[1]毕映燕,程晓华,李翔,等.中医内治法联合甲氨蝶呤治疗寒湿痹阻型类风湿关节炎有效性与安全性的Meta分析[J].西部中医药,2025,38(03):42-47.[doi:10.12174/j.issn.2096-9600.2025.03.09]
　BI Yingyan,CHENG Xiaohua,LI Xiang,et al.The Effectiveness and Safety of TCM Internal Therapy and Methotrexate in the Treatment of Rheumatoid Arthritis of Cold-dampness Obstruction Pattern: A Meta Analysis[J].Western Journal of Traditional Chinese Medicine,2025,38(03):42-47.[doi:10.12174/j.issn.2096-9600.2025.03.09]
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中医内治法联合甲氨蝶呤治疗寒湿痹阻型类风湿关节炎有效性与安全性的Meta分析()
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《西部中医药》[ISSN:2096-9600/CN:62-1204/R]

卷:
38
期数:
2025年03期
页码:
42-47
栏目:
二次研究
出版日期:
2025-03-15

文章信息/Info

Title:
The Effectiveness and Safety of TCM Internal Therapy and Methotrexate in the Treatment of Rheumatoid Arthritis of Cold-dampness Obstruction Pattern: A Meta Analysis
作者:
毕映燕, 程晓华, 李翔, 李喜香
甘肃省中医院，甘肃 兰州 730050
Author(s):
BI Yingyan, CHENG Xiaohua, LI Xiang, LI Xixiang
Gansu Provincial Hospital of Traditional Chinese Medicine, Lanzhou 730050, China
关键词:
类风湿关节炎; 寒湿痹阻; 系统评价; 中西药联用; 甲氨蝶呤; Meta分析
Keywords:
rheumatoid arthritis; cold-dampness obstruction; systematic assessment; traditional Chinese medicine combined with Western medicine; methotrexate; Meta analysis
分类号:
R593.22
DOI:
10.12174/j.issn.2096-9600.2025.03.09
文献标志码:
A
摘要:
目的评价中医内治法与甲氨蝶呤（methotrexate，MTX）联合使用治疗寒湿痹阻型类风湿关节炎（rheumatoid arthritis，RA）的临床疗效与安全性。 方法检索中国知网、重庆维普、万方数据、中国生物医学文献数据库、Web of Science、PubMed、EMbase数据库及Cochrane图书馆8个中外文数据库中关于中药内治法联合MTX治疗寒湿痹阻型RA的随机对照试验（randomized controlled trials，RCTs），时间从建库截止至2023年11月。由2名人员根据纳入与排除标准，独立进行文献筛选、数据提取、质量评价、并交叉核对结果，采用RevMan 5.3软件进行Meta分析。 结果共纳入15个RCTs，共1 356例寒湿痹阻型类风湿关节炎患者。Meta分析显示，在有效率升高（RR=1.20，95%CI：1.14～1.27，P＜0.000 01）、晨僵时间（SMD=0.75，95%CI：0.59～0.90，P＜0.000 01）、肿胀关节数（MD=0.59，95%CI：0.50～0.68，P＜0.000 01）、压痛关节数（MD=0.71，95%CI：0.58～0.84，P＜0.000 01）、ESR（MD=6.16，95%CI：5.02～7.31，P＜0.000 01）、CRP（MD=1.48，95%CI：0.71～2.25，P=0.000 2）、不良反应（RR=0.45，95%CI：0.31～0.65，P＜0.000 1）方面的影响试验组优于对照组，差异有统计学意义；对TNF-α（MD=-0.17，95%CI：-1.41～1.08，P=0.79）的影响差异无统计学意义。其中13篇RCT关注了不良反应，有7个研究详细报告了不良反应发生率，所有文献均未见严重的不良反应报道。 结论基于当前临床证据初步得出，中医内治法联合甲氨蝶呤治疗寒湿痹阻型RA的有效性和安全性可能优于单纯使用MTX治疗，但尚需要高质量的RCT验证。
Abstract:
ObjectiveTo evaluate clinical effects and the safety of TCM internal therapy and methotrexate (MTX) in the treatment of rheumatoid arthritis (RA) of cold-dampness obstruction pattern. MethodsRandomized controlled trials (RCTs) on the treatment of cold-dampness obstruction type of RA with TCM internal therapy and MTX were searched from CNKI, VIP, Wanfang, CBMdisc, Web of Science, PubMed, EMbase database and Cochrane library, and the retrieval time was between the time of establishing the database and November 2023. According to the inclusion and exclusion criterion, two researchers carried out the literature screening, data extraction, quality evaluation independently, and intersected the check results, and performed Meta analysis using RevMan 5.3 software. ResultsThe study included 15 RCTs, involving 1 356 patients. Meta analysis results displayed that the study group was better than the control group in the increase in effective rate (RR=1.20, 95%CI:1.14-1.27, P<0.000 01), morning stiffness time (SMD=0.75, 95%CI:0.59-0.90, P<0.000 01), number of swollen joints (MD=0.59, 95%CI:0.50-0.68, P<0.000 01), the number of tender joints (MD=0.71, 95%CI:0.58-0.84, P<0.000 01), ESR(MD=6.16, 95%CI:5.02-7.31, P<0.000 01), CRP (MD=1.48, 95%CI:0.71-2.25, P=0.000 2), as well as adverse reaction (RR=0.45, 95%CI:0.31-0.65, P<0.000 01), and the difference showed statistical meaning; while the difference had no statistical meaning in the influence on TNF-α (MD=-0.17, 95%CI:-1.41-1.08, P=0.79). 13 of these RCTs focused on adverse reactions and seven studies reported the incidences of adverse reactions in detail, and no serious adverse reactions have been reported in any of the literature. ConclusionCurrently, clinical evidence primarily reveals that the effectiveness and the safety of TCM internal therapy and MTX in the treatment of RA might be better than these of single use of MTX, however, we still need high quality RCTs to perform the validation.

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备注/Memo

备注/Memo:
毕映燕（1984—），女，硕士学位，主管药师。研究方向：中药质量控制。2015年度中医药行业科研专项（201507001-06）；甘肃省中医药科研项目（GZK-2019-1）；2022年中央转移支付医疗服务与保障能力提升中医药事业传承与发展部分——中医药人才培养重点学科建设项目（甘财社〔2022〕48号）。
更新日期/Last Update: 2025-03-15