基于自发呈报系统预警分析大株红景天注射液不良反应/事件报告
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摘要
目的:通过对大株红景天注射液不良反应/事件的分析,得出药物不良反应/事件(ADR/ADE)发生的一般规律及临床特点。方法:采用描述性统计方法,对国家药品不良反应监测中心2009-2016年自发呈报系统(SRS)中1 029例大株红景天ADR/ADE进行预警分析。结果:大株红景天注射液病例报告以45岁中老年人为主要人群,不良反应/事件主要表现为皮疹、瘙痒、寒战、头晕等,以全身性损害、皮肤及附件损害为主;过敏反应患者病例报告主要ADR/ADE表现为过敏性紫癜、过敏性休克以及过敏样反应,主要涉及全身性损害。结论:大株红景天注射液引发的ADR/ADE在说明书中尚不明确,应采取进一步主动监测研究,完善相关ADR信息,重视中药注射剂临床用药安全问题。
Objective: To conclude the general rules and clinical features through the analysis of adverse drug reactions or events(ADR/ADE) in Sofren Injection. Methods: Descriptive statistical methods were used to analyze the 1 029 Sofren Injection's ADR cases, which were ranged from 2009 to 2016 of spontaneous reporting system from the National Center for Adverse Drug Reaction Monitoring. Results: In these Sofren Injection case reports, elderly people over 45 years-old were the main crowd. And main symptoms of ADR were rash, itching, chills, dizziness etc., which involved in systemic damage, damage to the skin and accessories. Allergic reaction included allergic purpura, anaphylaxis, anaphylactoid reaction, which mainly involved in systemic damage. Conclusion: ADR/ADE triggered by Sofren Injection is not clear in its instruction, and we should take more active monitoring to complete the relevant information about ADRs, and pay more attention to the safety of clinical traditional Chinese medicine injections.
Objective: To conclude the general rules and clinical features through the analysis of adverse drug reactions or events(ADR/ADE) in Sofren Injection. Methods: Descriptive statistical methods were used to analyze the 1 029 Sofren Injection's ADR cases, which were ranged from 2009 to 2016 of spontaneous reporting system from the National Center for Adverse Drug Reaction Monitoring. Results: In these Sofren Injection case reports, elderly people over 45 years-old were the main crowd. And main symptoms of ADR were rash, itching, chills, dizziness etc., which involved in systemic damage, damage to the skin and accessories. Allergic reaction included allergic purpura, anaphylaxis, anaphylactoid reaction, which mainly involved in systemic damage. Conclusion: ADR/ADE triggered by Sofren Injection is not clear in its instruction, and we should take more active monitoring to complete the relevant information about ADRs, and pay more attention to the safety of clinical traditional Chinese medicine injections.
引文
[1]李幼平.循证医学.北京:人民卫生出版社,2014:84
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[12]张晓霞.中药注射剂的不良反应研究进展.中医临床研究,2017,9(9):141-142
[13]孙丽,吴雪茹,黄凤婷,等.活血化瘀类中药注射剂用于骨伤科疾病的合理性探讨.中华中医药杂志,2017,32(6):2494-2496
[14]黎元元,向永洋,谢雁鸣,等.基于自发呈报系统1390例灯盏细辛注射液不良反应报告预警分析.中国中药杂志,2013,38(18):2998-3002
[15]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.世界中医药,2014,9(9):1132-1136
[2]张冰.中药药物警戒.北京:人民卫生出版社,2015:11
[3]刘孟华,李沛波,苏薇薇.红景天化学成分及其药理作用研究进展.中南药学,2006,4(6):463-465
[4]王彦斌,邱服斌,任素芳,等.大株红景天注射液对冠心病患者学业流变学的影响.中西医结合心脑血管杂志,2012,10(3):360-361
[5]王雪晶,谢雪,罗鑫,等.大株红景天化学成分研究(Ⅰ).2015,46(23):3471-3474
[6]王爱玲,曲玮,梁敬钰.红景天属植物化学成分及药理作用研究进展.海峡药学,2014,26(1):1-8
[7]滕静如,熊佳鹏,肖诚,等.红景天的现代药理学研究进展.中国中医基础医学杂志,2006,12(4):319-320
[8]阙翼,谢雁鸣,廖星,等.大株红景天注射液的安全性系统评价.中国中药杂志,2016,41(20):3866-3874
[9]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.中国中药杂志,2012,37(18):2748-2751
[10]毕凤兰,张力.中药注射剂安全性问题探讨.中国药物警戒,2012,9(2):89-92
[11]任德权,张伯礼.中药注射剂临床应用指南.北京:人民卫生出版社,2011:16
[12]张晓霞.中药注射剂的不良反应研究进展.中医临床研究,2017,9(9):141-142
[13]孙丽,吴雪茹,黄凤婷,等.活血化瘀类中药注射剂用于骨伤科疾病的合理性探讨.中华中医药杂志,2017,32(6):2494-2496
[14]黎元元,向永洋,谢雁鸣,等.基于自发呈报系统1390例灯盏细辛注射液不良反应报告预警分析.中国中药杂志,2013,38(18):2998-3002
[15]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.世界中医药,2014,9(9):1132-1136