摘要
目的分析并评价当归属药物的不良反应/不良事件(ADR/AE)信号特征,识别潜在风险,为临床安全合理用药提供参考。方法提取世界卫生组织药品不良反应报告数据库(WHO-VigiAccess)中当归属(Angelica spp.)相关ADR/AE的自发报告数据,时间截至2024年。采用报告比值比(ROR)和比例报告比值比(PRR)方法进行信号检测,使用MHRA综合标准法判定阳性信号。结果共纳入1737例次ADR/AE报告,涉及1015名患者。患者以女性为主(98.52%),主要年龄段为45~64岁(47.68%),报告多来自亚洲地区(98.92%)。经分析筛选出59个阳性信号,涉及15个系统器官分类(SOC)。其中生殖系统及乳腺疾病占比最高(43.18%),主要包括阴道出血、乳房疼痛、月经间期出血等首选术语(PT),频数及信号强度排名前30的PT中有15个重复出现。对既往已有和新发的ADR/AE,如生殖、内分泌、神经、皮肤等系统症状等进行了总结。结论当归属药物ADR/AE主要累及女性生殖系统,并可能对神经系统、皮肤系统和消化系统等多个系统产生影响。临床使用时应充分考虑患者个体差异,对特殊人群采取针对性的监测措施。
Objective To analyze and evaluate the signal characteristics of adverse drug reactions/adverse events(ADR/AE)associated with Angelica spp.drugs,identify potential risks,and provide a reference for their safe and rational clinical use.Methods Spontaneous report data on ADR/AE related to Angelica spp.drugs were extracted from the World Health Organization's VigiAccess database(WHO-VigiAccess)up to 2024.Signal detection was performed using the reporting odds ratio(ROR)and proportional reporting ratio(PRR)methods,and positive signals were determined according to the MHRA comprehensive criteria.Results A total of 1,737 ADR/AE reports involving 1,015 patients were included.The majority of patients were female(98.52%),with the predominant age group being 45-64 years(47.68%),and most reports originated from Asia(98.92%).Analysis identified 59 positive signals spanning 15 System Organ Classes(SOCs).Reproductive system and breast disorders accounted for the highest proportion(43.18%),primarily including preferred terms(PT)such as vaginal bleeding,breast pain,and intermenstrual bleeding.Among the top 30 PTs ranked by frequency and signal strength,15 were repeatedly observed.A summary of both previously reported and newly emerging ADRs and AEs,including symptoms affecting the reproductive,endocrine,nervous,and dermatological systems,has been conducted.Conclusion ADRs/AEs associated with Angelica spp.drugs primarily affect the female reproductive system and may also impact the nervous,integumentary,and digestive systems.In clinical practice,individual patient differences should be carefully considered,and targeted monitoring measures should be implemented for special populations.
作者
严鸣
胡采薇
姚敏
崔学军
YAN Ming;HU Caiwei;YAO Min;CUI Xuejun(Longhua Hospital Shanghai University of Traditional Chinese Medicine,Shanghai 200032,China;Institute of Spinal Disease,Shanghai University of Traditional Chinese Medicine,Shanghai 200032,China;Shanghai Pudong New Area Traditional Chinese Medicine Hospital,Shanghai 201299,China)
出处
《中国中医基础医学杂志》
2025年第9期1639-1645,共7页
JOURNAL OF BASIC CHINESE MEDICINE
基金
国家自然科学基金面上项目(82174409,82374476,82474540)
上海市科学技术委员会项目(22ZR1461700)。
