中国药物警戒 ›› 2013, Vol. 10 ›› Issue (1): 46-50.

• 药械安全性研究 • 上一篇    下一篇

253例莲必治注射液不良反应/事件文献分析

杨卫彬1, 王兴文1,于江泳2,荆志伟1*,王忠1,曹俊岭3,江锋3   

  1. 1.中国中医科学院,北京100700；
    2.国家药典委员会,北京100026；
    3.北京中医药大学东直门医院,北京100700
  • 收稿日期:2012-08-06 修回日期:2016-03-12 出版日期:2013-01-08 发布日期:2016-03-09
  • 通讯作者: 荆志伟,男,医学博士,副研究员,中药临床安全性评价。E-mail:drjzw@163.com
  • 作者简介:杨卫彬,男,医学博士,主任医师,中医肾病临床及中药安全性评价。
  • 基金资助:
    国家自然科学基金资助项目（81001596）、国家科技重大专项资助项目（2012ZX10005009）

Analysis of 253 Cases of ADR/AE Induced by Lianbizhi Injection

YANG Wei-bin1, WANG Xing-wen1 ,YU Jiang-yong2, JING Zhi-wei1*, WANG Zhong1, CAO Jun-ling3 ,JIANG Feng3   

  1. 1.China Academy of Chinese Medical Science, Beijing 100700, China;
    2.Chinese Pharmacopoeia Commission, Beijing 100700, China;
    3.Dongzhimen Hospital, Beijing University of Chinese Medicine, Beijing 100700, China
  • Received:2012-08-06 Revised:2016-03-12 Online:2013-01-08 Published:2016-03-09

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摘要： 目的 探讨莲必治注射液致不良反应/ 事件（ADR/AE）发生的发生类型、特点及相关风险因素,为临床安全用药提供参考。方法检索中国期刊全文数据库、万方数据、维普医药信息资源系统等期刊数据库（1978 年1 月~2012年3 月）,以“莲必治注射液”、“不良反应”、“治疗”、“病例报道”等为检索词,检索文献全文136 篇,纳入分析的文献36 篇,进行统计学分析。结果该药不良反应可累积多个系统- 器官,以皮肤损害、过敏反应、胃肠道损害最为常见,严重者可致过敏性休克,急性肾功能衰竭；男女比例各占53.23%、41.94%,19～60 岁占比为43.48%,不良反应发生在30 分钟以内的占45.05%,1 小时内占51.37%,联合用药时占70.36%,结论莲必治注射液的不良反应以速发型为主兼具迟发型,多发于青壮年,并且联合用药时不良反应发生率较高。

关键词: 莲必治注射液, 不良反应, 不良事件

Abstract: Objective To analyse the types and risk factors of adverse reactions of Lianbizhi injection in order to provide the reference for safe use of this drug. Methods We used "Lianbizhi Injection", "adverse reaction", "treatment"," care report", ect. as the key words, downloaded the original case reports from Chinese Journal Full -text Database (1978.1~2012.3), CNKI and VIP. 36 literatures were picked up from the whole 136 Results . Results Adverse drug reactions can be accumulated and prompted several organ systems to skin damage, such as allergic reactions and gastrointestinal damage, ect. The adverse drug reaction was abrupt and usually occured within 30 minutes and it also could be delayeda few days. The severe cases can cause anaphylactic shock and acute renal failure. Conclusion Lianbizhi injection can cause varies type of adverse drug reactions, it happens mainly to the young adults and those use the combination of Lianbizhi Injection and other drugs at the same time.

Key words: Lianbizhi injection, adverse drug reaction(ADR), adverse event(AE)

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