中国新药杂志

基于FAERS数据库的真实世界分析：非唑奈坦和雌二醇不良事件信号挖掘与风险再评价

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左家伟 ¹ , 孟涛 ² , 吴君 ¹ , 王媛媛 ¹^,^*

中国新药杂志 | 药物安全与合理应用 2026,35(16): 1785-1792

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中国新药杂志 |药物安全与合理应用 2026 , 35 (16) : 1785 -1792

基于FAERS数据库的真实世界分析：非唑奈坦和雌二醇不良事件信号挖掘与风险再评价

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左家伟¹, 孟涛², 吴君¹, 王媛媛¹^,^*

作者信息

¹安徽医科大学第二附属医院药学部，合肥 230601

²安徽医科大学第三附属医院（合肥市第一人民医院）普外科，合肥 230061

通讯作者:

^* 王媛媛，女，博士，主要从事临床药学和药事管理学研究。E-mail: wangyuanyuan@ahmu.edu.cn。

作者简介:

左家伟，女，硕士，主要从事临床药学和药事管理学研究。E-mail: 2998314741@qq.com。

孟涛，男，硕士，主要从事肝脏疾病研究。E-mail: joe_mt@163.com。

A real-world analysis based on the FAERS database: mining and risk reassessment of adverse event signals of fezolinetant and estradiol

Jia-wei ZUO¹, Tao MENG², Jun WU¹, Yuan-yuan WANG¹^,^*

Affiliations

¹Department of Pharmacy, the Second Affiliated Hospital of Anhui Medical University, Hefei 230601, China

²Department of General Surgery, the Third Affiliated Hospital of Anhui Medical University, Hefei 230061, China

出版时间: 2026-08-30 doi: 10.20251/j.cnki.1003-3734.2026.16.014

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摘要

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目的：

挖掘非唑奈坦和雌二醇药物不良事件（adverse drug event, ADE）信号，为女性更年期血管舒缩症状（vasomotor symptoms, VMS）合理用药提供临床参考。

方法：

从第三方数据平台OpenVigil 2.1挖掘美国FDA不良事件报告系统（FDA Adverse Event Reporting System, FAERS）中非唑奈坦和雌二醇的ADE信号，采用报告比值比法和比例报告比值比法分析和对比二者的风险信号。

结果：

本研究共挖掘72 255份ADE报告（非唑奈坦1 616例，雌二醇70 639例）。经标准化筛选后，非唑奈坦相关ADE 344个，33个阳性信号（绝经期症状、肝脏功能检查值升高和绝经后出血等），涉及11个系统器官分类（system organ classification，SOC，包括各类检查、全身性疾病及给药部位各种反应和胃肠系统疾病等）；雌二醇相关ADE 3 540个，557个阳性信号（子宫肌瘤坏死、睾丸混合型生殖细胞肿瘤和假性性早熟等），覆盖26个SOC（全身性疾病及给药部位各种反应、产品问题和生殖系统及乳腺疾病等）。本研究发现了新的潜在风险信号：非唑奈坦包括脑雾、构音障碍、口腔不适及心悸等；雌二醇相关SOC则包括良性、恶性及性质不明的肿瘤以及神经、泌尿和胃肠等系统。

结论：

非唑奈坦主要ADE体现在各种肝功能指标异常和胃肠系统疾病，而雌二醇相关ADE则主要表现在产品使用和生殖系统及乳腺疾病方面。临床在治疗患者绝经期VMS等症状时，应注意个体化用药，严格监测ADE。

关键词

非唑奈坦 / 雌二醇 / FAERS数据库 / 药物不良事件 / 回顾性分析

Abstract

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Objective:

To detect the adverse drug event (ADE) signals of fezolinetant and estradiol to provide references for rational drug use in treatment of vasomotor symptoms (VMS) in women during menopause.

Methods:

The ADE signals of fezolinetant and estradiol from the FDA Adverse Event Reporting System (FAERS) database were mined from the third-party data platform OpenVigil 2.1. The reporting odds ratio (ROR) and proportional reporting ratio (PRR) methods were adopted to analyze and compare the risk signals of the two drugs.

Results:

A total of 72 255 adverse event reports (1 616 cases of fezolinetant and 70 639 cases of estradiol) were mined. After standardized screening, 344 cases of fezolinetant-related ADE were detected, and 33 positive signals were detected (menopausal symptoms, elevated liver function test values and postmenopausal bleeding, etc.), involving 11 system organ classification (SOC, all kinds of examinations, systemic diseases and various reactions at the administration site, and gastrointestinal system diseases, etc.). In 3 540 estradiol-associated ADE, 557 positive signals were detected (necrosis of uterine fibroids, testicular mixed germ cell tumors and pseudo-precocious puberty, etc.), covering 26 SOC classes (systemic diseases and various reactions at the administration site, product issues, and reproductive system and breast diseases, etc.). This study identified the following new potential risk signals: new ADE related to brain fog, dysarthria, oral discomfort and palpitations were discovered for fezolinetant; the SOC related to the estradiol group included benign, malignant and tumors of unknown nature, as well as those in the nervous, urinary and gastrointestinal systems.

Conclusion:

The major adverse events of fezolinetant were associated with abnormal liver function indicators and gastrointestinal system diseases, while estradiol related ADE were associated with product use, reproductive system and breast diseases. The treatment of menopausal patients with vasomotor and other symptoms should be individualized and adverse drug reactions should be monitored.

Key words

fezolinetant / estradiol / FAERS database / adverse drug event / retrospective analysis

引用本文

左家伟, 孟涛, 吴君, 王媛媛. 基于FAERS数据库的真实世界分析：非唑奈坦和雌二醇不良事件信号挖掘与风险再评价. 中国新药杂志, 2026 , 35 (16) : 1785 -1792 . DOI: 10.20251/j.cnki.1003-3734.2026.16.014

Jia-wei ZUO, Tao MENG, Jun WU, Yuan-yuan WANG. A real-world analysis based on the FAERS database: mining and risk reassessment of adverse event signals of fezolinetant and estradiol[J]. Chinese Journal of New Drugs, 2026 , 35 (16) : 1785 -1792 . DOI: 10.20251/j.cnki.1003-3734.2026.16.014

基金

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安徽省教育厅高等学校省级质量工程项目(2024jyxm0769)
安徽省高等学校科学研究项目(AHWJ2023BAa20181)
安徽省卫生健康科研项目(2024AH050782)
安徽医科大学附属医院青年科技人才培养项目(2023cy020)

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2026年第35卷第16期

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文章信息

doi: 10.20251/j.cnki.1003-3734.2026.16.014

首发时间：2026-10-26
出版时间：2026-08-30

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出版历史

录用日期：2025-10-23

基金

安徽省教育厅高等学校省级质量工程项目(2024jyxm0769)

安徽省高等学校科学研究项目(AHWJ2023BAa20181)

安徽省卫生健康科研项目(2024AH050782)

安徽医科大学附属医院青年科技人才培养项目(2023cy020)

作者信息

¹安徽医科大学第二附属医院药学部，合肥 230601

²安徽医科大学第三附属医院（合肥市第一人民医院）普外科，合肥 230061

通讯作者:

^* 王媛媛，女，博士，主要从事临床药学和药事管理学研究。E-mail: wangyuanyuan@ahmu.edu.cn。

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https://castjournals.cast.org.cn/joweb/zgxyzz/CN/10.20251/j.cnki.1003-3734.2026.16.014

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2种不同金属材料的力学参数

科 Family	属数 Number of genus	种数 Number of species	占总种数比例 Percentage of total species (%)	属 Genus	种数 Number of species	占总种数比例 Percentage of total species (%)
鹅膏菌科Amanitaceae	2	11	5.26	鹅膏菌属 Amanita	10	4.78
小菇科 Mycenaceae	2	12	5.74	丝盖伞属 Inocybe	5	2.39
多孔菌科 Polyporaceae	8	14	6.70	蜡蘑属 Laccaria	5	2.39
红菇科 Russulaceae	3	23	11.00	小皮伞属 Marasmius	6	2.87
				小菇属 Mycena	11	5.26
				光柄菇属 Pluteus	5	2.39
				红菇属 Russula	17	8.13
				栓菌属 Trametes	5	2.39

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