摘要
目的：挖掘和评价西格列汀上市后的安全警戒信号,为临床用药提供参考。方法：采用报告比值比法（ROR）对美国食品药品监督管理局（FDA）的不良事件报告系统（AERS）进行西格列汀的安全信号挖掘,利用SPSS 16.0分析年龄、性别、用药时间、剂量对安全信号的影响。结果：纳入2009-2011年AERS的数据共挖掘出西格列汀165个可疑的不良反应信号,其中消化系统不良反应信号51个。通过统计学分析发现消化系统不良反应相对其他不良反应在性别（P=0.134）、年龄（P=0.395）、用药剂量（P=0.641）中的分布差异均无统计学意义,在用药时间（P=0.000）差异有统计学意义。消化系统ADR中,性别构成无差异;45-65岁组和65岁以上组的患者明显多于25岁以下组和25-45岁组;ADR较多发生在用药半年内;剂量集中在50-100 mg·d-1。结论：通过对西格列汀安全信号的挖掘和评价为进一步的研究奠定基础。
OBJECTIVE To mine and evaluate the safe warning signals induced by sitagliptin in post-marketing experience and to provide references for clinic.METHODS ROR was used to mine the signals from the AERS submitted to the FDA and SPSS 16.0was used to analyze the effect of age,gender,medication duration,dosage on the signals.RESULTS The data of AERS from2009 to 2011 was mined to find 165 warning signals,the digestive system warning signals were 51.The digestive system adverse reactions compared with other adverse drug reactions,there was no difference in gender（P=0.134）,age（P =0.395）,dosage（P=0.641）;there was significant difference in medication duration（P=0.000）.In ADR of digestive system,there was no difference in gender proportion;the patients in age group of 45-65 and the age more than 65 occurred more ADR of digestive system than the age group of below25 and at 25-45;there was higher incidence occurred within six months of medication,and the dosage concentrated at 50 to 100 mg·d-1.CONCLUSION Mining and evaluating the safe warning signals provide the foundation for further research.
出处
《中国医院药学杂志》
CAS
CSCD
北大核心
2014年第1期33-36,共4页
Chinese Journal of Hospital Pharmacy
关键词
西格列汀
信号
数据挖掘
药物警戒
sitagliptin
signal
data mining
pharmacovigilance
