真实世界中清开灵注射液发生疑似过敏反应的相关影响因素研究
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摘要
目的:基于巢式病例对照设计,探讨真实世界清开灵注射液发生疑似过敏反应的影响因素。方法:本文基于全国16家大型三甲医院信息系统中使用过清开灵注射液患者的信息,采用巢式病例对照研究方法,对比过敏组与对照组的合并疾病、合并用药、住院天数分段、用药剂量等信息,运用Logistic回归分析导致过敏反应发生的可疑因素。结果:分析发现,泌尿系感染和神经肌肉系统疾病是发生可疑类过敏反应的危险因素,使用清开灵注射液的同时服用维生素C或泼尼松龙片会增加可疑类过敏反应发生的机会,利多卡因注射液与清开灵注射液同用发生可疑类过敏反应的危险性更大,单次使用剂量在20mL及以上增加了发生可疑类过敏反应的可能,住院天数、疗程及日剂量不是发生可疑类过敏反应的危险因素。结论:本研究在方法上可行,为临床安全用药提供了一定的线索,但还需要更多的临床研究和药学实验探讨其原因及机制。
Objective: Based on nested case-control design,to explore the influencing factors of suspected allergic reaction of Qingkailing injection in the real world. Methods: Based on the hospital information system of 16 large hospitals in China,Qingkailing injection was used in the information system. A nested case-control study was used to compare the information on the combination of diseases,combined medication,hospital days,dosage and so on between the allergy group and the control group. Results: The results showed that urinary tract infection and neuromuscular system diseases were the risk factors for suspicious allergic reactions. Take vitamin C or prednisolone tablets together with Qingkailing injection could increase the chance of suspicious allergic reaction,and the risk of suspicious allergic reaction of lidocaine injection and Qingkailing injection was higher than that of Qingkailing injection. The single dose of 20 m L or could increased the possibility of suspicious allergic reaction. The days of hospitalization,course of treatment and daily dose were not the risk factors for suspicious allergic reactions. Conclusion: This study is feasible and provides some clues for clinical safety of drug use,but more clinical studies and pharmacological experiments are needed to explore the causes and mechanisms.
Objective: Based on nested case-control design,to explore the influencing factors of suspected allergic reaction of Qingkailing injection in the real world. Methods: Based on the hospital information system of 16 large hospitals in China,Qingkailing injection was used in the information system. A nested case-control study was used to compare the information on the combination of diseases,combined medication,hospital days,dosage and so on between the allergy group and the control group. Results: The results showed that urinary tract infection and neuromuscular system diseases were the risk factors for suspicious allergic reactions. Take vitamin C or prednisolone tablets together with Qingkailing injection could increase the chance of suspicious allergic reaction,and the risk of suspicious allergic reaction of lidocaine injection and Qingkailing injection was higher than that of Qingkailing injection. The single dose of 20 m L or could increased the possibility of suspicious allergic reaction. The days of hospitalization,course of treatment and daily dose were not the risk factors for suspicious allergic reactions. Conclusion: This study is feasible and provides some clues for clinical safety of drug use,but more clinical studies and pharmacological experiments are needed to explore the causes and mechanisms.
引文
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[13]王连心,唐浩,谢雁鸣,等.巢式病例对照研究在HIS真实世界参麦注射液疑似过敏因素分析中的应用[J].中国中药杂志,2013,38(18):3019-3023.
[14]谢鹏扬,谢雁鸣,王连心,等.巢式病例对照设计在痰热清注射液过敏反应机制研究中的应用举隅[J].中国中药杂志,2014,39(18):3567-3570.
[15]赵玉斌,肖颖,谢雁鸣.清开灵注射液过敏反应患者血清免疫球蛋白及相关指标变化规律的临床研究[J].中国中药杂志,2011,36(18):2579-2583.
[16]王克军,丁红丽.超量维生素C的不良反应[J].临床合理用药杂志,2013,6(35):107.
[17]张小勇,徐卫平.利多卡因的不良反应及其处理[J].中国现代药物应用,2010,4(24):6-7.
[18]崔宏玉,易艳,李春英,等.清开灵注射液类过敏反应的实验研究[J].中国中药杂志,2014,39(3):511-514.
[19]史留喜,肖玉春,李莎莎.清开灵注射液不良反应及对策分析[J].江西中医药,2011,42(11):30-32.
[20]王连心,谢雁鸣,常艳鹏,等.主动监测在中药注射剂上市后临床安全性评价的应用及范例[J].世界中医药,2014,9(9):1132-1136.
[2]杨花平,郭春丽.清开灵注射液致过敏反应的机理及预防[J].内蒙古中医药,2007,26(7):15.
[3]叶冬青.巢式病例对照研究的设计及分析[J].疾病控制杂志,2001,5(1):65-68.
[4]庄严,谢邦铁,翁盛鑫,等.中药上市后再评价HIS“真实世界”集成数据仓库的构建与实现[J].中国中药杂志,2011,36(20):2883-2887.
[5]庄严,谢邦铁,翁盛鑫,等.基于HIS的中成药不良反应监测系统设计与思考[J].医疗卫生装备,2011,32(12):47-49.
[6]张寅,谢雁鸣,陈岑,等.基于关联规则Apriori算法的真实世界复方苦参注射液治疗恶性肿瘤联合用药药理作用特征的回顾分析[J].中国中药杂志,2017,42(2):378-384.
[7]魏戌,谢雁鸣.中药注射剂不良反应的影响因素与发生机制分析[J].中国中药杂志,2012,37(18):2748-2751.
[8]马静,李学林,唐进法.中药注射剂的定位与特点[J].中国现代中药,2016,18(2):259-262.
[9]王守东,张跃文,徐亚丽,等.清开灵过敏反应情况分析[J].河南中医学院学报,2005,20(1):34-36.
[10]韦堆库,王芳兰.清开灵注射液过敏致急性喉头水肿和哮喘1例[J].中国社区医师:医学专业,2010,12(19):188.
[11]杨立芝.清开灵注射液致过敏反应2例报告[J].中国社区医师:医学专业,2012,14(25):390.
[12]易艳,李春英,张宇实,等.3种中药注射剂类过敏反应评价及其机制探讨[J].中国中药杂志,2015,40(14):2711-2716.
[13]王连心,唐浩,谢雁鸣,等.巢式病例对照研究在HIS真实世界参麦注射液疑似过敏因素分析中的应用[J].中国中药杂志,2013,38(18):3019-3023.
[14]谢鹏扬,谢雁鸣,王连心,等.巢式病例对照设计在痰热清注射液过敏反应机制研究中的应用举隅[J].中国中药杂志,2014,39(18):3567-3570.
[15]赵玉斌,肖颖,谢雁鸣.清开灵注射液过敏反应患者血清免疫球蛋白及相关指标变化规律的临床研究[J].中国中药杂志,2011,36(18):2579-2583.
[16]王克军,丁红丽.超量维生素C的不良反应[J].临床合理用药杂志,2013,6(35):107.
[17]张小勇,徐卫平.利多卡因的不良反应及其处理[J].中国现代药物应用,2010,4(24):6-7.
[18]崔宏玉,易艳,李春英,等.清开灵注射液类过敏反应的实验研究[J].中国中药杂志,2014,39(3):511-514.
[19]史留喜,肖玉春,李莎莎.清开灵注射液不良反应及对策分析[J].江西中医药,2011,42(11):30-32.
[20]王连心,谢雁鸣,常艳鹏,等.主动监测在中药注射剂上市后临床安全性评价的应用及范例[J].世界中医药,2014,9(9):1132-1136.