基于FDA不良事件报告系统度拉糖肽安全信号的检测与分析

Detections and evaluations of adverse drug reaction signals of trulicity based upon FDA adverse event reporting system

目的:检测和分析度拉糖肽的安全信号,为度拉糖肽的临床合理用药提供参考。方法:采用报告比值法(ROR)和比例报告比法(PRR)对美国FDA不良事件报告系统(FAERS)上报的度拉糖肽的药物不良反应(ADR)信号进行数据挖掘和分析。结果:在纳入的72 189例报告中,女性(52.2%)略多于男性(42.9%),年龄主要集中在41~80岁,利用ROR法和PRR法筛选后获得145个共同信号,经系统器官分类(SOC)后主要集中在胃肠疾病、一般疾病和给药部位反应,其中运动亢进性心脏综合征(PRR=269.8,ROR=270.0)、剂量不足(PRR=144.2,ROR=148.9)、糖尿病肌萎缩(PRR=95.4,ROR=95.5)、BMI异常(PRR=70.9,ROR=70.9)和梗阻性胰腺炎(PRR=52.2,ROR=52.2)为中等强度信号,其余为弱信号。与甲状腺肿瘤(降钙素水平升高、甲状腺肿块、甲状腺良性肿瘤、甲状腺髓样癌)、胰腺炎(血淀粉酶升高、血脂肪酶升高、胰腺炎、急性胰腺炎、梗阻性胰腺炎、水肿性胰腺炎)和胰腺肿瘤(胰腺肿块、胰腺肿瘤、胰腺癌、胰腺导管内乳头状黏液瘤)相关的指标和疾病,均是度拉糖肽的安全信号。结论:度拉糖肽可能会增加胰腺炎、甲状腺和胰腺肿瘤的发病风险,此类不良反应的高风险人群应慎用。

OBJECTIVE To detect and analyze the safety signals of trulicity and provide references for rational clinical drug dosing.METHODS The methods of reporting odds ratio(ROR)and proportional reporting ratio(PRR)were employed for excavating the adverse drug reaction(ADR)of trulicity from FDA Adverse Event Reporting System(FAERS).RESULTS A total of 72 189 cases were retrieved.Females(52.2%)were slightly more than males(42.9%)and the age range was 41-80 years.A total of 145 common signals were obtained by reporting odds ratio(ROR)and relative reporting ratio(PRR)focusing upon gastrointestinal disorders, general disorders and administration site conditions through systematic organ classification(SOC).Among them, hyperkinetic heart syndrome(PRR=269.8,ROR=270.0),accidental underdosing(PRR=144.2,ROR=148.9),diabetic amyotrophy(PRR=95.4,ROR=95.5),abnormal body mass index(PRR=70.9,ROR=70.9)and obstructive pancreatitis(PRR=52.2,ROR=52.2)exhibited moderate intensity signals while the remainders weak signals.Thyroid tumor(elevated blood calcitonin, thyroid mass, benign thyroid neoplasm & medullary thyroid cancer),pancreatitis(elevated amylase, elevated lipase, pancreatitis, acute pancreatitis, obstructive pancreatitis & edematous pancreatitis)and pancreatic tumor(pancreatic mass, pancreatic neoplasm, pancreatic carcinoma & intraductal papillary mucinous neoplasm)related parameters and diseases were the safety signals of trulicity.CONCLUSION Associated with elevated risks of pancreatitis, thyroid tumors and pancreatic tumors, trulicity should be dosed precautiously in high-risk patients.