基于倾向性评分匹配法的美罗培南仿制药与原研药对重症肺炎患者的疗效和安全性比较

Comparison of Efficacy and Safety of Meropenem Generic Drug and Innovator Drug in Patients with Severe Pneumonia Based on the Propensity Score Matching Method

目的:依据倾向性评分匹配(propensity score matching,PSM)方法,评价和比较美罗培南仿制药与原研药对重症肺炎患者的疗效和安全性,为临床重症肺炎患者的用药治疗提供参考。方法:选取2016年11月—2020年11月新疆维吾尔自治区人民医院收治的612例使用美罗培南仿制药或原研药的重症肺炎患者作为研究对象,根据所用药物的不同将其分为仿制药组和原研药组,采集2组患者的年龄、性别、种族、用药状况、基础疾病、临床结局、病原学检查结果、感染指标水平变化等信息,并进行PSM,然后评价和比较美罗培南仿制药与原研药的一致性状况。结果:经过筛查,612例重症肺炎中符合纳入要求的有330例,其中原研药组109例、仿制药组221例,以1∶1进行PSM后,原研药组和仿制药组患者均为96例;PSM前,2组患者的性别、种族、美罗培南的疗程和用法、合并用药、基础疾病、病原菌数量等一般情况均无明显差异(P>0.05),而PSM后,2组患者这些一般状况亦无明显差异(P>0.05);PSM前后,原研药组和仿制药组患者的临床有效率、细菌清除率,以及白细胞计数、C反应蛋白、中性粒细胞百分比、降钙素原等感染指标水平的下降率经比较其差异均无统计学意义(P>0.05);PSM前后,仿制药组仅有2例患者发生药物不良反应,而原研药组患者没有发生药物不良反应,经比较2组患者的药物不良反应发生率无统计学意义(P>0.05)。结论:美罗培南仿制药和原研药对重症肺炎患者的疗效和安全性均无明显差异,具有较好的一致性。

Objective:To evaluate and compare the efficacy and safety of meropenem generic drug and innovator drug in patients with severe pneumonia based on the propensity score matching(PSM)method,and provide reference for the clinical medication of patients with severe pneumonia.Methods:A total of 612 patients with severe pneumonia admitted to the People's Hospital of the Xinjiang Uygur Autonomous Region from November 2016 to November 2020 who used meropenem generic drug or innovator drug were selected as the research objects,and divided into the generic drug group and innovator drug group based on the drugs.The information of the two groups of patients,such as age,gender,race,medication status,underlying diseases,clinical outcomes,etiological examination results,change in infection indicator levels,etc.,was collected,and PSM was performed,and then the consistency of meropenem generic drug and innovator drug was evaluated and compared.Results:After screening,330 of 612 cases with severe pneumonia met the inclusion criteria,including 109 cases in the innovator drug group and 221 cases in the generic drug group.After PSM was performed at a ratio of 1:1,there were 96 patients in both groups.Before PSM,there were no significant differences in general conditions of patients such as gender,race,course and administration of meropenem,concomitant medications,underlying diseases,and number of pathogenic bacteria between the two groups(P>0.05).After PSM,there was also no significant difference in said general conditions between the two groups(P>0.05);before and after PSM,there were no statistically significant differences in the clinical response rate,bacterial clearance rate,WBC count,C-reactive protein level,neutrophil percentage,procalcitonin level and other infection indicators between the two groups(P>0.05);before and after PSM,adverse drug reactions(ADRs)occurred in only 2 patients in the generic drug group,while no ADRs occurred in the innovator drug group.There was no statistically significant difference in the incidence of ADRs between the two groups(P>0.05).Conclusion:The efficacy and safety of meropenem generic drugs are not significantly different from the meropenem innovator drugs in the treatment of patients with severe pneumonia,with good consistency between them.