基于自发呈报系统丹参多酚酸盐安全信号预警分析  

Pharmacovigilance of parenterally administered salvianolate based on analysis of spontaneous reporting system data

作　　者：卢鹏飞[1] 向永洋[2] 谢雁鸣[1] 常艳鹏[1] 王志国[1] 

机构地区：[1]中国中医科学院中医临床基础医学研究所,北京100700 [2]中国人民大学统计学院,北京100872

出　　处：《中国中药杂志》2013年第18期3003-3007,共5页China Journal of Chinese Materia Medica

基　　金：国家"重大新药创制"科技重大专项(2009ZX09502-030);国家自然科学基金青年基金项目(81202776);中国中医科学院第7批自主选题项目(Z0255);中国中医科学院客座研究员联合创新研究项目(ZZ070817)

摘　　要：自发呈报系统是目前世界上进行ADR监测、发现ADR信号最基本的方法,能够及时有效的发现药品不良反应信号,对有效预防和避免药害事件具有重要的意义。注射用丹参多酚酸盐具有活血、化瘀、通脉的功效,主要用于治疗冠心病稳定型心绞痛。随着该药在临床中的广泛运用及ADR的及时上报,来自国家药品不良反应监测中心SRS数据库中该药不良反应报告信息逐渐增多,及时有效地发现可疑ADR成了人们关注的主要问题。该文采用贝叶斯置信传播神经网络法(BCPNN)与报告率比例法(PRR)对发生的不良反应进行药物警戒数据挖掘分析及采用倾向评分法分析预警信号。结果显示SRS数据库中注射用丹参多酚酸盐全部739份ADR病例报告涉及不良反应106种共1 310次,涉及全身22个系统和器官,其中发生严重不良反应24例,占全部报告的3.25%,无死亡病例。报告频数排在前10位的不良反应分别为"皮疹"、"头晕"、"瘙痒"、"头痛"、"寒战"、"憋气"、"恶心"、"心悸"、"过敏样反应"、"发热"。药物警戒PRR法提示"头晕"、"头痛"、"恶心"、"瘙痒"和"皮疹"出现预警信号,BCPNN法提示"头晕"和"头痛"出现预警信号。倾向性评分结果显示PRR方法和BCPNN方法完全一致,"头痛"和"头晕"于匹配前和匹配后都预警。SRS数据库中注射用丹参多酚酸盐不良反应信号"头晕"和"头痛"反应强烈,主要以神经系统表现为主。Spontaneous reporting system（SRS） is currently a basic method to monitor and find adverse drug reactions （ADR） signals used worldwide. This method can promptly and effectively discover ADR signals and is of great significance to effectively pre- vent and avoid ADRs. Parenterally administered salvianolate has the functions of activating blood circulation and removing stasis. It is mainly used in the treatment of stable angina pectoris. As the drug is widely used clinically and ADRs are increasingly reported prompt- ly, ADR information in the national ADR monitoring center＇s SRS database has also increased. How to quickly and effectively identify suspicious ADRs is a major concern. This study uses BCPNN and PRR to detect early warning signals. $739 ADR case reports were identified. There were 106 types, 1 310 events, and 24 serious ADR cases （ 3.25% of 739 case reports） There wre no deaths. The ten most frequent ADRs were： rash, dizziness, itch, headache, chills and breath, nausea, palpitation, anaphylactic reaction and hot. The drugs early warning signs were dizziness, headache, nausea, itchiness and rash estimated using PRR. Early warning signs based on BCPNN were dizziness and headache. The ADRs of dizziness and headache are early warning signals associated with the nervous system.

关 键 词：自发呈报系统 丹参多酚酸盐 药物警戒 药物预警 贝叶斯法 传统频数法 

分 类 号：R288[医药卫生—中药学]