Article(id=1236369014579065146, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1236369013111050820, 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=1686153600000, acceptedDateStr=2023-06-08, onlineDate=1772702943700, onlineDateStr=2026-03-05, pubDate=1694707200000, pubDateStr=2023-09-15, doiRegisterDate=null, doiRegisterDateStr=null, onlineIssueDate=1772702943700, onlineIssueDateStr=2026-03-05, onlineJustAcceptDate=null, onlineJustAcceptDateStr=null, onlineFirstDate=null, onlineFirstDateStr=null, sourceXml=null, magXml=null, createTime=1772702943700, creator=13701087609, updateTime=1772702943700, updator=13701087609, issue=Issue{id=1236369013111050820, tenantId=1146029695717560320, journalId=1235980733773295621, year='2023', volume='32', issue='17', pageStart='1697', pageEnd='1800', issueExtLink='null', onlineDate='null', pubDate='null', beforeIssueId=null, nextIssueId=null, price=null, status=1, issueComplete=1, articleOrder=1, issueType=-1, specialIssue=null, createTime=1772702943351, creator=13701087609, updateTime=1772703317941, updator=13701087609, preIssue=null, nextIssue=null, ext={EN=IssueExt(id=1236370584322495028, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1236369013111050820, language=EN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=), CN=IssueExt(id=1236370584326689333, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1236369013111050820, language=CN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=)}, issueFiles=null}, startPage=1749, endPage=1755, ext={EN=ArticleExt(id=1236369014910415181, articleId=1236369014579065146, tenantId=1146029695717560320, journalId=1235980733773295621, language=EN, title=The treatment of 104 cases of active elderly-onset rheumatoid arthritis with iguratimod or methotrexate combined with leflunomide, columnId=null, journalTitle=Chinese Journal of New Drugs, columnName=null, runingTitle=null, highlight=null, articleAbstract=
Objective: To compare the efficacy and safety of iguratimod or methotrexate combined with leflunomide in patients with active elderly-onset rheumatoid arthritis.
Methods: A single-center, randomized, double-blinded, controlled clinical trial was conducted in elderly-onset patients. The patients were randomly assigned to two groups of iguratimod combined with leflunomide (Group Iguratimod) or methotrexate combined with leflunomide (Group Methotrexate) treatments at a ratio of 1∶1. The efficacy and safety of both groups were evaluated at weeks 4, 12, 24 and 52, respectively. The primary endpoint was the American Colleague of Rheumatology 20 (ACR20) response rates at week 52 and disease activity score (DAS28) (CRP) at 52 weeks after treatment.
Results: A total of 104 patients with elderly-onset rheumatoid arthritis were enrolled in the study. The comparison of the two groups on the baseline demographic data and RA activity showed that the iguratimod group was older (67.0 and 64.0, Z=-2.874, P=0.004), and the methotrexate group had a higher DAS28 (CRP) score (4.7 and 6.0, Z=-3.163, P=0.002). There was no statistically significant difference between the remaining results of the two groups. After 52 weeks of treatment, the ACR20 compliance rates in the iguratimod group and the methotrexate group were 90.0% and 93.9%, respectively (χ2=0.115, P=0.735). There was no statistically significant difference in compliance rates of ACR20, ACR50 and ACR70 between the groups at other time points compared to the baseline. There was no statistically significant difference in the DAS28 (CRP) score between the two groups at the end point of 52 weeks. Fewer adverse events were observed in the iguratimod group compared to the methotrexate group (26.0% and 46.9%, χ2=4.689, P=0.030). No serious adverse events were found in Group Iguratimod, but 3 cases of pneumonia were hospitalized in Group Methotrexate.
Conclusion: Iguratimod combined with leflunomide is an effective regimen with good safety for the treatment of active elderly-onset rheumatoid arthritis, with comparable efficacy and better safety compared to methotrexate combined with leflunomide.
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目的： 评价艾拉莫德或甲氨蝶呤联合来氟米特治疗活动性老年类风湿关节炎的疗效和安全性。
方法： 本研究是一项单中心、随机、双盲、对照临床试验。研究纳入活动期老年类风湿关节炎患者，按照1∶1比例随机分配到艾拉莫德联合来氟米特治疗组（艾拉莫德组）与甲氨蝶呤联合来氟米特治疗组（甲氨蝶呤组）。分别在用药后4，12，24，52周对两组的疗效和安全性进行评价。主要疗效终点是治疗后52周美国风湿病学会20%缓解（American College of Rheumatology 20, ACR20）达标率和28个关节C反应蛋白水平的疾病活动评分［disease activity score 28（C-reactive protein），DAS28（CRP）］评分改善值。
结果： 共有104例患者纳入研究。基线两组人口统计学资料和类风湿关节炎活动度比较，艾拉莫德组年龄更大（67.0和64.0，Z=-2.874，P=0.004），甲氨蝶呤组DAS28（CRP）评分更高（4.7和6.0，Z=-3.163，P=0.002），其他两组差异均无统计学意义。艾拉莫德组和甲氨蝶呤组治疗后52周ACR20达标率分别为90.0%与93.9%（χ2=0.115，P=0.735）。ACR20，ACR50，ACR70达标率与基线比较下降值差异无统计学意义（P>0.05）。在终点52周时DAS28（CRP）评分改善值两组比较无统计学差异（P>0.05）。艾拉莫德组与甲氨蝶呤组比较不良事件更少（26.0%和46.9%， χ2=4.689，P=0.030）。艾拉莫德组无严重不良事件发生，但甲氨蝶呤组发生3例肺部感染住院治疗。
结论： 艾拉莫德联合来氟米特是一种有效且安全的治疗活动性老年类风湿关节炎的方案，疗效与甲氨蝶呤联合来氟米特相当，安全性更好。
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1湘雅常德医院风湿免疫科，常德 415000, bio={"content":"
韩玉艳，女，硕士，副主任医师，主要从事类风湿关节炎、系统性红斑狼疮等风湿免疫疾病的诊治研究。联系电话：(0736)2120523，E-mail: lovelifehanyuyan@163.com。
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韩玉艳，女，硕士，副主任医师，主要从事类风湿关节炎、系统性红斑狼疮等风湿免疫疾病的诊治研究。联系电话：(0736)2120523，E-mail: lovelifehanyuyan@163.com。
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