Smieja M, MacPherson D W, Kean W, Schmuck M L, Goldsmith C H, Buchanan W, Hart L E, Mahony J B
Department of Pathology and Molecular Medicine, McMaster University, Hamilton, ON, Canada.
Ann Rheum Dis. 2001 Dec;60(12):1088-94. doi: 10.1136/ard.60.12.1088.
To determine whether long term doxycycline improves symptoms in patients with chronic seronegative or reactive arthritis.
A randomised, triple blind, controlled clinical trial of three months' treatment with doxycycline or placebo of patients with chronic reactive or seronegative arthritis was conducted. The primary study end points were three month pain and functional status measured by a self administered Arthritis Impact Measurement Scales version 2 (AIMS2) quality of life questionnaire. Secondary end points were pain and functional status at 6-12 months, three month rheumatologist assessed joint count, pain, and arthritis activity, and treatment efficacy in those with previous exposure to chlamydia.
Of 60 patients randomly allocated to receive doxycycline or placebo, results from 37 were evaluable at three months. Groups were well balanced for major prognostic variables. Doxycycline had no detectable effect at three months on pain change scores (mean difference 1.5, 95% CI -1.2 to 4.2, p=0.25) or composite functional change scores (mean difference 0.8, 95% CI -5.6 to 7.1, p=0.81). Furthermore, there were no differences in secondary study end points, and no apparent treatment effect in patients with previous chlamydia infection.
Three months' treatment with doxycycline did not improve pain or functional status in patients with chronic reactive or seronegative arthritis.
确定长期使用强力霉素是否能改善慢性血清阴性或反应性关节炎患者的症状。
对慢性反应性或血清阴性关节炎患者进行了一项随机、三盲、对照临床试验,患者接受为期三个月的强力霉素或安慰剂治疗。主要研究终点是通过自我管理的关节炎影响测量量表第2版(AIMS2)生活质量问卷测量的三个月疼痛和功能状态。次要终点是6至12个月时的疼痛和功能状态、三个月时风湿病学家评估的关节计数、疼痛和关节炎活动,以及既往接触过衣原体的患者的治疗效果。
在随机分配接受强力霉素或安慰剂治疗的60例患者中,37例患者在三个月时的结果可评估。主要预后变量在两组间分布均衡。强力霉素在三个月时对疼痛变化评分(平均差值1.5,95%可信区间-1.2至4.2,p=0.25)或综合功能变化评分(平均差值0.8,95%可信区间-5.6至7.1,p=0.81)无明显影响。此外,次要研究终点无差异,既往衣原体感染患者也无明显治疗效果。
为期三个月的强力霉素治疗未能改善慢性反应性或血清阴性关节炎患者的疼痛或功能状态。