Article(id=1322906878392541521, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1322906824709648449, articleNumber=null, orderNo=null, doi=null, 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=1620489600000, acceptedDateStr=2021-05-09, onlineDate=1793335178229, onlineDateStr=2026-10-30, pubDate=1635523200000, pubDateStr=2021-10-30, doiRegisterDate=null, doiRegisterDateStr=null, onlineIssueDate=1793335178229, onlineIssueDateStr=2026-10-30, onlineJustAcceptDate=null, onlineJustAcceptDateStr=null, onlineFirstDate=null, onlineFirstDateStr=null, sourceXml=null, magXml=null, createTime=1793335178229, creator=13701087609, updateTime=1793335178229, updator=13701087609, issue=Issue{id=1322906824709648449, tenantId=1146029695717560320, journalId=1235980733773295621, year='2021', volume='30', issue='20', pageStart='1825', pageEnd='1920', issueExtLink='null', onlineDate='null', pubDate='1635523200000', pubDateStr='2021-10-30', beforeIssueId=null, nextIssueId=null, price=null, status=1, issueComplete=1, articleOrder=1, issueType=-1, specialIssue=null, createTime=1793335165428, creator='13701087609', updateTime=1793337419278, updator='13701087609', preIssue=null, nextIssue=null, articleTotal=null, ext={EN=IssueExt(id=1322916278284976934, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1322906824709648449, language=EN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=), CN=IssueExt(id=1322916278284976935, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1322906824709648449, language=CN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=)}, issueFiles=null, downloadFileDto=null}, startPage=1911, endPage=1914, ext={EN=ArticleExt(id=1322906878556119378, articleId=1322906878392541521, tenantId=1146029695717560320, journalId=1235980733773295621, language=EN, title=Analysis of withdrawal outcomes of 32 patients with melanoma in clinical trials, columnId=null, journalTitle=Chinese Journal of New Drugs, columnName=null, runingTitle=null, highlight=null, articleAbstract=
Objective:

To analyze the information of clinical trial subjects who stopped taking drugs during the epidemic period, so as to provide guidance for the follow-up of clinical trial subjects under special events.

Methods:

The data of subjects in clinical trials of melanoma who stopped treatment during the epidemic period from February 3, 2020 to May 29, 2020 were collected. SPSS 24.0 statistical analysis software was used to compare the general data and clinical trial information between patients with advanced disease and patients without disease progression.

Results:

A total of 32 subjects were included, including 15 progressive subjects and 17 non progressing subjects. Gender, primary site, enrollment test, previous treatment, recurrence and metastasis site, best evaluation during enrollment, and administration regimen were independent risk factors for disease-free progression (P<0.05). There was significant difference in the number of medication cycles between the two groups.

Conclusion:

The previous best efficacy, medication regimen, and number of medication cycles have significant effects on the outcome of cancer clinical trials under special public health events.

, authors=Dan LI1, Yan ZHANG2, Dong-qing LU1, Kang JIAN1, authorsList=Dan LI, Yan ZHANG, Dong-qing LU, Kang JIAN, authorCompany=null, correspAuthors=null, 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=1322906878979744083, articleId=1322906878392541521, tenantId=1146029695717560320, journalId=1235980733773295621, language=CN, title=32例黑色素瘤临床试验受试者的停药结局分析, columnId=1236331163573342670, journalTitle=中国新药杂志, columnName=药物安全与合理应用, runingTitle=null, highlight=null, articleAbstract=
目的:

分析疫情期间停药的临床试验受试者信息,为后续特殊事件下临床试验受试者的随访提供借鉴和指导。

方法:

收集2020年2月3日至2020年5月29日疫情期间停药的黑色素瘤临床试验受试者信息,使用SPSS 24.0统计分析软件比较疾病进展患者与疾病未进展患者之间的一般资料及临床试验信息差异。

结果:

共纳入32例受试者,对于15例进展受试者与17例未进展受试者,性别、原发部位、入组试验、既往治疗、复发转移部位、入组期间最佳评效、给药方案是影响受试者无疾病进展的独立危险因素(P<0.05),其用药周期数存在显著差异,停药天数无显著差异。

结论:

公共卫生特殊事件下肿瘤临床试验受试者的既往最佳疗效、用药方案及用药周期数对于结局有显著影响。

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张燕,女,硕士,工程师,主要从事数据工程师数据分析师数据仓库和数据挖掘相关研究。E-mail:。

李丹,女,主管护师,主要从事药物临床试验及研究护士相关研究。E-mail:。

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李丹,女,主管护师,主要从事药物临床试验及研究护士相关研究。E-mail:。

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李丹,女,主管护师,主要从事药物临床试验及研究护士相关研究。E-mail:。

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32例黑色素瘤临床试验受试者的停药结局分析
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李丹 1 , 张燕 2 , 卢冬青 1 , 见康 1
中国新药杂志 | 药物安全与合理应用 2021,30(20): 1911-1914
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中国新药杂志 |药物安全与合理应用 2021 , 30 (20) : 1911 -1914
32例黑色素瘤临床试验受试者的停药结局分析
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李丹1 , 张燕2 , 卢冬青1, 见康1
作者信息
  • 1北京大学肿瘤医院 北京市肿瘤防治研究所国家药物临床试验机构,北京 100142
  • 2北京大学肿瘤医院 北京市肿瘤防治研究所胃肠肿瘤中心,恶性肿瘤发病机制及转化研究教育部重点实验室,北京 100142
作者简介:

张燕,女,硕士,工程师,主要从事数据工程师数据分析师数据仓库和数据挖掘相关研究。E-mail:。

李丹,女,主管护师,主要从事药物临床试验及研究护士相关研究。E-mail:。

Analysis of withdrawal outcomes of 32 patients with melanoma in clinical trials
Dan LI1 , Yan ZHANG2 , Dong-qing LU1, Kang JIAN1
Affiliations
  • 1Peking University Cancer Hospital National Drug Clinical Trial Center, Beijing Institute for Cancer Research, Beijing 100142, China
  • 2Peking University Cancer Hospital Key Laboratory of Carcinogenesis and Translational Research, Gastrointestinal Cancer Center, Beijing 100142, China
出版时间: 2021-10-30
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目的:

分析疫情期间停药的临床试验受试者信息,为后续特殊事件下临床试验受试者的随访提供借鉴和指导。

方法:

收集2020年2月3日至2020年5月29日疫情期间停药的黑色素瘤临床试验受试者信息,使用SPSS 24.0统计分析软件比较疾病进展患者与疾病未进展患者之间的一般资料及临床试验信息差异。

结果:

共纳入32例受试者,对于15例进展受试者与17例未进展受试者,性别、原发部位、入组试验、既往治疗、复发转移部位、入组期间最佳评效、给药方案是影响受试者无疾病进展的独立危险因素(P<0.05),其用药周期数存在显著差异,停药天数无显著差异。

结论:

公共卫生特殊事件下肿瘤临床试验受试者的既往最佳疗效、用药方案及用药周期数对于结局有显著影响。

黑色素瘤  /  临床试验  /  受试者  /  停药
Objective:

To analyze the information of clinical trial subjects who stopped taking drugs during the epidemic period, so as to provide guidance for the follow-up of clinical trial subjects under special events.

Methods:

The data of subjects in clinical trials of melanoma who stopped treatment during the epidemic period from February 3, 2020 to May 29, 2020 were collected. SPSS 24.0 statistical analysis software was used to compare the general data and clinical trial information between patients with advanced disease and patients without disease progression.

Results:

A total of 32 subjects were included, including 15 progressive subjects and 17 non progressing subjects. Gender, primary site, enrollment test, previous treatment, recurrence and metastasis site, best evaluation during enrollment, and administration regimen were independent risk factors for disease-free progression (P<0.05). There was significant difference in the number of medication cycles between the two groups.

Conclusion:

The previous best efficacy, medication regimen, and number of medication cycles have significant effects on the outcome of cancer clinical trials under special public health events.

melanoma  /  clinical trial  /  subjects  /  drug withdrawal
李丹, 张燕, 卢冬青, 见康. 32例黑色素瘤临床试验受试者的停药结局分析. 中国新药杂志, 2021 , 30 (20) : 1911 -1914 .
Dan LI, Yan ZHANG, Dong-qing LU, Kang JIAN. Analysis of withdrawal outcomes of 32 patients with melanoma in clinical trials[J]. Chinese Journal of New Drugs, 2021 , 30 (20) : 1911 -1914 .

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2021年第30卷第20期
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  • 首发时间:2026-10-30
  • 出版时间:2021-10-30
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    1北京大学肿瘤医院 北京市肿瘤防治研究所国家药物临床试验机构,北京 100142
    2北京大学肿瘤医院 北京市肿瘤防治研究所胃肠肿瘤中心,恶性肿瘤发病机制及转化研究教育部重点实验室,北京 100142
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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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