Effect of Yiqi Qingluo Formula on inflammation and bone destruction in patients with rheumatoid arthritis

Yutian XIAO; Luan XUE; Cuiyun ZHU; Xuemei PIAO

doi:10.16306/j.1008-861x.2022.04.003

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Effect of Yiqi Qingluo Formula on inflammation and bone destruction in patients with rheumatoid arthritis

Clinical Research | 更新时间：2022-08-29

- Effect of Yiqi Qingluo Formula on inflammation and bone destruction in patients with rheumatoid arthritis
- Academic Journal of Shanghai University of Traditional Chinese Medicine Vol. 36, Issue 4, Pages: 19-25(2022)
- 作者机构：
  
  1.上海中医药大学附属岳阳中西医结合医院风湿科（上海　200437）
  2.上海市公共卫生临床中心（上海　200093）
- 作者简介：
- 基金信息：
- DOI：10.16306/j.1008-861x.2022.04.003
  CLC：
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校钰湉,薛鸾,朱翠云等.益气清络方对类风湿关节炎患者炎症和骨破坏的影响[J].上海中医药大学学报,2022,36(04):19-25.

XIAO Yutian,XUE Luan,ZHU Cuiyun,et al.Effect of Yiqi Qingluo Formula on inflammation and bone destruction in patients with rheumatoid arthritis[J].Academic Journal of Shanghai University of Traditional Chinese Medicine,2022,36(04):19-25.
校钰湉,薛鸾,朱翠云等.益气清络方对类风湿关节炎患者炎症和骨破坏的影响[J].上海中医药大学学报,2022,36(04):19-25. DOI： 10.16306/j.1008-861x.2022.04.003.

XIAO Yutian,XUE Luan,ZHU Cuiyun,et al.Effect of Yiqi Qingluo Formula on inflammation and bone destruction in patients with rheumatoid arthritis[J].Academic Journal of Shanghai University of Traditional Chinese Medicine,2022,36(04):19-25. DOI： 10.16306/j.1008-861x.2022.04.003.

摘要

目的,2,探讨益气清络方联合西药治疗对类风湿关节炎（RA）患者炎症和骨破坏的影响。,方法,2,纳入146例气虚络热证RA患者，随机分为治疗组和对照组，每组各73例。治疗组患者给予益气清络方颗粒剂与甲氨蝶呤（MTX）口服，对照组患者给予益气清络方颗粒安慰剂与MTX口服，疗程均为24周。治疗前后，采用以红细胞沉降率（ESR）为基础的28处关节疾病活动度评分（DAS28-ESR）评估患者的疾病活动度，检测患者的炎症指标［包括ESR、C-反应蛋白（CRP）、,D,-二聚体（,D,-Di）、血小板（PLT）、白介素（IL）-6、肿瘤坏死因子-ɑ（TNF-ɑ）］、骨代谢指标［包括碱性磷酸酶（AKP）、维生素D（Vit D）、骨钙素（OC）、β型胶原降解产物（β-CTX）、Ⅰ型胶原羧基端前肽（PICP）］水平，评估患者的骨破坏相关影像学指标（包括骨密度及X线sharp评分、关节超声半定量评分），同时，对纳入RA患者的炎症指标与骨代谢指标、骨破环指标进行相关性分析。,结果,2,治疗全程，对照组5例患者被剔除，最终纳入统计分析者治疗组73例、对照组68例。①治疗后，两组患者的ESR、CRP、,D,-Di、PLT、IL-6、TNF-ɑ水平及DAS28-ESR较治疗前均明显降低（,P,<,0.05），且治疗组患者的上述指标水平均低于对照组（,P,<,0.05）。②治疗后，两组患者的AKP、Vit D、OC、PICP水平较治疗前均明显升高（,P,<,0.05），β-CTX水平较治疗前明显降低（,P,<,0.05），且治疗组患者的AKP、Vit D、OC、PICP水平高于对照组（,P,<,0.05）。③治疗后，两组患者的关节超声半定量评分降低（,P,<,0.05）、X线sharp评分升高（,P,<,0.05），且治疗组患者的关节超声半定量评分低于对照组（,P,<,0.05）；治疗后，治疗组患者的骨密度升高（,P,<,0.05），而对照组患者的骨密度降低（,P,<,0.05），且治疗组患者的骨密度高于对照组（,P,<,0.05）。④RA患者的炎症指标水平与关节超声半定量评分、β-CTX水平呈正相关，与OC、PICP、AKP、骨密度水平呈负相关。,结论,2,益气清络方联合西药治疗可更显著地改善RA患者的异常炎症状态和骨代谢异常，改善患者的骨密度，从而在一定程度上延缓骨破坏的进展。

Abstract

Objective： To investigate the effects of Yiqi Qingluo Formula combined with western medicine on inflammation and bone destruction in treating patients with rheumatoid arthritis （RA）.,Methods,2,A total of 146 RA patients with qi-deficiency and collateral-heat syndrome were enrolled and randomly divided into the treatment group and control group， 73 cases in each group. The patients in the treatment group were treated with Yiqi Qingluo Formula granule and methotrexate （MTX） orally， and the patients in the control group were treated with Yiqi Qingluo Formula granule placebo and MTX orally， with a course of 24 weeks. Before and after treatment， the disease activity of the patients was assessed by disease activity score in 28 joints based on erythrocyte sedimentation rate （DAS28-ESR）. The levels of inflammatory indicators including ESR， C-reactive protein （CRP）， ,D,-dimer （,D,-Di）， platelet count （PLT）， interleukin （IL）-6 and tumor necrosis factor-α （TNF-α）， and bone metabolism indicators including alkaline phosphatase （AKP）， vitamin D （Vit D）， osteocalcin （OC），β isomer of C-terminal telopeptide of type Ⅰ collagen （β-CTX） and propeptide of typeⅠprocollagen （PICP） were detected. The imaging indicators related to bone destruction including bone density， X-ray sharp score and semi-quantitative score of joint ultrasound were evaluated. Meanwhile， correlation analysis was conducted between inflammatory indexes and bone metabolism and bone destruction indexes in RA patients.,Results,2,During the course of treatment， 5 patients in the control group were eliminated， finally 73 patients in the treatment group and 68 patients in the control group were included in the statistical analysis. ①After treatment， the levels of ESR， CRP， ,D,-Di， PLT， IL-6 and TNF-ɑ and DAS28-ESR in the two groups were significantly decreased compared with those before treatment （,P,<,0.05）， and the levels of above indexes in the treatment group were lower than those in the control group （,P,<,0.05）. ②After treatment， the levels of AKP， Vit D， OC and PICP in the two groups were significantly increased compared with those before treatment （,P,<,0.05）， the level of β-CTX was significantly decreased compared with that before treatment （,P,<,0.05）， and the levels of AKP， Vit D， OC and PICP in the treatment group were higher than those in the control group （,P,<,0.05）. ③After treatment， the semi-quantitative scores of joint ultrasound in the two groups were decreased （,P,<,0.05）， the X-ray sharp scores were increased （,P,<,0.05）， and the semi-quantitative score of joint ultrasound in the treatment group was lower than that in the control group （,P,<,0.05）. After treatment， the bone density in the treatment group was increased （,P,<,0.05）， while the bone density in the control group was decreased （,P,<,0.05）， and the bone density of the treatment group was higher than that of the control group （,P,<,0.05）. ④The levels of inflammatory indexes of RA patients were positively correlated with the semi-quantitative scores of joint ultrasound and β-CTX level， and were negatively correlated with the levels of OC， PICP， AKP and bone density.,Conclusion,2,Yiqi Qingluo Formula combined with western medicine can more significantly improve the abnormal inflammatory state and bone metabolism in RA patients， improve the bone density， and thus slow down the progression of bone destruction to a certain extent.

关键词

类风湿关节炎益气清络方炎症骨代谢骨破坏

Keywords

rheumatoid arthritisYiqi Qingluo Formulainflammationbone metabolismbone destruction

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