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在三项关于确诊类风湿关节炎的随机对照试验中,基于美国风湿病学会(ACR)50反应,使用阿达木单抗、依那西普和英夫利昔单抗进行治疗所需的人数:一项系统文献综述。

The number needed to treat for adalimumab, etanercept, and infliximab based on ACR50 response in three randomized controlled trials on established rheumatoid arthritis: a systematic literature review.

作者信息

Kristensen L E, Christensen R, Bliddal H, Geborek P, Danneskiold-Samsøe B, Saxne T

机构信息

Department of Rheumatology, Lund University Hospital, Lund, Sweden.

出版信息

Scand J Rheumatol. 2007 Nov-Dec;36(6):411-7. doi: 10.1080/03009740701607067.

DOI:10.1080/03009740701607067
PMID:18092260
Abstract

OBJECTIVE

To compare the efficacy of adalimumab, etanercept, and infliximab in patients with established rheumatoid arthritis (RA) taking concomitant methotrexate (MTX) by calculating the number needed to treat (NNT) using three different methods.

METHODS

A systematic literature search of the Cochrane Library, MEDLINE, and EMBASE was conducted from inception to 30 June 2006. Two pairs of investigators, a Danish and a Swedish pair, independently conducted a structured literature review. The reviewers selected any published randomized, double-blind, MTX controlled study of adalimumab, etanercept, and infliximab, presenting the American College of Rheumatology 50% response (ACR50) after 12 months in RA patients with a mean disease duration of at least 5 years. The two review groups independently extracted the estimates necessary to calculate the NNT.

RESULTS

The reviewers consistently selected the same three randomized, controlled trials (RCTs), one for each of the drugs, and extracted equal data for the number of patients completing the 12-month intervention, and the corresponding number of ACR50 responding patients after therapy. Some baseline differences were noted: patients in the etanercept trial had a shorter disease duration and did not receive MTX prior to inclusion; patients in the adalimumab study had lower Health Assessment Questionnaire (HAQ) scores. The calculated NNTs varied slightly depending on the method used. The fully adjusted NNTs (95% confidence intervals) for adalimumab, etanercept, infliximab standard dosage and infliximab double dosage were 4 (3-6), 4 (3-6), 8 (4-66), and 4 (3-11) patients, respectively.

CONCLUSION

This study indicates equal efficacy of the three anti-tumour necrosis factor (TNF) therapies.

摘要

目的

通过使用三种不同方法计算治疗所需人数(NNT),比较阿达木单抗、依那西普和英夫利昔单抗在已确诊类风湿关节炎(RA)且同时服用甲氨蝶呤(MTX)的患者中的疗效。

方法

从创刊至2006年6月30日,对Cochrane图书馆、MEDLINE和EMBASE进行了系统的文献检索。两组研究人员,一组丹麦人和一组瑞典人,独立进行了结构化文献综述。评审人员选择任何已发表的随机、双盲、MTX对照的阿达木单抗、依那西普和英夫利昔单抗研究,这些研究呈现了平均病程至少5年的RA患者在12个月后达到美国风湿病学会50%缓解(ACR50)的情况。两个评审小组独立提取计算NNT所需的估计值。

结果

评审人员一致选择了相同的三项随机对照试验(RCT),每种药物一项,并提取了完成12个月干预的患者数量以及治疗后相应的ACR50缓解患者数量的相同数据。注意到一些基线差异:依那西普试验中的患者病程较短,纳入前未接受MTX;阿达木单抗研究中的患者健康评估问卷(HAQ)得分较低。根据所使用的方法,计算出的NNT略有不同。阿达木单抗、依那西普、英夫利昔单抗标准剂量和英夫利昔单抗双倍剂量的完全调整NNT(95%置信区间)分别为4(3 - 6)、4(3 - 6)、8(4 - 66)和4(3 - 11)名患者。

结论

本研究表明三种抗肿瘤坏死因子(TNF)疗法疗效相当。

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