基于大型前瞻性安全性监测的参附注射液不良反应影响因素分析
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摘要
采用前瞻性、多中心、大样本、登记注册式医院集中监测的方法采集不良反应人群的人口学资料、既往史、个人史、家族史、剂量、溶媒、合并用药等信息,采用交叉列联的方法分析其对ADR发生的影响及相互关系。结果发现,19~45岁的用药人群,有过敏史者ADR比例较高;46~65岁的用药人群中,有过敏史的男性ADR比例较高;合并用药人群中,未成年人ADR比例较高;无论是否符合说明书适应证,19~45岁患者,有合并用药、有过敏史者ADR比例较高;非适应证人群中合并用药且超说明书剂量用药者ADR比例较高;非适应证用药人群中有合并用药、高浓度、非说明书溶媒、非常规剂量者ADR比例较高。提示参附注射液ADR的发生主要与患者是否有药物过敏史,以及临床用药时是否按照说明书适应证、溶媒、剂量和浓度使用有关。
This study collected demographic data,past history,personal history,family history,dosage,solvent,combined medication information of adverse reaction cases from a prospective,multi center,large sample intensive hospital monitoring,and found the influencing factors with cross-tab analysis. The results showed that in the medication group of 19-45,patients with allergic histories had a higher proportion in ADR; in the medication group of 46-65,male patients with allergic histories had a higher proportion in ADR; indication and non-indication group,patients of 19-45 years old,with combined medications and allergy histories had a higher proportion in ADR; Non-indication medication group,patients with combined medication,higher concentration,out-instruction solvent and dosage,had a higher proportion in ADR. So,the ADRs of Shenfu injection were related to the history of drug allergy,and also related to the indication,dosage,solvent,concentration when it was used.
This study collected demographic data,past history,personal history,family history,dosage,solvent,combined medication information of adverse reaction cases from a prospective,multi center,large sample intensive hospital monitoring,and found the influencing factors with cross-tab analysis. The results showed that in the medication group of 19-45,patients with allergic histories had a higher proportion in ADR; in the medication group of 46-65,male patients with allergic histories had a higher proportion in ADR; indication and non-indication group,patients of 19-45 years old,with combined medications and allergy histories had a higher proportion in ADR; Non-indication medication group,patients with combined medication,higher concentration,out-instruction solvent and dosage,had a higher proportion in ADR. So,the ADRs of Shenfu injection were related to the history of drug allergy,and also related to the indication,dosage,solvent,concentration when it was used.
引文
[1]谢雁鸣,廖星,赵玉斌,等.中药上市后安全性医院集中监测技术规范(征求意见稿)[J].中国中药杂志,2013,38(18):2919.
[2]杨丽君,邓剑雄,林国良,等.323例儿童严重药品不良反应报告分析[J].中国药物警戒,2008,5(2):108.
[3]白义霞.中药注射剂的常见不良反应原因及预防措施[J].中国医药指南,2012,10(33):266.
[4]范碧亭.中药药剂学[M].上海:上海科学技术出版社,1997:269.
[5]田月洁,李泮海,李彩利.中药注射剂在临床应用中的配伍禁忌概况[J].中国药物警戒,2010,7(2):105.
[6]付莹坤,谢雁鸣.参附注射液临床应用及其不良反应文献分析[J].中国中药杂志,2012,37(18):2796.
[7]李廷谦.中药注射剂不良反应及临床合理用药[J].中国循证医学杂志,2010,10(2):111.
[8]王晓璐,刘雪丽.黄芪注射液41例ADR分析研究[J].河北医学,2006,12(9):877.
[9]王德才,张玲,李爱珍.中药注射剂致死亡39例文献分析[J].药物流行病学杂志,2004,13(2):77.
[10]李廷谦,刘雪梅,冯敏,等.生脉注射液临床应用及不良反应的系统评价[J].中国中西医结合杂志,2009,29(11):965.
[11]李廷谦,马建昕,周宇丹.参附注射液临床应用及其不良反应调查[J].中国循证医学杂志,2009,9(3):19.
[12]任学琴,刘玉梅.影响中药注射液澄明度的几个因素[J].山西临床医药,2001,10(7):559.
[2]杨丽君,邓剑雄,林国良,等.323例儿童严重药品不良反应报告分析[J].中国药物警戒,2008,5(2):108.
[3]白义霞.中药注射剂的常见不良反应原因及预防措施[J].中国医药指南,2012,10(33):266.
[4]范碧亭.中药药剂学[M].上海:上海科学技术出版社,1997:269.
[5]田月洁,李泮海,李彩利.中药注射剂在临床应用中的配伍禁忌概况[J].中国药物警戒,2010,7(2):105.
[6]付莹坤,谢雁鸣.参附注射液临床应用及其不良反应文献分析[J].中国中药杂志,2012,37(18):2796.
[7]李廷谦.中药注射剂不良反应及临床合理用药[J].中国循证医学杂志,2010,10(2):111.
[8]王晓璐,刘雪丽.黄芪注射液41例ADR分析研究[J].河北医学,2006,12(9):877.
[9]王德才,张玲,李爱珍.中药注射剂致死亡39例文献分析[J].药物流行病学杂志,2004,13(2):77.
[10]李廷谦,刘雪梅,冯敏,等.生脉注射液临床应用及不良反应的系统评价[J].中国中西医结合杂志,2009,29(11):965.
[11]李廷谦,马建昕,周宇丹.参附注射液临床应用及其不良反应调查[J].中国循证医学杂志,2009,9(3):19.
[12]任学琴,刘玉梅.影响中药注射液澄明度的几个因素[J].山西临床医药,2001,10(7):559.