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常规和生物疾病修饰抗风湿药物治疗骨关节炎:随机对照试验的荟萃分析。

Conventional and biologic disease-modifying anti-rheumatic drugs for osteoarthritis: a meta-analysis of randomized controlled trials.

机构信息

Academic Rheumatology, Arthritis Research UK Pain Centre, University of Nottingham, Nottingham, UK.

出版信息

Rheumatology (Oxford). 2018 Oct 1;57(10):1830-1837. doi: 10.1093/rheumatology/key131.

Abstract

OBJECTIVES

The role of inflammation in OA is controversial and it is unclear whether suppressing inflammation with conventional or biologic DMARDs is effective. A systematic review and meta-analysis of randomized controlled trials (RCTs) was conducted to compare DMARDs with placebo in participants with symptomatic OA.

METHODS

Databases (Medline, Embase, Allied and Complementary Medicine Database, Web of Science and Cochrane Library), conference abstracts and ClinicalTrials.gov were searched to end of November 2017 for placebo-controlled RCTs of DMARDs, including biologics, in symptomatic OA. Pain data at treatment peak time point were extracted and combined using a random-effects meta-analysis. Markers of inflammation and adverse events were extracted and reviewed. Risk of bias assessment was conducted using Cochrane's tool.

RESULTS

Eleven RCTs (1205 participants) were meta-analysed, including six for conventional DMARDs (757 participants) and five for biologics (448 participants). Overall, DMARDs were statistically superior to placebo [effect size (ES) = 0.18, 95% CI: 0.03, 0.34], although the difference was not clinically significant (0.5 ES threshold). Furthermore, no statistically significant differences were observed in sub-analysis of high-quality trials (ES = 0.11, 95% CI : -0.06, 0.28), biologics (ES = 0.16, 95% CI: -0.02, 0.34) or conventional DMARDs (ES = 0.24, 95% CI: -0.05, 0.54). No difference was found between erosive vs non-erosive hand OA, hand vs knee OA or anti-IL1 vs anti-TNF biologics.

CONCLUSION

DMARDs did not offer clinically significant pain relief above placebo in OA. This poor efficacy indicates that inflammation may not be a prime driver for OA pain.

摘要

目的

炎症在 OA 中的作用存在争议,目前尚不清楚使用传统或生物 DMARD 抑制炎症是否有效。我们进行了一项系统评价和荟萃分析,以比较 DMARD 与安慰剂在有症状的 OA 患者中的疗效。

方法

检索了数据库(Medline、Embase、补充和综合医学数据库、Web of Science 和 Cochrane 图书馆)、会议摘要和 ClinicalTrials.gov,以获取截止 2017 年 11 月底的 DMARD(包括生物制剂)治疗有症状的 OA 的安慰剂对照 RCT 的相关信息。提取并使用随机效应荟萃分析综合治疗峰值时间点的疼痛数据。提取并审查了炎症标志物和不良反应。使用 Cochrane 工具进行了偏倚风险评估。

结果

对 11 项 RCT(1205 名参与者)进行了荟萃分析,其中 6 项为传统 DMARD(757 名参与者),5 项为生物制剂(448 名参与者)。总体而言,DMARD 治疗组在统计学上优于安慰剂组[效应量(ES)=0.18,95%置信区间:0.03,0.34],尽管差异无临床意义(0.5 ES 阈值)。此外,在高质量试验的亚组分析中[ES=0.11,95%置信区间:-0.06,0.28]、生物制剂[ES=0.16,95%置信区间:-0.02,0.34]或传统 DMARD 组[ES=0.24,95%置信区间:-0.05,0.54]中,差异均无统计学意义。在侵蚀性与非侵蚀性手部 OA、手部与膝部 OA 或抗 IL1 与抗 TNF 生物制剂之间,差异无统计学意义。

结论

DMARD 在 OA 中并未提供优于安慰剂的临床显著疼痛缓解。这种较差的疗效表明,炎症可能不是 OA 疼痛的主要驱动因素。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/1eb4/6199417/0a340e3b5df1/key131f1.jpg

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