Article(id=1236331825283527020, 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=1772694077081, onlineDateStr=2026-03-05, pubDate=1701273600000, pubDateStr=2023-11-30, doiRegisterDate=null, doiRegisterDateStr=null, onlineIssueDate=1772694077081, onlineIssueDateStr=2026-03-05, onlineJustAcceptDate=null, onlineJustAcceptDateStr=null, onlineFirstDate=null, onlineFirstDateStr=null, sourceXml=null, magXml=null, createTime=1772694077081, creator=13701087609, updateTime=1772694077081, 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=2264, endPage=2269, ext={EN=ArticleExt(id=1236331825501630847, articleId=1236331825283527020, tenantId=1146029695717560320, journalId=1235980733773295621, language=EN, title=The effect of Qingre Lishi Huoxue method combined with iguratimod tablets on bone metabolism and clinical efficacy observation in treating primary rheumatoid arthritis, columnId=null, journalTitle=Chinese Journal of New Drugs, columnName=null, runingTitle=null, highlight=null, articleAbstract=
Objective: To explore the effect of Qingre Lishi Huoxue method combined with iguratimod tablets on bone metabolism and observe the clinical efficacy in treating primary rheumatoid arthritis.
Methods: Ninety patients with RA of damp-heat paralysis type who were treated for the first time in the rheumatology department of our hospital from June 2021 to December 2022 were selected and randomly divided into two groups, 45 cases in each group. The control group was treated with iguratimod tablets, while the treatment group was treated with Qingre Lishi Huoxue method in addition. At 12 weeks of treatment, the effective rate of TCM syndromes in the two groups was observed, and the changes of BMD and bone metabolism levels were measured, including serum osteocalcin (BGP), type I procollagen N-terminal propeptide (PINP), β-collagen special series (β-CTX), 25-hydroxy vitamin D (25(OH)D), and parathyroid hormone (PTH); at the same time, disease activity indicators were evaluated, including joint swelling number (SJC), tenderness number (TJC), the patient global assessment (PGA), disease activity index 28-CRP (DAS28-CRP), anti-cyclic citrullinated peptide antibody (ACPA), erythrocyte sedimentation rate (ESR), C-reactive protein (CRP), and safety indicators such as blood and urine routine, liver and kidney function, and ECG.
Results: At 12 weeks of treatment, the effective rate of TCM syndromes in the treatment group was significantly higher than that in the control group (χ2=5.07, P<0.05). The BMD level of the right forearm in both the treatment group and the control group was significantly improved compared with that before treatment (P<0.05). The BMD levels of the lumbar spine and left hip in the two groups were improved compared with those before treatment, but the difference was not statistically significant (P>0.05). The BMD level of the right forearm in the treatment group was significantly higher than that in the control group (P<0.05). The bone metabolism levels in the treatment group were significantly improved compared with those before treatment (P<0.05), however, for the control group only the levels of BGP and 25(OH)D were improved compared with those before treatment. The efficacy evaluation indexes in the treatment group were significantly improved compared with those before treatment (P<0.05), while in the control group, only TJC and ACPA were significantly decreased compared with those before treatment (P<0.05). The levels of ESR and CRP in the treatment group were significantly lower than those in the control group (P<0.05). Comparison of safety indicators showed that neither group experienced significant adverse reactions such as heart, liver, and kidney dysfunction or severe infections.
Conclusion: Qingre Lishi Huoxue method combined with iguratimod tablets can improve bone metabolism, promote bone formation, inhibit bone resorption, increase bone density, prevent and delay osteoporosis and even fractures while controlling RA disease and reducing inflammatory indicators, improve joint function, and improve the quality of life of patients, with good tolerance and safety.
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目的： 观察清热利湿活血法联合艾拉莫德片对初次治疗的类风湿关节炎（RA）患者的骨代谢影响及临床疗效与安全性。
方法： 选取自2021年6月至2022年12月于我院风湿病科门诊及病房就诊的初次治疗90例RA湿热瘀阻证患者，随机分为两组，每组各45例，对照组予艾拉莫德片治疗，治疗组在此基础上联合清热利湿活血法治疗，疗程均为12周，观察两组的中医证候有效率、骨密度（BMD）及骨代谢水平，包括血清骨钙素（BGP）、Ⅰ型前胶原N-端前肽（PINP）、β-胶原特殊系列（β-CTX）、25羟维生素D（25（OH）D）、甲状旁腺素（PTH），同时评估有效性评价指标包括关节肿胀数（SJC）、压痛数（TJC）、患者整体评价（PGA）、疾病活动指数28-CRP（DAS28-CRP）、抗环瓜氨酸肽抗体（ACPA）；炎性指标包括血沉（ESR）、C反应蛋白（CRP）；安全性指标包括血尿便常规、肝肾功能、心电图。
结果： 治疗12周时中医证候疗效比较，治疗组的中医证候有效率高于对照组，差异有统计学意义（χ2=5.07，P<0.05）。BMD比较，两组均为右前臂部位较治疗前有显著改善，且治疗组优于对照组，差异有统计学意义（P<0.05），而两组的腰椎和左髋部位较治疗前均无明显改善。骨代谢水平比较，治疗组较治疗前均有明显改善，且优于对照组，差异有统计学意义（P<0.05），而对照组仅有BGP和25（OH）D较治疗前有显著改善，差异有统计学意义（P<0.05）；有效性评价指标比较治疗组较治疗前均有明显改善，且优于对照组，差异有统计学意义（P<0.05），而对照组仅有TJC和ACPA较治疗前有显著下降，差异有统计学意义（P<0.05）。炎性指标比较两组的ESR和CRP较治疗前均有明显下降，且治疗组均优于对照组，差异有统计学意义（P<0.05）。安全性指标比较两组均未出现明显心、肝、肾功能不全及严重感染等不良反应。
结论： 清热利湿活血法联合艾拉莫德片在控制RA病情、降低炎症指标的同时，还可改善人体的骨代谢水平，促进骨形成，抑制骨吸收，使骨密度增加，预防及延缓骨质疏松甚至骨折的发生，改善关节功能，提高患者生活质量，且耐受性与安全性好。
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李大可，女，博士研究生，主任医师，主要从事中西医结合治疗风湿免疫性疾病的研究。联系电话：(0531)68901654，E-mail:
2351039700@qq.com。
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1山东中医药大学附属医院，济南 250011, bio={"content":"
张迪，女，硕士研究生，主治医师，主要从事中西医结合治疗风湿免疫系统疾病的研究。联系电话：(0531)68901654，E-mail: zhangdi213216000@163.com。
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张迪，女，硕士研究生，主治医师，主要从事中西医结合治疗风湿免疫系统疾病的研究。联系电话：(0531)68901654，E-mail: zhangdi213216000@163.com。
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