van Denderen J Christiaan, van der Horst-Bruinsma Irene, Bezemer P Dick, Dijkmans Ben A C
Jan van Breemen Instituut, Department of Rheumatology, Vrije Universiteit Medical Center, Amsterdam, The Netherlands.
J Rheumatol. 2003 Jul;30(7):1558-60.
Mesalazine (Salofalk) was found to be effective and showed low toxicity in patients with inflammatory bowel disease. The association of gut lesions and spondyloarthropathy (SpA) is well known and we studied the efficacy and safety of a relatively high dose of mesalazine in patients with ankylosing spondylitis (AS).
In an open study, mesalazine (3-4 g/day) was prescribed for 24 weeks to 20 patients (aged 18-70 yrs) with active AS, defined as the presence of at least one clinical criterion (morning stiffness > 30 min, peripheral synovitis, enthesopathy, or pain score > 2 on a visual analog scale of 10 cm) and one laboratory criterion [erythrocyte sedimentation rate (ESR) > 20 mm/h or C-reactive protein (CRP) > 20 mg/l]. Data on toxicity and disease activity variables (ESR, CRP, BASDAI, BASFI, BASMI, global assessment, and joint count) were obtained at baseline and after 4, 12, and 24 weeks, and analyzed on an intention-to-treat basis.
Study patients had a mean age of 41 years, with mean disease duration of 7.9 years and a mean ESR at baseline of 29 mm/h. After a mean of 9.3 weeks (range 2-22), 8 of the 20 patients prematurely stopped the medication because of adverse effects, mainly gastrointestinal complaints. Twelve patients completed the 24 weeks of the study using a mean dose of 3.2 g/day (range 1-4) mesalazine. Analysis of the data showed improvement in ESR, CRP, and physician's global assessment, but only the change in ESR (29 mm/h on baseline and 25 mm/h at week 24) reached statistical significance (p = 0.03). No change was observed in the other disease activity variables.
No significant improvement in any disease activity variable of active AS was observed during treatment with Salofalk except for the ESR. Many side effects were seen.
已发现美沙拉嗪（莎尔福）对炎症性肠病患者有效且毒性低。肠道病变与脊柱关节病（SpA）之间的关联已为人熟知，我们研究了相对高剂量美沙拉嗪对强直性脊柱炎（AS）患者的疗效和安全性。
在一项开放性研究中，对20例年龄在18至70岁之间的活动性AS患者（定义为至少存在一项临床标准，即晨僵>30分钟、外周滑膜炎、附着点病或在10厘米视觉模拟量表上疼痛评分>2，以及一项实验室标准，即红细胞沉降率（ESR）>20毫米/小时或C反应蛋白（CRP）>20毫克/升）给予美沙拉嗪（3 - 4克/天）治疗24周。在基线以及4周、12周和24周后获取毒性和疾病活动变量（ESR、CRP、巴斯强直性脊柱炎疾病活动指数（BASDAI）、巴斯强直性脊柱炎功能指数（BASFI）、巴斯强直性脊柱炎测量指数（BASMI）、整体评估和关节计数）的数据，并基于意向性分析进行分析。
研究患者的平均年龄为41岁，平均病程为7.9年，基线时平均ESR为29毫米/小时。平均9.3周（范围2 - 22周）后，20例患者中有8例因不良反应过早停药，主要是胃肠道不适。12例患者完成了为期24周的研究，使用的美沙拉嗪平均剂量为3.2克/天（范围1 - 4克）。数据分析显示ESR、CRP和医生整体评估有所改善，但只有ESR的变化（基线时为29毫米/小时，第24周时为25毫米/小时）达到统计学意义（p = 0.03）。其他疾病活动变量未见变化。
除ESR外，在使用莎尔福治疗期间，活动性AS的任何疾病活动变量均未观察到显著改善。出现了许多副作用。
