[Post-marketing study on clinical safety of ginkgo diterpene lactone meglumine injection in 6 300 patients with ischemic stroke].

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.

• Authors: Li Zhou, Ying Gao, Xin-Xing Lai, Tian-Shu Xu, Ming Yu, Yan Wang, Jian-Jun Zhao, Zi-Hu Tan
• Journal: Zhongguo Zhong yao za zhi = Zhongguo zhongyao zazhi = China journal of Chinese materia medica (Zhongguo Zhong Yao Za Zhi) Vol. 42 Issue 24 Pg. 4744-4749 (Dec 2017) ISSN: 1001-5302 [Print] China
• PMID: 29493141 (Publication Type: Journal Article)
• Copyright: Copyright© by the Chinese Pharmaceutical Association.

Chemical References

• Diterpenes
• Drugs, Chinese Herbal
• Lactones
• Meglumine

Topics

• Brain Ischemia (drug therapy)
• Diterpenes (adverse effects, pharmacology)
• Drugs, Chinese Herbal (adverse effects, pharmacology)
• Ginkgo biloba (adverse effects, chemistry)
• Humans
• Lactones (adverse effects, pharmacology)
• Meglumine
• Product Surveillance, Postmarketing
• Prospective Studies
• Stroke (drug therapy)