论著

基于 OpenFDA 数据库的盐酸环喷托酯滴眼液不良反应信号检索与分析

Retrieval and analysis of cyclopentolate hydrochloride eye drops related adverse drug reaction signals based on OpenFDA

:331-339
 

目的:利用美国食品药品监督管理局公共数据开放项目(OpenFDA)检索并分析盐酸环喷托酯滴眼液药品不良反应adverse drug reactionsADRs的报告情况,为临床安全用药提供参考 方法: 盐酸环喷托酯滴眼液作为检索词,在OpenFDA数据库中检索200411日至202481日期间盐酸环喷托酯滴眼液相关ADRs的所有信息,对检索到的数据进行分析。 结果:共检索到盐酸环喷托酯滴眼液相关ADRs 11851185患者中,剔除性别不详,女性男性分别为516和48343.54% vs 40.76%;剔除年龄不详后,ADRs发生率较高的是65~<80患者221例,18.65%50~<65患者176例,14.85%3~<13患者140例,11.81%)。盐酸环喷托酯滴眼液发生率较高ADRs眼器官疾病(767例,64.73%神经系统疾病(254例,21.43%及胃肠系统疾病(228例,19.24% 结论:盐酸环喷托酯滴眼液可发生眼局部和全身ADRs临床在使用时应详细询问患者疾病史和用药史,加强用药监护,提高患者用药的安全性。

Objective: To retrieve and analyze adverse drug reactions (ADRs) of cyclopentolate hydrochloride eye drops on the US Food and drug Administration Public Data Open Project (OpenFDA), so as to provide reference for clinical rational drug use. Methods: Using "Cyclopentolate hydrochloride eye drops" as the search term, retrieve all information related to ADRs of cyclopentolate hydrochloride eye drops from the OpenFDA database from January 1, 2004 to August 1, 2024, and analyze the retrieved data  Results: A total of 1 185 cases of ADRs associated with cyclopentolate hydrochloride eye drops were found. Among the 1185 patients, 516 were female and 483 were male ( 43.54 % vs 40.76 % ) after excluding the unknown gender. After excluding patients with unknown age, the incidence of ADRs was higher in patients aged 65~ < 80 years old ( 221 cases, 18.65 % ), 50~< 65 years old ( 176 cases, 14.85 % ), and 3~ < 13 years old ( 140 cases, 11.81 % ). The ADRs with high incidence of cyclopentolate hydrochloride eye drops were ocular organ diseases ( 767 cases, 64.73 % ), nervous system diseases ( 254 cases, 21.43 % ) and gastrointestinal system diseases ( 228 cases, 19.24 % ). Conclusions: Cyclopentolate hydrochloride eye drops can cause local and systemic adverse reactions. In clinical use, the patient 's disease history and medication history should be asked in detail, and medication monitoring should be strengthened to improve the safety of patient medication.

其他期刊
  • 眼科学报

    主管:中华人民共和国教育部
    主办:中山大学
    承办:中山大学中山眼科中心
    主编:林浩添
    主管:中华人民共和国教育部
    主办:中山大学
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  • Eye Science

    主管:中华人民共和国教育部
    主办:中山大学
    承办:中山大学中山眼科中心
    主编:林浩添
    主管:中华人民共和国教育部
    主办:中山大学
    浏览
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