注射用比阿培南治疗急性细菌性感染的多中心、随机、平行对照临床试验

【作者】 赵立； 李德天； 王秋月； 苗里宁； 蔡绍曦； 陈良安； 邱晨； 贾正平； 袁发焕； 张高魁； 赵敏； 张勇；

【机构】 中国医科大学附属第二医院； 中国医科大学附属第一医院； 吉林大学第二医院； 南方医科大学南方医院； 中国人民解放军总医院； 深圳市人民医院； 兰州军区兰州总医院； 第三军医大学第二附属医院； 北京迪美斯科技发展有限公司； 天津天士力集团研究院；

【摘要】 目的:评价比阿培南治疗急性细菌性感染的疗效和安全性。方法本研究为多中心、随机、开放、平行对照试验,呼吸系统和泌尿系统感染患者分别按中心分层随机接受比阿培南或亚胺培南西司他丁钠(商品名:泰能)治疗。结果①比阿培南组和泰能组有效率分别为93.80%(121/129)和88.72%(118/133),其中两组治疗呼吸系统感染有效率分别为91.67%(55/60)和83.08%(54/65),泌尿系统感染有效率分别为95.65%(66/69)和94.12%(64/68);②两组细菌清除率分别95.45%(63/66)和87.14%(61/70),其中呼吸系统感染细菌清除率分别为95.65%(22/23)和73.08%(19/26),泌尿系统感染细菌清除率分别为细菌清除率分别为95.35%(41/43)和95.45%(42/44);③两组不良反应发生率分别为10.37%(14/135)和11.03%(15/136),比阿培南组没有导致脱落的不良反应发生。泰能组有2例患者分别由于严重皮疹和头晕无法耐受而退出试验。经统计学分析两组的有效率、细菌清除率和不良反应发生率差异均无统计学意义。结论比阿培南治疗中重度急性细菌性感染疗效确切,患者耐受性良好,其临床和细菌学疗效以及不良反应发生率均与对照药亚胺培南西司他丁钠相似。更多还原

【Abstract】 Objective To evaluate the efficacy and safety of biapenem versus than in treatment of bacterial pneumonia and urinary tract infection . Methods for multicenter, open, randomized controlled trials, bacterial pneumonia and urinary tract infection, respectively, by the Center to receive more than a stratified random biapenem or meropenem treatment. Results ①biapenem group than in the United States meropenem group were efficient and, of which two groups of bacterial pneumonia were efficient and, urinary tract infection and were efficient; ② the bacterial clearance rate of the two groups and were, in which bacterial pneumonia and clearance rates were, Bacterial urinary tract infection and clearance rates were; ③ incidence of adverse reactions were, respectively, and, drug-related laboratory abnormalities and the occurrence rates were, respectively, two cases () and 4 cases () the termination of treatment because of adverse reactions. By statistical analysis of the efficiency of the two groups, the bacterial clearance rate and the incidence of adverse reactions had no statistically significant difference. Conclusion biapenem than the treatment of bacterial pneumonia and urinary tract infection is effective, well tolerated in patients with clinical and bacteriological efficacy and the incidence of adverse reactions are related to control drugs similar to meropenem.更多还原