Article(id=1292135565579809439, tenantId=1146029695717560320, journalId=1246415772164075586, issueId=1292135425250976333, articleNumber=null, orderNo=null, doi=10.13699/j.cnki.1001-6821.2026.10.013, pmid=null, cstr=null, oa=null, hot=null, price=null, onlineType=0, articleFormat=0, articleType=null, articleTypeStr=null, receivedDate=1777737600000, receivedDateStr=2026-05-03, revisedDate=null, revisedDateStr=null, acceptedDate=null, acceptedDateStr=null, onlineDate=1785998725551, onlineDateStr=2026-08-06, pubDate=1779897600000, pubDateStr=2026-05-28, doiRegisterDate=null, doiRegisterDateStr=null, onlineIssueDate=1785998725551, onlineIssueDateStr=2026-08-06, onlineJustAcceptDate=null, onlineJustAcceptDateStr=null, onlineFirstDate=null, onlineFirstDateStr=null, sourceXml=null, magXml=null, createTime=1785998725551, creator=13701087609, updateTime=1785998725551, updator=13701087609, issue=Issue{id=1292135425250976333, tenantId=1146029695717560320, journalId=1246415772164075586, year='2026', volume='42', issue='10', pageStart='1351', pageEnd='1500', issueExtLink='null', onlineDate='null', pubDate='1779897600000', pubDateStr='2026-05-28', beforeIssueId=null, nextIssueId=null, price=null, status=1, issueComplete=1, articleOrder=1, issueType=-1, specialIssue=null, createTime=1785998692095, creator='13701087609', updateTime=1786014373634, updator='13701087609', preIssue=null, nextIssue=null, articleTotal=null, ext={EN=IssueExt(id=1292201198489202995, tenantId=1146029695717560320, journalId=1246415772164075586, issueId=1292135425250976333, language=EN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=), CN=IssueExt(id=1292201198489202996, tenantId=1146029695717560320, journalId=1246415772164075586, issueId=1292135425250976333, language=CN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=)}, issueFiles=null, downloadFileDto=null}, startPage=1433, endPage=1438, ext={EN=ArticleExt(id=1292135565802107552, articleId=1292135565579809439, tenantId=1146029695717560320, journalId=1246415772164075586, language=EN, title=Analysis of adverse drug reactions of riluzole in 67 Chinese amyotrophic lateral sclerosis patients, columnId=1292126489844151289, journalTitle=Chinese Journal of Clinical Pharmacology, columnName=Adverse Drug Reactions, runingTitle=null, highlight=null, articleAbstract=
Objective To analyze the characteristics of adverse drug reactions (adverse drug reaction, ADRs) of oral riluzole in patients with amyotrophic lateral sclerosis (amyotrophic lateral sclerosis, ALS), and to provide references for clinical safe medication.
Methods Data of ALS patients treated with riluzole at Peking Union Medical College Hospital from May 2018 to August 2023 were collected. Patients with ADRs were retrospectively analyzed regarding demographic information, medication details, clinical manifestations, time of onset, management, and outcomes. Causality assessment was performed according to China’s Measures for Reporting and Monitoring of Adverse Drug Reactions, severity was evaluated using CTCAE V5.0, and ADRs were coded using MedDRA terms.
Results A total of 67 ALS patients were included, among whom 22 experienced ADRs (32.8%). The incidence of ADRs was higher in females (44.0%) than in males (26.2%). A total of 54 ADR episodes were recorded. The most common ADRs involved the nervous system (20 cases/54 cases, 37.0%), followed by gastrointestinal system disorders (13 cases/54 cases, 24.1%), general disorders and administration site conditions (7 cases/54 cases, 13.0%), and various laboratory investigations (6 cases/54 cases, 11.1%). One patient (1.5%) experienced a grade 3 serious ADR (interstitial lung disease). Seventeen patients (77.3%) developed ADRs within the first three months of treatment. Sixteen patients (72.7%) tolerated the ADRs without specific intervention, while six (27.3%) improved after drug discontinuation, dose reduction, or symptomatic treatment.
Conclusion The most common ADRs of riluzole in ALS patients involve the nervous system, gastrointestinal tract, and elevated liver enzymes (all not higher than twice the normal value), mostly occurring early in the treatment course. Clinicians should remain vigilant for respiratory ADRs and potential heightened inflammatory responses, with close monitoring recommended during the first six months of treatment.
, authors=Zhuo SUN
1a, Xin LIU
1a, Wei ZUO
1a, Bo ZHANG
1a, Li-ying CUI
1b, authorsList=Zhuo SUN, Xin LIU, Wei ZUO, Bo ZHANG, Li-ying CUI, authorCompany=null, correspAuthors=Bo ZHANG, Li-ying CUI, authorNote=null, correspAuthorsNote=null, copyrightStatement=null, copyrightOwner=null, extLink=null, articleAbsUrl=null, sourceXml=null, magXml=null, pdfUrl=null, pdf=null, pdfFileSize=null, pdfExtLink=null, richHtmlUrl=null, mobilePdfUrl=null, reviewReport=null, pdfFirstPage=null, abstractGraph=null, abstractGraphContent=null, abstractVideo=null, citation=null, cebUrl=null, magXmlContent=null, mapNumber=null, fund=null), CN=ArticleExt(id=1292135566104097441, articleId=1292135565579809439, tenantId=1146029695717560320, journalId=1246415772164075586, language=CN, title=67例中国肌萎缩侧索硬化症患者服用利鲁唑后药物不良反应的分析, columnId=1292126489986757627, journalTitle=中国临床药理学杂志, columnName=药物不良反应, runingTitle=null, highlight=null, articleAbstract=
目的 分析肌萎缩侧索硬化症（amyotrophic lateral sclerosis，ALS）患者口服利鲁唑后药物不良反应（adverse drug reaction，ADR）的发生特点，为临床安全用药提供参考。
方法 收集2018年5月至2023年8月于北京协和医院服用利鲁唑的ALS患者资料，对发生ADR的患者进行回顾性分析，包括人口学信息、用药情况、ADR临床表现、发生时间、处置及预后。依据我国《药品不良反应报告和监测管理办法》进行因果关系评价，采用CTCAE V5.0评估严重程度，按MedDRA术语进行编码。
结果 共纳入67例ALS患者，其中22例发生ADR（32.8%），女性ADR发生率（44.0%）高于男性（26.2%）。共发生54例次ADR，最常见为神经系统异常（20例/54例，37.0%），其次为胃肠道系统异常（13例/54例，24.1%）、全身性疾病及给药部位反应（7例/54例，13.0%）和各类检查异常（6例/54例，11.1%）。严重ADR 1例（1.5%），表现为3级间质性肺疾病。17例（77.3%）ADR发生在用药后3个月内。16例（72.7%）患者ADR可耐受，未做特殊处理；6例（27.3%）患者经停药、减量或对症治疗后好转。
结论 利鲁唑在ALS患者中常见ADR涉及神经系统、胃肠道及肝功能指标升高（均不高于2倍正常值），多在用药早期出现。临床需警惕呼吸系统ADR及潜在的炎症反应增强风险，建议用药前6个月加强监测。
, authors=孙卓
1a, 刘鑫
1a, 左玮
1a, 张波
1a, 崔丽英
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孙卓（1993-），女，药师，主要从事神经系统罕见病药物临床研究
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