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医院集中监测嵌套巢式病例对照设计的30026例参芪扶正注射液上市后临床安全性研究 被引量:9

Clinical safety studies based on 30 026 post-marketing cases of Shenqi Fuzheng injection by intensive hospital monitoring nested NCCS
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摘要 该文采取大样本、多中心、前瞻性、注册登记式医院集中监测嵌套前瞻性巢式病例对照设计方法,从参芪扶正注射液上市后临床应用真实世界着眼,监测使用参芪扶正注射液患者30 026例,共发生药品不良反应(adverse drug reaction,ADR)51例,包括1例严重不良反应,计算ADR发生率为0.17%;采集发生过敏反应的患者及其匹配患者的血液样本,对过敏反应相关生物指标进行统一检测与分析,以探讨过敏反应发生机制,从而促进临床安全合理用药。 This study adopted a large sample, multicenter, registered hospital centralized monitoring nested prospective case-control study design. From the real world clinical application of Shenqi Fuzheng injection, monitored 30 026 cases of patients with the use of Shenqi Fuzheng injection. A total of 51 adverse drug reaction(ADR) cases was monitored, including 1 case of severe adverse reactions. ADR incidence rate was 1.7 per 1 000. Blood samples were collected from patients with allergic reactions and their matched controls. Related biological indicators of allergic reactions were unified detected and analysed in order to explore the mechanism of allergic reaction and promote the clinical safety.
出处 《中国中药杂志》 CAS CSCD 北大核心 2015年第24期4739-4745,共7页 China Journal of Chinese Materia Medica
基金 国家自然科学基金面上项目(81473798) 中央级公益性科研院所基本业务费项目(Z0406 PY1303) 国家"重大新药创制"科技重大专项(2015ZX09501004-001-002)
关键词 参芪扶正注射液 医院集中监测 巢式病例对照设计 ADR发生率 过敏反应机制 Shenqi Fuzheng injection hospital centralized monitoring NCCS ADR incidence rate allergic reaction
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