由药品不良反应/事件看我院中药注射剂临床应用药物相关问题
|
摘要
目的:通过对我院中药注射剂不良反应/事件分析,探讨我院中药注射剂临床应用的药物相关问题(drug-related problems,DRPs),为中药注射剂的临床合理应用提供参考。方法:以我院2012年1月~2016年6月收集的108例中药注射剂不良反应/事件(ADR/ADE)病历为研究对象,探讨我院中药注射剂ADR/ADE发生的药物流行病学特点,同时采用国际通用的西班牙药物相关性问题研究方法(Granada-Ⅱ分类法)对中药注射剂相关性问题进行必要性、安全性、有效性研究。结果:108例ADR/ADE病历中,主要为60岁以上患者(45.27%),共涉及22个品种,血必净注射剂病例数最多(23例,占26.14%)累及的器官系统以皮肤及其附件损害为主(54.63%),涉及DRPs具体问题分类有DRP2、DRP4、DRP5、DRP6,分别为13例、9例、82例及4例。结论:临床医生与药师应重视中药注射剂临床应用的DRPs,对中药注射剂ADR/ADE进行针对性预防,促进临床安全合理用药。
Objective: To discuss the causes and characteristics of drug-related problems of traditional Chinese medicine( TCM) injections in clinical application based on adverse drug reaction / events in our hospital and provide reference for the rational drug use in clinic. Methods: Statistical analysis was conducted on 108 cases of ADR / ADE induced by TCM injections reported from January 2012 to June 2016. With the investigation methods of drug related problems of the Spanish Granada-Ⅱclassification,the clinical effectiveness,necessity,safety of TCM injections in our hospital were studied. Results: Of the 108 cases,mainly for patients over 60 years old( 45. 27%),22 varieties were involved,and the largest number were related to Xuebijing injection( 23 cases,26. 14%). Organs and( or) systems involved in ADR / ADE mainly were lesion of skin and its appendants( 54. 63%). The drug-related problems were DRP2( 13 cases),DRP4( 9cases),DRP5( 82 cases),and DRP6( 4 cases). Conclusion: Clinicians and pharmacists should pay more attention to drug-related problems of TCM injection in clinical application,and prevent the occurrence of ADR / ADE induced by TCM injections,so as to promote rational and safe use of TCM injections.
Objective: To discuss the causes and characteristics of drug-related problems of traditional Chinese medicine( TCM) injections in clinical application based on adverse drug reaction / events in our hospital and provide reference for the rational drug use in clinic. Methods: Statistical analysis was conducted on 108 cases of ADR / ADE induced by TCM injections reported from January 2012 to June 2016. With the investigation methods of drug related problems of the Spanish Granada-Ⅱclassification,the clinical effectiveness,necessity,safety of TCM injections in our hospital were studied. Results: Of the 108 cases,mainly for patients over 60 years old( 45. 27%),22 varieties were involved,and the largest number were related to Xuebijing injection( 23 cases,26. 14%). Organs and( or) systems involved in ADR / ADE mainly were lesion of skin and its appendants( 54. 63%). The drug-related problems were DRP2( 13 cases),DRP4( 9cases),DRP5( 82 cases),and DRP6( 4 cases). Conclusion: Clinicians and pharmacists should pay more attention to drug-related problems of TCM injection in clinical application,and prevent the occurrence of ADR / ADE induced by TCM injections,so as to promote rational and safe use of TCM injections.
引文
1 赵清利.探讨有关中药注射剂不良反应的原因和预防[J].中医临床研究,2015,7(32):138-140
2 Strand LM,Morley PC,Cipolle RJ,et al.Drug-related problems:their structure and function[J].DICP,1990,24(11):1093-1097
3 Costa S,Madeira A,Saantas MR,et al.Tools developed to assist portugeses community pharmacists use PCNEORP classificntion[C].Hilleroed(DK):Third Working Conference on Pharmaceuticeal Care-the next generation,2003
4 Baena MI.Problemas relacionados con los medicamentos comocausa de consulta en el servicio de urgencias del Hospital Universitario Virgen de las Nieves de Granada[D].Spain:Doctoral Dissertation of University of Granada,2003
5 Barris D,Faus MJ.Iniciación a la metodología Dáder de seguimiento farmacoterapéutico en una farmacia comunitaria[J].Ars Pharm,2003,44(3):225-237
6 郑飞跃,吴燕,饶跃峰,等.诺氏评估量表在药物不良反应评价中的作用及实例分析[J].中国药学杂志,2012,47(8):650-652
7 卫生部,国家食品药品监督管理局,国家中医药管理局.中成药临床应用指导原则[S].2010.12
8 任德权,张佰礼.中药注射剂临床应用指南[M].北京:人民卫生出版社,2011.7-10
9 张小龙,沈亚兵,王晓军.中药注射剂超说明书用药评价与药物利用研究分析[J].中国药事,2015,9(29):993-998
10 李绪翠,中药注射剂质量标准与用药安全的相关性[J.]药物流行病学杂志,2012,21(1):38-40
11 刘芳,应颖秋,赵荣生,等.北京市醒脑静注射液医疗保险用药指南的建立[J].中国药房,2010,21(28):2686-2688
12 林晓辉.中药注射剂超说明书用药调查与分析[J].海峡药学,2016,21(28):187-189
13 国家食品药品监督管理总局.国家药品不良反应监测年度报告(2014)[EB/OL].http://www.sda.gov.cn/WS01/CL0078/124407.html,2015-07-17/2016-01-09
14 朱敏.144例中药注射剂不良反应报告分析[J].中国药业,2014,23(4):64-66
15 孙维红,马泽通.血必净注射液不良反应及事件的Meta分析[J].宁夏医科大学学报,2015,37(11):1296-1299
16 王楠楠.血必净注射液21例药品不良反应[J].中国医院药学杂志,2013,33(9):751-754
17 崔冉,谢彦军,翟淑越,等.28例血必净注射液严重不良反应报告分析[J].药物流行病学杂志,2015,24(11):669-674
18 梁俐丽,王琳,高水丽,等.红花注射液不良反应文献概述[J].中国药物滥用防治杂志,2015,21(4):241-242
19 赵冉,古丽艳,王淳.1994-2014年复方丹参注射液不良反应病案文献分析[J].中医药导报,2016,22(4):63-65
20 孙立恩.清开灵注射液致不良反应104例分析[J].中国药房,2012,23(24):2276
2 Strand LM,Morley PC,Cipolle RJ,et al.Drug-related problems:their structure and function[J].DICP,1990,24(11):1093-1097
3 Costa S,Madeira A,Saantas MR,et al.Tools developed to assist portugeses community pharmacists use PCNEORP classificntion[C].Hilleroed(DK):Third Working Conference on Pharmaceuticeal Care-the next generation,2003
4 Baena MI.Problemas relacionados con los medicamentos comocausa de consulta en el servicio de urgencias del Hospital Universitario Virgen de las Nieves de Granada[D].Spain:Doctoral Dissertation of University of Granada,2003
5 Barris D,Faus MJ.Iniciación a la metodología Dáder de seguimiento farmacoterapéutico en una farmacia comunitaria[J].Ars Pharm,2003,44(3):225-237
6 郑飞跃,吴燕,饶跃峰,等.诺氏评估量表在药物不良反应评价中的作用及实例分析[J].中国药学杂志,2012,47(8):650-652
7 卫生部,国家食品药品监督管理局,国家中医药管理局.中成药临床应用指导原则[S].2010.12
8 任德权,张佰礼.中药注射剂临床应用指南[M].北京:人民卫生出版社,2011.7-10
9 张小龙,沈亚兵,王晓军.中药注射剂超说明书用药评价与药物利用研究分析[J].中国药事,2015,9(29):993-998
10 李绪翠,中药注射剂质量标准与用药安全的相关性[J.]药物流行病学杂志,2012,21(1):38-40
11 刘芳,应颖秋,赵荣生,等.北京市醒脑静注射液医疗保险用药指南的建立[J].中国药房,2010,21(28):2686-2688
12 林晓辉.中药注射剂超说明书用药调查与分析[J].海峡药学,2016,21(28):187-189
13 国家食品药品监督管理总局.国家药品不良反应监测年度报告(2014)[EB/OL].http://www.sda.gov.cn/WS01/CL0078/124407.html,2015-07-17/2016-01-09
14 朱敏.144例中药注射剂不良反应报告分析[J].中国药业,2014,23(4):64-66
15 孙维红,马泽通.血必净注射液不良反应及事件的Meta分析[J].宁夏医科大学学报,2015,37(11):1296-1299
16 王楠楠.血必净注射液21例药品不良反应[J].中国医院药学杂志,2013,33(9):751-754
17 崔冉,谢彦军,翟淑越,等.28例血必净注射液严重不良反应报告分析[J].药物流行病学杂志,2015,24(11):669-674
18 梁俐丽,王琳,高水丽,等.红花注射液不良反应文献概述[J].中国药物滥用防治杂志,2015,21(4):241-242
19 赵冉,古丽艳,王淳.1994-2014年复方丹参注射液不良反应病案文献分析[J].中医药导报,2016,22(4):63-65
20 孙立恩.清开灵注射液致不良反应104例分析[J].中国药房,2012,23(24):2276