论文部分内容阅读
目的:利用“医疗机构ADE主动监测与智能评估警示系统”分析丹参酮Ⅱ_A磺酸钠注射液致变态反应的发生率及相关影响因素。方法:借助系统回顾性调取我院2014~2016年使用丹参酮Ⅱ_A磺酸钠注射液住院患者的病历,设置“变态反应”与“过敏性休克”模块的事件配置器参数,分析系统阳性报警病例及各ADR发生率,并利用巢式病例对照研究设计,对丹参酮Ⅱ_A磺酸钠注射液致皮肤类变态反应的影响因素进行分析。结果:借助系统自动监测11 969例丹参酮Ⅱ_A磺酸钠注射液用药患者,用时约2 h;经临床药师再评估,皮肤类变态反应的发生率分别为0.15%,过敏样反应0.01%,无过敏性休克。丹参酮Ⅱ_A磺酸钠注射液致皮肤类变态反应在年龄、性别、过敏史、溶媒、BMI等方面差异无统计学意义。结论:专项软件系统可以高效快速进行丹参酮Ⅱ_A磺酸钠注射液致变态反应的自动监测,且能够初步预测其ADR相关影响因素,是中药注射剂上市后安全性再评价的好工具。
OBJECTIVE: To analyze the incidence and related factors of allergic reaction induced by tanshinone Ⅱ_A sodium sulfonate injection by using ADE Active Monitoring and Intelligent Assessment Warning System in Medical Institutions. Methods: The medical records of hospitalized patients who received tanshinone Ⅱ_A sodium sulfonate injection from 2014 to 2016 in our hospital were retrospectively retrieved. Event configurator parameters of “allergy” and “anaphylactic shock” were set up and analyzed. System positive alarm cases and the incidence of ADR, and the use of nested case-control study design, tanshinone Ⅱ_A sodium sulfonate injection of skin-induced allergic reaction factors were analyzed. Results: 11 969 patients were treated with sodium tanshinone Ⅱ_A sodium sulfonate auto-monitoring system for about 2 hours. Re-evaluation by clinical pharmacists resulted in 0.15% of allergic skin reactions and no allergic reactions, respectively Sexual shock. Tanshinone Ⅱ A sodium sulfonate injection caused by dermal allergy in age, gender, history of allergy, vehicle, BMI, etc. There was no significant difference. Conclusion: The special software system can automatically and efficiently monitor the allergic reaction induced by sodium tanshinone Ⅱ_A sodium sulfonate injection and predict the influencing factors of ADR. It is a good tool to re-evaluate the safety of traditional Chinese medicine injection after it is marketed.