Chinese Journal of Pharmacovigilance ›› 2013, Vol. 10 ›› Issue (2): 111-113.

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Analysis of Shenmai Injection Application and Adverse Reaction at Our Hospital

ZHU Ling-qi1,2, ZHOU Xin2 ,Du Lei3 ,Wang Hong-min3, Jin Hui-lin3, XU Li-wen2   

  1. 1.School of Pharmacy, Fudan University, Shanghai 201203, China;
    2.Department of Pharmacy, Longhua Hospital Affiliated to Shanghai University of Traditional Chinese Medicine, Shanghai 200032, China;
    3.Shanghai Center for ADR Monitoring, Shanghai 200233, China
  • Received:2012-05-02 Revised:2016-03-09 Online:2013-02-08 Published:2016-03-09

Abstract: Objective To analyze the clinical application and adverse reaction of Shenmai injection at our hospital, and provide reference for medical staff and regulators. Methods By the method of hospital intensive monitoring, we reviewed the medical records of all patients who ever used Shenmai injection from January to October 2011 at our hospital, and statistically analyzed the ADR of Shenmai injection. Results We collected 468 cases, 85.5% patients are over 50 years old. In most cases, indications, dosage and duration of treatment of Shenmai injection are consistent with the drug instruction. The incidence of ADR is 1.7%, belonging toa common category.The symptoms of adverse reactions are relatively light and transient, such as dizziness, fatigue, chest pain and discomfort. Conclusion Hospital intensive monitoring method isa good supplement of spontaneous reporting system, which can get a referential incidence rate of ADR, but multicenter studies are needed to make the data more representative.

Key words: Shenmai injection, adverse reaction, hospital intensive monitoring

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