田晓江 董志 唐学文 季欢欢 贾运涛

中图分类号 R95 文献标志码 A 文章编号 1001-0408（2018）13-1827-05

DOI 10.6039/j.issn.1001-0408.2018.13.24

摘 要 目的：对莫西沙星致肌腱损伤相关安全信号发生的状况和一般规律进行检测和分析，为临床安全用药提供参考。方法：采用数据挖掘技术，以报告比值比法（ROR）对美国FDA不良事件公开数据库中莫西沙星的安全信号进行关键词检索，限定时间为“2004/01/01”至“2016/12/31”，限定目标药物通用名为“ Moxifloxacin”，应用 Microsoft Excel 2010建立信息提取表，并对肌腱损伤安全信号数据从患者基本信息、莫西沙星的应用情况等进行分析。结果：在检索到的16 543份以莫西沙星为首要怀疑药物的不良事件报告中，以ROR法检测出排名前10位的安全信号，其中肌腱安全信号占4个（共921份报告），经排除后纳入合格的报告477例；对报告进行分析后表明，患者平均体质量为（58.95±18.14） kg，女性占比略高于男性（56.81% vs. 42.14%），平均年龄为（50.55±15.43）岁（18～91岁）；肌腱不良事件大多发生在用药后1～7 d（59.54%），中位天数为5 d，合并用药以其他氟喹诺酮类药物（36.79%）和糖皮质激素类药物（31.60%）多见。结论：在莫西沙星所有不良事件信號中，肌腱损伤信号与不良事件有着显著的统计学关联，提示临床应该高度关注莫西沙星肌腱不良事件的发生；影响莫西沙星肌腱安全信号的主要危险因素包括老年、合并应用激素或其他类型的氟喹诺酮类药物等。

关键词 盐酸莫西沙星；数据挖掘；不良事件；肌腱损伤；比值比法；信号检测

ABSTRACT OBJECTIVE： To detect and analyze the related safety signals and general regularity of moxifloxacin induced tendon injury， and to provide reference for safe drug use in clinic. METHODS： By data mining， reporting odd ratio （ROR） method was used for keyword retrieval of safety signals of moxifloxacin from FDA adverse event database. The retrieval duration ranged from “2004/01/01” to “2016/12/31”， and the general name of target drug was “Moxifloxacin”. Data extraction table was established by using Microsoft Excel 2010， and safety signals of tendon injury were analyzed in respects of general information of patients， moxifloxacin use， etc. RESULTS： Among 16 543 adverse event reports with moxifloxacin as the primary suspect drug， top 10 safety signals were detected by using ROR method， including 4 safety signal of tendon （921 reports）. After exclusion， 477 cases of qualified report were included. After report analysis， mean body weight of the patients was （58.95±18.14） kg， female accounted for slightly higher than male （56.81% vs. 42.14%）； average age was （50.55±15.43） years （18 to 91 years）. Most of tendon ADR occurred 1-7 d after treatment （59.54%）， median was 5 days； In drug combination， fluoroquinolones （36.79%） and glucocorticoids （31.60%） were most common. CONCLUSIONS： Among ADE signals of moxifloxacin， tendon injury signal have significant statistical relationship with adverse events， which indicates the attention should be closely paid to the occurrence of moxifloxacin tendon adverse events. The main risk factors affecting the tendon safety signal of moxifloxacin include senile， combined with hormone or other types of fluoroquinolones.

KEYWORDS Moxifloxacin hydrochloride； Data mining； Adverse events； Tendon injury； Reporting odd ratio method； Signal detection

药品不良事件（Adverse drug reaction，ADE）监测是世界各国卫生部门监管ADE的重要手段，其主要方法是基于对自发呈报数据库（Spontaneous reporting system，SRS）的数据挖掘，从而获取药品与ADE之间可能存在的因果关联以及关联程度，用于了解各类ADE 的发生、发展及与药品是否关联及关联程度等信息[1]。……