注射用比阿培南治疗重症细菌性感染的多中心随机对照研究及经济学评价  

Multicenter randomized controlled study of effect of biapenem injection on treatment of severe bacterial infections and evaluation of pharmacoeconomics

作　　者：任玉红[1] 李红义[2] 许世琴[3] 李芬[4] 王业民[5] 李海霞 

机构地区：[1]新乡市第一人民医院医保办,河南新乡453000 [2]新乡市第一人民医院呼吸内科,河南新乡453000 [3]新乡市中心医院检验科,河南新乡453000 [4]新乡市第一人民医院药剂科,河南新乡453000 [5]新乡医学院第一附属医院药剂科,河南卫辉453100 [6]新乡市第二人民医院药剂科,河南新乡453000

出　　处：《中华医院感染学杂志》2017年第6期1232-1235,共4页Chinese Journal of Nosocomiology

基　　金：河南省医学科技攻关计划基金资助项目(201602362);新乡市重点科技攻关计划基金资助项目(ZG15035)

摘　　要：目的研究注射用比阿培南治疗重症细菌性感染的效果及价值,以期用最小成本控制感染、阻断耐药菌株蔓延、降低患者经济负担。方法选取2014年2月-2016年2月新乡市4所医院重症细菌性感染者366例,分为观察组和对照组,各183例,比较患者临床指标、实验室指标、细菌学指标,评价临床疗效、细菌学疗效和不良反应及成本-效果比、敏感度。结果全分析集(FAS)病例366例(观察组和对照组各183例),符合方案标准数据集(PPS)病例364例(观察组、对照组各182例);通过痰培养、血培养和尿培养共获得病原菌株192株,观察组可评价病例94例、对照组98例;FAS中,痊愈率、总有效率、各等级细菌清除率,观察组与对照组比较,差异无统计学意义;PPS中,与对照组比较,差异无统计学意义;不良反应发生率,与对照组比较,差异无统计学意义;抗菌药物成本、C/E、敏感度,与对照组比较,差异有统计学意义(P<0.05)。结论注射用比阿培南治疗重症细菌性感染效果显著,经济实惠,符合当下效果与成本兼顾的理念,值得推广。OBJECTIVE To study the effect of value of biapenem injection in treatment of severe bacterial infections so as to minimize the cost of control of infections,block the spread of drug-resistant bacteria,and reduce the economic burden of patients.METHODS A total of 366 patients with severe bacterial infections who were treated in 4hospitals of Xinxiang city from Feb 2014 to Feb 2016 were enrolled in the study and divided into the observation group and the control group,with 183 cases in each group.The clinical indexes,clinical laboratory indexes,and bacteriological indexes were observed and compared;the clinical efficacy,bacteriological efficacy,incidence of adverse reactions,cost-effectiveness ratio,and sensitivity were evaluated.RESULTS Totally 366 patients were included in the full analysis set（FAS）,with 183 cases in the observation group,183 cases in the control group,and364 patients were included in the per-protocol set（PPS）,with 182 cases in the observation group,182 cases in the control group.Totally 192 strains of pathogens were isolated via sputum culture,blood culture,and urine culture.There were 94 patients who could be evaluated in the observation group and 98 patients in the control group.Among the patients in the FAS,there was no significant difference in the cure rate,total effective rate,or bacterial clearance rate of each grade between the observation group and the control group.Among the patients in the PPS,there was no significant difference between the observation group and the control group.There was no significant difference in the incidence of adverse reactions between the observation group and the control group.There was significant difference in the cost of antibiotics,C/E,or sensitivity between the observation group and the control group（P〈0.05）.CONCLUSIONThe biapenem injection can achieve significant effect on treatment of severe bacterial infection,which is economical and conforms to the idea of giving consideration to both cost and effect,and it is worthy to be promoted.

关 键 词：重症 细菌性感染 比阿培南 多中心 药物经济学 

分 类 号：R978.1[医药卫生—药品]