补肾活血膏方对肾虚血瘀证强直性脊柱炎患者的临床疗效  

Clinical effects of Bushen Huoxue Ointment Formula on patients with ankylosing spondylitis of Kidney Deficiency and Blood Stasis Pattern

作　　者：杨晔颖[1] 何东仪 薛鸾[3] 于盈盈 程鹏 孙宇[3] 苏励[1] YANG Ye-ying;HE Dong-yi;XUE Luan;YU Ying-ying;CHENG Peng;SUN Yu;SU Li(Longhua Hospital Affiliated to Shanghai University of Traditional Chinese Medicine,Shanghai 200032,China;Shanghai Guanghua Hospital of Integrated Traditional Chinese and Western Medicine,Shanghai 200030,China;Yueyang Hospital of Integrated Traditional Chinese and Western Medicine Affiliated to Shanghai University of Traditional Chinese Medicine,Shanghai 200437,China;Qingpu District Hospital of Traditional Chinese Medicine,Shanghai 201700,China)

机构地区：[1]上海中医药大学附属龙华医院,上海200032 [2]上海光华中西医结合医院,上海200030 [3]上海中医药大学附属岳阳中西医结合医院,上海200437 [4]青浦区中医医院,上海201700

出　　处：《中成药》2024年第2期458-465,共8页Chinese Traditional Patent Medicine

基　　金：上海市科委科研项目(23Y11920400);上海中医药大学发展基金科研项目(23KFL072)。

摘　　要：目的 探讨补肾活血膏方对肾虚血瘀证强直性脊柱炎患者的临床疗效。方法 167例患者随机分为对照组(常规治疗,55例)、暴露组(常规治疗+补肾活血汤剂,54例)、高暴露组(常规治疗+补肾活血汤剂+补肾活血膏方,58例),疗程2年。检测临床疗效、BASDAI评分、ASDAS-CRP、BASFI评分、脊柱痛评分、PGA评分、BASMI评分、ASQoL评分、SPARCC评分、肾虚血瘀证评分、ESR、CRP、IL-6、TNF-α、IL-17、IL-23、IL-35、NLR、PLR、安全性指标变化。结果 高暴露组ASAS40、ASAS5/6、BASDAI50例数多于暴露组和对照组(P<0.05)。治疗后,高暴露组BASDAI评分、ASDAS-CRP、BASFI评分、脊柱痛评分、PGA评分、BASMI评分、SPARCC评分、ASQoL评分、肾虚血瘀证评分、ESR、CRP、IL-6、TNF-α、IL-17、IL-23低于其他2组(P<0.05),IL-35更高(P<0.05)。经Logistic回归分析校正混杂因素后,补肾活血汤、补肾活血膏方降低BASDAI评分和ASDAS-CRP(P<0.05),提高临床疗效(P<0.05)。3组未发现严重不良反应。结论 补肾活血膏方可安全有效地抑制肾虚血瘀证强直性脊柱炎患者炎症,降低疾病活动度,减轻骨髓水肿,改善临床症状,提高关节功能和生活质量。AIM To explore the clinical effects of Bushen Huoxue Ointment Formula on patients with ankylosing spondylitis of Kidney Deficiency and Blood Stasis Pattern.METHODS One hundred and sixty-seven patients were randomly assigned into control group(55 cases)for 2-year intervention of conventional treatment,exposure group(54 cases)for 2-year intervention of both Bushen Huoxue Decoction and conventional treatment,and high exposure group(58 cases)for 2-year intervention of Bushen Huoxue Ointment Formula,Bushen Huoxue Decoction and conventional treatment.The changes in clinical effects,BASDAI score,ASDAS-CRP,BASFI score,spinal pain score,PGA score,BASMI score,ASQoL score,SPARCC score,Kidney Deficiency and Blood Stasis Pattern score,ESR,CRP,IL-6,TNF-α,IL-17,IL-23,IL-35,NLR,PLR and safety indices were detected.RESULTS The high exposure group demonstrated more ASAS40,ASASAS5/6,BASDAI50 cases than the exposure group and the control group(P<0.05).After the treatment,the high exposure group displayed lower BASDAI score,ASDAS-CRP,BASFI score,spinal pain score,PGA score,BASMI score,SPARCC score,ASQoL score,Kidney Deficiency and Blood Stasis Pattern score,ESR,CRP,IL-6,TNF-α,IL-17,IL-23 than the other two groups(P<0.05),and higher IL-35(P<0.05).After adjusting confounding factors by logistic regression analysis,Bushen Huoxue Decoction and Bushen Huoxue Ointment Formula reduced BASDAI score,ASDAS-CRP(P<0.05),and enhanced clinical effects(P<0.05).No serious adverse reactions were found in the three groups.CONCLUSION For the patients with ankylosing spondylitis of Kidney Deficiency and Blood Stasis Pattern,Bushen Huoxue Ointment Formula can safely and effectively inhibit inflammation,reduce disease activity,alleviate bone marrow edema,improve clinical symptoms,and enhance joint functions and life quality.

关 键 词：补肾活血膏方 常规治疗 补肾活血汤 强直性脊柱炎 肾虚血瘀 

分 类 号：R287[医药卫生—中药学]