基于大数据的中药注射剂不良反应自动监测方法研究

Research on automatic monitoring method for adverse reactions of traditional Chinese medicine injection based on big data

目的研究基于大数据的中药注射剂不良反应自动监测的方法。方法选取河北省中医院2018年至2020年药物不良反应(adverse drug reaction,ADR)报道率最高的5种中药注射剂,基于中国知网数据库中相关ADR大数据筛选报道最多ADR,选择其中可通过计算机手段进行监测的5类ADR生成ADR风险监测信号,设置监测规则,利用ADR自动监测软件对2021年我院中药注射剂进行实时ADR风险监测;以报告比数比(reporting odds ratio,ROR)法为风险信号评价方法,95%CI下限>1为有效风险信号产生条件进行风险数据挖掘。结果ADR风险信号监测结果显示:参麦注射液在恶心呕吐、肾损害和白细胞减少三个不良反应上的95%CI下限大于1。挖掘到“喜炎平注射液致恶心呕吐”、“参麦注射液致肾损害”、“参麦注射液致白细胞减少”三个有效风险信号。其中喜炎平注射液致恶心呕吐217例,参麦注射液致白细胞减少14例,参麦注射液致肾损害5例。结论中药注射剂ADR监测中应用基于大数据的ADR自动监测,可实现实时主动监测,提升工作效率,减少误报率,提升临床用药风险防范及管控能力。

Objective To study the method of automatic monitoring of adverse reactions of TCM injections based on big data.Methods The five kinds of TCM injections with the highest reporting rate of adverse drug reaction(ADR)in Hebei Hospital of Traditional Chinese Medicine from 2018 to 2020 were selected,the most reported ADRs were screened based on the big data of relevant ADRs in the CNKI database,and the 5 types of ADRs that could be monitored by computer were selected to generate ADR risk monitoring signals and set monitoring rules.The automatic ADR monitoring software was used to conduct real-time ADR risk monitoring of TCM injections in our hospital in 2021.Risk data mining was carried out with reporting odds ratio(ROR)method as risk signal evaluation method and 95%CI lower limit>1 as the generation condition of effective risk signals.Results ADR risk signal monitoring results showed that the 95%CI lower limit of Shenmai injection was greater than 1 in the three adverse reactions of nausea and vomiting,kidney damage and leukocyte reduction.Three effective risk signals were found:"Xiyanping injection induced nausea and vomiting","Shenmai injection induced kidney damage"and"Shenmai injection induced leukocyte reduction".There were 217 cases of nausea and vomiting caused by Xiyanping injection,14 cases of leukocyte decrease caused by Shenmai injection,and 5 cases of kidney damage caused by Shenmai injection.Conclusions The application of automatic monitoring of ADR based on big data in the monitoring of TCM injections can realize real-time active monitoring,improve work efficiency,reduce false positive rate,and improve the ability of clinical drug risk prevention and control.