<italic style="font-style: italic">Yiqi Yangyin Tongluo Formula </italic>（益气养阴通络方） in the Treatment of Sjögren's Syndrome of Deficiency of both <italic style="font-style: italic">Qi</italic> and <italic style="font-style: italic">Yin</italic> Pattern in 30 Cases： A Randomized Controlled Trial

SUN Siling; WANG Yuan; LIU Jian; HUANG Chuanbing; ZHANG Wandong; SUN Yue; HUANG Dan

doi:10.13288/j.11-2166/r.2023.09.010

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Yiqi Yangyin Tongluo Formula （益气养阴通络方） in the Treatment of Sjögren's Syndrome of Deficiency of both Qi and Yin Pattern in 30 Cases： A Randomized Controlled Trial

更新时间：2023-04-27

- Yiqi Yangyin Tongluo Formula （益气养阴通络方） in the Treatment of Sjögren's Syndrome of Deficiency of both Qi and Yin Pattern in 30 Cases： A Randomized Controlled Trial
- Journal of Traditional Chinese Medicine Vol. 64, Issue 9, Pages: 916-923(2023)
- 作者机构：
  
  1.安徽中医药大学研究生院，安徽省合肥市蜀山区梅山路117号，230000
  2.安徽中医药大学第一附属医院
- 作者简介：
- 基金信息：
- DOI：10.13288/j.11-2166/r.2023.09.010
  CLC：
- Received：30 November 2022，
  
  Revised：2023-02-28，
  
  Published：02 May 2023
- 稿件说明：
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孙思凌,汪元,刘健等.益气养阴通络方治疗气阴两虚型干燥综合征患者30例随机对照研究[J].中医杂志,2023,64(09):916-923.

SUN Siling,WANG Yuan,LIU Jian,et al.Yiqi Yangyin Tongluo Formula （益气养阴通络方） in the Treatment of Sjögren's Syndrome of Deficiency of both Qi and Yin Pattern in 30 Cases： A Randomized Controlled Trial[J].Journal of Traditional Chinese Medicine,2023,64(09):916-923.
孙思凌,汪元,刘健等.益气养阴通络方治疗气阴两虚型干燥综合征患者30例随机对照研究[J].中医杂志,2023,64(09):916-923. DOI： 10.13288/j.11-2166/r.2023.09.010.

SUN Siling,WANG Yuan,LIU Jian,et al.Yiqi Yangyin Tongluo Formula （益气养阴通络方） in the Treatment of Sjögren's Syndrome of Deficiency of both Qi and Yin Pattern in 30 Cases： A Randomized Controlled Trial[J].Journal of Traditional Chinese Medicine,2023,64(09):916-923. DOI： 10.13288/j.11-2166/r.2023.09.010.

摘要

目的

观察益气养阴通络方治疗气阴两虚型干燥综合征（SS）患者的临床疗效，并探讨其可能作用机制。

方法

选取60例气阴两虚型SS患者随机分为治疗组及对照组各30例，另选取同时期健康人30名为正常组。治疗组给予益气养阴通络方，每日1剂，分早晚两次温服；对照组给予硫酸羟氯喹口服，每次0.1 g，每日3次。两组均连续治疗8周后比较两组患者临床疗效总有效率，分别采用酶联免疫吸附测定法（ELASA）检测正常组及治疗组、对照组患者治疗前后血清白细胞介素1β（IL-1β）和白细胞介素18（IL-18）水平，免疫印迹实验法（WB）检测外周血单个核细胞（PBMC）中Nod样受体蛋白3（NLRP3）、半胱天冬氨酸蛋白酶-1（Caspase-1）、消皮素D（GSDMD）蛋白表达。透射电镜观察PBMC细胞焦亡形态。评估疾病活动指数（ESSDAI）、自我报告指数（ESSSPRI）评分、中医证候积分。魏氏法检测两组红细胞沉降率（ESR），免疫散射比浊法测C反应蛋白（CRP）、免疫球蛋白（IgG）、补体C3、C4水平。

结果

治疗组临床疗效总有效率（86.7%）优于对照组（60.0%，

＜0.05）。与对照组治疗后比较，治疗组中医证候积分、ESSDAI、ESSSPRI评分、ESR、CRP、IgG水平明显降低，C3、C4明显升高，均优于对照组（

＜0.05或

＜0.01）。与正常组比较，透射电镜下治疗组与对照组患者PBMC均出现胞浆肿胀、膜破裂、鼓泡等焦亡形态学变化，患者血清IL-1β、IL-18水平及PBMC中NLRP3、caspase-1、GSDMD蛋白表达均显著升高（

＜0.01）；治疗组与对照组治疗后NLRP3、caspase-1、GSDMD水平及IL-1β、IL-18水平均明显下调（

＜0.05），两组患者PBMC细胞焦亡均减少，治疗组细胞焦亡减少更明显（

＜0.01）。

结论

益气养阴通络方可有效缓解SS临床症状及免疫炎症反应，其作用机制可能与调控NLRP3/Caspase-1/GSDMD信号轴功能，抑制细胞焦亡有关。

Abstract

Objective

Methods

Sixty SS patients of deficiency of both

and

yin

pattern were randomly divided into a treatment group and a control group with 30 cases in each， and another 30 healthy people were selected as the normal group. The treatment group was given YYTF， one dose for twice daily， each in the morning and evening， and the control group was given hydroxychloroquine sulfate orally， 0.1 g per time， three times daily. Both groups were treated continuously for 8 weeks. The total effective rate was evaluated and compared between groups. The changes of serum interleukin （IL）-1β and IL-18 levels were detected by enzyme-linked immunosorbent assay （ELASA）， and protein expression of Nod-like receptor protein 3 （NLRP3）， caspase-1 （Caspase-1）， and sadermin D （GSDMD） in peripheral blood mononuclear cells （PBMC） were detected by Western blot （WB） before and after treatment in the treatment group and the control group， and also health subjects. The pyroptotic morphology of PBMC cells was observed by transmission electron microscope. The EULAR SS disease activity index （ESSDAI）， EULAR SS patient reported index （ESSSPRI）， and TCM syndrome scores were evaluated. The erythrocyte sedimentation rate （ESR） of the two groups was detected by Wei's method， and the levels of C-reactive protein （CRP）， immunoglobulin （IgG）， and complement C3 and C4 were measured by immunoscattering turbidimetry.

Results

he total effective rate in the treatment group （86.7%） was higher than that in the control group （60.0%，

＜0.05）. The treatment group was superior than the control group in decreasing TCM syndrome scores， ESSDAI and ESSSPRI scores， ESR， CRP， and IgG levels， and increasing C3 and C4 （

＜0.05 or

＜0.01）. Compared to those in the normal group， PBMCs in the treatment group and the control group showed pyroptotic morphological changes such as cytoplasmic swelling， membrane rupture， and bubbling under the transmission electron microscope， and the levels of serum IL-1β and IL-18 as well as the protein expressions of NLRP3， caspase-1 and GSDMD in PBMCs significantly increased （

＜0.05）； after treatment， the levels of NLRP3， caspase-1 and GSDMD， as well as the IL-1β and IL-18 levels in the two groups were significantly down-regulated （

＜0.05）， while the pyroptosis of PBMC cells in the two groups was reduced； the reduction of pyroptosis was more obvious in the treatment group （

＜0.01）.

Conclusion

YYTF can effectively relieve SS clinical symptoms and immune inflammatory responses， and the mechanism of action may be functional with the regulation of NLRP3/CASPase-1/GSDMD signal axis function and the inhibition of cell pyroptosis.

关键词

Keywords

references

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Yiqi Yangyin Tongluo Formula （益气养阴通络方） in the Treatment of Sjögren's Syndrome of Deficiency of both Qi and Yin Pattern in 30 Cases： A Randomized Controlled Trial

DOI：10.13288/j.11-2166/r.2023.09.010

摘要

Abstract

关键词

Keywords

references