背景:类风湿性关节炎(RA)是一种影响关节并产生疼痛的慢性自身免疫性疾病,肿胀,和刚度。它在世界范围内的终生患病率高达1%。雷公藤提取物F(TwHF),中国南方广泛使用的海参科草药家族的成员,自1960年代以来一直用于治疗RA。
方法:当前的共识实践指南(CPG)旨在为TwHF在活动性RA的临床管理中的应用提供指导。CPG遵循了世界卫生组织(WHO)的建议程序,进行了三项系统评价,以综合来自19项随机对照试验(RCT)的数据,该试验涉及1795名参与者.我们利用了建议的分级,评估,开发和评估(等级),以评估证据的确定性并得出建议。我们严格遵守《评估研究与评估指南II》(AGREEII)作为行为指南,以最大程度地减少偏见并提高透明度。
结果:TwHF单药治疗与甲氨蝶呤(MTX)单药治疗ACR20无明显差异(RCT=2,N=390,RR=1.06,95CI0.90-1.26,中度确定性),ACR50(RCT=3,N=419,RR=1.03,95CI0.80-1.34,中等确定性),ACR70(RCT=2,N=390,RR=1.12,95CI0.69-1.79,低确定性)。对ACR20,TwHF单药治疗可能优于水杨酸磺胺吡啶单药治疗,对ACR50和ACR70的影响可能相似。七个随机对照试验比较了MTX联合TwHF与MTX单药治疗,和荟萃分析结果有利于联合治疗组的ACR20(RCT=3,N=470,RR=1.44,95CI1.28-1.62,中度确定性),ACR50(RCT=4,N=500,RR=1.88,95CI1.56-2.28,中度确定性)和ACR70(RCT=2,N=390,RR=2.12,95CI1.40-3.19,低度确定性)。我们发现两组在关键安全性结果上没有明显差异,包括感染(RCT=3,N=493,RR=1.37,95CI0.84-2.23),肝功能障碍(RCT=5,N=643,RR=1.14,95CI0.71-1.85),肾损害(RCT=3,N=450,RR=2.20,95CI0.50-9.72)。
结论:在对证据进行全面审查后,指导小组就活动性RA患者使用TwHF的建议达成共识,作为单一疗法或与MTX联合疗法。
Rheumatoid arthritis (RA) is a chronic autoimmune disorder that affects the joints and produces pain, swelling, and stiffness. It has a lifetime prevalence of up to 1% worldwide. An extract of Tripterygium wilfordii Hook F (TwHF), a member of the Celastraceae herbal family widely available in south China, has been used for treatment of RA since 1960s.
The current
consensus practice guidance (CPG) aims to offer guidance on the application of TwHF in the clinical management of active RA. The CPG followed World Health Organisation (WHO)\'s recommended process, carried out three systematic reviews to synthesize data from 19 randomised controlled trials (RCT) involving 1795 participants. We utilized Grading of Recommendations, Assessment, Development and Evaluation (GRADE) to evaluate certainty of evidence and derive recommendations. We rigorously followed The Appraisal of
Guidelines for Research and Evaluation II (AGREE II) as conduct guides to minimise bias and promote transparency.
There was no obvious difference between TwHF monotherapy and
methotrexate (MTX) monotherapy on ACR20 (RCT = 2, N = 390, RR = 1.06, 95%CI 0.90-1.26, moderate certainty), ACR50 (RCT = 3, N = 419, RR = 1.03, 95%CI 0.80-1.34, moderate certainty), ACR70 (RCT = 2, N = 390, RR = 1.12, 95%CI 0.69-1.79, low certainty). TwHF monotherapy may be better than salicylazosulfapyridine monotherapy on ACR20 and the effect may be similar on ACR50 and ACR70. Seven RCTs compared MTX combined with TwHF versus MTX monotherapy, and the meta-analysis results favoured combination therapy group on ACR20 (RCT = 3, N = 470, RR = 1.44, 95%CI 1.28-1.62, moderate certainty), ACR50 (RCT = 4, N = 500, RR = 1.88, 95%CI 1.56-2.28, moderate certainty) and ACR70 (RCT = 2, N = 390, RR = 2.12, 95%CI 1.40-3.19, low certainty). We found no obvious difference between groups on critical safety outcomes, including infection (RCT = 3, N = 493, RR = 1.37, 95%CI 0.84-2.23), liver dysfunction (RCT = 5, N = 643, RR = 1.14, 95%CI 0.71-1.85), renal damage (RCT = 3, N = 450, RR = 2.20, 95%CI 0.50-9.72).
Upon full review of the evidence, the guidance panel reached
consensus on recommendations for the use of TwHF in people with active RA, either as monotherapy or as combination therapy with MTX.