丹参酮Ⅱ_A磺酸钠注射液致变态反应的自动监测研究

Automatic Surveillance of Allergic Reaction Induced by Sodium Tanshinone Ⅱ_A Sulfonate Injection

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 rate and the related factors of allergic reaction induced by Sodium Tanshinone ⅡA Sulfonate Injection with active surveillance and assessment system of adverse drug events. Methods： The data of hospitalized patients in our hospital were extracted and analyzed retrospectively from January in 2014 to December in 2016. Event configuration parameters for ＂allergic reaction＂ and ＂anaphylactic shock＂ were set, and positive warning rate, incidence rate of adverse drug reactions were analyzed. This study adopted nested case-control study design to analyze relat- ed factors of skin allergic reaction induced by Sodium Tanshinone ⅡA Sulfonate Injection. Results ： A total of 11 969 cases using Sodium Tanshinone ⅡA Sulfonate Injection were automatically surveilled, and the runtime of this system was about 2 hours. After re-evaluation by clinical pharmacists, the incidence rate of skin allergic reaction, anaphylactoid reaction and anaphylactic shock was respectively 0.15% ,0.01% and 0%. There were no significant differences in age, sex, allergies solvent and BMI associated with skin allergic reaction induced by Sodium Tanshinone ⅡA Sulfonate Injection. Conclusion： The automatic surveillance of allergic reaction induced by induced by Sodium Tanshinone ⅡA Sulfonate Injection could be realized by this system with high speed and efficiency. It also could be used for predicting the related factors of adverse drug reaction of Sodium Tanshinone ⅡA Sulfonate Injection. So it was a good tool of post-market safety research for traditional Chinese medicine injection.