中国药物警戒 ›› 2011, Vol. 8 ›› Issue (9): 566-569.

• 药品不良反应监测 • 上一篇    下一篇

1768例中药制剂不良反应报告分析

姚苑梅1, 徐玉红1, *, 吴斌2, 王玉荣1, 杨蕾萍1, 钟芬1   

  1. 1 深圳市福田人民医院,广东 深圳 518033;
    2 深圳市药品不良反应监测中心,广东 深圳 518034
  • 收稿日期:2010-12-01 出版日期:2011-09-10 发布日期:2015-07-30
  • 通讯作者: 徐玉红,主任药师,医院药学、药事管理。E-mail:szftyyyf@126.com
  • 作者简介:姚苑梅,女,主管药师,药品不良反应监测。

A Retrospective Analysis of 1768 Adverse Drug Reaction Cases Induced by Traditional Chinese Medicine Preparations

YAO Yuan-mei1, XU Yu-hong1, *, WU Bin2, WANG Yu-rong1, YANG Lei-ping1, ZHONG Fen1   

  1. 1 Futian People's Hospital of Shenzhen, Guangdong Shenzhen 518033, China;
    2 Shenzhen Center for ADR Monitoring, Guangdong Shenzhen 518034, China
  • Received:2010-12-01 Online:2011-09-10 Published:2015-07-30

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摘要： 目的 了解本地区中药制剂不良反应/事件总体发生情况、特点及规律,加深对中药不良反应的认识,促进中药合理应用。方法 采用回顾性研究方法。从广东省药品不良反应监测中心数据库下载2008~2009年深圳市各单位上报的不良反应/事件报告表,筛选出中药制剂不良反应/事件报告表进行分类统计、分析。结果 共筛选出中药制剂不良反应/事件报告1 768例,涉及368个生产厂家的468个中药制剂品种。61个中药注射剂品种导致ADR 854例次,占总例数的48.30％。注射剂是导致中药不良反应/事件的主要剂型且绝大多数采用静脉滴注给药方式;其次是357种不同剂型的口服制剂,占45.59%。累及的器官/系统主要为皮肤及其附件,其次为消化系统、全身性损害、神经系统等。新的不良反应/事件1 144例次,占64.71％,绝大多数转归良好。结论 中药制剂不良反应/事件具有普遍性;应加强对中药制剂,特别是注射制剂不良反应/事件的监测,临床应减少或避免中药注射剂的的使用,特别是在儿童人群中的使用;有关部门应加强对中药制剂说明书的审核、监管,保障患者用药安全。

关键词: 中药制剂, 药品不良反应, 分析

Abstract: Objective To find out the essential features of adverse drug reactions/events(ADR/ADE) induced by traditional Chinese medicine preparations, deepen our recognition of Chinese medicine's ADR/ADE and boost the rational use of Chinese medicine preparations. Methods Retrospective analysis was used. All reported ADR/ADE cases from all organizations from 2008 to 2009 in Shenzhen were downloaded from Guangdong Center for ADR Monitoring in the form of Excel electronic forms. ADR/ADE reports of traditional Chinese medicine preparations were screened and analyzed. Results 1 768 ADR/ADE cases of traditional Chinese medicine preparations were screened out and involved 468 traditional Chinese medicine products from 368 manufacturers. The injection was the primary dosage form that caused ADR/ADE. Total 61 injection products led to 854(48.30%) ADR/ADE reports and the intravenous route of administration were used in the absolutely most of cases. All kinds of oral dosage forms led to 45.59% of ADR/ADE cases. The lesions of ADR/ADE involved primarily in skin and its accessories, followed by the gastrointestinal system, systemic lesions, the nerve system, etc. The new ADR/ADE cases reached 1 144 (64.71%). Most of ADR/ADE cases had good prognosis. Conclusion The occurrence of ADR/ADE induced by traditional Chinese medicine preparations is universal and monitoring of ADR/ADE induced by traditional Chinese medicine preparations, especially injection, should be enhanced. The use of traditional Chinese medicine injections should be decreased or avoided as possible, especially in children population. The drug administration authorities should pay more attention to the instruction of traditional Chinese medicines.

Key words: Chinese Medicine preparations, adverse drug reactions/events(ADR/ADE), analysis

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