银杏二萜内酯葡胺注射液用于6300例缺血性脑卒中患者的上市后临床安全性再评价研究

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

进一步评价银杏二萜内酯葡胺注射液上市后扩大用药人群范围对缺血性脑卒中患者的临床安全性。采用多中心、前瞻性、开放、非对照的临床研究设计方法,于2013年6月—2014年12月,在82家临床单位开展银杏二萜内酯葡胺注射液上市后临床安全性再评价研究。完成病例入组6 300例,试验中,共观察记录到29例次不良反应,ADR发生率为0.46%,其中约86.21%(25例次)的ADR为轻度,表现为一过性,无需干预即可缓解或消失;13.79%(4例次)为中度,头痛2例次,头晕1例次,皮疹1例次;未见重度不良反应。银杏二萜内酯葡胺注射液安全性研究中发生的不良反应均为前期已知不良反应或注射剂常见不良反应,整体不良反应发生率较低且风险可控。

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.