FDA公共数据开放项目中屈螺酮炔雌醇片的分析研究

中国药物警戒 ›› 2015, Vol. 12 ›› Issue (9): 552-555.

FDA公共数据开放项目中屈螺酮炔雌醇片的分析研究

施雯慧^{1, 2}, 陈颖^{1, 2}, 姚捷^{1, 2}, 孙志明^{1, 2}, 许豪勤^{1, 2}

1.国家人口计生委计划生育药具不良反应监测中心，江苏南京 210036;
2.江苏省计划生育科学技术研究所，江苏南京 210036

收稿日期:2015-06-30 修回日期:2015-12-07 出版日期:2015-09-08 发布日期:2015-12-07
通讯作者: 许豪勤，女，副主任医师，副研究员，计划生育药具不良反应监测。E-mail：1325825613@qq.com
作者简介:施雯慧，女，硕士，研究实习员，计划生育药具不良反应监测。
基金资助:
江苏省科技厅科技基础设施建设计划(BM2013058)。

Study on Drospirenone and Ethinylestradiol Tablets Using FDA Public Data Program

SHI Wen-hui^{1, 2}, CHEN Ying^{1, 2}, YAO Jie^{1, 2}, SUN Zhi-ming^{1, 2}, XU Hao-qin^{1, 2}

1.State Contraceptives Adverse Reaction Surveillance Center, Jiangsu Nanjing 210036, China;
2.Jiangsu Institute of Planned Parenthood Research, Jiangsu Nanjing 210036, China

Received:2015-06-30 Revised:2015-12-07 Online:2015-09-08 Published:2015-12-07

摘要/Abstract

摘要： 目的利用FDA公共数据开放项目(openFDA)检索屈螺酮炔雌醇片的不良反应报告，了解该药品不良反应情况，探讨openFDA的特点及利用其分析的可行性。方法检索openFDA系统中2001年1月1日至2014年12月31日期间提交的屈螺酮炔雌醇片不良反应报告数据，使用R软件jsonlite包对数据进行转换分析。结果检索到相关报告38 617份，报告的时间分布呈现先上升后下降的趋势，转折点发生在FDA发布对含屈螺酮药品的安全性通报之后;发生不良反应的患者平均年龄为30.02岁，用药原因前3位为避孕、痤疮、经前期综合征，不良反应表现前3位为疼痛、伤害、肺栓塞。结论 openFDA简化了对FDA药品不良反应报告数据库(FAERS)的分析所需的前期处理过程，方便使用者即时了解某种药品的不良反应情况，但数据质量仍存在一些问题，进行精确分析会受到影响，而利用其进行不良反应信号挖掘是值得进一步研究的方向。

关键词: FDA公共数据开放项目, 屈螺酮炔雌醇片, FDA药品不良反应报告数据库, 药品不良反应

Abstract: Objective To understand the drug adverse reaction of drospirenone and ethinylestradiol tablets and discuss the characteristics and feasibility of FDA public data program (openFDA) through analyzing adverse reactions reports from the openFDA. Methods The openFDA database was searched with term"drospirenone and ethinylestradiol" from January 1, 2001 to December 31, 2014, and the data was transformed and analyzed by R software with jsonlite package. Results 38617 reports were retrieved, and the distribution of received date showed a curve of rises first and then fall with the turning point occurred in May,2011 when FDA published safety review of possibly increased risk of blood clots with birth control pills containing drospirenone. The mean age of patients was 30.02 years, the top three drugs use indications were contraception, acne and premenstrual syndrome, and the top three adverse reactions were pain, injury and pulmonary embolism. Conclusion Compared with the FAERS database, openFDA simplifies the data cleaning procedure, which is a more convenient way to get to know adverse reactions of certain drug, however, problems on the quality of raw data still exist, which would affect the accuracy of analysis result , therefore, the mining of adverse reaction signals using openFDA comparatively has better potential applications.

Key words: openFDA, drospirenone and ethinylestradiol tablets, FAERS, drug adverse reaction

中图分类号:

R951

施雯慧, 陈颖, 姚捷, 孙志明, 许豪勤. FDA公共数据开放项目中屈螺酮炔雌醇片的分析研究[J]. 中国药物警戒, 2015, 12(9): 552-555.

SHI Wen-hui, CHEN Ying, YAO Jie, SUN Zhi-ming, XU Hao-qin. Study on Drospirenone and Ethinylestradiol Tablets Using FDA Public Data Program[J]. Chinese Journal of Pharmacovigilance, 2015, 12(9): 552-555.

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