补肾强督清化汤治疗强直性脊柱炎肾虚湿热证临床疗效评估  

Clinical efficacy evaluation of Qiangdu Qinghua Decoction in treating ankylosing spondylitis with kidney deficiency and damp heat syndrome

作　　者：穆闻君 孙文婷 胡丽芳 李孟霞 马秉志 李栋[3] 陶庆文[3] 阎小萍[3] 孔维萍[3] MU Wen-jun;SUN Wen-ting;HU Li-fang;LI Meng-xia;MA Bing-zhi;LI Dong;TAO Qing-wen;YAN Xiao-ping;KONG Wei-ping(Beijing University of Chinese Medicine,Beijing 100029,China;China Academy of Chinese Medical Sciences,Beijing 100700;Department of Rheumatology of Traditional Chinese Medicine, China-Japan Friendship Hospital, Key Laboratory of Immune Inflammatory Diseases of Beijing,Beijing 100029)

机构地区：[1]北京中医药大学,北京100029 [2]中国中医科学院,北京100700 [3]中日友好医院中医风湿病科免疫炎性疾病北京市重点实验室,北京100029

出　　处：《北京中医药》2022年第8期838-843,共6页Beijing Journal of Traditional Chinese Medicine

基　　金：北京市中医药科技发展资金项目(JJ-2020-87)。

摘　　要：目的 探讨补肾强督清化汤治疗强直性脊柱炎(AS)肾虚湿热证临床疗效。方法 采用单盲、随机对照的研究方法,将70例AS肾虚湿热证患者按随机数字表法分为观察组和对照组。观察组予补肾强督清化汤联合塞来昔布治疗,对照组予中药安慰剂联合塞来昔布治疗,疗程均为12周。评价2组患者治疗前后临床症状及体征、中医证候评分、疾病活动度、炎症反应指标,采用AS国际评估委员会的工作小组(ASAS)制定的疗效标准评价体系,即ASAS20、ASAS40、ASAS5/6,Bath AS活动性指数50 (BASDAI50)和中医证候评分改善率评估补肾强督清化汤的临床疗效。结果 治疗12周后观察组与对照组ASAS20应答率分别为73.5%、44.1%;ASAS40应答率分别为47.1%、17.6%;ASAS5/6应答率分别为52.9%、23.5%;中医总有效率分别为91.88%、55.88%,上述指标2组差异有统计学意义(P<0.05)。治疗后2组AS患者综合指数(BAS-G)、BASDAI、疾病活动评分-C反应蛋白指标(ASDAS-CRP)、Bath功能指数(BASFI)、夜间痛VAS评分、脊柱痛VAS评分、中医证候评分及实验室指标等与治疗前相比均显著改善,差异有统计学意义(P<0.05);组间比较,观察组BAS-G、BASDAI、BASFI、ASDAS-CRP、夜间痛、中医证候评分均优于对照组,差异有统计学意义(P<0.05)。结论 补肾强督清化汤治疗AS肾虚湿热证,临床疗效显著,优于单纯使用塞来昔布,且不良反应少,安全性高。Objective To investigate the clinical efficacy of Bushen Qiangdu Qinghua Decoction on ankylosing spondylitis(AS) of kidney deficiency and dampness heat syndrome.Methods Using a single-blind, randomized controlled study method, 70 patients with kidney deficiency and dampness heat syndrome of AS were randomly divided into observation and control groups according to random number table method.The observation group was treated with Bushen Qiangdu Qinghua Decoction combined with celecoxib, while the control group was treated with Chinese herbal medicine placebo combined with celecoxib.The course of treatment was 2 weeks for both groups.The clinical symptoms and signs, TCM symptom scores, disease activity, inflammatory response indexes of the two groups were evaluated before and after the treatment, and the clinical efficacy of Bushen Qiangdu Qinghua Decoction was assessed using the evaluation system of efficacy criteria developed by the working group of AS International Assessment Committee(ASAS), namely ASAS20, ASAS40, ASAS5/6, BASDAI50 and the improvement rate of TCM symptom scores.Results After 12 weeks of treatment,the ASAS20 response rate was 73.5% and 44.1% in the observation group and the control group respectively;ASAS40 response rate was 47.1% and 17.6% respectively;ASAS5/6 response rate was 52.9% and 23.5% respectively;the total TCM effective rate was 91.88% and 55.88% respectively, and the differences of above indexes between the two groups were statistically significant(P<0.05).After treatment, BAS-G, BASDAI, ASDAS-CRP, BASFI,nocturnal pain VAS score, spinal pain VAS score, TCM evidence score, laboratory index of AS patients in both groups were significantly improved compared with those before treatment, and the differences were statistically significant(P<0.05);compared two groups, BAS-G, BASDAI, ASDAS-CRP nocturnal pain, TCM symptoms scores in the observation group were better than those in the control group, and the differences were statistically significant(P<0.05).Conclusion The clinical efficacy of B

关 键 词：补肾强督清化汤 强直性脊柱炎 肾虚湿热证 疗效评价 

分 类 号：R259[医药卫生—中西医结合]