Shire Biqing Pill in Treatment of Rheumatoid Arthritis with Damp-heat Obstruction Syndrome and Its Effect on OPG/RANKL/RANK Signaling Pathway and TNF-<italic style="font-style: italic">α</italic>

ZHOU Zhifeng; GUO Huiqing; CUI Pengtao; CAO Yuju

doi:10.13422/j.cnki.syfjx.202202321

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Shire Biqing Pill in Treatment of Rheumatoid Arthritis with Damp-heat Obstruction Syndrome and Its Effect on OPG/RANKL/RANK Signaling Pathway and TNF-α

更新时间：2023-05-16

- Shire Biqing Pill in Treatment of Rheumatoid Arthritis with Damp-heat Obstruction Syndrome and Its Effect on OPG/RANKL/RANK Signaling Pathway and TNF-α
- Chinese Journal of Experimental Traditional Medical Formulae Vol. 29, Issue 12, Pages: 121-127(2023)
- 作者机构：
  
  1.郑州中医骨伤病医院，郑州 450016
  2.河南省中医院，郑州 450000
- 作者简介：
- 基金信息：
- DOI：10.13422/j.cnki.syfjx.202202321
  CLC： R22;R242;R2-031;R287
- Published：20 June 2023，
  
  Published Online：10 October 2022，
  
  Received：29 May 2022，
- 稿件说明：
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周志锋,郭会卿,崔朋涛等.湿热痹清丸治疗类风湿关节炎湿热痹阻证的临床观察及对OPG/RANKL/RANK通路和TNF-α的影响[J].中国实验方剂学杂志,2023,29(12):121-127.

ZHOU Zhifeng,GUO Huiqing,CUI Pengtao,et al.Shire Biqing Pill in Treatment of Rheumatoid Arthritis with Damp-heat Obstruction Syndrome and Its Effect on OPG/RANKL/RANK Signaling Pathway and TNF-α[J].Chinese Journal of Experimental Traditional Medical Formulae,2023,29(12):121-127.
周志锋,郭会卿,崔朋涛等.湿热痹清丸治疗类风湿关节炎湿热痹阻证的临床观察及对OPG/RANKL/RANK通路和TNF-α的影响[J].中国实验方剂学杂志,2023,29(12):121-127. DOI： 10.13422/j.cnki.syfjx.202202321.

ZHOU Zhifeng,GUO Huiqing,CUI Pengtao,et al.Shire Biqing Pill in Treatment of Rheumatoid Arthritis with Damp-heat Obstruction Syndrome and Its Effect on OPG/RANKL/RANK Signaling Pathway and TNF-α[J].Chinese Journal of Experimental Traditional Medical Formulae,2023,29(12):121-127. DOI： 10.13422/j.cnki.syfjx.202202321.

摘要

目的

通过研究湿热痹清丸治疗类风湿关节炎湿热痹阻证的临床疗效及对患者血清骨保护素（OPG）、核转录因子-

B受体活化因子配体（RANKL）、肿瘤坏死因子-

（TNF-

）表达的影响，从骨破坏的角度探讨其作用机制。

方法

采用随机数字表法将纳入的类风湿关节炎湿热痹阻证患者分为两组，每组各36例患者。对照组给予口服甲氨蝶呤片、塞来昔布胶囊治疗；治疗组在对照组的基础上配合口服中成药湿热痹清丸治疗，其治疗周期为3个月。分别记录治疗前和治疗后疼痛视觉模拟（VAS）评分、关节压痛数、关节肿胀数、疾病活动度评分（DAS28-ESR）、中医症状量化积分及相关不良反应并检测外周血清OPG、RANKL、TNF-

、红细胞沉降率（ESR）、C反应蛋白（CRP）水平。

结果

治疗后，治疗组总有效率为88.57%（31/35），对照组总有效率为79.41%（27/34），治疗组总有效率高于对照组（

=-2.089，

0.05）。与本组治疗前比较，两组疼痛VAS评分、关节压痛数、关节肿胀数及DAS28-ESR均明显降低（

0.05）；治疗后与对照组比较，治疗组疼痛VAS评分、关节压痛数、关节肿胀数及DAS28-ESR改善更明显（

0.05）。与本组治疗前比较，两组中医症状量化积分明显降低（

0.05）；治疗后与对照组比较，治疗组中医症状量化积分降低更明显（

0.05）。与本组治疗前比较，两组RANKL、TNF-

α、

ESR、CRP水平均明显降低，OPG水平明显升高（

0.05）；治疗后与对照组比较，治疗组RANKL、TNF-

α、

ESR、CRP水平降低更明显，OPG水平升高更明显（

0.05）。在本次临床试验期间未出现任何严重不良事件及严重不良反应。

结论

湿热痹清丸可以有效改善湿热痹阻型类风湿关节炎患者的临床症状，有较好的安全性；湿热痹清丸可以有效调控OPG/RANKL/RANK系统，同时降低促炎因子TNF-

，这有可能是其干预RA骨破坏的作用机制。

Abstract

Objective

To study the clinical efficacy of Shire Biqing pill in the treatment of rheumatoid arthritis （damp-heat obstruction syndrome） and its effect on the expression of serum osteoprotegerin （OPG）， nuclear factor-

B receptor activating factor ligand （RANKL）， and tumor necrosis factor-

（TNF-

）， and to explore its mechanism from the perspective of bone destruction.

Method

Patients with rheumatoid arthritis （damp-heat obstruction syndrome） were randomly divided into two groups， with 36 patients in each group. The control group was treated with methotrexate tablets and celecoxib capsule， while the treatment group was treated with Shire Biqing pill based on the control group. The treatment period was 3 months. The pain visual analogue scale （VAS） score， joint tenderness number， joint swelling number， disease activity score （DAS28-ESR）， traditional Chinese medicine （TCM） symptom quantitative score， and related adverse reactions were recorded before and after treatment， and the peripheral serum OPG， RANKL， TNF-

， erythrocyte sedimentation rate （ESR）， and Creactive protein （CRP） were detected.

Result

After treatment， the total effective rate was 88.57% （31/35） in the treatment group and 79.41% （27/34） in the control group. The total effective rate of the treatment group was higher than that of the control group （

=-2.089，

0.05）. The pain VAS score， joint tenderness number， joint swelling number， and DAS28-ESR of the two groups were significantly lower than those before treatment （

0.05）， and the pain VAS score， joint tenderness number， joint swelling number， and DAS28-ESR of the treatment group were significantly better than those of the control group after treatment （

0.05）. Compared with that before treatment， the TCM symptom quantitative score in the two groups decreased significantly （

0.05）， and the decrease was more obvious in the treatment group than in the control group （

0.05）. Compared with those before treatment， the levels of RANKL， TNF-

， ESR， and CRP in the two groups decreased and the level of OPG increased （

0.05）， and the changes in the treatment group were more obvious that in the control group （

0.05）. There were no serious adverse events or serious adverse reactions during this clinical trial.

Conclusion

Shire Biqing pill can effectively improve the clinical symptoms of rheumatoid arthritis （damp-heat obstruction syndrome） with good safety. Shire Biqing pill effectively regulate the OPG/RANKL/RANK system and reduce the pro-inflammatory factor TNF-

， which may be its mechanism in the intervention in rheumatoid arthritis bone destruction.

关键词

类风湿关节炎湿热痹清丸骨破坏骨保护素/核转录因子-κB受体活化因子配体/核转录因子-κB受体系统

Keywords

rheumatoid arthritisShire Biqing pillbone destructionosteoprotegerin/nuclear factor-κB（NF-κB） receptor activating factor ligand/ NF-κB receptor activatorsystem

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Shire Biqing Pill in Treatment of Rheumatoid Arthritis with Damp-heat Obstruction Syndrome and Its Effect on OPG/RANKL/RANK Signaling Pathway and TNF-α

DOI：10.13422/j.cnki.syfjx.202202321

摘要

Abstract

关键词

Keywords

references