1 477例清开灵注射剂及其口服制剂不良反应对比分析
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摘要
目的促进临床合理选用清开灵制剂。方法选取江苏省药品不良反应监测中心2013年至2016年收集的1 477例清开灵制剂不良反应(ADR)报告,比较注射剂与口服制剂ADR的特点及差异。结果 1 477例ADR报告中有1 171例为注射剂,306例为口服制剂;注射剂ADR的多发人群为中老年人和儿童,口服制剂为青壮年;注射剂ADR主要表现为皮肤及其附件损害(33. 64%)、免疫系统反应(15. 03%)、呼吸系统反应(14. 90%);口服制剂ADR主要表现为消化系统损害(51. 71%);注射剂严重ADR及新的严重ADR的构成比(7. 17%,6. 53%)均高于口服制剂(1. 31%,1. 36%)。结论 ADR的发生率口服制剂明显低于注射剂,临床应科学、合理选用清开灵制剂,以确保用药安全。
Objective To promote the rational selection of Qingkailing preparations in the clinic. Methods Totally 1 477 adverse drug reaction( ADR) reports of Qingkailing preparations collected by Jiangsu Adverse Drug Reaction Monitoring Center from 2013 to 2016 were selected to compare the characteristics and differences of ADR between injections and oral preparations. Results There were1 171 injections and 306 oral preparations in 1 477 ADR reports. The ADRs of injections occurred mostly in the middle-aged,elderly and children,while the ADRs of oral preparations occurred in the young adults. Injection-induced ADRs mainly manifested skin and its appendages damage( 33. 64%),immune system( 15. 03%) and respiratory system( 14. 90%). Oral preparations-induced ADRs mainly manifested digestive system damage( 51. 71%). The composition ratios of severe ADR and severe new ADR in injections( 7. 17%,6. 53 %) were higher than those in oral preparations( 1. 31 %,1. 36 %). Conclusion The incidence of ADR in oral preparations is significantly lower than that in injections. Qingkailing preparations should be selected scientifically and reasonably in order to ensure the safety of drug use.
Objective To promote the rational selection of Qingkailing preparations in the clinic. Methods Totally 1 477 adverse drug reaction( ADR) reports of Qingkailing preparations collected by Jiangsu Adverse Drug Reaction Monitoring Center from 2013 to 2016 were selected to compare the characteristics and differences of ADR between injections and oral preparations. Results There were1 171 injections and 306 oral preparations in 1 477 ADR reports. The ADRs of injections occurred mostly in the middle-aged,elderly and children,while the ADRs of oral preparations occurred in the young adults. Injection-induced ADRs mainly manifested skin and its appendages damage( 33. 64%),immune system( 15. 03%) and respiratory system( 14. 90%). Oral preparations-induced ADRs mainly manifested digestive system damage( 51. 71%). The composition ratios of severe ADR and severe new ADR in injections( 7. 17%,6. 53 %) were higher than those in oral preparations( 1. 31 %,1. 36 %). Conclusion The incidence of ADR in oral preparations is significantly lower than that in injections. Qingkailing preparations should be selected scientifically and reasonably in order to ensure the safety of drug use.
引文
[1]吴嘉瑞,蔺梦娟,刘鑫馗.基于网络药理学的清开灵注射液作用机制研究[J].中国医院用药评价与分析,2018,8(1):23-29.
[2]李正昌.清开灵注射液致36例不良反应分析及合理应用探讨[J].内蒙古中医药,2013,32(22):83-84.
[3]王茹.清开灵注射液的合理应用[J].河南中医,2015,35(10):2552-2554.
[4]于大海,李蓓,程梅. 34例清开灵注射液不良反应分析[J].中国执业药师,2010,7(12):6-8.
[5]郝园,孔翔瑜,吴泰相. 277篇1 486例清开灵注射液不良反应/不良事件系统评价[J].中国循证医学杂志,2010,10(2):162-175.
[6]滕月,荆志伟,王连心,等.基于真实世界的12 385例使用清开灵注射液患者临床用药特征分析[J].中医杂志,2018,59(3):215-219.
[7]李曼,王忠,荆志伟.清开灵注射剂致82例不良反应/不良事件文献分析[J].中国执业药师,2013,10(3):3-7.
[8]李风雷.清开灵注射液不良反应37例报道研究与分析[J].中国民间疗法,2016,24(1):84-85.
[9]王庆文,李东,冯志泓. 287例清开灵注射液致不良反应文献分析[J].中国医院用药评价与分析,2010,10(7):652-654.
[10]薛婧,张蕊,卢旺.清开灵注射液的不良反应分析及风险管理探讨[J].中医药导报,2013,19(9):81-83.
[11]张晓霞.中药注射剂的不良反应研究进展[J].中医临床研究,2017,9(9):141-142.
[12]孟庆磊.中药注射剂不良反应及临床合理用药[J].中国处方药,2017,15(7):59-60.
[13]叶勇峰,钟佳媚.中药注射剂不良反应及合理应用分析[J].临床合理用药杂志,2017,10(27):119-120.
[14]朱峰,吕晓川,高峰,等.中成药不良反应的诱发原因及热点问题分析[J].中国临床保健杂志,2018(1):127-130.
[2]李正昌.清开灵注射液致36例不良反应分析及合理应用探讨[J].内蒙古中医药,2013,32(22):83-84.
[3]王茹.清开灵注射液的合理应用[J].河南中医,2015,35(10):2552-2554.
[4]于大海,李蓓,程梅. 34例清开灵注射液不良反应分析[J].中国执业药师,2010,7(12):6-8.
[5]郝园,孔翔瑜,吴泰相. 277篇1 486例清开灵注射液不良反应/不良事件系统评价[J].中国循证医学杂志,2010,10(2):162-175.
[6]滕月,荆志伟,王连心,等.基于真实世界的12 385例使用清开灵注射液患者临床用药特征分析[J].中医杂志,2018,59(3):215-219.
[7]李曼,王忠,荆志伟.清开灵注射剂致82例不良反应/不良事件文献分析[J].中国执业药师,2013,10(3):3-7.
[8]李风雷.清开灵注射液不良反应37例报道研究与分析[J].中国民间疗法,2016,24(1):84-85.
[9]王庆文,李东,冯志泓. 287例清开灵注射液致不良反应文献分析[J].中国医院用药评价与分析,2010,10(7):652-654.
[10]薛婧,张蕊,卢旺.清开灵注射液的不良反应分析及风险管理探讨[J].中医药导报,2013,19(9):81-83.
[11]张晓霞.中药注射剂的不良反应研究进展[J].中医临床研究,2017,9(9):141-142.
[12]孟庆磊.中药注射剂不良反应及临床合理用药[J].中国处方药,2017,15(7):59-60.
[13]叶勇峰,钟佳媚.中药注射剂不良反应及合理应用分析[J].临床合理用药杂志,2017,10(27):119-120.
[14]朱峰,吕晓川,高峰,等.中成药不良反应的诱发原因及热点问题分析[J].中国临床保健杂志,2018(1):127-130.