中国执业药师Issue(1)：10-15,6.DOI:10.3969/j.issn.1672-5433.2014.01.002
参芪扶正注射液上市后安全性再评价
Post-marketing Safety Reassessment of Shenqifuzheng Injection
喻锦扬 1邓剑雄 1马光瑜 2袁志明 1朱飞跃 3蓝韵华3
作者信息
- 1. 广东省药品不良反应监测中心，广东 广州 510080
- 2. 广东省食品药品监督管理局
- 3. 广东省药理学会
- 折叠
摘要
Abstract
Objective:To assess the clinical use and occurrence of adverse reactions of shenqifuzheng injection . Methods: The epidemiology survey was conducted using nested case-control study and the questionnaires methods for the clinical use and the ADR incidence of shenqifuzheng injection . The descriptive statistic analysis and the Poisson distribution methods were used to estimate the ADR incidence of shenqifuzheng injection with 95% confidence inter-val . Results: The incidence of ADR/ADE of shenqifuzheng injection was 1 . 84‰, 95% confidence interval ( 1 . 30‰, 2 . 54‰) . The ADRs/ADEs were mild to moderate . Conclusion:The ADR/ADE rate of shenqifuzheng injection be-longs to uncommon .关键词
参芪扶正注射液/不良反应/不良事件/上市后/安全性再评价Key words
Shenqifuzheng Injection/ADR/ADE/Post-marketing/Safety Reassessment引用本文复制引用
喻锦扬,邓剑雄,马光瑜,袁志明,朱飞跃,蓝韵华..参芪扶正注射液上市后安全性再评价[J].中国执业药师,2014,(1):10-15,6.
