尪痹制剂联合西药治疗类风湿关节炎疗效及安全性的系统评价和Meta分析

Effectiveness and Safety of Wangbi Preparations(尪痹制剂)Combined with western Medicine for Rheuma-toid Arthritis:A Systematic Review and Meta analysis

目的系统性评价尪痹制剂治疗类风湿关节炎的疗效及安全性。方法检索中国知网(CNKI)、万方数据库(WanFang)、中国生物医学文献数据库(CBM)、MEDLINE、Embase、Cochrane Library Trials、Clinical Trials和Web of Science数据库中采用尪痹制剂(包括尪痹片、尪痹胶囊、尪痹冲剂、尪痹颗粒)联合西药治疗类风湿关节炎的随机对照试验,时间范围均为各数据库建库至2020年7月12日。由两名研究者根据文献纳入、排除标准独立进行文献筛选,并独立进行数据提取和评价。采用Cochrane偏倚风险评估表评价研究质量,评价结局指标包括红细胞沉降率(ESR)、C反应蛋白(CRP)、晨僵时间、关节肿胀数、关节压痛数、有效率和不良反应。采用Revman 5.3软件进行Meta分析和R 3.6. 3的Meta包进行发表偏倚评价。结果共纳入12篇文献,涉及1182例患者,但其证据质量偏低。与单纯西药治疗相比,尪痹制剂联合西药可进一步降低类风湿关节炎患者的CRP水平[MD=-5.53,95%CI (-8.25,-2.81)],缩短晨僵时间[MD=-13.75,95%CI (-23.51,-4.00)],降低关节压痛数[MD=-1.43,95%CI(-2.55,-0.30)]和关节肿胀数[MD=-0.63,95%CI(-1.13,-0.14)],且用药早期可显著降低ESR水平[MD=-25.20,95%CI (-30.64,-19.76)],还可减少不良反应的发生[RR=0.39,95%CI (0.29,0.53)]。结论尪痹制剂联合西药治疗类风湿性关节炎与单纯西药治疗相比具有较好的疗效和安全性,可显著降低患者CRP水平和改善症状。但由于现有文献数量有限且质量偏低,还需大样本、高质量的研究来进一步验证。

Objective To systematically assess the effectiveness and safety of Wangbi preparations(尪痹制剂)in treatment of rheumatoid arthritis(RA).Methods Databases including CNKI,Wanfang,CBM,MEDLINE,Embase,Cochran Library Trials,Clinical Trials and Web of Science were searched from the inception dates to July 12th,2020 for randomized controlled trials(RCITs)on Wangbi preparations(Wangbi tablets,capsules,soluble granules,granules)combined with W estern medicine for RA.Literature was screened by two independent research-ers according to the inelusion criteria;the data were extracted,and the included researchers were appraised by two in-dependent researchers.The Cochrane risk of bias tool was used to assess the methodological quality of the included RCTs.The outcomes included erythrocyte sedimentation rate(ESR),C-reactive protein(CRP),morning stiffness time,joint swelling,joint tenderness,effective rate and adverse events.Revman 5.3 software was used to perform meta-analyses,and R 3.6.3 meta package was used for publication bias analysis.Results A total of 12 RCTs with low quality were included,involving 1182 participants.Compared to western medicine alone,W angbi preparations in addition to wester medicine can sigificantly lower the level of CRP(MD=-5.53,95%CI[-8.25,-2.81]),shorten the morning stiffness time(MD=-13.75,95%CI[-23.51,-4.00]),reducing joint tenderness(MD=-1.43,95%CI[-2.55,-0.30])and joint swelling(MD=0.63,95%CT[-1.13,-0.14]),lowering ESR in the early medication stage(MD=--25.20,95%CI[-30.64,-19.76]),and reducing adverse events(RR=0.39,95%CI[0.29,0.53]).Conclusion Wangbi preparations combined with western medicine has better effectiveness and higher safety than western medicine alone in treating RA,with significant decrease in the level of CRP and improvement of symptoms.Nevertheless,considering the limited methodological quality and strength of evidence,more large-sample,high-quality RCTs are still necessary to verify the conclusion.