左氧氟沙星750mg注射液5日短程疗法治疗社区获得性肺炎的多中心临床研究

发布时间：2018-07-16 16:59

【摘要】：目的比较左氧氟沙星750 mg注射液5 d短程疗法与500 mg注射液7~14 d常规疗法治疗社区获得性肺炎(CAP)疗效和安全性差异。方法本临床试验为随机对照、开放、非劣效性多中心临床试验。CAP患者被随机分配到左氧氟沙星750 mg组治疗5 d或500 mg组治疗7~14 d,两组均接受静脉给药治疗,观察其临床表现、实验室检查、影像学改变及微生物学检查等,比较两组安全性和疗效差异。结果 10个研究中心共入选病例241例。其中全分析集(FAS)223例,包括750 mg组111例,500 mg组112例。符合方案分析集(PPS)211例,包括750 mg组107例,500 mg组104例。安全性分析集(SS)241例,包括750 mg组121例,500 mg组120例。FAS750 mg组疗程中位数为5.0d,500 mg组疗程中位数为9.0d。750 mg组总剂量中位数为3 750 mg,500 mg组总剂量中位数为4 500 mg。FAS第4次随访750 mg组有效率为86.2%,500 mg组有效率为84.7%,两组综合疗效评价相比为非劣效。FAS750 mg组可进行微生物疗效评价者共40例,获病原菌41株,500 mg组可行微生物疗效评价者共49例,获病原菌51株,两组细菌清除率均为100%。另外,750 mg组和500 mg组的非典型病原体的临床有效率均为100%。对750 mg组安全性观察结果显示,临床不良反应最常见为注射部位瘙痒、疼痛和充血等,其次为失眠、恶心、皮疹等。较常见的实验室指标异常为中性粒细胞比率降低、白细胞总数降低、ALT升高、AST升高等。以上不良反应多属轻微,患者可耐受,与500 mg组相比,因药物中止试验和不良反应发生率差异无统计学意义,提示两组安全性相仿。结论左氧氟沙星750 mg注射液5 d短程疗法治疗CAP与左氧氟沙星500 mg注射液7~14 d常规疗程相比,其临床和微生物疗效相仿,不良反应发生率相仿,均较轻微,患者耐受性好。
[Abstract]:Objective to compare the efficacy and safety of levofloxacin 750mg injection in the treatment of community-acquired pneumonia (CAP). Methods the patients in this clinical trial were randomly assigned to levofloxacin 750 mg group for 5 days or 500 mg group for 7 days. Both groups were given intravenous administration and their clinical manifestations were observed. Laboratory examination, imaging changes and microbiological examination were used to compare the safety and efficacy between the two groups. Results 241 patients were enrolled in 10 research centers. The total analysis set (FAS) was 223 cases, including 111 cases in 750 mg group and 112 cases in 500 mg group. There were 211 cases of PPS, including 107 cases in 750 mg group and 104 cases in 500 mg group. Safety analysis set (SS) 241 cases, The median course of treatment of 500mg group including 750mg group was 120 cases. The median course of treatment of FAS750mg group was 5.0dago 500mg group, the median of total dose of 9.0d.750 group was 3 750mg / 500mg group, the median of total dose of 500mg group was 4 500mg.FAS, the effective rate of 750mg group was 86.2mg / 500mg group. The effective rate was 84.7. Compared with the non-inferior effect. FAS750mg group, 40 cases could be evaluated by microorganism. A total of 49 patients with 41 strains of pathogenic bacteria and 51 strains of pathogenic bacteria were obtained in the 500 mg group. The bacterial clearance rates of both groups were 100. In addition, the clinical effective rate of atypical pathogens in 750mg group and 500mg group was 100%. The safety observation of 750mg group showed that the most common adverse reactions were pruritus, pain and congestion at injection site, followed by insomnia, nausea, rash and so on. The more common laboratory indexes were decreased neutrophil ratio, decreased leukocyte count, elevated alt, and increased AST, etc. Most of the adverse reactions were mild and tolerable. Compared with the 500mg group, there was no significant difference in the incidence of drug termination test and adverse reaction between the two groups, suggesting that the safety of the two groups was similar. Conclusion the clinical efficacy of levofloxacin 750mg injection is similar to that of levofloxacin 500mg injection for 714 days compared with that of levofloxacin injection for 714 days. The incidence of adverse reactions is similar and mild, and the patient has good tolerance.
【作者单位】：复旦大学附属华山医院抗生素研究所卫生部抗生素临床药理重点实验室;上海长征医院;首都医科大学附属朝阳医院;南京大学附属鼓楼医院;苏州大学附属第一医院;中山大学附属第一医院;中南大学附属湘雅三院;四川大学附属华西医院;广州军区武汉总医院;江西省人民医院;
【基金】：国家科技部“重大新药创制”科技重大专项(2012ZX09303004001)
【分类号】：R563.1

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