Chinese Journal of Pharmacovigilance ›› 2011, Vol. 8 ›› Issue (8): 501-503.

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Analysis of 47 ADR Cases of Severe Hypotension Induced by Protamine

JIANG La-mei1, ZHAO-Yan2   

  1. 1 Jinan Adverse Drug Reaction Monitoring Center of Medical Device Adverse Events, Shandong Jinan 250001, China;
    2 Center for Drug Reevaluation, SFDA, Beijing 100045, China
  • Received:2011-05-08 Online:2011-08-10 Published:2015-07-30

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Abstract: Objective To analyze the adverse reaction of severe hypotension and rise of tracheal pressure due to Protamine combined with heparin in heart surgery and clinical emergency treatment. Methods To analyze retrospectively 47 severe ADR cases of Protamine from 2009 to 2010 in Jinan. 38 patients were caused moderate or severe hypertension(blood pressure decreased by 30~≥50mmHg) after Protamine injection, 9 patients were caused slight hypertension(blood pressure decreased by 20~29mmHg). Results After emergency treatment and blood transfusion, 40 cases returned to normal blood pressure in 5min, 85.11% in 47 patients. While 7 patients had been improved in 10~30min through extracorporeal circulation rebuilt and manually controlled respiration besides of the medicine treatment. Conclusion Protamine may cause severe hypotension. In surgery, the preventive measures and active treatment is the key to lower the occurring rate of severe ADR.

Key words: Protamine, combined with heparin, severe hypotension, treatment

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