Chinese Journal of Pharmacovigilance ›› 2014, Vol. 11 ›› Issue (11): 675-678.

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Literature Review of 582 Adverse Reaction Cases Induced by Potassium Sodium Dehydroandrographolide Succinate Injection

DING Wei1, CHENG Gang2, DONG Duo2, Han WEN-min3, WU Gui-zhi2   

  1. 1 Changzhou Wujin District Center for ADR Monitoring, Jiangsu Changzhou 213000, China;
    2 Center for Drug Reevaluation, CFDA, Beijing 100045, China;
    3 Changzhou NO.2 People's Hospital, Jiangsu Changzhou 213000, China
  • Received:2014-08-14 Revised:2018-07-18 Online:2014-11-08 Published:2016-03-02

Abstract: Objective Through investigating the characteristics and mechanism of adverse reactions induced by potassium sodium dehydroandrographolide succinate injection to find its risk factors and provide technical support for safe and rational use of drugs in clinic. Methods Using "potassium sodium dehydroandrographolide succinate" and "adverse reaction" as key words to retrieve the CNKI database. Fifty-three articles which met the inclusion and exclusion criteria were extracted and analyzed. Results Pediatric patients appear to have higher ADR occurrence rate by using succinate injection. Systems and organs mainly involved in adverse reactions are skin and its appendages, systemic damage, respiratory damage, and etc. Rash, fever, and allergic reaction are the most common reported adverse reactions. Anaphylactic shock which is life threatening is also reported in several cases. Conclusion It is important to pay attention to the adverse reactions caused by potassium sodium dehydroandrographolidesuccinate injection, specially to strengthen pediatric postmarketing surveillance, in order to prevent adverse drug reactions and ensure the safe drug use in clinic.

Key words: potassium sodium dehydroandrographolide succinate injection, adverse drug reactions, literature review

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