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中国中医科学院 中药研究所,北京 100700
Published:05 March 2023,
Published Online:28 September 2022,
Received:24 April 2022,
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杨超,胡智星,明瑞蕊等.雷公藤多苷片联用甲氨蝶呤和/或来氟米特对类风湿关节炎自身抗体影响的Meta分析[J].中国实验方剂学杂志,2023,29(05):39-48.
YANG Chao,HU Zhixing,MING Ruirui,et al.Meta-analysis of Effect of Tripterygium wilfordii Polyglycoside Tablets Combined with Methotrexate and/or Leflunomide on Autoantibodies in Rheumatoid Arthritis[J].Chinese Journal of Experimental Traditional Medical Formulae,2023,29(05):39-48.
杨超,胡智星,明瑞蕊等.雷公藤多苷片联用甲氨蝶呤和/或来氟米特对类风湿关节炎自身抗体影响的Meta分析[J].中国实验方剂学杂志,2023,29(05):39-48. DOI: 10.13422/j.cnki.syfjx.20222190.
YANG Chao,HU Zhixing,MING Ruirui,et al.Meta-analysis of Effect of Tripterygium wilfordii Polyglycoside Tablets Combined with Methotrexate and/or Leflunomide on Autoantibodies in Rheumatoid Arthritis[J].Chinese Journal of Experimental Traditional Medical Formulae,2023,29(05):39-48. DOI: 10.13422/j.cnki.syfjx.20222190.
目的
2
评价雷公藤多苷片(TWPT)联用常用传统抗风湿病情药(csDMARDs)包括甲氨蝶呤(MTX)和/或来氟米特(LEF)对类风湿关节炎(RA)患者自身抗体及其相关指标的影响。
方法
2
检索PubMed、EMBASE、WebofScience、Cochrane图书馆、中国知网(CNKI)、VIP数据库、万方数据库、中国生物医学文献服务系统(SinoMed)等数据库中关于TWPT与MTX和/或LEF联用治疗RA患者截止到2021年12月1日的随机对照试验(RCT)。主要结局指标包括类风湿因子(RF)、抗瓜氨酸化蛋白抗体(ACPA),次要结局指标包括免疫球蛋白(IgA、IgG、IgM)和药物不良反应事件(ADE)。
结果
2
共纳入31项RCT,2 643名成年患者,其中TWPT联用MTX共20项,TWPT联用LEF共10项,TWPT同时联用MTX和TWPT仅1项,随访时间从2周到13个月不等;与csDMARDs单用相比,联用TWPT显著改善了RA患者血清RF[SMD=-2.45, 95% CI(-2.97, -1.93)],
P
<
0.000 01],anti-CCP[SMD=-1.41,95% CI(-2.35, -0.48),
P=
0.003],IgM[SMD=-1.90, 95% CI(-3.03, -0.76),
P=
0.001]和IgA[SMD=-1.18, 95% CI(-2.23, -0.12),
P=
0.03]水平;对IgG[SMD=-1.02, 95% CI(-2.04, 0.01),
P=
0.05]水平和ADE[RR=0.87, 95% CI(0.66, 1.15),
P=
0.32]无显著影响。
结论
2
基于现有证据,临床TWPT联用csDMARDs比csDMARDs单用能更显著改善RA患者自身抗体水平,且不增加不良反应事件发生率。但由于所纳入RCT在质量及数量上存在一定局限性,相关结论仅作为RA临床诊疗的参考,仍然需更多高质量的研究进一步证实其疗效。
Objective
2
To evaluate the effect of
Tripterygium wilfordii
polyglycoside tablets (TWPT) combined with conventional synthetic disease-modifying antirheumatic drugs (csDMARDs) including methotrexate (MTX) and/or leflunomide (LEF) on autoantibodies in rheumatoid arthritis (RA) patients.
Method
2
PubMed, EMBASE, Web of Science, Cochrane Library, China National Knowledge Infrastructure (CNKI), VIP, Wanfang Data, and China Biomedical Literature Service System (SinoMed) were searched for randomized controlled trials (RCTs) of TWPT combined with MTX and/or LEF in the treatment of RA patients from database inception to December 1, 2021. Primary outcome indicators included rheumatoid factor (RF) and anti-citrullinated protein antibody (ACPA), and secondary outcome indicators included immunoglobulin (IgA, IgG, and IgM) and adverse drug events (ADE).
Result
2
Thirty-one RCTs, involving 2 643 adult patients, were included, including 20 RCTs of TWPT combined with MTX, 10 of TWPT combined with LEF, and one of TWPT combined with MTX and TWPT. The follow-up time ranged from two weeks to 13 months. Compared with csDMARDs alone, TWPT combined with other drugs significantly improved serum RF of RA patients [SMD=-2.45, 95% CI [-2.97, -1.93],
P
<
0.000 01], anti-CCP [SMD=-1.41, 95% CI (-2.35, -0.48),
P
=0.003], IgM [SMD=-1.90, 95% CI (-3.03, -0.76),
P
=0.001], and IgA [SMD=-1.18, 95% CI (-2.23, -0.12),
P
=0.03]. There were no significant effects on IgG [SMD=-1.02, 95% CI (-2.04, 0.01),
P
=0.05] and ADE [RR=0.87, 95% CI (0.66, 1.15),
P
=0.32].
Conclusion
2
The results of this study show that compared with csDMARDs alone, TWPT combined with csDMARDs can effectively improve the levels of autoantibodies in RA patients without increasing the incidence of ADE. However, due to the limited quality and quantity of the included RCTs, the relevant conclusions are only used as a reference for the clinical diagnosis and treatment of RA, and more high-quality studies are still needed to further confirm their efficacy.
雷公藤多苷片类风湿关节炎自身抗体Meta分析
Tripterygium wilfordii polyglycoside tabletsrheumatoid arthritisautoantibodiesMeta-analysis
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