脊痛宁胶囊治疗强直性脊柱炎临床疗效与安全性研究.pdfVIP

2006年 4月第 13卷第 4期 中国中医药信息杂志 ·9· ·论著 · 脊痛宁胶囊治疗强直性脊柱炎临床疗效与安全性研究 王炎焱,黄 烽,郝爱真 (中国人民解放军总医院,北京 100853) 摘要：目的 通过为期 6 个月的开放性试验来观察脊痛宁胶囊对强直性脊柱炎(AS)患者的临床疗效及安全性。 方法 65 例早中期 AS 患者入组。治疗组 35 例,给予脊痛宁胶囊口服,1.4 g/次,3 次/d。对照组 30 例,给予柳氮磺 吡啶口服,1.0 g/次,2 次/d。两组分别于服药后第 1、3、6 月对 Bath 强直性脊柱炎病情活动指数、Bath 强直性脊 柱炎功能指数、Bath 强直性脊柱炎测量指数及患者总体评价 VAS 评分、脊柱痛、全身痛、夜间痛、血沉、C 反应 蛋白进行观察,并评价两组 ASAS20。结果 56 例患者完成了该项试验,其中治疗组 33 例,对照组 23 例。两组药物 毒副作用均很小,而且较轻。治疗组治疗 6 月后 ASAS20 的人数为 22 人(66.67%),对照组治疗 6 月后 ASAS20 的人数 为 14(60.86%)。结论 脊痛宁胶囊对早中期的 AS 患者有一定的治疗作用,同时短期观察安全性较好,与柳氮磺吡 啶片组比较未见明显差异。 关键词：强直性脊柱炎；脊痛宁胶囊；柳氮磺吡啶 中图分类号：R593.23 文献标识码：A 文章编号：1005-5304(2006)04-0009-03 Clinical Study of Jitongning Capsule in the Treatment of Ankylosing Spondylitis WANG Yan-yan, HUANG Feng, HAO Ai-zhen (Chinese PLA General Hospital, Beijing 100853, China) Abstract ：Objective To evaluate in a large open study if Jitongning capsule is potentially useful in the treatment of ankylosing spondylitis, and observe the safety of Jitongning capsule. Methods Sixty-five patients with ankylosing spondylitis were recruited. Jitongning capsule group were thirty-five patients, using Jitongning capsule at a dose of 4.2 g/d. The control group was using Sulfasalazine. There were thirty patients, using Sulfasalazine at a dose of 2.0 g/d. The Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), the Bath Ankylosing Spondylitis Functional Index (BASFI), the Bath Ankylosing Spondylitis Metrology Index (BASMI), patient’s global assessment, total body pain, spinal pain and night pain, ESR and CRP were measured at 1, 3, 6 months. The primary end point in this study was the proportion of patients with a 20% improvement r