柳氮磺胺吡啶与安慰剂治疗反应性关节炎（赖特综合征）的比较。退伍军人事务部合作研究。

Comparison of sulfasalazine and placebo in the treatment of reactive arthritis (Reiter's syndrome). A Department of Veterans Affairs Cooperative Study.

作者信息

Clegg D O, Reda D J, Weisman M H, Cush J J, Vasey F B, Schumacher H R, Budiman-Mak E, Balestra D J, Blackburn W D, Cannon G W, Inman R D, Alepa F P, Mejias E, Cohen M R, Makkena R, Mahowald M L, Higashida J, Silverman S L, Parhami N, Buxbaum J, Haakenson C M, Ward R H, Manaster B J, Anderson R J, Henderson W G

机构信息

VAMC, Salt Lake City, Utah, USA.

出版信息

Arthritis Rheum. 1996 Dec;39(12):2021-7. doi: 10.1002/art.1780391211.

DOI:10.1002/art.1780391211

PMID:8961907

Abstract

OBJECTIVE

To determine whether sulfasalazine (SSZ) at a dosage of 2,000 mg/day is effective in the treatment of reactive arthritis (ReA) that has been unresponsive to nonsteroidal antiinflammatory drug (NSAID) therapy.

METHODS

One hundred thirty-four patients with ReA who had failed to respond to NSAIDs were recruited from 19 clinics, randomized (double-blind) to receive either SSZ or placebo, and followed up for 36 weeks. The definition of treatment response was based on joint pain/tenderness and swelling scores and physician and patient global assessments.

RESULTS

Longitudinal analysis revealed improvement in the patients taking SSZ compared with those taking placebo, which appeared at 4 weeks and continued through the trial (P = 0.02). At the end of treatment, response rates were 62.3% for SSZ treatment compared with 47.7% for placebo treatment. The Westergren erythrocyte sedimentation rate declined more with SSZ treatment than with placebo (P < 0.0001). Adverse reactions were fewer than expected and were mainly due to nonspecific gastrointestinal complaints.

CONCLUSION

SSZ at a dosage of 2,000 mg/day is well tolerated and effective in patients with chronically active ReA.

摘要

目的

确定每日剂量为2000毫克的柳氮磺胺吡啶（SSZ）对非甾体抗炎药（NSAID）治疗无效的反应性关节炎（ReA）是否有效。

方法

从19个诊所招募了134例对NSAIDs无反应的ReA患者，随机（双盲）接受SSZ或安慰剂治疗，并随访36周。治疗反应的定义基于关节疼痛/压痛和肿胀评分以及医生和患者的整体评估。

结果

纵向分析显示，与服用安慰剂的患者相比，服用SSZ的患者病情有所改善，这种改善在4周时出现并持续至试验结束（P = 0.02）。治疗结束时，SSZ治疗的反应率为62.3%，而安慰剂治疗的反应率为47.7%。与安慰剂治疗相比，SSZ治疗使魏氏血沉率下降得更多（P < 0.0001）。不良反应比预期的少，主要是由于非特异性胃肠道不适。