摘要
目的:挖掘与评价西格列汀皮肤不良反应的信号,为临床用药提供参考。方法:采用报告比值比(ROR)法对美国不良事件报告系统(AERS)进行信号挖掘,找出西格列汀皮肤不良反应的相关信号,利用SPSS16.0分析年龄、性别、用药时间、剂量对信号的影响。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,其中皮肤不良反应信号24个。通过统计学分析发现皮肤不良反应相对于其他不良反应,在性别(P=0.341)、年龄(P=0.229)、用药时间(P=0.078)、用药剂量(P=0.226)中的分布差异均无统计学意义。结论:挖掘和评价AERS数据库得到西格列汀皮肤不良反应的信号及影响因素,为其在临床使用提供依据,为进一步的药物警戒工作奠定基础。
OBJECTIVE： To mine and evaluate the skin ADR signals induced by sitagliptin, and to provide reference for drug use in the clinic. METHODS： ROR was used to mine the signals from the AERS and find the skin ADR signals . SPSS16.0 was used to analyze the effect of age, gender, medication duration and dosage on the signals. RESULTS： The data of AERS from 2009 to 2011 was mined to find 165 warning signals, 24 skin ADR signals. Compared with other ADR, skin ADR had no statistical significance in gender （P=0.341）, age （P=0.229）, medication duration （P=0.078） and dosage （P：0.226）. CONCLUSIONS： The mining and evaluation of AERS can get sitagliptin skin ADR signals and their influential factors, and it provides the basis for clinical use and lays the foundation for further research of pharmacovigilance.
出处
《中国药房》
CAS
CSCD
2014年第2期156-158,共3页
China Pharmacy
