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黑龙江地区云南白药胶囊临床安全性集中监测统计与分析
Statistical Analysis of Clinical Safety on Centralized Monitoring of Yunnan Baiyao Capsules in Heilongjiang Province
【摘要】 目的探讨云南白药胶囊不良反应发生的影响因素,促进临床合理用药。方法采用巢式病例对照研究法,以集中监测中出现严重不良反应的患者作为病例,以未发生不良反应的患者为对照,收集其临床资料及其他特征,进行对照研究。结果收集的906例服用云南白药胶囊的病例中,出现不良反应1例,发生率为0. 11%。结论云南白药胶囊在合并用药的情况下,临床大样本集中监测发现未知或罕见不良反应极少且临床症状轻微。
【Abstract】 Objective To investigate the influencing factors of adverse drug reactions caused by Yunnan Baiyao Capsules and to promote rational drug use in clinic. Methods Nested case-control study was adopted to collect clinical data and other characteristics of patients for case-control study by taking the patients with severe adverse reactions during centralized monitoring as ″cases″ and the patients without adverse reactions during centralized monitoring as ″controls″. Results Among 906 patients treated with Yunnan Baiyao Capsules,1 case had adverse reactions,the incidence rate was 0. 11%. Conclusion In the cases of Yunnan Baiyao Capsules combined with the other drugs,the centralized monitoring of large clinical samples shows that unknown or rare adverse drug reactions were very few and the clinical symptoms were mild.
【Key words】 Yunnan Baiyao Capsules; safety re-evaluation; adverse drug reactions; adverse drug events; nested case-control; rational drug use;
- 【文献出处】 中国药业 ,China Pharmaceuticals , 编辑部邮箱 ,2019年12期
- 【分类号】R285.6
- 【下载频次】54