Article(id=1236330556456227143, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1236330549866975405, 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=1695139200000, acceptedDateStr=2023-09-20, onlineDate=1772693774570, onlineDateStr=2026-03-05, pubDate=1697299200000, pubDateStr=2023-10-15, doiRegisterDate=null, doiRegisterDateStr=null, onlineIssueDate=1772693774570, onlineIssueDateStr=2026-03-05, onlineJustAcceptDate=null, onlineJustAcceptDateStr=null, onlineFirstDate=null, onlineFirstDateStr=null, sourceXml=null, magXml=null, createTime=1772693774570, creator=13701087609, updateTime=1772693774570, updator=13701087609, issue=Issue{id=1236330549866975405, tenantId=1146029695717560320, journalId=1235980733773295621, year='2023', volume='32', issue='19', pageStart='1905', pageEnd='2008', issueExtLink='null', onlineDate='null', pubDate='null', beforeIssueId=null, nextIssueId=null, price=null, status=1, issueComplete=1, articleOrder=1, issueType=-1, specialIssue=null, createTime=1772693772998, creator=13701087609, updateTime=1772695059296, updator=13701087609, preIssue=null, nextIssue=null, ext={EN=IssueExt(id=1236335945046348400, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1236330549866975405, language=EN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=), CN=IssueExt(id=1236335945046348401, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1236330549866975405, language=CN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=)}, issueFiles=null}, startPage=1935, endPage=1940, ext={EN=ArticleExt(id=1236330556691108187, articleId=1236330556456227143, tenantId=1146029695717560320, journalId=1235980733773295621, language=EN, title=Scientific considerations on clinical trial design of drugs for the treatment of psoriasis, columnId=null, journalTitle=Chinese Journal of New Drugs, columnName=null, runingTitle=null, highlight=null, articleAbstract=
Objective: To explore the key technical elements of clinical trial design for the treatment of plaque psoriasis vulgaris.
Methods: By searching both relevant domestic and international literature, and combined with research and evaluation practices in China, scientific considerations on innovative drug clinical trial design for the treatment of psoriasis are summarized and proposed.
Results and Conclusion: The overall design of clinical trials for the treatment of psoriasis vulgaris should be based on the characteristics of the disease's pathophysiology and drug action mechanisms, with a reasonable selection of control and population, as well as the design of trial duration, efficacy, and safety indicators. To comprehensively evaluate the effectiveness and safety of drugs, attention should be paid to the improvement of patients' quality of life, relapse or rebound after drug withdrawal, and long-term medication while evaluating the improvement of psoriasis symptoms and signs after drug treatment.
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目的： 探讨寻常型斑块状银屑病治疗药物临床试验设计的关键技术要素。
方法： 通过检索国内外相关文献，结合我国研发和审评实践，梳理、总结并提出该疾病领域创新药物临床试验设计的科学考虑。
结果和结论： 寻常型斑块状银屑病治疗药物临床试验总体设计应基于疾病病理生理及药物作用机制等特点，合理选择对照、试验人群，设计试验周期、疗效和安全性指标。为全面评价药物的有效性及安全性，应在评价药物治疗后银屑病症状、体征改善的同时，关注患者生活质量的改善、停药后复发或反弹、长期用药等。
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韵文萍，女，主治医师，主要从事新药临床技术审评。E-mail: yunwp@cde.org.cn。
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