RESUMEN
ObjectiveTo 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. MethodPubMed， 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）. ResultThirty-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］. ConclusionThe 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.
RESUMEN
OBJECTIVE： To analyze the formulation regularity of Chinese patent medicine for knee osteoarthritis （KOA）， and to provide reference for the clinical standard use of Chinese patent medicine for KOA and the research and development of new drugs. METHODS： Chinese Pharmacopoeia （2015 edition， part Ⅰ），National Drug Reimbursement List （2017 edition）， National Essential Drug List （2017 edition）， Chinese Materia Medica Preparation （1992 version）， Compilation of National Standard for Chinese Patent Medicines （2002 edition）， Handbook of Rational Application of Chinese Patent Medicines in Surgery and Orthopedics （2010 edition） were searched to collect the type and formulation of Chinese patent medicines for “KOA”， “osteoarthritis”， “Bi syndrome”， “promoting blood circulation and removing blood stasis， dispelling wind and removing dampness， tonifying liver and kidney”. Supplementary the type and formulations of Chinese patent medicines for KOA by questionaire survey of clinial experts. The types， properties， meridian tropism， frequency and combination of medicinal materials used in Chinese patent medicine formulations were counted by using TCM inheritance auxiliary platform software V 2.5. The association rules and entropy clustering method were used to analyze the formulation regularity. RESULTS： A total of 190 Chinese patent medicines were collected， involving 289 TCM. With the top 10 used frequency being Angelica sinensis （75 times）， Boswellia carterii （55 times）， Carthamus tinctorius （53 times）， Commiphora myrrha （51 times）， Achyranthes bidentata （49 times）， Notopterygium incisum （47 times）， Angelica pubescens （45 times）， Saposhnikovia divaricata （45 times）， Angelica dahurica （39 times）， Ligusticum chuanxiong （39 times）. Medicinal material were mainly Xinwen in properties field and mainly liver meridian and spleen meridian in meridian entry field. Top 5 frequency of medicinal material combinations were C. myrrha-B. carterii， B. carterii-A. sinensis， A. sinensis-N. incisum， A. bidentata-A. sinensis， L. chuanxiong-A. sinensis. 14 core medicinal material combinations and 7 new developed formulations were concluded. CONCLUSIONS： This study analyzed the formulation regularity of Chinese patent medicines for KOA with the help of TCM inheritance auxiliary platform software V 2.5， which can provide reference for clinical differentiation of symptoms and signs and research and development of related new medicines related to KOA.