现代中西医结合杂志2025，Vol.34Issue(19)：2649-2655,2673,8.DOI:10.3969/j.issn.1008-8849.2025.19.004
补肾强脊汤联合IL-17A抑制剂治疗强直性脊柱炎达标控制的随机对照研究
Treat-to-target strategy with Bushen Qiangji Decoction combined with IL-17A inhibitor in the treatment of ankylosing spondylitis:a randomized control study
摘要
Abstract
Objective It is to evaluate the clinical efficacy and safety of Bushen Qiangji Decoction combined with IL-17A inhibitor in the treatment of ankylosing spondylitis(AS)with syndrome of kidney deficiency and blood stasis.Meth-ods Eighty-five AS patients with syndrome of kidney deficiency and blood stasis treated at Guang'anmen Hospital of China Academy of Chinese Medical Sciences from January to October 2023 were divided into two groups by a randomized con-trolled study design,the combined treatment group was treated with oral administration of Bushen Qiangji Decoction along with subcutaneous injection of the IL-17A inhibitor,Secukinumab,while the traditional Chinese medicine group was treated with oral administration of Bushen Qiangji Decoction,both groups were continuously treated for 24 weeks.The AS disease activity(ASDAS-CRP scores),the rate of achieving ASDAS-CRP<1.3,levels of C-reactive protein(CRP)and erythro-cyte sedimentation rate(ESR)before treatment and after 12 weeks and 24 weeks of treatment,the scores of Bath Ankylo-sing Spondylitis Disease Activity Index(BASDAI),Bath Ankylosing Spondylitis Functional Index(BASFI),Patient Glob-al Assessment(PGA),nocturnal pain visual analogue scale(VAS)before treatment and after 4,12,24 weeks of treat-ment were observed and compared in the patients of the two groups,and the adverse reactions occurred in the patients were monitored.Results A total of 38 patients in the combined treatment group and 37 patients in the traditional Chinese medi-cine group were ultimately enrolled in the study.After 12 weeks and 24 weeks of treatment,the ASDAS-CRP scores in the two groups were significantly lower than those before treatment(both P<0.05);after12 weeks of treatment,the ASDAS-CRP score in the combined treatment group was significantly lower,while the rate of achieving ASDAS-CRP<1.3 was sig-nificantly higher than those in the Chinese medicine group at the same time period(both P<0.05);after 24 weeks of treatment,there were no statistically significant differences in ASDAS-CRP scores and the rate of achieving ASDAS-CRP<1.3 between the two groups(both P>0.05).After 4 weeks,12 weeks,and24 weeks of treatment,the BASDAI scores,BASFI scores(except for 12 weeks of treatment),PGA scores,and VAS scores in the two groups were significantly lower than those before treatment(all P<0.05),the BASDAI scores,BASFI scores,PGA scores and VAS scores after 4 weeks,12 weeks,and 24 weeks of treatment,the BASFI scores and VAS scores after 24 weeks of treatment were signifi-cantly lower in the combined treatment group than those in the control group at the same time period(all P<0.05).After 24 weeks of treatment,the serum level of CRP in the combined treatment group and ESR in both groups were significantly lower than those before treatment(all P<0.05),however,there was no statistically significant differences in these indica-tors between the two groups at each time point(all P>0.05).Conclusion Combination therapy with Bushen Qiangji De-coction and IL-17A inhibitors can increase achieving rate of treatment and shorten the time of treat to target in the treatment of AS,and this therapy can more effectively alleviate patients'clinical symptoms and enhance spinal functional mobility.关键词
补肾强脊汤/IL-17A抑制剂/中西医结合治疗方案/达标治疗Key words
Bushen Qiangji Decoction/IL-17A inhibitor/integrated treatment with traditional Chinese and western medicine/treat to target分类
医药卫生引用本文复制引用
杨琨,刘宏潇,耿昭阳,何夏秀..补肾强脊汤联合IL-17A抑制剂治疗强直性脊柱炎达标控制的随机对照研究[J].现代中西医结合杂志,2025,34(19):2649-2655,2673,8.基金项目
北京市中医药科技发展资金项目(BJZYZD-2023-02) （BJZYZD-2023-02）
北京市自然科学基金面上项目(7252264) （7252264）
医疗机构制剂研发与新药转化专项(HLCMHPP2023049) （HLCMHPP2023049）
