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Article(id=1291704889340621406, tenantId=1146029695717560320, journalId=1246415772164075586, issueId=1291704786705993936, articleNumber=null, orderNo=null, doi=10.13699/j.cnki.1001-6821.2025.20.021, pmid=null, cstr=null, oa=null, hot=null, price=null, onlineType=0, articleFormat=0, articleType=null, articleTypeStr=null, receivedDate=1747152000000, receivedDateStr=2025-05-14, revisedDate=null, revisedDateStr=null, acceptedDate=null, acceptedDateStr=null, onlineDate=1785896044334, onlineDateStr=2026-08-05, pubDate=1761580800000, pubDateStr=2025-10-28, doiRegisterDate=null, doiRegisterDateStr=null, onlineIssueDate=1785896044334, onlineIssueDateStr=2026-08-05, onlineJustAcceptDate=null, onlineJustAcceptDateStr=null, onlineFirstDate=null, onlineFirstDateStr=null, sourceXml=null, magXml=null, createTime=1785896044334, creator=13701087609, updateTime=1785896044334, updator=13701087609, issue=Issue{id=1291704786705993936, tenantId=1146029695717560320, journalId=1246415772164075586, year='2025', volume='41', issue='20', pageStart='2851', pageEnd='3000', issueExtLink='null', onlineDate='null', pubDate='1761580800000', pubDateStr='2025-10-28', beforeIssueId=null, nextIssueId=null, price=null, status=1, issueComplete=1, articleOrder=1, issueType=-1, specialIssue=null, createTime=1785896019864, creator='13701087609', updateTime=1785896741492, updator='13701087609', preIssue=null, nextIssue=null, articleTotal=null, ext={EN=IssueExt(id=1291707813508702571, tenantId=1146029695717560320, journalId=1246415772164075586, issueId=1291704786705993936, language=EN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=), CN=IssueExt(id=1291707813508702572, tenantId=1146029695717560320, journalId=1246415772164075586, issueId=1291704786705993936, language=CN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=)}, issueFiles=null, downloadFileDto=null}, startPage=2976, endPage=2981, ext={EN=ArticleExt(id=1291704889776829024, articleId=1291704889340621406, tenantId=1146029695717560320, journalId=1246415772164075586, language=EN, title=Analysis and intervention strategies for 528 cases of serious adverse events in tumor drug clinical trials based on ethical review, columnId=1291704889697137247, journalTitle=Chinese Journal of Clinical Pharmacology, columnName=Special Column of Clinical Trials Administration, runingTitle=null, highlight=null, articleAbstract=
Objective

To track and follow up serious adverse event (SAE) occurring at a tertiary hospital clinical trial institution in Hunan province, analyze and summarize the occurrence and outcomes of SAEs, and propose interventions and improvement measures to standardize the handling of SAE, report them promptly, protect the safety of research participants, ensure the reliability of clinical trial data, and improve the level of clinical trials.

Methods

A total of 528 SAEs related to cancer drugs were collected from this clinical trial institution from January 2020 to December 2024 and analyzed using SPSS 25.0 software.

Results

The results showed that the main departments where SAEs occurred were oncology (35.25%), pulmonology (21.21%), and hematology (10.04%). SAEs were mainly concentrated in phase III clinical trials, accounting for 69.51% of the total SAE cases. The SAE predominantly affected the respiratory system, hematologic system, and gastrointestinal system, with grade 3 severity being most common (46.02%). The outcomes for research participants were generally favorable, 39.77% fully recovered and 25.00% improved.

Conclusion

Clinical trial institutions need to strengthen drug safety monitoring, promptly evaluate SAE, enhance supervision over SAEs, and safeguard the rights and safety of research participants.

, authors=Shu-hao KOU1, 2, 3, 4, Qin XIAO1, 3, Ya-ting LIU1, 2, 3, 4, Pei-jun XIAO1, 3, Yan-hong LUO1, 3, Jia ZHOU1, 2, 3, 4, Bin-yu ZENG1, 2, 3, 4, Qun QIN1, 2, 3, 4, Xin ZHANG1, 3, authorsList=Shu-hao KOU, Qin XIAO, Ya-ting LIU, Pei-jun XIAO, Yan-hong LUO, Jia ZHOU, Bin-yu ZENG, Qun QIN, Xin ZHANG, authorCompany=null, correspAuthors=Qun QIN, 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=1291704890552775266, articleId=1291704889340621406, tenantId=1146029695717560320, journalId=1246415772164075586, language=CN, title=基于伦理审查对临床试验中528例肿瘤药物严重不良事件的分析及干预策略, columnId=1291704889869103713, journalTitle=中国临床药理学杂志, columnName=临床试验管理专栏, runingTitle=null, highlight=null, articleAbstract=
目的

对湖南某三级甲等医院临床试验机构发生的严重不良事件（SAE）进行跟踪随访，分析总结SAE发生与转归情况，并提出干预和改进措施，规范SAE的处理方法并及时上报，保护研究参与者的安全，保证临床试验的数据可靠，提高临床试验水平。

方法

收集该临床试验机构2020年1月~2024年12月发生的528例次肿瘤药物SAE，采用SPSS 25.0软件进行统计分析。

结果

结果显示，发生的主要专业为肿瘤科（35.25%）、呼吸内科（21.21%）、血液科（10.04%）；SAE主要集中在Ⅲ期临床试验，发生SAE例次占比69.51%；且发生的SAE主要累积呼吸系统、血液系统、胃肠道系统，多为3级较为严重不良事件（46.02%）；研究参与者转归情况良好，痊愈占39.77%，好转占比25.00%。

结论

临床试验机构需加强对药品进行安全性监测、及时判定，加强对SAE的监管，保护研究参与者的权益和安全。

, authors=寇舒豪1, 2, 3, 4, 肖秦1, 3, 刘雅婷1, 2, 3, 4, 肖佩君1, 3, 罗艳红1, 3, 周佳1, 2, 3, 4, 曾宾宇1, 2, 3, 4, 秦群1, 2, 3, 4, 张欣1, 3, authorsList=寇舒豪, 肖秦, 刘雅婷, 肖佩君, 罗艳红, 周佳, 曾宾宇, 秦群, 张欣, authorCompany=null, correspAuthors=秦群, authorNote=

寇舒豪（2001-），男，硕士研究生，主要从事临床药学以及药物临床研究

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秦群，主任药师，博士生导师 Tel: （0731）84327918 E-mail:
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2.Department of Pharmacy, Xiangya Hospital, Central South University, Changsha 410008, Hunan Province, China
3.National Clinical Research Center for Geriatric Diseases, Xiangya Hospital, Central South University, Changsha 410008, Hunan Province, China
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3.中南大学 湘雅医院 国家老年疾病临床医学研究中心，湖南 长沙 410008
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2.Department of Pharmacy, Xiangya Hospital, Central South University, Changsha 410008, Hunan Province, China
3.National Clinical Research Center for Geriatric Diseases, Xiangya Hospital, Central South University, Changsha 410008, Hunan Province, China
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2.中南大学 湘雅医院 药学部，湖南 长沙 410008
3.中南大学 湘雅医院 国家老年疾病临床医学研究中心，湖南 长沙 410008
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2.Department of Pharmacy, Xiangya Hospital, Central South University, Changsha 410008, Hunan Province, China
3.National Clinical Research Center for Geriatric Diseases, Xiangya Hospital, Central South University, Changsha 410008, Hunan Province, China
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2.中南大学 湘雅医院 药学部，湖南 长沙 410008
3.中南大学 湘雅医院 国家老年疾病临床医学研究中心，湖南 长沙 410008
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2.Department of Pharmacy, Xiangya Hospital, Central South University, Changsha 410008, Hunan Province, China
3.National Clinical Research Center for Geriatric Diseases, Xiangya Hospital, Central South University, Changsha 410008, Hunan Province, China
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2.中南大学 湘雅医院 药学部，湖南 长沙 410008
3.中南大学 湘雅医院 国家老年疾病临床医学研究中心，湖南 长沙 410008
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基于伦理审查对临床试验中528例肿瘤药物严重不良事件的分析及干预策略
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寇舒豪 1, 2, 3, 4 , 肖秦 1, 3 , 刘雅婷 1, 2, 3, 4 , 肖佩君 1, 3 , 罗艳红 1, 3 , 周佳 1, 2, 3, 4 , 曾宾宇 1, 2, 3, 4 , 秦群 1, 2, 3, 4 , 张欣 1, 3
中国临床药理学杂志 | 临床试验管理专栏 2025,41(20): 2976-2981
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中国临床药理学杂志 |临床试验管理专栏 2025 , 41 (20) : 2976 -2981
基于伦理审查对临床试验中528例肿瘤药物严重不良事件的分析及干预策略
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2.Department of Pharmacy, Xiangya Hospital, Central South University, Changsha 410008, Hunan Province, China
3.National Clinical Research Center for Geriatric Diseases, Xiangya Hospital, Central South University, Changsha 410008, Hunan Province, China
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2.中南大学 湘雅医院 药学部，湖南 长沙 410008
3.中南大学 湘雅医院 国家老年疾病临床医学研究中心，湖南 长沙 410008
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2.Department of Pharmacy, Xiangya Hospital, Central South University, Changsha 410008, Hunan Province, China
3.National Clinical Research Center for Geriatric Diseases, Xiangya Hospital, Central South University, Changsha 410008, Hunan Province, China
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2.中南大学 湘雅医院 药学部，湖南 长沙 410008
3.中南大学 湘雅医院 国家老年疾病临床医学研究中心，湖南 长沙 410008
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2.中南大学 湘雅医院 药学部，湖南 长沙 410008
3.中南大学 湘雅医院 国家老年疾病临床医学研究中心，湖南 长沙 410008
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寇舒豪1, 2, 3, 4, 肖秦1, 3, 刘雅婷1, 2, 3, 4, 肖佩君1, 3, 罗艳红1, 3, 周佳1, 2, 3, 4, 曾宾宇1, 2, 3, 4, 秦群1, 2, 3, 4 , 张欣1, 3
作者信息
  • 1.中南大学 湘雅医院，湖南 长沙 410008
  • 2.中南大学 湘雅医院 药学部，湖南 长沙 410008
  • 3.中南大学 湘雅医院 国家老年疾病临床医学研究中心，湖南 长沙 410008
  • 4.湖南省生物制剂早期临床试验国际科技创新合作基地，湖南 长沙，410008
通讯作者:
秦群，主任药师，博士生导师 Tel: （0731）84327918 E-mail:
作者简介:

寇舒豪（2001-），男，硕士研究生，主要从事临床药学以及药物临床研究

Analysis and intervention strategies for 528 cases of serious adverse events in tumor drug clinical trials based on ethical review
Shu-hao KOU1, 2, 3, 4, Qin XIAO1, 3, Ya-ting LIU1, 2, 3, 4, Pei-jun XIAO1, 3, Yan-hong LUO1, 3, Jia ZHOU1, 2, 3, 4, Bin-yu ZENG1, 2, 3, 4, Qun QIN1, 2, 3, 4 , Xin ZHANG1, 3
Affiliations
  • 1.Xiangya Hospital, Central South University, Changsha 410008, Hunan Province, China
  • 2.Department of Pharmacy, Xiangya Hospital, Central South University, Changsha 410008, Hunan Province, China
  • 3.National Clinical Research Center for Geriatric Diseases, Xiangya Hospital, Central South University, Changsha 410008, Hunan Province, China
  • 4.Hunan Provincial International Science and Technology Innovation Cooperation Base for Early Clinical Trials of Biological Products, Changsha 410008, Hunan Province, China
出版时间: 2025-10-28 doi: 10.13699/j.cnki.1001-6821.2025.20.021
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摘要
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目的

对湖南某三级甲等医院临床试验机构发生的严重不良事件（SAE）进行跟踪随访，分析总结SAE发生与转归情况，并提出干预和改进措施，规范SAE的处理方法并及时上报，保护研究参与者的安全，保证临床试验的数据可靠，提高临床试验水平。

方法

收集该临床试验机构2020年1月~2024年12月发生的528例次肿瘤药物SAE，采用SPSS 25.0软件进行统计分析。

结果

结果显示，发生的主要专业为肿瘤科（35.25%）、呼吸内科（21.21%）、血液科（10.04%）；SAE主要集中在Ⅲ期临床试验，发生SAE例次占比69.51%；且发生的SAE主要累积呼吸系统、血液系统、胃肠道系统，多为3级较为严重不良事件（46.02%）；研究参与者转归情况良好，痊愈占39.77%，好转占比25.00%。

结论

临床试验机构需加强对药品进行安全性监测、及时判定，加强对SAE的监管，保护研究参与者的权益和安全。

临床试验  /  严重不良事件  /  安全性监测
Objective

To track and follow up serious adverse event (SAE) occurring at a tertiary hospital clinical trial institution in Hunan province, analyze and summarize the occurrence and outcomes of SAEs, and propose interventions and improvement measures to standardize the handling of SAE, report them promptly, protect the safety of research participants, ensure the reliability of clinical trial data, and improve the level of clinical trials.

Methods

A total of 528 SAEs related to cancer drugs were collected from this clinical trial institution from January 2020 to December 2024 and analyzed using SPSS 25.0 software.

Results

The results showed that the main departments where SAEs occurred were oncology (35.25%), pulmonology (21.21%), and hematology (10.04%). SAEs were mainly concentrated in phase III clinical trials, accounting for 69.51% of the total SAE cases. The SAE predominantly affected the respiratory system, hematologic system, and gastrointestinal system, with grade 3 severity being most common (46.02%). The outcomes for research participants were generally favorable, 39.77% fully recovered and 25.00% improved.

Conclusion

Clinical trial institutions need to strengthen drug safety monitoring, promptly evaluate SAE, enhance supervision over SAEs, and safeguard the rights and safety of research participants.

clinical trial  /  serious adverse events  /  safety monitoring
寇舒豪, 肖秦, 刘雅婷, 肖佩君, 罗艳红, 周佳, 曾宾宇, 秦群, 张欣. 基于伦理审查对临床试验中528例肿瘤药物严重不良事件的分析及干预策略. 中国临床药理学杂志, 2025 , 41 (20) : 2976 -2981 . DOI: 10.13699/j.cnki.1001-6821.2025.20.021
Shu-hao KOU, Qin XIAO, Ya-ting LIU, Pei-jun XIAO, Yan-hong LUO, Jia ZHOU, Bin-yu ZENG, Qun QIN, Xin ZHANG. Analysis and intervention strategies for 528 cases of serious adverse events in tumor drug clinical trials based on ethical review[J]. Chinese Journal of Clinical Pharmacology, 2025 , 41 (20) : 2976 -2981 . DOI: 10.13699/j.cnki.1001-6821.2025.20.021
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  • 湖南省卫生健康委科研课题基金资助项目(20221501452)
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doi: 10.13699/j.cnki.1001-6821.2025.20.021
  • 接收时间：2025-05-14
  • 首发时间：2026-08-05
  • 出版时间：2025-10-28
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  • 收稿日期：2025-05-14
基金
湖南省卫生健康委科研课题基金资助项目(20221501452)
作者信息
    1.中南大学 湘雅医院，湖南 长沙 410008
    2.中南大学 湘雅医院 药学部，湖南 长沙 410008
    3.中南大学 湘雅医院 国家老年疾病临床医学研究中心，湖南 长沙 410008
    4.湖南省生物制剂早期临床试验国际科技创新合作基地，湖南 长沙，410008

通讯作者:

秦群，主任药师，博士生导师 Tel: （0731）84327918 E-mail:
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https://castjournals.cast.org.cn/joweb/zglcylxzz/CN/10.13699/j.cnki.1001-6821.2025.20.021
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2种不同金属材料的力学参数
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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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