A randomized double⁃blind controlled study on Jiedu Tongluo Huashi Formula in the treatment of primary Sjögren’s syndrome with damp⁃heat type

LI Ben; ZHU Cuiyun; HOU Jiaqi; CHEN Yueying; QUAN Feng; XUE Luan

doi:10.16306/j.1008-861x.2023.02.007

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A randomized double⁃blind controlled study on Jiedu Tongluo Huashi Formula in the treatment of primary Sjögren’s syndrome with damp⁃heat type

Clinical Research | 更新时间：2023-03-24

- A randomized double⁃blind controlled study on Jiedu Tongluo Huashi Formula in the treatment of primary Sjögren’s syndrome with damp⁃heat type
- Academic Journal of Shanghai University of Traditional Chinese Medicine Vol. 37, Issue 2, Pages: 41-47(2023)
- 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感染科（上海　201508）
- 作者简介：
- 基金信息：
- DOI：10.16306/j.1008-861x.2023.02.007
  CLC：
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李奔,朱翠云,侯佳奇等.解毒通络化湿方治疗湿热型原发性干燥综合征的随机双盲对照研究[J].上海中医药大学学报,2023,37(02):41-47.

LI Ben,ZHU Cuiyun,HOU Jiaqi,et al.A randomized double⁃blind controlled study on Jiedu Tongluo Huashi Formula in the treatment of primary Sjögren’s syndrome with damp⁃heat type[J].Academic Journal of Shanghai University of Traditional Chinese Medicine,2023,37(02):41-47.
李奔,朱翠云,侯佳奇等.解毒通络化湿方治疗湿热型原发性干燥综合征的随机双盲对照研究[J].上海中医药大学学报,2023,37(02):41-47. DOI： 10.16306/j.1008-861x.2023.02.007.

LI Ben,ZHU Cuiyun,HOU Jiaqi,et al.A randomized double⁃blind controlled study on Jiedu Tongluo Huashi Formula in the treatment of primary Sjögren’s syndrome with damp⁃heat type[J].Academic Journal of Shanghai University of Traditional Chinese Medicine,2023,37(02):41-47. DOI： 10.16306/j.1008-861x.2023.02.007.

摘要

目的,2,评估解毒通络化湿方结合羟基氯喹片治疗无内脏累及的湿热型原发性干燥综合征（pSS）患者的临床疗效，寻求治疗pSS的新方法。,方法,2,采用随机双盲对照研究方法，纳入86例无内脏累及的湿热型pSS患者，分为治疗组43例和对照组43例。治疗组患者给予解毒通络化湿方联合羟基氯喹片口服，对照组患者给予安慰剂联合羟基氯喹片口服，治疗周期为12周。评价两组患者的临床疗效，并采用患者可接受症状状态（PASS）和临床最小重要改善（MCII）达标率来进一步判定临床疗效；治疗前后评估并比较两组患者的中医证候总积分、欧洲抗风湿联盟干燥综合征患者报告指数（ESSPRI）评分、欧洲抗风湿联盟干燥综合征疾病活动指数（ESSDAI）评分；采用未刺激状态下唾液流率评价患者的口干情况，采用Schirmer’s试验、BUT试验评价患者的眼干情况；治疗前后检测并比较两组患者的血清免疫球蛋白（Ig）G、补体C3、补体C4水平及外周血CXC型趋化因子配体13（CXCL13）表达情况。,结果,2,研究过程中，治疗组2例患者剔除或脱落，对照组3例患者剔除或脱落，最终纳入统计分析者治疗组41例、对照组40例。①治疗后，治疗组患者的临床总有效率为82.93%，对照组为60.00%，治疗组的疗效明显优于对照组（,P,<,0.01）。②治疗后，两组达到PASS患者的比例较治疗前均明显升高（,P,<,0.05，,P,<,0.01），但组间比较差异无统计学意义（,P,>,0.05）。治疗后，根据ESSPRI，治疗组中达到MCII的患者比例较对照组明显升高（,P,<,0.05）。③治疗后，两组患者的中医证候总积分较治疗前均明显降低（,P,<,0.05，,P,<,0.01），且治疗组患者的积分降低程度优于对照组（,P,<,0.05）。④治疗后，治疗组患者的ESSPRI评分及干燥、疲乏、疼痛维度评分较治疗前均明显降低（,P,<,0.05，,P,<,0.01），对照组患者的ESSPRI评分及疼痛维度评分较治疗前亦明显降低（,P,<,0.05），且治疗组患者的ESSPRI评分及干燥、疲乏维度评分降低程度优于对照组（,P,<,0.05）。⑤治疗后，两组患者的ESSDAI评分较治疗前均明显降低（,P,<,0.05，,P,<,0.01），但其评分降低程度组间比较差异无统计学意义（,P,>,0.05）。⑥治疗后，两组患者的未刺激状态下唾液流率较治疗前均升高（,P,<,0.05，,P,<,0.01），但其升高程度组间比较差异无统计学意义（,P,>,0.05）。⑦治疗后，治疗组患者的IgG、CXCL13水平较治疗前明显降低（,P,<,0.01），且治疗组患者的CXCL13水平降低程度优于对照组（,P,<,0.05）。,结论,2,解毒通络化湿方结合羟基氯喹片治疗pSS，可有效改善患者的主观症状及客观指标，其作用可能与抑制CXCL13改善腺体功能、减少pSS的病情活动相关。

Abstract

Objective： To evaluate the clinical efficacy of Jiedu Tongluo Huashi Formula combined with hydroxychloroquine tablet in treating patients with primary Sjögren’s syndrome （pSS） without visceral involvement of damp-heat type， in order to seek a new method for the treatment of pSS.,Methods,2,A randomized double-blind controlled study was applied. A total of 86 patients with pSS without visceral involvement of damp-heat type were included and divided into the treatment group （43 cases） and control group （43 cases）. The patients in the treatment group were treated with Jiedu Tongluo Huashi Formula combined with hydroxychloroquine tablet orally， and the patients in the control group were treated with placebo combined with hydroxychloroquine tablet orally， with a course of 12 weeks. The clinical efficacy of the two groups was evaluated， and patient-acceptable symptom state （PASS） and minimal clinically important improvement （MCII） compliance rates were used to further determine the clinical efficacy. Before and after treatment， the total score of Chinese medical syndrome， the EULAR Sjögren’s syndrome patient reported index （ESSPRI） score， EULAR Sjögren’s syndrome disease activity index （ESSDAI） score in the two groups were evaluated and compared. The salivary flow rate in the unstimulated state was applied to estimate the dry mouth status of the patients， and the Schirmer’s test and BUT test were applied to estimate the dry eye status of the patients. Before and after treatment， the levels of serum immunoglobulin （Ig） G， complement C3， complement C4 and peripheral blood CXC-chemokine ligand 13（CXCL13） expression were detected and compared.,Results,2,During the study， 2 patients in the treatment group and 3 patients in the control group were excluded or shed off. Finally， 41 cases in the treatment group and 40 cases in the control group were included in the statistical analysis. ①After treatment， the total clinical effective rate was 82.93% in the treatment group and 60.00% in the control group， and the effect of the treatment group was significantly better than that of the control group （,P,<,0.01）. ②After treatment， the ratio of the patients achieving PASS in the two groups was significantly increased compared with that before treatment （,P,<,0.05， ,P,<,0.01）， while there was no statistically significant difference between the two groups （,P,>,0.05）. After treatment， the ratio of the patients achieving MCII according to ESSPRI in the treatment group was significantly increased compared with that in the control group （,P,<,0.05）. ③After treatment， the total scores of Chinese medical syndrome in the two groups were significantly decreased compared with those before treatment （,P,<,0.05， ,P,<,0.01）， and the reduction degree of the score in the treatment group was superior to the control group （,P,<,0.05）. ④After treatment， the ESSPRI score and the scores of dry， fatigue and pain dimensions in the treatment group were significantly decreased compared with those before treatment （,P,<,0.05， ,P,<,0.01）， the ESSPRI score and the score of pain dimension in the control group were also significantly decreased compared with those before treatment （,P,<,0.05）， and the reduction degree of ESSPRI score and the scores of dry and fatigue dimensions in the treatment group were superior to the control group （,P,<,0.05）. ⑤After treatment， the scores of ESSDAI in the two groups were significantly decreased compared with those before treatment （,P,<,0.05， ,P,<,0.01）， while there was no statistically significant difference on the reduction degree of the score between the two groups （,P,>,0.05）. ⑥After treatment， the salivary flow rate in the unstimulated state of the two groups was increased compared with that before treatment （,P,<,0.05， ,P,<,0.01）， while there was no statistically significant difference on the elevation degree between the two groups （,P,>,0.05）.⑦After treatment， the levels of IgG and CXCL13 in the treatment group were significantly decreased compared with those before treatment （,P,<,0.01）， and the reduction degree of CXCL13 level in the treatment group was superior to the control group （,P,<,0.05）.,Conclusion,2,Jiedu Tongluo Huashi Formula combined with hydroxychloroquine tablet can effectively improve the subjective symptoms and objective indicators in treating patients with pSS， and its effect may be related to inhibiting CXCL13 to improve gland function and reducing the disease activity of pSS.

关键词

原发性干燥综合征湿热型解毒通络化湿方随机双盲对照试验

Keywords

primary Sjögren’s syndromedamp-heat typeJiedu Tongluo Huashi Formularandomized double-blind controlled trial

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