| 郭鑫,裴贵珍,鲁宁杰,等.基于真实世界丹参川芎嗪注射液不良反应信号挖掘[J].安徽医药,2020,24(2):421-424. |
| 基于真实世界丹参川芎嗪注射液不良反应信号挖掘 |
| Signal mining of ADR signals for salviae miltiorrhiza and ligustrazine hydrochloride injection in the real world |
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| DOI：10.3969/j.issn.1009?6469.2020.02.053 |
| 中文关键词: 丹参 川芎嗪 副作用 药物副反应报告系统 心血管系统 信号挖掘 报告比值法 |
| 英文关键词: Salviae miltiorrhiza Tetramethylpyrazine Adverse effects Adverse drug reaction reporting systems Cardiovas?cular system Signal mining Reporting odds ratio |
| 基金项目:新疆生产建设兵团科技计划项目(2015AB034) |
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| 中文摘要: |
| 目的通过对丹参川芎嗪注射液不良反应的信号挖掘分析，为临床安全合理用药提供参考。方法采用报告比值法(ROR)对新疆地区丹参川芎嗪注射液 2013—2017年的药品不良反应(ADR)报告进行数据挖掘，并采用 logistic回归对信号在性别、年龄、用药时间等进行分析。结果共检测到 18个不良反应信号，其中 17个未被说明书收录。 ROR值较大的不良反应信号为瘙痒、寒战、心悸、胸闷、静脉炎。经 logistic回归分析得到年龄是全身性损害(OR＝2.174)的危险因素；性别是发生神经系统损害( OR＝16.187)和心血管系统损害(OR＝10.130)的危险因素；用药时间是胃肠道损害(OR＝2.228)的危险因素。结论对丹参川芎嗪注射液 ADR信号的挖掘，可为临床合理安全用药提供参考。 |
| 英文摘要: |
| Objective This study provides a reference for rational and safe clinical medication through the signal mining analysison the adverse reactions of Salviae Miltiorrhiza and Ligustrazine Hydrochloride Injection.Methods We used the reporting odds ra? tio(ROR) and logistic regression analysis to analysize the data of Salviae Miltiorrhiza and Ligustrazine Hydrochloride Injectionfrom 2013 to 2017 in xinjiang adverse event reporting system，and the distribution of signals among patients with different sexes，ag? es，and time was analyzed.Results A total of 18 ADR signals were detected，among which 17 were not include in the package in? sert.Among these signals，pruritus，chills，palpitation，tightness and phlebitis had the higher ROR value.According to the logistic re? gression analysis，age was the risk factor of systemic damage(OR＝2.174)； sex was the risk factor of cardiovascular system damage(OR＝16.187)and centra1 nervous system damage(OR＝10.130)； Medication time was the risk factor of Gastrointestinal damage(OR＝2.228).Conclusion Mining the signals of the adverse drug reactions of Salviae Miltiorrhiza and Ligustrazine HydrochlorideInjection can provide reference for domestic clinical rational safe drug use. |
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