以喜炎平注射液为例探究处方序列对称分析对过敏信号的检出能力

Performance of Prescription Sequence Symmetry Analysis in Detecting Allergic Signals of Xiyanping Injection：A Case Study

目的:研究喜炎平注射液与过敏反应的关系以及处方序列对称分析(PSSA)对过敏反应信号的检出能力。方法:提取2015年全国基本医疗保险抽样数据库中处方过喜炎平注射液和抗过敏药的患者进行处方序列对称分析。以抗组胺药、糖皮质激素、钙剂和肾上腺素作为过敏反应的标签药,计算调整序列比(ASR)作为评估相关性的效应指标。结果:研究共纳入6 629例患者,其中4 503例患者在同一天处方喜炎平注射液和抗过敏药。纳入同一天处方两种药物的患者时ASR(95%CI)为2.45(2.33,2.59),排除同一天处方两种药物的患者时ASR(95%CI)为2.00(1.83,2.19)。各类抗过敏药均可识别出安全信号。结论:喜炎平注射液和过敏反应之间可能存在关联,PSSA可以通过对标签药的选择以及纳入同一天处方指示药和标签药的患者,增加对过敏反应的探测能力。

Objective:To study the association between Xiyanping injection and allergic reactions and the ability of signal detecting of prescription sequence symmetry analysis(PSSA).Methods:PSSA was conducted using the records of patients who were prescribed both Xiyanping injection and antiallergic drugs in 2015 from Chinese basic medical insurance database.Antihistamines,glucocorticoids,calcium gluconate and adrenaline were selected as the proxy of allergic reactions.Patients newly prescribed Xiyanping injection and antiallergic drugs on the same day were included.Adjusted sequence ratio(ASR)was calculated to measure the signal of allergic reaction.Results:6 629 patients were included and 4 503 patients were prescribed Xiyanping injection and antiallergic drugs on the same day.The ASRs(95%CI)were 2.45(2.33,2.59)when including patients with the same prescription date of Xiyanping injection and antiallergic drugs and 2.00(1.83,2.19)when excluding thoses patients.Signals were detected by each of the four kinds of antiallergic drugs.Conclusion:PSSA indicated that there might be potential association between Xiyanping injection use and allergic reactions.The ability of detecting allergic reactions of PSSA can be improved by choosing appropriate marker drugs and including patients who newly prescribed index drugs and marker drugs on the same day.