 mg/kg) per day in divided doses. All randomized patients were to receive a minimum of 48 h of primary study drug treatment, after which the primary treatment could be modified. Clinical and microbiological responses were evaluated at 7-21 days post-treatment after study treatment and long term (maximum 28 days), in intent-to-treat and modified intent-to-treat populations. RESULTS: Clinafloxacin and ceftazidime-amikacin were statistically equivalent for the 72-h defervescence rate, overall defervescence rate, time to defervescence, clinical success rate, by-pathogen microbiological eradication rate, and survival rate. Clinical cure was achieved in 84% (59/70) of patients who received clinafloxacin monotherapy. There were no significant differences between treatments in rates of adverse events or treatment discontinuation rates due to adverse events. CONCLUSIONS: Clinafloxacin appears to be an appropriate agent for empirical treatment in febrile neutropenic cancer patients.
机译：目的：评估克林沙星作为单一药物对中性粒细胞减少癌患者高热发作和细菌感染的经验治疗的有效性和安全性。方法：进行了一项开放标签，主动控制，随机，平行治疗的多中心研究，将克林沙星单药治疗与头孢他啶联合阿米卡星（加可选的万古霉素或替考拉宁）的治疗进行了比较。 419名患者被随机分配为每12小时静脉给予200毫克克林沙星或每8小时静脉给予头孢他啶（2克）静脉内静脉注射加丁胺卡那霉素（15毫克/千克），分次服用。所有随机分组的患者均应接受至少48小时的主要研究药物治疗，此后可以更改主要治疗方法。在意向性治疗和改良意向性治疗人群中，在研究治疗后的治疗后7-21天和长期（最长28天）评估临床和微生物学应答。结果：克林沙星和头孢他啶-阿米卡星在72小时的去铁率，总去铁率，去铁时间，临床成功率，副病原微生物根除率和存活率方面具有统计学意义。 84％（59/70）接受克林沙星单药治疗的患者达到了临床治愈。治疗之间不良事件发生率或因不良事件导致的治疗中止率之间无显着差异。结论：克林沙星似乎是高发性中性粒细胞减少症患者经验治疗的合适药物。

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