Article(id=1321425578981437960, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1321425569611362746, articleNumber=null, orderNo=null, doi=10.20251/j.cnki.1003-3734.2026.07.007, pmid=null, cstr=null, oa=null, hot=null, price=null, onlineType=0, articleFormat=0, articleType=null, articleTypeStr=null, receivedDate=null, receivedDateStr=null, revisedDate=null, revisedDateStr=null, acceptedDate=1754755200000, acceptedDateStr=2025-08-10, onlineDate=1792982008929, onlineDateStr=2026-10-26, pubDate=1776182400000, pubDateStr=2026-04-15, doiRegisterDate=null, doiRegisterDateStr=null, onlineIssueDate=1792982008929, onlineIssueDateStr=2026-10-26, onlineJustAcceptDate=null, onlineJustAcceptDateStr=null, onlineFirstDate=null, onlineFirstDateStr=null, sourceXml=null, magXml=null, createTime=1792982008929, creator=13701087609, updateTime=1792982008929, updator=13701087609, issue=Issue{id=1321425569611362746, tenantId=1146029695717560320, journalId=1235980733773295621, year='2026', volume='35', issue='7', pageStart='673', pageEnd='784', issueExtLink='null', onlineDate='null', pubDate='1776182400000', pubDateStr='2026-04-15', beforeIssueId=null, nextIssueId=null, price=null, status=1, issueComplete=1, articleOrder=1, issueType=-1, specialIssue=null, createTime=1792982006695, creator='13701087609', updateTime=1792983136833, updator='13701087609', preIssue=null, nextIssue=null, articleTotal=null, ext={EN=IssueExt(id=1321430309837587328, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1321425569611362746, language=EN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=), CN=IssueExt(id=1321430309837587329, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1321425569611362746, language=CN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=)}, issueFiles=null, downloadFileDto=null}, startPage=722, endPage=726, ext={EN=ArticleExt(id=1321425579174375945, articleId=1321425578981437960, tenantId=1146029695717560320, journalId=1235980733773295621, language=EN, title=Analysis and standardization strategies of serious adverse event reports in pediatric drug clinical trials, columnId=null, journalTitle=Chinese Journal of New Drugs, columnName=null, runingTitle=null, highlight=null, articleAbstract=
Objective:

To analyze the issues in the reporting of serious adverse events (SAEs) in pediatric drug clinical trials, propose standardized reporting strategies, ensure the safety and legitimate rights and interests of pediatric research participants, and improve the pharmacovigilance system for pediatric clinical trials.

Methods:

An analysis was conducted on 136 SAEs reported to the medical ethics committee of our hospital from our hospital between January 1, 2015 and April 30, 2025. The analysis covered the gender and age of affected children, medical specialities involved, types of drugs, patterns of SAE occurrence, causal relationship with the study drug, reporting issues, and whether they were judged as suspected unexpected serious adverse reactions (SUSARs).

Results:

Among the 136 SAEs, the pediatric hematology specialty had the highest number of cases (35 cases); the number of male cases (77 cases) was higher than that of female cases (59 cases), and most occurred during childhood (86 cases); among the drug types, therapeutic biological products had the highest number of cases (76 cases); the most significant impact on research participants was the requirement for hospitalization (124 cases); the number of cases where SAEs were "definitely unrelated" to the trial drug was the highest (47 cases), and the most significant impact on clinical trials was "no change in dose, continue medication" (76 cases); 13 cases were judged as SUSARs.

Conclusion:

It is necessary to establish a standardized reporting and handling system for SAEs in pediatric drug clinical trials, to develop SAE reporting forms suitable for children, and to attach great importance to the assessment of children's specific conditions. Sponsors, researchers, and ethics committees must fully understand the differences in SAE spectra between children and adults, strengthen safety monitoring, and maximize the protection of the rights and safety of pediatric subjects.

, authors=Chun-yan GUO, Yi ZHANG, Yu-xin YANG, Yu-guang LIANG, Qian DING, Qian WANG, Meng ZHANG, Li-juan SONG, Cheng-yue ZHANG, Yu SUN, Peng GUO*, authorsList=Chun-yan GUO, Yi ZHANG, Yu-xin YANG, Yu-guang LIANG, Qian DING, Qian WANG, Meng ZHANG, Li-juan SONG, Cheng-yue ZHANG, Yu SUN, Peng GUO, authorCompany=null, correspAuthors=Peng GUO, 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=1321425579430228490, articleId=1321425578981437960, tenantId=1146029695717560320, journalId=1235980733773295621, language=CN, title=儿童药物临床试验严重不良事件报告分析及规范策略, columnId=1236331741447778310, journalTitle=中国新药杂志, columnName=药物临床试验规范与进展专栏, runingTitle=null, highlight=null, articleAbstract=
目的:

分析儿童药物临床试验严重不良事件报告存在的问题,提出规范的报告策略,保障儿童研究参与者的安全和合法权益,健全儿童临床试验的药物警戒体系。

方法:

分析我院2015年1月1日—2025年4月30日上报医学伦理委员会的药物临床试验中发生的136例严重不良事件(serious adverse event, SAE),分析SAE发生的性别、年龄、专业、药物种类、发生类型、SAE与药物的相关性、SAE报告问题、是否判断为可疑且非预期严重不良反应(suspected unexpected serious adverse reaction, SUSAR)。

结果:

136例SAE中,小儿血液专业发生例数(35例)最多;男童发生例数(77例)多于女童(59例),主要发生于儿童期(86例);药物种类中,治疗用生物制品发生例数最多(76例);对研究参与者的最主要影响是导致住院(124例);SAE与试验药物“肯定无关”例数最多(47例),对临床试验的最主要影响是“剂量不变,继续用药”(76例),SAE判断为SUSAR的共13例。

结论:

规范建立儿童药物临床试验中SAE的报告与处置体系,设计适宜儿童的SAE报告表,高度重视对儿童特有情况的评估,申办者、研究者和伦理委员会必须充分理解儿童与成人SAE谱的差异,强化安全性监测,最大程度保障儿童受试者的权益和安全。

, authors=郭春彦, 张怡, 杨禹欣, 梁宇光, 丁倩, 王谦, 张萌, 宋丽娟, 张成玥, 孙雨, 郭鹏*, authorsList=郭春彦, 张怡, 杨禹欣, 梁宇光, 丁倩, 王谦, 张萌, 宋丽娟, 张成玥, 孙雨, 郭鹏, authorCompany=null, correspAuthors=郭鹏, authorNote=

郭春彦,女,硕士研究生,副主任药师,研究方向:儿童药物临床试验、临床中药学。E-mail: 。

, correspAuthorsNote=
* 郭鹏,男,教授,博士生导师,研究方向:儿童药物临床试验、儿童合理用药及药物作用机制研究。E-mail: 。
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郭春彦,女,硕士研究生,副主任药师,研究方向:儿童药物临床试验、临床中药学。E-mail: 。

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郭春彦,女,硕士研究生,副主任药师,研究方向:儿童药物临床试验、临床中药学。E-mail: 。

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儿童药物临床试验严重不良事件报告分析及规范策略
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郭春彦 , 张怡 , 杨禹欣 , 梁宇光 , 丁倩 , 王谦 , 张萌 , 宋丽娟 , 张成玥 , 孙雨 , 郭鹏 *
中国新药杂志 | 药物临床试验规范与进展专栏 2026,35(7): 722-726
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中国新药杂志 |药物临床试验规范与进展专栏 2026 , 35 (7) : 722 -726
儿童药物临床试验严重不良事件报告分析及规范策略
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郭春彦,女,硕士研究生,副主任药师,研究方向:儿童药物临床试验、临床中药学。E-mail: 。

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郭春彦 , 张怡, 杨禹欣, 梁宇光, 丁倩, 王谦, 张萌, 宋丽娟, 张成玥, 孙雨, 郭鹏*
作者信息
  • 国家儿童医学中心/首都医科大学附属北京儿童医院临床研究中心,北京 100045
通讯作者:
* 郭鹏,男,教授,博士生导师,研究方向:儿童药物临床试验、儿童合理用药及药物作用机制研究。E-mail: 。
作者简介:

郭春彦,女,硕士研究生,副主任药师,研究方向:儿童药物临床试验、临床中药学。E-mail: 。

Analysis and standardization strategies of serious adverse event reports in pediatric drug clinical trials
Chun-yan GUO , Yi ZHANG, Yu-xin YANG, Yu-guang LIANG, Qian DING, Qian WANG, Meng ZHANG, Li-juan SONG, Cheng-yue ZHANG, Yu SUN, Peng GUO*
Affiliations
  • Department of clinical research center, Beijing Children's Hospital Affiliated to Capital Medical University, National Children's Medical Center, Beijing 100045, China
出版时间: 2026-04-15 doi: 10.20251/j.cnki.1003-3734.2026.07.007
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目的:

分析儿童药物临床试验严重不良事件报告存在的问题,提出规范的报告策略,保障儿童研究参与者的安全和合法权益,健全儿童临床试验的药物警戒体系。

方法:

分析我院2015年1月1日—2025年4月30日上报医学伦理委员会的药物临床试验中发生的136例严重不良事件(serious adverse event, SAE),分析SAE发生的性别、年龄、专业、药物种类、发生类型、SAE与药物的相关性、SAE报告问题、是否判断为可疑且非预期严重不良反应(suspected unexpected serious adverse reaction, SUSAR)。

结果:

136例SAE中,小儿血液专业发生例数(35例)最多;男童发生例数(77例)多于女童(59例),主要发生于儿童期(86例);药物种类中,治疗用生物制品发生例数最多(76例);对研究参与者的最主要影响是导致住院(124例);SAE与试验药物“肯定无关”例数最多(47例),对临床试验的最主要影响是“剂量不变,继续用药”(76例),SAE判断为SUSAR的共13例。

结论:

规范建立儿童药物临床试验中SAE的报告与处置体系,设计适宜儿童的SAE报告表,高度重视对儿童特有情况的评估,申办者、研究者和伦理委员会必须充分理解儿童与成人SAE谱的差异,强化安全性监测,最大程度保障儿童受试者的权益和安全。

儿童药物临床试验  /  严重不良事件  /  用药安全  /  药物警戒  /  规范策略
Objective:

To analyze the issues in the reporting of serious adverse events (SAEs) in pediatric drug clinical trials, propose standardized reporting strategies, ensure the safety and legitimate rights and interests of pediatric research participants, and improve the pharmacovigilance system for pediatric clinical trials.

Methods:

An analysis was conducted on 136 SAEs reported to the medical ethics committee of our hospital from our hospital between January 1, 2015 and April 30, 2025. The analysis covered the gender and age of affected children, medical specialities involved, types of drugs, patterns of SAE occurrence, causal relationship with the study drug, reporting issues, and whether they were judged as suspected unexpected serious adverse reactions (SUSARs).

Results:

Among the 136 SAEs, the pediatric hematology specialty had the highest number of cases (35 cases); the number of male cases (77 cases) was higher than that of female cases (59 cases), and most occurred during childhood (86 cases); among the drug types, therapeutic biological products had the highest number of cases (76 cases); the most significant impact on research participants was the requirement for hospitalization (124 cases); the number of cases where SAEs were "definitely unrelated" to the trial drug was the highest (47 cases), and the most significant impact on clinical trials was "no change in dose, continue medication" (76 cases); 13 cases were judged as SUSARs.

Conclusion:

It is necessary to establish a standardized reporting and handling system for SAEs in pediatric drug clinical trials, to develop SAE reporting forms suitable for children, and to attach great importance to the assessment of children's specific conditions. Sponsors, researchers, and ethics committees must fully understand the differences in SAE spectra between children and adults, strengthen safety monitoring, and maximize the protection of the rights and safety of pediatric subjects.

clinical trials of drugs in children  /  serious adverse events  /  medication safety  /  pharmacovigilance  /  regulatory strategies
郭春彦, 张怡, 杨禹欣, 梁宇光, 丁倩, 王谦, 张萌, 宋丽娟, 张成玥, 孙雨, 郭鹏. 儿童药物临床试验严重不良事件报告分析及规范策略. 中国新药杂志, 2026 , 35 (7) : 722 -726 . DOI: 10.20251/j.cnki.1003-3734.2026.07.007
Chun-yan GUO, Yi ZHANG, Yu-xin YANG, Yu-guang LIANG, Qian DING, Qian WANG, Meng ZHANG, Li-juan SONG, Cheng-yue ZHANG, Yu SUN, Peng GUO. Analysis and standardization strategies of serious adverse event reports in pediatric drug clinical trials[J]. Chinese Journal of New Drugs, 2026 , 35 (7) : 722 -726 . DOI: 10.20251/j.cnki.1003-3734.2026.07.007
  • 北京市卫生健康科技成果和适宜技术推广项目(BHTPP2024068)
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doi: 10.20251/j.cnki.1003-3734.2026.07.007
  • 首发时间:2026-10-26
  • 出版时间:2026-04-15
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  • 录用日期:2025-08-10
基金
北京市卫生健康科技成果和适宜技术推广项目(BHTPP2024068)
作者信息
    国家儿童医学中心/首都医科大学附属北京儿童医院临床研究中心,北京 100045

通讯作者:

* 郭鹏,男,教授,博士生导师,研究方向:儿童药物临床试验、儿童合理用药及药物作用机制研究。E-mail: 。
参考文献
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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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