PSM法评价两种哌拉西林复合制剂治疗COPD伴下呼吸道感染的疗效与安全性

Effectiveness and safety of two compound preparations of piperacillin in the treatment of COPD with lower respiratory tract infection by PSM

目的比较两种哌拉西林与β内酰胺酶抑制剂复合制剂在治疗慢性阻塞性肺疾病(chronic obstructive pulmonary disease,COPD)合并下呼吸道感染的疗效与安全性,并评价倾向性评分匹配(propensity score matching,PSM)法在观察性研究中的匹配效果。方法基于HIS系统,根据纳排标准抽取复旦大学附属浦东医院呼吸与危重医学科2018年1月1日—2020年12月31日诊断为“COPD合并下呼吸道感染”患者的电子病历。根据主要抗感染方案,将患者分为哌拉西林钠舒巴坦钠组(5 g,q8h)以及哌拉西林钠他唑巴坦钠组(2.5 g,bid)。分别以疗效和疗程为因变量,利用PSM法平衡两组患者的性别、年龄和合并疾病等混杂因素,考察两组间哌拉西林复合制剂的疗程、疗效以及不良反应方面的差异。结果哌拉西林钠舒巴坦钠组纳入病例376例,哌拉西林钠他唑巴坦钠组纳入病例411例,两组1∶1匹配后组间平衡性良好。匹配疗程等因素时,哌拉西林钠舒巴坦钠和哌拉西林钠他唑巴坦钠的有效率分别为88.92%和83.38%,差异有统计学意义(P<0.05);匹配疗效等因素时,两药的使用疗程分别为(9.35±2.73)天和(10.05±2.89)天,差异有统计学意义(P<0.05);使用疗程≥3天时,两组患者未发现显著关联的药物不良反应。结论PSM法可有效均衡观察性研究中的组间混杂因素。哌拉西林钠舒巴坦钠(5 g,q8h)在治疗COPD伴下呼吸道感染(非重症)时,疗效优于哌拉西林钠他唑巴坦钠(2.5 g,bid),而使用疗程≥3天的长期安全性相当。

Objective To compare effectiveness and safety of two piperacillin compound preparations in the treatment of chronic obstructive pulmonary disease(COPD)with lower respiratory tract infection and evaluate the matching effect of propensity score matching(PSM)in observational studies.Methods Based on hospital information system(HIS),electronic medical records of patients diagnosed as COPD with lower respiratory tract infection discharged on Jan 1,2018 to Dec 31,2020 in the Department of Respiratory and Critical Care Medicine,Shanghai Pudong Hospital were extracted according to our inclusion and exclusion criteria.Depending on the main anti-infection regimen,patients were divided into the group of piperacillin sodium and sulbactum sodium(PIP/SBT)(5 g,q8h)and the group of piperacillin sodium and tazobactam sodium(PIP/TAZ)(2.5 g,bid).The effectiveness and treatment course of piperacillin compound preparations were taken as the dependent variables respectively,and the gender,age,comorbidity,combined medication and other factors of patients in the two groups were balanced by PSM.The differences in the treatment course,effectiveness and adverse drug reactions of piperacillin compound preparations between the two groups were investigated.Results A total of 376 cases in the PIP/SBT group and 411 cases in the PIP/TAZ group were collected.The balance between the two groups was good after 1∶1 matching.When matching treatment course and other factors,the effective rates of piperacillin sulbactam and piperacillin tazobactam were 88.92% and 83.38%,respectively,with statistically significant difference(P<0.05).When the effectiveness and other factors were matched,the treatment courses of PIP/SBT and PIP/TAZ were(9.35±2.73)days and(10.05±2.89)days respectively,with statistically significant difference(P<0.05).When the treatment course was longer than 3 days,no obvious ADRs were found in both groups.Conclusion The PSM can effectively balance the differences of intergroup confounding factors in observational studies.PIP/SBT(5 g,q8h)had better efficacy than PIP/TAZ(2.5g,bid)in the treatment of COPD with lower respiratory tract infection(non-severe),and the safety was similar when the treatment course was longer than 3 days.