背景:大量临床研究证实,在用中药成分如青藤碱(SIN)治疗后,类风湿性关节炎(RA)患者的基质金属蛋白酶-3(MMP-3)水平显著降低,而MMP-3可能参与人类骨基质的降解,所以在RA患者骨关节损伤的进展中,血清MMP-3可作为重要的生化标志物。临床常用的中药成分包括白芍总苷,SIN,和雷公藤多甙,具有抗风湿药和非甾体抗炎药的特点,虽然它们可以减少甲氨蝶呤(MTX)的毒副作用,与其他药物如MTX和来氟米特(HWA486)的联合使用已成为临床上治疗RA的重要方案。因此,本研究方案旨在评价常用中药成分联合MTX治疗RA骨关节损伤的辅助效果。
方法:本研究的检索时间为2000年1月至2020年9月。EMBASE数据库,科克伦图书馆,PubMed,WebofScience,科学直接,中国国家知识基础设施,中国生物医学光盘(CBM),中国科技期刊数据库(VIP),并以万方数据库为检索来源,筛选降低MMP-3的中药成分,使用MTX治疗RA。采用临床随机对照试验,并设定了筛选的纳入标准和排除标准.在这项研究中,MMP-3,红细胞沉降率(ESR),C反应蛋白(CRP),以含瓜氨酸环肽(CCP)和类风湿因子(RF)为主要终点,和疾病活动评分28(DAS28)的改善,关节骨矿物质密度,临床疾病活动指数(CDAI)选择其他临床相关症状作为次要结局.本荟萃分析使用Revman软件5.3版进行数据统计分析和偏差风险评估。在这项研究中,一名研究人员进行了研究方向选择,文学探究,和文献下载,2名独立审稿人进行文献数据提取和文献质量评估。二分数据以相对风险表示,连续数据表示为平均差或标准平均差,最后根据数据的异质性,采用固定效应模型或随机效应模型进行综合。
结果:通过血清MMP-3,ESR评估中药成分联合MTX下调MMP-3水平对RA患者骨损伤进展的影响。CRP,CCP,和RF。
结论:本研究方案可用于评价中药成分联合MTX治疗RA患者骨损伤的有效性和安全性。
■这项研究是基于已发表的临床研究的次要研究;因此,本研究不需要伦理委员会的批准.根据系统审查和荟萃分析方案(PRISMA-P)的首选报告项目,这项研究的结果将发表在同行评审的科学期刊和会议论文上.注册号::是INPLASY202090064。
BACKGROUND: A large number of clinical studies have confirmed that after treatment with traditional Chinese medicine components such as sinomenine (SIN), the matrix -metalloproteinase3 (MMP-3) level of patients with rheumatoid arthritis (RA) shows a significant decrease, whereas MMP-3 can be involved in degrading bone matrix in humans, so in the progression of bone and joint injury in patients with RA, serum MMP-3 can be used as an important biochemical marker. The traditional Chinese medicine components commonly used in clinical practice include total glucosides of paeony (TGP), SIN, and tripterygium glycosides, which have the characteristics of disease-modifyinganti-rheumatic drugs and non-steroidal anti-inflammatory drugs, while they can reduce the toxic side effects of methotrexate (MTX), and their combination with other drugs such as MTX and leflunomide (HWA486) has become an important regimen for the treatment of RA in clinical practice. Therefore, we designed this study protocol to evaluate the adjuvant effect of commonly used traditional Chinese medicine components combined with MTX in the treatment of osteoarticular injury in RA.
METHODS: The search time was set from January 2000 to September 2020 in this study. EMBASE database, Cochrane Library, PubMed, Web of Science, Science Direct, Chinese National Knowledge Infrastructure, China Biology Medicine disc (CBM), Chinese Scientifific Journals Database (VIP), and Wanfang Database were used as search sources to select the traditional Chinese medicine components that reduce MMP-3 and use MTX in the treatment of RA. Clinical randomized controlled trials were used, and inclusion criteria and exclusion criteria were set for screening. In this study, MMP-3, erythrocyte sedimentation rate (ESR), C-reactive protein (CRP), cyclic peptide containing citrulline (CCP) and rheumatoid factor (RF) were used as the main outcomes, and the improvement of Disease Activity Score 28 (DAS28), joint bone mineral density, Clinical Disease Activity Index (CDAI), and other clinically relevant symptoms was selected as the secondary outcomes. Revman software version 5.3 was used for statistical analysis of data and risk assessment of deviation in this meta-analysis. In this study, one researcher performed study direction selection, literature inquiry, and literature download, and 2 independent reviewers performed literature data extraction and literature quality assessment. Dichotomized data are expressed as relative risk, continuous data are expressed as mean difference or standard mean difference, and finally fixed-effect model or random-effect model is used for synthesis according to the heterogeneity of data.
RESULTS: To evaluate the effect of downregulation of MMP-3 level by traditional Chinese medicine components combined with MTX on the progression of bone injury in patients with RA by serum MMP-3, ESR, CRP, CCP, and RF.
CONCLUSIONS: This study protocol can be used to evaluate the efficacy and safety of traditional Chinese medicine components combined with MTX in the treatment of bone injury in patients with RA.
UNASSIGNED: This study is a secondary study based on the published clinical research; therefore, approval from an ethics committee is not required for this study. In accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analysis Protocol (PRISMA-P), the results of this study will be published in peer-reviewed scientific journals and conference papers. REGISTRATION NUMBER:: is INPLASY202090064.