摘要
目的:利用美国食品药品监督管理局公共数据公开项目(US Food and Drug Administration Public Data Open Project, OpenFDA)检索孟鲁司特不良反应报告情况,并进行数据挖掘和分析,为临床安全用药提供参考。方法:根据OpenFDA药物不良反应端点的交互式图表板块访问API,检索2004年1月至2020年5月期间孟鲁司特不良反应报告数据,并对相关数据进行分析。结果:共检索到孟鲁司特相关不良反应报告97 406份,其中死亡、危及生命、住院、致残、先天畸形及其他严重不良反应报告61 766份,约占总数的63%。上报不良反应的职业分布以消费者或非医务人员为主,占总数的近50%。其次为医师和其他医务人员。发生不良反应年龄分布以成年人居多,性别方面女性患者发生比例更高,占70%。不良反应常见类型包括呼吸困难、疲劳、头痛、胃肠道反应和呼吸道感染,此外,神经精神方面的不良反应也有较多的报道。结论:基于OpenFDA数据库可方便快捷的对孟鲁司特不良反应相关信息进行全面的挖掘分析,在临床使用过程中应密切关注孟鲁司特的使用适应证,开展必要的药学监护,特别要警惕神经、精神不良反应的发生。
OBJECTIVE To access the database of OpenFDA(US Food and Drug Administration Public Data Open Project)to retrieve the reports of adverse reactions of montelukast and perform data mining and analysis to provide references for drug safety in clinical practices.METHODS An interactive chart section of adverse drug reaction endpoints was employed for accessing via application programming interface(API).The data of montelukast adverse reaction reports from January 2004 to May 2020 were retrieved and analyzed.RESULTS A total of 97 406 reports of adverse reactions related to montelukast were retrieved.And 61 766(63%)belonged to serious adverse drug reactions including death, life-threatening, hospitalization, disability, congenital malformations and other serious adverse reactions.The occupational distribution of reported adverse reactions concerned mostly consumers and non-medical personnel, accounting for approximately 50%.It was followed by physicians and other medical staff.Adverse reactions occurred predominatly in adults and the proportion of female was higher, accounting for 70%.Common types of adverse reactions included dyspnea, fatigue, headache, gastrointestinal reactions and respiratory infections.In addition, there were many reports of neuropsychiatric adverse reactions.CONCLUSION It is convenient and quick to carry out mining and analysis of montelukast adverse reactions based upon the database of OpenFDA.In clinical practices, clinicians should pay close attention to the indications of montelukast and carry out the necessary pharmaceutical monitoring.Also it is necessary to watch out for the occurrence of neurological/psychiatric adverse reactions.
作者
张宏亮
黄天敏
黄振光
李卉
林忠秋
丘岳
ZHANG Hong-liang;HUANG Tian-min;HUANG Zhen-guang;LI Hui;LIN Zhong-qiu;QIU Yue(Department of Pharmacy,First Affiliated Hospital,Guangxi Medical University,Guangxi Nanning 530021,China)
出处
《中国医院药学杂志》
CAS
北大核心
2021年第6期628-631,共4页
Chinese Journal of Hospital Pharmacy
基金
广西自然科学基金项目(编号:2017GXNSFBA198177)
广西中医药适宜技术开发与推广项目(编号:GZSY20-10)
广西医科大学第一附属医院优秀医学英才计划项目。
