环孢素A治疗早期类风湿关节炎时关节损伤进展缓慢。

Slow progression of joint damage in early rheumatoid arthritis treated with cyclosporin A.

作者信息

Pasero G, Priolo F, Marubini E, Fantini F, Ferraccioli G, Magaro M, Marcolongo R, Oriente P, Pipitone V, Portioli I, Tirri G, Trotta F, Della Casa-Alberighi O

机构信息

Milan University, Italy.

出版信息

Arthritis Rheum. 1996 Jun;39(6):1006-15. doi: 10.1002/art.1780390618.

DOI:10.1002/art.1780390618

PMID:8651963

Abstract

OBJECTIVE

To evaluate the ability of low-dose cyclosporin A (CsA) to control radiologic disease progression, and to assess the clinical efficacy and tolerability of CsA, compared with conventional disease-modifying antirheumatic drugs (DMARDs), in patients with early active rheumatoid arthritis (RA).

METHODS

In this long-term, multicenter, prospective, open, blinded end point, randomized trial, 361 consenting patients with early (<4 years since diagnosis) active RA were enrolled. Of the eligible patients, 167 were treated with CsA at 3 mg/kg/day, and 173 with DMARDs. The decision to use conventional antirheumatic drugs as controls was based on the fact that joint erosion could be expected to occur after 1 year regardless of the type of DMARD being used. The possibility of switching therapies in both groups was intended to keep the largest possible number of patients in the study.

RESULTS

Blinded evaluation of hand and foot radiographs after 12 months of treatment showed that CsA led to a significant (P < 0.001) delay in the mean +/- SD progression in the eroded joint count (1.3 +/- 3.1 versus 2.4 +/- 3.0 for the control group) and in the joint damage score (3.6 +/- 8.9 versus 6.9 +/- 9.1 for the control group), both measured by the Larsen-Dale method. When only the patients without erosion at baseline were considered (37 in the CsA-treated group and 54 in the control group), erosion appeared in only 10.8% of the CsA-treated patients, but in 51.8% of the controls (P = 0.00005). Low-dose CsA was as effective as traditional DMARDs in controlling clinical symptoms. Maintenance on the initially prescribed treatment regimen ("survival on treatment") was also better at 12 months with CsA than with DMARDs (89.2% versus 77.5%; P = 0.002). The tolerability of CsA was acceptable.

CONCLUSION

These 12-month results suggest that low-dose CsA decreases the rate of further joint damage in previously involved joints as well as the rate of new joint involvement in previously uninvolved joints, in patients with early RA.

摘要

目的

评估低剂量环孢素A（CsA）控制放射学疾病进展的能力，并与传统改善病情抗风湿药（DMARDs）相比，评估CsA在早期活动性类风湿关节炎（RA）患者中的临床疗效和耐受性。

方法

在这项长期、多中心、前瞻性、开放、盲终点、随机试验中，纳入了361例同意参与的早期（诊断后<4年）活动性RA患者。在符合条件的患者中，167例接受3mg/kg/天的CsA治疗，173例接受DMARDs治疗。选择传统抗风湿药作为对照的依据是，无论使用何种DMARDs，预计1年后都会出现关节侵蚀。两组均有换药的可能，目的是使研究中尽可能多的患者留在研究中。

结果

治疗12个月后手和足X线片的盲法评估显示，CsA使侵蚀关节计数的平均±标准差进展显著延迟（P<0.001）（CsA组为1.3±3.1，对照组为2.4±3.0），以及关节损伤评分显著延迟（CsA组为3.6±8.9，对照组为6.9±9.1），两者均采用Larsen-Dale法测量。仅考虑基线时无侵蚀的患者（CsA治疗组37例，对照组54例）时，CsA治疗组仅10.8%的患者出现侵蚀，而对照组为51.8%（P=0.00005）。低剂量CsA在控制临床症状方面与传统DMARDs同样有效。在12个月时，CsA组维持初始规定治疗方案（“治疗持续率”）也优于DMARDs组（89.2%对77.5%；P=0.002）。CsA的耐受性可以接受。