Article(id=1236331825740697730, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1236331822909550881, 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=1692547200000, acceptedDateStr=2023-08-21, onlineDate=1772694077191, onlineDateStr=2026-03-05, pubDate=1701273600000, pubDateStr=2023-11-30, doiRegisterDate=null, doiRegisterDateStr=null, onlineIssueDate=1772694077191, onlineIssueDateStr=2026-03-05, onlineJustAcceptDate=null, onlineJustAcceptDateStr=null, onlineFirstDate=null, onlineFirstDateStr=null, sourceXml=null, magXml=null, createTime=1772694077191, creator=13701087609, updateTime=1772694077191, updator=13701087609, issue=Issue{id=1236331822909550881, tenantId=1146029695717560320, journalId=1235980733773295621, year='2023', volume='32', issue='22', pageStart='2225', pageEnd='2328', issueExtLink='null', onlineDate='null', pubDate='null', beforeIssueId=null, nextIssueId=null, price=null, status=1, issueComplete=1, articleOrder=1, issueType=-1, specialIssue=null, createTime=1772694076516, creator=13701087609, updateTime=1772696919965, updator=13701087609, preIssue=null, nextIssue=null, ext={EN=IssueExt(id=1236343749253591892, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1236331822909550881, language=EN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=), CN=IssueExt(id=1236343749253591893, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1236331822909550881, language=CN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=)}, issueFiles=null}, startPage=2284, endPage=2292, ext={EN=ArticleExt(id=1236331825979773060, articleId=1236331825740697730, tenantId=1146029695717560320, journalId=1235980733773295621, language=EN, title=Analysis of clinical trials registration for ankylosing spondylitis based on data on the web of ClinicalTrials.gov, columnId=null, journalTitle=Chinese Journal of New Drugs, columnName=null, runingTitle=null, highlight=null, articleAbstract=
Objective: To analyze all clinical trials of ankylosing spondylitis (AS) up to December 31, 2022, so as to provide information reference for clinical studies related to AS drug treatment.
Methods: The website ClinicalTrials.gov was searched, then the items of the retrieved trials were described and analyzed.
Results: There were 392 clinical trials of AS, with 59 countries/regions participating in the world, and the top three were the United States, China, and Germany. The primary objective of the trials was treatment (n=187), followed by prevention (n=9). Nearly two-thirds of the trials excluded children, and 97% of the trials were not gender restricted. Most studies were designed to be randomized, parallel-assigned, and unblinded. The largest number of interventional trials involved biological agents (n=201), followed by chemical agents (n=65), and a small number of trials (n=3) also investigated the therapeutic effects of stem cells.
Conclusion: Most of the clinical trials of AS registered on ClinicalTrials.gov are randomized, parallel-assigned, unblinded interventional trials based on therapeutic purposes. The participating countries and sponsors are mostly in the United States, and a majority of the trials are funded by pharmaceutical companies. At the same time, new biological agents targeting different targets have gradually become the mainstream, bringing new opportunities for the treatment of AS.
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目的： 分析截至2022年12月31日的所有强直性脊柱炎（ankylosing spondylitis, AS）的临床试验，旨在为AS药物治疗相关的临床研究提供信息参考。
结果： AS临床试验共有392项，全球有59个国家/地区参与，数量排名前3的是美国、中国和德国。临床试验主要目的是治疗（187项），其次是预防（9项）。近2/3的临床试验排除了儿童，97%的临床试验不受性别限制。大多数临床试验设计为随机化、平行分配且非盲。干预性试验中生物制剂数量最多（201项），其次是化学制剂（65项），少量试验（3项）也研究了干细胞的疗效。
结论： AS在ClinicalTrials.gov上注册的大部分临床试验都是基于治疗目的随机、平行分配、不设盲的干预性试验，参与国家及申办机构均以美国居多，基金支持以医药企业为主。同时，针对不同靶点的新型生物制剂逐渐成为主流，为AS的治疗带来新机遇。
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, authorsList=白丽娜, 苗华丽, 李婉玲, 苏闫兵, 范秀英, 张莉芸)}, authors=[Author(id=1236334077872239063, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1236331825740697730, orderNo=0, firstName=null, middleName=null, lastName=null, nameCn=null, orcid=null, stid=null, country=null, authorPic=null, dead=0, email=1185063267@qq.com, emailSecond=null, emailThird=null, correspondingAuthor=0, authorType=1, ext={EN=AuthorExt(id=1236334077951930841, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1236331825740697730, authorId=1236334077872239063, language=EN, stringName=Li-na BAI, firstName=Li-na, middleName=null, lastName=BAI, prefix=null, suffix=null, authorComment=null, nameInitials=null, affiliation=null, department=null, xref=
1, address=
1Department of Rheumatology and Immunology, Third Hospital of Shanxi Medical University, Shanxi Bethune Hospital, Shanxi Academy of Medical Sciences, Tongji Shanxi Hospital, Taiyuan 030032, China, bio=null, bioImg=null, bioContent=null, aboutCorrespAuthor=null), CN=AuthorExt(id=1236334078052594138, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1236331825740697730, authorId=1236334077872239063, language=CN, stringName=白丽娜, firstName=null, middleName=null, lastName=null, prefix=null, suffix=null, authorComment=null, nameInitials=null, affiliation=null, department=null, xref=
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1山西医科大学第三医院，山西白求恩医院，山西医学科学院，同济山西医院 风湿免疫科，太原 030032, bio={"content":"
白丽娜，女，硕士研究生，主管护师，主要从事风湿免疫性疾病的慢病管理。E-mail: 1185063267@qq.com。
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白丽娜，女，硕士研究生，主管护师，主要从事风湿免疫性疾病的慢病管理。E-mail: 1185063267@qq.com。
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1Department of Rheumatology and Immunology, Third Hospital of Shanxi Medical University, Shanxi Bethune Hospital, Shanxi Academy of Medical Sciences, Tongji Shanxi Hospital, Taiyuan 030032, China), AuthorCompanyExt(id=1236334077423448520, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1236331825740697730, companyId=1236334077410865606, language=CN, country=null, province=null, city=null, postcode=null, companyName=null, departmentName=null, remark=
1山西医科大学第三医院，山西白求恩医院，山西医学科学院，同济山西医院 风湿免疫科，太原 030032)])]), Author(id=1236334078128091612, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1236331825740697730, orderNo=1, firstName=null, middleName=null, lastName=null, nameCn=null, orcid=null, stid=null, country=null, authorPic=null, dead=0, email=null, emailSecond=null, emailThird=null, correspondingAuthor=0, authorType=1, ext={EN=AuthorExt(id=1236334078245532126, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1236331825740697730, authorId=1236334078128091612, language=EN, stringName=Hua-li MIAO, firstName=Hua-li, middleName=null, lastName=MIAO, prefix=null, suffix=null, authorComment=null, nameInitials=null, affiliation=null, department=null, xref=
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2Nursing Department, Third Hospital of Shanxi Medical University, Shanxi Bethune Hospital, Shanxi Academy of Medical Sciences, Tongji Shanxi Hospital, Taiyuan 030032, China, bio=null, bioImg=null, bioContent=null, aboutCorrespAuthor=null), CN=AuthorExt(id=1236334078304252383, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1236331825740697730, authorId=1236334078128091612, language=CN, stringName=苗华丽, firstName=null, middleName=null, lastName=null, prefix=null, suffix=null, authorComment=null, nameInitials=null, affiliation=null, department=null, xref=
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2山西医科大学第三医院，山西白求恩医院，山西医学科学院，同济山西医院 护理部，太原 030032, bio=null, bioImg=null, bioContent=null, aboutCorrespAuthor=null)}, companyList=[AuthorCompany(id=1236334077490557385, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1236331825740697730, xref=2, ext=[AuthorCompanyExt(id=1236334077498945994, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1236331825740697730, companyId=1236334077490557385, language=EN, country=null, province=null, city=null, postcode=null, companyName=null, departmentName=null, remark=
2Nursing Department, Third Hospital of Shanxi Medical University, Shanxi Bethune Hospital, Shanxi Academy of Medical Sciences, Tongji Shanxi Hospital, Taiyuan 030032, China), AuthorCompanyExt(id=1236334077507334603, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1236331825740697730, companyId=1236334077490557385, language=CN, country=null, province=null, city=null, postcode=null, companyName=null, departmentName=null, remark=
2山西医科大学第三医院，山西白求恩医院，山西医学科学院，同济山西医院 护理部，太原 030032)])]), Author(id=1236334078362972641, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1236331825740697730, orderNo=2, firstName=null, middleName=null, lastName=null, nameCn=null, orcid=null, stid=null, country=null, authorPic=null, dead=0, email=null, emailSecond=null, emailThird=null, correspondingAuthor=0, authorType=1, ext={EN=AuthorExt(id=1236334078442664419, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1236331825740697730, authorId=1236334078362972641, language=EN, stringName=Wan-ling LI, firstName=Wan-ling, middleName=null, lastName=LI, prefix=null, suffix=null, authorComment=null, nameInitials=null, affiliation=null, department=null, xref=
3, address=
3General Medical Department, Tongji Hospital of Tongji Medical College of Huazhong University of Science and Technology, Wuhan 430033, China, bio=null, bioImg=null, bioContent=null, aboutCorrespAuthor=null), CN=AuthorExt(id=1236334078509773284, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1236331825740697730, authorId=1236334078362972641, language=CN, stringName=李婉玲, firstName=null, middleName=null, lastName=null, prefix=null, suffix=null, authorComment=null, nameInitials=null, affiliation=null, department=null, xref=
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3华中科技大学同济医学院同济医院综合医疗科，武汉 430033, bio=null, bioImg=null, bioContent=null, aboutCorrespAuthor=null)}, companyList=[AuthorCompany(id=1236334077578637772, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1236331825740697730, xref=3, ext=[AuthorCompanyExt(id=1236334077582832077, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1236331825740697730, companyId=1236334077578637772, language=EN, country=null, province=null, city=null, postcode=null, companyName=null, departmentName=null, remark=
3General Medical Department, Tongji Hospital of Tongji Medical College of Huazhong University of Science and Technology, Wuhan 430033, China), AuthorCompanyExt(id=1236334077591220686, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1236331825740697730, companyId=1236334077578637772, language=CN, country=null, province=null, city=null, postcode=null, companyName=null, departmentName=null, remark=
3华中科技大学同济医学院同济医院综合医疗科，武汉 430033)])]), Author(id=1236334078576882150, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1236331825740697730, orderNo=3, firstName=null, middleName=null, lastName=null, nameCn=null, orcid=null, stid=null, country=null, authorPic=null, dead=0, email=null, emailSecond=null, emailThird=null, correspondingAuthor=0, authorType=1, ext={EN=AuthorExt(id=1236334078656573928, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1236331825740697730, authorId=1236334078576882150, language=EN, stringName=Yan-bing SU, firstName=Yan-bing, middleName=null, lastName=SU, prefix=null, suffix=null, authorComment=null, nameInitials=null, affiliation=null, department=null, xref=
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4Science and Research Department, Third Hospital of Shanxi Medical University, Shanxi Bethune Hospital, Shanxi Academy of Medical Sciences, Tongji Shanxi Hospital, Taiyuan 030032, China, bio=null, bioImg=null, bioContent=null, aboutCorrespAuthor=null), CN=AuthorExt(id=1236334078719488489, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1236331825740697730, authorId=1236334078576882150, language=CN, stringName=苏闫兵, firstName=null, middleName=null, lastName=null, prefix=null, suffix=null, authorComment=null, nameInitials=null, affiliation=null, department=null, xref=
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4山西医科大学第三医院，山西白求恩医院，山西医学科学院，同济山西医院 科研部，太原 030032, bio=null, bioImg=null, bioContent=null, aboutCorrespAuthor=null)}, companyList=[AuthorCompany(id=1236334077666718160, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1236331825740697730, xref=4, ext=[AuthorCompanyExt(id=1236334077675106769, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1236331825740697730, companyId=1236334077666718160, language=EN, country=null, province=null, city=null, postcode=null, companyName=null, departmentName=null, remark=
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4山西医科大学第三医院，山西白求恩医院，山西医学科学院，同济山西医院 科研部，太原 030032)])]), Author(id=1236334078790791659, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1236331825740697730, orderNo=4, firstName=null, middleName=null, lastName=null, nameCn=null, orcid=null, stid=null, country=null, authorPic=null, dead=0, email=null, emailSecond=null, emailThird=null, correspondingAuthor=0, authorType=1, ext={EN=AuthorExt(id=1236334078862094829, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1236331825740697730, authorId=1236334078790791659, language=EN, stringName=Xiu-ying FAN, firstName=Xiu-ying, middleName=null, lastName=FAN, prefix=null, suffix=null, authorComment=null, nameInitials=null, affiliation=null, department=null, xref=
5, address=
5Drug Clinical Trial Institution, Third Hospital of Shanxi Medical University, Shanxi Bethune Hospital, Shanxi Academy of Medical Sciences, Tongji Shanxi Hospital, Taiyuan 030032, China, bio=null, bioImg=null, bioContent=null, aboutCorrespAuthor=null), CN=AuthorExt(id=1236334078937592302, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1236331825740697730, authorId=1236334078790791659, language=CN, stringName=范秀英, firstName=null, middleName=null, lastName=null, prefix=null, suffix=null, authorComment=null, nameInitials=null, affiliation=null, department=null, xref=
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5山西医科大学第三医院，山西白求恩医院，山西医学科学院，同济山西医院 药物临床试验机构办公室，太原 030032, bio=null, bioImg=null, bioContent=null, aboutCorrespAuthor=null)}, companyList=[AuthorCompany(id=1236334077784158675, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1236331825740697730, xref=5, ext=[AuthorCompanyExt(id=1236334077792547284, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1236331825740697730, companyId=1236334077784158675, language=EN, country=null, province=null, city=null, postcode=null, companyName=null, departmentName=null, remark=
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5Drug Clinical Trial Institution, Third Hospital of Shanxi Medical University, Shanxi Bethune Hospital, Shanxi Academy of Medical Sciences, Tongji Shanxi Hospital, Taiyuan 030032, China, bio=null, bioImg=null, bioContent=null, aboutCorrespAuthor=null), CN=AuthorExt(id=1236334079168279027, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1236331825740697730, authorId=1236334079013089776, language=CN, stringName=张莉芸, firstName=null, middleName=null, lastName=null, prefix=null, suffix=null, authorComment=null, nameInitials=null, affiliation=null, department=null, xref=
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