中国药物警戒 ›› 2015, Vol. 12 ›› Issue (7): 417-419.

• 药械安全性研究 • 上一篇    下一篇

清开灵注射液上市后安全性医院集中监测5800例

张庆丽1, 王忠2, 荆志伟2, 杨卫彬2   

  1. 1. 国防大学医院,北京 100091;
    2. 中国中医科学院,北京 100700
  • 收稿日期:2015-09-01 修回日期:2015-09-01 出版日期:2015-07-08 发布日期:2015-09-02
  • 作者简介:张庆丽,女,主治医师,中药安全性评价。
  • 基金资助:
    国家自然科学基金资助项目（81473514,81001596）

Study on 5 800 Cases of Post-marketing Safety Intensive Hospital Monitoring of Qingkailing Injection

ZHANG Qing-li1, WANG Zhong2, JING Zhi-wei2, YANG Wei-bing2   

  1. 1. National Defense University Hospital,Beijing 100091, China;
    2. China Academy of Chinese Medicial Sciences, Beijing 100700, China
  • Received:2015-09-01 Revised:2015-09-01 Online:2015-07-08 Published:2015-09-02

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摘要： 目的 研究清开灵注射液不良反应的发生率、累及系统-器官的临床表现及性质,评价清开灵临床使用的安全性,为临床合理用药提供依据。方法 采取多中心、药物源性、非对照的医院集中监测。结果 清开灵注射液的不良反应发生率为0.086%,虽涉及全身多个系统,但症状均较轻微,停药后可较快好转或消失。结论 清开灵注射剂不良反应属于罕见,且与说明书基本相符,大规模的医院监测是安全性再评价的主要方法,可以实时反映临床用药的真实情况,确保安全用药。

关键词: 清开灵注射剂, 不良发应, 医院集中监测, 上市后临床安全性再评价

Abstract: Objective To study the adverse reaction incidence, clinical manifestation and nature of organ involvement of Qingkailing injection, evaluate the safety of clinical usage of Qingkailing injection, offer references for rational application in clinical practice. Methods The multi-center, drug-induced and non-controlled intensive hospital monitoring was conducted. Results The rate of Qingkailing injection adverse reaction is 0.086%.Although many systems of the patients were involved, the symptoms of Qingkailing injection adverse reactions were mild, which were improved or disappeared quickly after drug withdrawal. Conclusion The adverse reactions of Qingkailing injection are rare, and consistent with its specification. Large-scale hospital monitoring is the main method of safety re-evaluation, which can reflect the real situation of clinical application, thus ensure the safety of drug use.

Key words: Qingkailing injection, adverse reaction, intensive hospital monitoring, post-market re-evaluation of clinical safety

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