Post-marketing study on clinical safety of ginkgo diterpene lactone meglumine injection in 6 300 patients with ischemic stroke.
10.19540/j.cnki.cjcmm.2017.0211
- Author:
Li ZHOU
1
;
Ying GAO
1
;
Xin-Xing LAI
1
;
Tian-Shu XU
2
;
Ming YU
3
;
Yan WANG
4
;
Jian-Jun ZHAO
5
;
Zi-Hu TAN
6
Author Information
1. Dongzhimen Hospital Affiliated to Beijing University of Chinese Medicine, Beijing 100700, China.
2. Gulou Hospital Affiliated to Nanjing University, Nanjing 210008, China.
3. Affiliated Hospital of Jiangsu University, Zhenjiang 212000, China.
4. Tianjin Hospital of ITCWM Nankai Hospital, Tianjin 300100, China.
5. Affiliated Hospital of Changchun University of Traditional Chinese Medicine, Changchun 130103, China.
6. Hubei Provincial Hospital of Traditional Chinese Medicine, Wuhan 430061, China.
- Publication Type:Journal Article
- Keywords:
adverse events/adverse reactions;
ginkgo diterpene lactone meglumine injection;
post-marketing re-evaluation;
study on clinical safety
- From:
China Journal of Chinese Materia Medica
2017;42(24):4744-4749
- CountryChina
- Language:Chinese
-
Abstract:
To further evaluate the safety of ginkgo diterpene lactone meglumine injection in the clinical use in ischemic stroke patients. Clinical safety study was conducted in 82 clinical units and 6 300 cases were completed and included from June 2013 to December 2014 by using multicenter, prospective, open and uncontrolled design methods for clinical research. A total of 29 cases of adverse reactions were observed in the experiment. Adverse reaction ratio (ADR) was 0.46%, and about 86.21% (25 cases) of them was mild with transient response which could be alleviated or disappeared without intervention; about 13.79% (4 cases) was moderate, including 2 cases of headache, 1 case of dizziness and 1 case of rash; no serious adverse reactions were found. The adverse reactions occurred in this study were pre-known adverse reactions or common adverse reactions of Chinese medicine injection. The overall incidence of adverse reactions was low, and the risk was controllable.
