| ABSTRACT Objective:To investigate the characteristics of adverse reactions (ADR) induced by Niuhuangjiedu preparation, so as to provide a reference for rational use of drugs. 〖WTHZ〗Methods:〖WTBZ〗A total of 646 ADR cases of Niuhuangjiedu preparation in Jiangsu Province during 2004 2017 were collected and analyzed on age, gender, disease, method of medication and dosage, drug combination, times of ADR, clinical manifestations etc. 〖WTHZ〗Results:〖WTBZ〗The results of the relavence evaluation in the ADR reports were 122 cases confirmed, 157 cases probable, 367 cases possible respectively. There were 417 new ADR and 7 severe ADR. The male cases were slightly more than the females. The primary diseases were respiratory and digestive disease. Niuhuangjiedu preparation were oral administration, the dosage basically conforms to the specification. The most commonly used combination drugs were anti infective drugs. System organ classes (SOCs) mainly involved in adverse reactions were gastrointestinal disorders, which accounted for 60.42%, lesions of skin and its appendages followed. 〖WTHZ〗Conclusion:〖WTBZ〗The adverse reactions caused by Niuhuangjiedu preparation should be paid attention, and the package inserts should be improved to ensure the safe usage. |
