摘要
目的探讨真实世界中注射用灯盏花素临床发生过敏反应的可能影响因素。方法采用回顾性巢式病例对照研究设计,处方序列对称分析方法。基于医院信息管理系统(HIS)集成数据仓库,纳入其中37家三级甲等医院HIS中使用注射用灯盏花素后出现疑似过敏反应的患者,采集患者的入院信息、疾病诊断、医嘱、治疗结局等数据构建数据库。结局为疑似过敏的病例为病例组,根据一定条件在同一队列研究中的结局为非过敏的病例为对照组。可疑过敏反应变量为合并疾病(频数前10位)、合并用药(频数前10位)、住院天数分段、疗程分段、用药剂量分段。采用Logistic回归方法,探讨患者合并疾病、合并用药、用药单次剂量及日剂量、用药疗程、住院天数与疑似过敏反应发生的相关性。结果最终病例组纳入270例,对照组纳入1350例。合并疾病中腰椎间盘脱出、肺部感染的回归系数分别为0.29363912、0.14228938(P<0.05),合并用药中氯化钾、奥美拉唑的回归系数分别为0.13004015、0.08152833(P<0.05),单次剂量>50 mg回归系数为0.09793825(P<0.05),系数为正表明该变量为“是”,或取此水平时相对于对照组来说发生不良反应的可能性大,为疑似过敏反应发生的影响因素。结论合并腰椎间盘脱出、肺部感染,联用氯化钾、奥美拉唑,单次剂量>50 mg为使用注射用灯盏花素发生疑似过敏反应的可能影响因素。
Objective To explore the possible influencing factors of clinical allergic reactions related to breviscapine injection in the real world.Methods A retrospective nested case-control study design and a symmetrical analysis method of prescription sequence were adopted.Based on the information management system of 37 tertiary first-class hospitals across the country,patients with suspected allergic reactions after using breviscapine injection were included,and data on admission,disease diagnosis,doctor's orders,and treatment outcomes were collected to build a data warehouse.Cases whose outcome was suspected of allergy were the case group,and those whose outcome was non-allergic in the same cohort under certain conditions were the control group.The variables of suspected allergic reaction were combined disease(top 10 of frequency),combined medication(top 10 of frequency),length of hospital stay,duration of treatment,and dose of medication.Logistic regression method was used to explore the correlation among patients'combined diseases,combined medications,single and daily doses of medications,duration of medication,length of stay in hospital,and suspected allergic reactions.Results The final case group included 270 cases,and the control group included 1350 cases.The regression coefficients of lumbar intervertebral disc herniation and lung infection in combined diseases were 0.29363912,0.14228938(P<0.05),and the regression coefficients of potassium chloride and omeprazole in combined medication were 0.13004015 and 0.08152833(P<0.05),respectively.The regression coefficient of single time overdose was 0.09793825(P<0.05).A positive coefficient indicates that the variable was“yes”,or when this level was taken,the possibility of adverse reactions was high compared to the control group,which was the influencing factor of suspected allergic reactions.Conclusion Combined with prolapse of lumbar intervertebral disc,pulmonary infection,combined use of potassium chloride,omeprazole,singletime overdose are possible influencing factors for suspected allergic reactions when using breviscapine injection.
作者
成冯镜茗
谢雁鸣
王连心
黎元元
杨晓晨
CHENGFENG Jingming;XIE Yanming;WANG Lianxin;LI Yuanyuan;YANG Xiaochen(Institute of Basic Research in Clinical Medicine,China Academy of Chinese Medical Sciences,Beijing,100700;School of Statistics,Renmin University of China)
出处
《中医杂志》
CSCD
北大核心
2020年第24期2174-2178,共5页
Journal of Traditional Chinese Medicine
基金
国家重点研发计划(2018YFC1707400)
中央级公益性科研院所基本业务费项目(Z0597)。
作者简介
通讯作者:黎元元,chibjyy@163.com,(010)64093205。
