益肾温督小复方治疗肾虚督寒型强直性脊柱炎30例临床研究

目的研究益肾温督小复方治疗净虚督寒型强直性脊柱炎的临床疗效及安全性。方法观察益肾温督小复方治疗组（30例）与柳氮磺胺吡啶对照组（30例）强直性脊柱炎患者治疗前后临床症状、体征和实验室指标的变化。结果疗后治疗组达到ASAS20标准病例数的百分比和中医证候疗效的总有效率分别为95．8％和93．3％，优于柳氮磺胺吡啶对照组的82．5％和66．7％（P〈0．05）；患者的Bath强直性脊柱炎疾病活动指数（BASDM）、功能指数（BASFI）、测量指数（BASMI）及全身和脊柱疼痛Likert四级积分、中医证候积分、患者和医生的总体评分、晨僵时间、血沉（ESR）、C反应蛋白（CRP）、免疫球蛋白G（IgG）、肿瘤坏死因子α（TNF—α）等均有明显改善（P〈0．05／0．01），且在主要症状、体征及BASMI、IgG、TNF-α、关节影像学积分等方面治疗组的改善较对照组明显（P〈0．05／0．01）。安全性检测亦未见明显异常。结论益肾温督小复方治疗肾虚督寒型强直性脊柱炎有效、安全。

Clinical Study on Yishen Wendu Compound in Treatment of Ankylosing Spondylitis of Kidney Deficiency and Cold Governor Vessel Type

Objective To study the clinical effect and safety of Yishen Wendu Compound in treatment of ankylosing spondylitis （AS） of kidney deficiency and cold governor vessel type. Methods The diversification of the clinical symptoms, signs and laboratory indicators of ankylosing spondylitis patients in Yishen Wendu Compound 30 cases of treatment group and sulfasalazine （SASP） 30 cases of control group before and after treatment were observed. Results After treatment, the percentage of ASAS20 standard cases number （%） and the efficacy of TCM syndrome total effective rates of treatment group were 95.83% and 93.3% respectively, superior to sulfasalazine control group 82.5% and 66.7% （P〈0.05）. The patients＇ BASDAI, BASFI, the whole body and spine ache Likert level 4 integral, TCM syndromes integral, patients and doctors＇ overall score, morning stiffness time, BASMI, ESR, CRP, IgG, TNF-α were significantly improved （P〈0.05/0.01）. The improvement of patients＇ major symptoms, signs, BASMI, IgG, TNF-α, joint imaging integral in the treatment group were more obvious than that in the control group （P〈0.05/0.01）. Safety detection had no obvious abnormalities. Conclusions Yishen Wendu Compound in treating ankylosing spondylitis of kidney deficiency and cold governor vessel type is effective and safe.