培美曲塞上市后安全信号的检测和分析

发布时间：2018-03-07 08:47

本文选题：培美曲塞　切入点：不良反应　出处：《中国医院药学杂志》2015年19期 　论文类型：期刊论文

【摘要】：目的:检测培美曲塞上市后的安全信号,对其上市后安全性作初步评价,为临床合理用药提供参考。方法:采用报告比值比法(ROR)对美国食品药品监督管理局(FDA)不良事件报告系统(AERS)数据库进行培美曲塞安全信号检测,并利用SPSS 19.0分析年龄、性别、用药时长、剂量及适应证对不良反应的影响。结果:在进行分析的5 397 235份报告中,查找到以培美曲塞为首要怀疑药物的不良反应报告4 219份,经ROR法检测,共得到173个培美曲塞安全信号,其中心血管系统信号21个。统计学分析发现,相比于其他系统ADR,心血管系统ADR在用药时长(P=0.445)中分布无统计学意义,在性别(P=0.008)、年龄(P=0.035)、用药剂量(P=0.003)、适应证(P=0.000)中分布有统计学意义,其中,男性患者、40岁以上、MPM和非鳞状NSCLC、剂量800~1 000 mg可能更易发生心血管系统ADR。结论:通过对培美曲塞安全信号的检测和分析发现,有必要对其进行进一步信号评价和验证,决定临床应用中是否采取相应风险防范措施。
[Abstract]:Objective: to detect the safety signals of pemetrexed after listing and to evaluate its safety after listing. Methods: to detect the safety signals of pemetrexide in the adverse event reporting system of the Food and Drug Administration (FDA) and analyze the age and sex by using SPSS 19.0. Methods: the method of reporting ratio ratio was used to detect the safety signals of pemetrexide in the adverse event reporting system of the Food and Drug Administration (FDA). Results: of the 5 397,235 reports analyzed, 4 219 were reported with pemetrexide as the first suspected drug, and detected by ROR method. A total of 173 pemetrexide safety signals were obtained, of which 21 were cardiovascular system signals. Statistical analysis showed that the distribution of ADR in cardiovascular system was not statistically significant compared with that of other systems. There was statistical significance in the distribution of P0. 008, P0. 035, P0. 003, indication, P0. 000). Male patients over 40 years old with MPM and non-scaly NSCLC at a dose of 800 ~ 1 000 mg may be more likely to develop cardiovascular system ADR.Conclusion: it is necessary to evaluate and verify the safety signal of pemetrexide by detecting and analyzing the safety signal of pemetrexide. To determine whether to take appropriate risk prevention measures in clinical application.
【作者单位】：四川大学华西药学院;四川大学华西医院药剂科;
【分类号】：R95

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