Postmarketing Safety Surveillance and Reevaluation of Danhong Injection: Clinical Study of 30888 Cases.
Traditional Chinese medicine injections (TCMIs) have played an irreplaceable role for treating some clinical emergency, severe illness, and infectious diseases in China. In recent years, the incidence rates of adverse drug reactions (ADRs) of TCMIs have increased year by year. Danhong injection (DHI) is one representative TCMI comprised of Danshen and Honghua for treating cardiovascular and cerebrovascular diseases in clinic. In present study, the postmarketing safety surveillance and reevaluation of DHI were reported. Total 30888 patients in 37 hospitals from 6 provinces participated in the study. The results showed that the ADR incidence rate of DHI was 3.50‰. Seventeen kinds of new adverse reactions of DHI were found. The main type of ADRs of DHI was type A (including sweating, dizziness, headache, flushing, vasodilation, eye hemorrhage, faintness, chest pain, palpitations, breathlessness, anxious, nausea, flatulence, vomiting, hypotension, hypertension, local numbness, dyspnea, joint disease, and tinnitus) accounting for 57.75%. The severities of most ADRs of DHI were mild and moderate reactions accounting for 25.93% and 66.67%, respectively. The main disposition of ADRs of DHI was drug withdrawal and without any treatments. The results can provide basis for amendment and improvement of the instructions of DHI, as well as demonstration and reference for the postmarketing safety surveillance and reevaluation of other TCMIs. And the rationality, scientificity, and safety of clinical applications of TCMIs could be improved.
The First Affiliated Hospital of Henan University of Traditional Chinese Medicine, Zhengzhou 450000, China.
Xue-Lin
XL
Li
The First Affiliated Hospital of Henan University of Traditional Chinese Medicine, Zhengzhou 450000, China.
Jin-Fa
JF
Tang
The First Affiliated Hospital of Henan University of Traditional Chinese Medicine, Zhengzhou 450000, China.
Wei-Xia
WX
Li
The First Affiliated Hospital of Henan University of Traditional Chinese Medicine, Zhengzhou 450000, China.
Chun-Xiao
CX
Li
Shandong Buchang Pharmaceutical Co., Ltd., Heze 274000, China.
Tao
T
Zhao
Shandong Buchang Pharmaceutical Co., Ltd., Heze 274000, China.
Bu-Chang
BC
Zhao
Shandong Buchang Pharmaceutical Co., Ltd., Heze 274000, China.
Yong
Y
Wang
The First Affiliated Hospital of Henan University of Traditional Chinese Medicine, Zhengzhou 450000, China.
Hui
H
Zhang
The First Affiliated Hospital of Henan University of Traditional Chinese Medicine, Zhengzhou 450000, China.
Xiao-Fei
XF
Chen
The First Affiliated Hospital of Henan University of Traditional Chinese Medicine, Zhengzhou 450000, China.
Tao
T
Xu
The First Affiliated Hospital of Henan University of Traditional Chinese Medicine, Zhengzhou 450000, China.
Ming-Jun
MJ
Zhu