【摘要】 目的评价利奈唑胺注射液治疗革兰阳性菌感染的疗效与安全性。方法本试验为随机、双盲、对照、多中心临床试验,已知或怀疑为革兰阳性菌所致肺炎或复杂性皮肤软组织感染患者被随机分配接受利奈唑胺或万古霉素静脉给药治疗。结果共入选患者144例,改良的意向性治疗分析人群为141例,符合方案集116例,安全集142例。符合方案集中,停药后随访时,试验组和对照组临床有效率分别为86.9%(53/61)和61.7%(37/60),差异有统计学意义,其中肺炎两组有效率为78.6%(22/28)和52.9%(18/34),复杂性皮肤软组织感染两组有效率为78.6%(22/28)和52.9%(18/34),两组间差异均无统计学意义。两组总的细菌清除率以菌株数计分别为79.2%(42/53)和61.5%(32/52),两组间差异有统计学意义,其中肺炎细菌清除率为77.3%(17/22)和53.6%(15/28),复杂性皮肤软组织感染细菌清除率为80.6%(25/31)和70.8%(17/24),差异均无统计学意义。安全分析集中,试验组药物相关不良事件发生率为25.4%(18/71),其中3例同时发生临床不良反应与实验室异常,临床不良反应10例(14.1%,10/71),主要为发热、皮疹等过敏反应,以及胃纳减退等胃肠道反应,实验室异常11例(15.5%,11/71),主要为肝功能损害、轻度白细胞计数降低、血小板减少等;对照组药物相关不良事件发生率为16.9%(12/71),包括临床不良反应11例(15.5%,11/71),主要为过敏反应,包括药物热、皮疹、红人综合征等,实验室异常3例(5.2%,3/71),多为肝功能损害,经分析差异无统计学意义;试验组和对照组中停者各为5.6%和11.3%,其中与研究药物相关者各占1.4%和5.6%。所有病原菌均对利奈唑胺和万古霉素呈现敏感。结论利奈唑胺注射剂静脉给药用于革兰阳性菌所致肺炎和复杂性皮肤软组织感染的治疗可获良好疗效,疗效高于对照组,不良反应与对照组相似。更多还原

【Abstract】 Objective To evaluate the efficacy and safety of linezolid for injection in the treatment of gram positive bacterial infection.MethodsIn this randomized,double-blinded,controlled,multicenter clinical trial,patients with pneumonia or complicated skin and soft-tissue infections due to suspected or known gram-positive pathogens were randomized to receive either linezolid or vancomycin intravenously.ResultsA total of 144 patients were enrolled and 142 patients received study medication.The modified intention-to-treat(MITT)set was 141.The per-protocol(PP)set was 116.The safety set was 142.In the analysis with PP set,at follow-up,the clinical efficacy rates of linezolid group and vancomycin group were 86.9%(53/61)and 61.7%(37/60)respectively with statistically significant difference.In the population of pneumonia,the efficacy rates were 78.6%(22/28)and 52.9%(18/34).In the population of complicated skin and soft tissue infection,the efficacy rates were 78.6%(22/28)and 52.9%(18/34).the bacterial eradication rate was 79.2%(42/53)in linezolid group and 61.5%(32/52)in vancomycin group,with statistically significant difference.In the population of pneumonia,the bacterial eradication rates were 77.3%(17/22)and 53.6%(15/28);in the population of complicated skin and soft tissue infection,the bacterial eradication rates were 80.6%(25/31)and 70.8%%(17/24).In the analysis with safety set,the incidence of drug-related adverse event was 25.4%(18/71)in linezolid group,including 14.1%(10/71)clinical adverse reaction,such as fever,rash,dyspepsia,and 15.5%(11/71)laboratory abnormality,such as liver function abnormality,mild leukopenia,thrombocytopenia.The incidence of drug-related adverse event in vancomycin group was 16.9%(12/71),including 15.5%(11/71)clinical adverse reaction,such as fever,rash,red man syndrome,and 5.2%(3/71)laboratory abnormality,mainly liver function abnormality.Discontinuation rate due to adverse event(AE)was 5.6% in linezolid group and 11.3% in vancomycin group.Discontinuation rate due to drug-related adverse reaction was 1.4% and 5.6%,respectively.All the isolated pathogens were susceptible to linezolid and vancomycin.ConclusionsLinezolid for injection is well-tolerated and effective in the treatment of pneumonia and complicated skin and soft tissue infection caused by gram-positive pathogens.更多还原