运用巢式病例对照设计分析注射用丹参多酚酸盐疑似类过敏反应病例相关影响因素

Analysis of questionable allergic factors to parenterally administered salvianolate——a nested case control study using hospital information system data

基于全国20家三甲医院信息系统（HIS）数据库探索注射用丹参多酚酸盐临床疑似类过敏反应发生的影响因素。采用巢式病例对照设计,将使用注射用丹参多酚酸盐后使用地塞米松注射液的患者判断为发生可疑类过敏反应者,与可能未发生过敏反应人群进行对比,应用单因素、多因素1ogistic回归方法,探讨入院病情、过敏史、单次用药剂量、合并用药与可疑类过敏反应发生的相关性。通过分析发现,入院病情在第一亚组对比时有显著统计学差异,P〈0.000 1,第二亚组则无差异;在溶媒的对比上,第二亚组对比统计学有差异,P0.005 1。另外分析发现开始使用丹参多酚酸盐至停止使用丹参多酚酸盐时间在24 h以内的患者与对照组相比,可能的危险因素为头孢唑林、多巴胺、甘露醇、肾上腺素;24-48 h的患者与对照组相比,可能的危险因素为氨溴索、左旋氨氯地平、罂粟碱。虽然该研究在探索临床使用丹参多酚酸盐注射液发生可疑类过敏反应的影响因素方面做了相关分析,但这种回顾性的逆向分析思路还值得推敲,因此所得分析结果有待进一步的前瞻性研究验证。

This study aims to assess if adverse drug reactions（ADRs） to parenterally administered salvianolate are allergic in origin.Hospital information system（HIS） data from 20 hospitals in China were used to carry out a retrospective nested case control design study.Included were patients who received dexamethasone for suspected allergic reactions after receiving parenterally administered salvianolate.These were compared with non-allergic reaction people.Single factor logistic regression and multiple factor logistic regression were used to analyze data.Condition on admission,allergic history,dosage,disease status and drug combinations were taken into account in cases of suspected allergic reactions.After analysis in two subgroups we found that the condition on admission had a significant effect,P values was 0.000 1 on suspected cases of allergic reactions in the first subgroup analysis.For the second subgroup analysis,we found condition on solvents had a significant effects,P values was 0.005 1 on suspected cases of allergic reactions.We also found that using other four injections at the same time as parenterally administered salvianolate could be risky factors in suspected cases of allergic reactions.For the second subgroup analysis combining using three injections could increase risks.However,further research for verification is required.This study can provide guidance for safe clinical practice in using parenterally administered salvianolate.