补肾强督方联合司库奇尤单抗治疗强直性脊柱炎肾虚督寒证临床疗效观察  

Clinical curative effcet observation on Bushen Qiangdu Formula combined with Secukinumab in ankylosing spondylitis with kidney vacuity and Du channel-cold syndrome

作　　者：吴娟 鄢泽然[2] 黄振国[2] 张楠[2] 张英泽[2] 陶庆文[2,3] 孔维萍 阎小萍[2,3] WU Juan;YAN Zeran;HUANG Zhenguo;ZHANG Nan;ZHANG Yingze;TAO Qingwen;KONG Weiping;YAN Xiaoping(Guangzhou Nansha District Nansha Street Jinzhou Community Health Service Center,Guangzhou 511457,China;China-Japan Friendship Hospital,Beijing 100029,China;Beijing Key Laboratory ofImmunoinflammatory Diseases,Beijing 100029,China)

机构地区：[1]广州市南沙区南沙街道金洲社区卫生服务中心,广州511457 [2]中日友好医院,北京100029 [3]免疫炎性疾病北京市重点实验室,北京100029

出　　处：《中华中医药杂志》2024年第10期5646-5650,共5页China Journal of Traditional Chinese Medicine and Pharmacy

基　　金：中央高水平医院临床科研业务费(No.2022-NHLHCRF-LX-02-0104);国家自然科学基金青年科学基金项目(No.81403378);北京市自然科学基金项目(No.7182148);北京市中医药科技发展资金项目(No.JJ-2020-87)。

摘　　要：目的:观察补肾强督方联合司库奇尤单抗治疗强直性脊柱炎(AS)肾虚督寒证的临床疗效。方法:选择36例AS肾虚督寒证患者,予补肾强督方口服联合司库奇尤单抗皮下注射治疗16周。第4、16周进行疗效及安全性评价。以ASAS5/6作为主要疗效指标;以ASAS20、ASAS40、中医证候评分、脊柱疼痛评分、患者总体评价(PGA)、强直性脊柱炎疾病活动性指数(BASDAI)、强直性脊柱炎功能指数(BASFI)和Bath AS测量指数(BASMI)、血沉(ESR)、C反应蛋白(CRP)、ASDAS-CRP、骶髂关节及全脊柱磁共振成像(MRI)SPARCC评分作为次要疗效指标;以血、尿、便常规,肝肾功及心电图作为安全性指标。结果:治疗16周后,36例AS患者达到ASAS5/6、ASAS20和ASAS40和的比例分别为58.33%(21/36)、72.22%(26/36)、52.78%(19/36),中医证候疗效总有效率为88.89%(32/36)。与治疗前比较,治疗4、16周后BASFI、脊柱疼痛评分、PGA、BASDAI、ESR、CRP及ASDAS-CRP均显著降低(P<0.05);与治疗前比较,治疗16周后骶髂关节SPARCC评分及全脊柱SPARCC评分均显著降低(P<0.05)。结论:补肾强督方联合司库奇尤单抗能显著减轻AS患者炎症反应,改善患者症状、体征,降低患者骶髂关节、脊柱骨髓水肿,临床疗效确切。Objective:To observe the clinical efficacy of Bushen Qiangdu Formula combined with Secukinumab in ankylosing spondylitis(AS)patients with kidney vacuity and Du channel-cold syndrome.Methods:Thirty-six AS patients with kidney vacuity and Du channel-cold syndrome were enrolled.All patients have treated with Bushen Qiangdu Formula and subcutaneous injections of Secukinumab for 16 weeks.Efficacy and safety evaluations were conducted at the 4th and 16th weeks.The primary endpoint was the proportion of patients with at least 20%improvement in the assessment of ASAS5/6 response criteria at week 16.Spondyloarthritis International Society(ASAS20),ASAS40,TCM syndrome score,spinal pain score,PGA,BASDAI,BASFI,BASMI,ESR,CRP,ASDAS-CRP,SPARCC score of sacroiliac joint and whole spine MRI were used as the secondary efficacy indicators.Blood,urine,stool routine,liver and kidney function and electrocardiogram were used as safety indicators.Results:After 16 weeks treatment,among the total of 36 patients,ASAS5/6 response rate was 58.33%(21/36),ASAS20 and ASAS40 response rates were 72.22%(26/30),and 52.78%(19/36)respectively.After 16 weeks treatment,the total efficacy rate of TCMSS in 36 patients was 88.89%(32/36).Compared with before treatment,significant reductions were seen in BASFI,spinal pain score,PGA,BASDAI,ESR,CRP,ASDAS-CRP at the 4th week or 16th week(P<0.05).Compared with before treatment,SPARCC SI joint scores and SPARCC spine scores decreased after 16 weeks of continuous treatment(P<0.05).Conclusion:The efficacy of Bushen Qiangdu Formula combined with Secukinumab in AS patients was confirmed,accompanied by reduced inflammatory conditions in the SI joint and the spine,also improvement in clinical symptoms and signs.

关 键 词：强直性脊柱炎 补肾强督方 司库奇尤单抗 临床研究 磁共振成像 骨髓水肿 

分 类 号：R593.23[医药卫生—内科学]