PSA结合NCCS研究参芪扶正注射液疑似过敏反应影响因素

Analysis suspected allergic factors to Shenqi Fuzheng injection based on prescription sequence analysis and nested case control study

该研究采用处方序列分析结合巢式病例对照研究探讨基于全国20家三级甲等医院的医院信息系统(HIS)中参芪扶正注射液(简称参芪扶正)发生疑似过敏反应的主要影响因素。研究设计按照开始至停止使用参芪扶正后是否使用地塞米松注射液将人群分为观察组与对照组,每个观察病例选择4个匹配对照,2组年龄与性别均匹配良好。采用卡方检验、Fisher精确检验、单因素和多因素logistic回归,探讨入院病情、过敏史、单次用药剂量及合并用药与疑似类过敏反应发生的相关性。研究结果显示,单次用药剂量(P=0.000 2),合并使用苦参碱注射液(P<0.000 1,OR=14.312,置信区间[8.184,25.029])对疑似过敏反应有显著影响。研究基于现有HIS数据及研究方法筛选疑似过敏反应发生的危险因素,为参芪扶正临床安全使用提供指导,也为中药上市后临床安全性评价研究提供新方法。

This study based on twenty 3A grade hospital information system（HIS） database in China,adopt to prescription sequence analysis（PSA） with nested case control study（NCCS） to analysis mainly suspected allergy factor of Shenqi Fuzheng injection（Shenqi Fuzheng）.Study design according to start to stop using Shenqi Fuzheng whether using dexamethasone injection will crowd divided into cases group and control group,each case matched 4 controls were selected,two groups according to the ratio of the age and sex matched well.Square test,Fisher exact test,single factor and multiple factor logistic regression were used to analyze data.Condition on admission,allergic history,dosage and drug combinations were taken into account in cases of suspected allergic reactions.After analysis in two subgroups we found that the single dose（P =0.000 2） and the combined use of matrine（P〈0.000 1,OR = 14.312,confidence interval[8.184,25.029]） had significant effects on the suspected allergic reaction.Study on the existing HIS data and the study method based on screening suspected risk factors for allergic reaction.This study can provide guidance for Shenqi Fuzheng injection safety using in clinical practice,and it can also provides new method for the clinical safety reevalualion of post-marketing Chinese medicine injection.