抗生素药品不良反应发生率与杂质总量的数据挖掘与关联分析

Data mining and association analysis of total related substance and adverse reaction rate of antibiotics

目的:通过挖掘抗生素药品不良反应发生率与杂质总量的相关数据,分析其内在的关系,为有效防控药品安全性风险提供科学依据。方法:选择注射用哌拉西林钠舒巴坦钠和注射用头孢曲松钠2个常用抗生素品种为研究对象,结合北京市近5年的药品抽验、药品不良反应监测数据,从杂质总量入手,比较不同生产企业样品之间的差异程度、选用生产企业的出厂检验数据进行验证,分析杂质总量与药品不良反应发生率的内在关系。结果:药品不良反应发生率偏高的生产企业样品中杂质总量的数据偏高且离散程度较大,不同年度样品杂质总量的变化趋势与其产品的不良反应发生率变化趋势存在相近现象。结论:通过数据挖掘和分析表明,抗生素药品不良反应发生率与其杂质总量存在内在关系,药品生产企业、药品监管部门应充分研究并利用其内在关系,进一步加强药品生产质量控制,强化药品安全监管,不断提升药品安全性风险的管理水平。

Objective： To provide scientific basis for effective preventing and controlling drug safety risk by analyzing the potential relationship between adverse reaction rate and total related substance based on mining related data. Methods： Two common antibiotics,piperacillin sodium / sulbactam sodium for injection and ceftriaxone sodium for injection were selected to analyze the potential relationship between adverse reaction rate and total related substance. The data included results of drug sampling and reports of adverse reaction in Beijing during five years.The potential relationship between adverse reaction rate and total related substance was analyzed by comparing the differences between samples with different manufacturers,and the results were verified by inspection data of manufacturers. Results： Compared with all the results of total related substance from different manufacturers,the difference was statistically significant. If the adverse reaction rate of product is higher,the average level of total related substance in it was also higher as well as the dispersion degree. There was similar changing trend between adverse reaction rate and total related substance of the two products during nearly five years. Conclusion： Based on the results,it was suggested that there was inherent relationship between adverse reaction rate and total related substance. Drug manufacturers and regulatory authorities should take full advantage of their inherent relationship to further strengthen drug quality control and safety supervision,and constantly enhance the management level of drug safety risk.