清肺化瘀方联合吡非尼酮治疗肺热血瘀型类风湿关节炎相关进行性纤维化表型间质性肺病的临床疗效

姚静慧; 王运超; 赵哲虹; 杨光辉; 胥晓芳; 何奕坤; 吴辉辉; 沈佳莹; 潘新

doi:10.16305/j.1007-1334.2022.2205075

您当前的位置：

首页 >

文章列表页 >

清肺化瘀方联合吡非尼酮治疗肺热血瘀型类风湿关节炎相关进行性纤维化表型间质性肺病的临床疗效

临床试验 | 更新时间：2022-09-30

- 清肺化瘀方联合吡非尼酮治疗肺热血瘀型类风湿关节炎相关进行性纤维化表型间质性肺病的临床疗效
- Efficacy of Qingfei Huayu Decoction combined with pirfenidone on progressive fibrosing interstitial lung disease associated with rheumatoid arthritis of lung heat and blood stasis syndrome type
- 上海中医药杂志 2022年56卷第9期页码：58-63
- 作者机构：
  
  1.上海中医药大学附属曙光医院风湿病科（上海 200021）
- 作者简介：
  
  姚静慧，女，硕士研究生，主治医师，主要从事中西医结合治疗风湿免疫疾病的临床研究工作；*为共同第一作者
  潘新，主任医师，硕士研究生导师； E-mail：panxin66@163.com
- 基金信息：
  
  上海市科委科研计划项目(17401971600);上海中医药大学预算内项目(2020LK052);上海中医药大学附属曙光医院四明基金项目(SGKJ-201823;SGKJ-201920)
- DOI：10.16305/j.1007-1334.2022.2205075
  中图分类号：
扫描看全文
姚静慧,王运超,赵哲虹,等.清肺化瘀方联合吡非尼酮治疗肺热血瘀型类风湿关节炎相关进行性纤维化表型间质性肺病的临床疗效[J].上海中医药杂志,2022,56(9):58-63.

YAO Jinghui,WANG Yunchao,ZHAO Zhehong,et al.Efficacy of Qingfei Huayu Decoction combined with pirfenidone on progressive fibrosing interstitial lung disease associated with rheumatoid arthritis of lung heat and blood stasis syndrome type[J].Shanghai Journal of Traditional Chinese Medicine,2022,56(9):58-63.
姚静慧,王运超,赵哲虹,等.清肺化瘀方联合吡非尼酮治疗肺热血瘀型类风湿关节炎相关进行性纤维化表型间质性肺病的临床疗效[J].上海中医药杂志,2022,56(9):58-63. DOI： 10.16305/j.1007-1334.2022.2205075.

YAO Jinghui,WANG Yunchao,ZHAO Zhehong,et al.Efficacy of Qingfei Huayu Decoction combined with pirfenidone on progressive fibrosing interstitial lung disease associated with rheumatoid arthritis of lung heat and blood stasis syndrome type[J].Shanghai Journal of Traditional Chinese Medicine,2022,56(9):58-63. DOI： 10.16305/j.1007-1334.2022.2205075.

摘要

目的,2,观察清肺化瘀方联合吡非尼酮治疗肺热血瘀型类风湿关节炎相关进行性纤维化表型间质性肺病（PF-ILD）的临床疗效。,方法,2,将73例类风湿关节炎相关PF-ILD患者随机分为对照组（37例）和中药组（36例），对照组予常规西药加吡非尼酮，中药组在对照组基础上加用清肺化瘀方，两组疗程均为6个月。疗程结束后比较两组患者的临床疗效、用力肺活量（FVC）、FVC的下降量（ΔFVC）、肺高分辨率CT（HRCT）半定量积分、中医证候积分、红细胞沉降率（ESR）、疾病活动度评分（DAS28-ESR）、血清涎液化糖链抗原-6（KL-6）、转化生长因子-β1（TGF-β1）、吡非尼酮最大剂量及不良反应情况。,结果,2,①试验过程中，中药组脱落3例，对照组脱落4例；最终完成试验者66例，中药组和对照组各33例。②中药组总有效率为51.52%，对照组总有效率为36.36%；两组总体疗效比较差异有统计学意义（,P,<,0.05）。治疗后，中药组中医证候有效率为69.70%，对照组中医证候有效率为33.33%；两组中医证候疗效比较差异有统计学意义（,P,<,0.05）。③治疗前后组内比较，对照组和中药组FVC均较治疗前降低（,P,<,0.05）；组间治疗后比较，中药组FVC较对照组高（,P,<,0.05），中药组ΔFVC较对照组低（,P,<,0.05）。④治疗前后组内比较，两组肺HRCT半定量积分差异均无统计学意义（,P,>,0.05），两组治疗后中医证候积分均较治疗前降低（,P,<,0.05）。组间治疗后比较，中药组中医证候积分低于对照组（,P,<,0.05）。⑤治疗前后组内比较，两组ESR、DAS28-ESR评分、KL-6、TGF-β1水平均较治疗前降低（,P,<,0.05）；组间治疗后比较，中药组ESR、DAS28-ESR评分、KL-6、TGF-β1水平均较对照组降低（,P,<,0.05）。⑥两组口服吡非尼酮最大剂量情况无统计学差异（,P,>,0.05）。,结论,2,清肺化瘀方联合吡非尼酮治疗类风湿关节炎相关PF-ILD疗效满意，较单用西药能更好地改善患者的中医证候，延缓本病患者FVC下降，其机制可能与下调血清TGF-β1表达水平有关。

Abstract

Objective,2,To observe the efficacy of Qingfei Huayu Decoction combined with pirfenidone in the treatment of progressive fibrosing interstitial lung disease （PF-ILD） associated with rheumatoid arthritis of lung in heat and blood stasis syndrome type.,Methods,2,Seventy-three patients with rheumatoid arthritis-related PF-ILD were randomly divided into the control group （,n,=37） and the traditional Chinese medicine（TCM） group （,n,=36）. The control group was treated with conventional western medicine plus pirfenidone for rheumatoid arthritis， and the TCM group was treated with Qingfei Huayu Decoction on the basis of the control group. After treatment for 6 months， the clinical efficacy， forced vital capacity （FVC）， decreased forced vital capacity （ΔFVC）， lung HRCT semi-quantitative score， TCM score， erythrocyte sedimentation rate （ESR）， disease activity score （DAS28-ESR）， serum KL-6， TGF-β1 levels， maximum dose of pirfenidone and adverse reactions were compared between the two groups.,Results,2,① During the trial， 3 cases dropped out in the TCM group， 4 cases dropped out in the control group， 66 cases finally completed the trial， and 33 cases in each group. ② The total effective rate of the TCM group was 51.52%， and the total effective rate of the control group was 36.36%. There was significant difference in the overall efficacy between the two groups （,P,<,0.05）.After treatment， the effective rate of TCM was 69.70% in the TCM group and 33.33% in the control group， and there was significant difference between the two groups （,P,<,0.05）. ③ After treatment， the FVC in the control group and the TCM group was lower than that before treatment （,P,<,0.05）.The FVC in the TCM group was higher than that in the control group （,P,<,0.05）.The ΔFVC was lower in the TCM group than in the control group （,P,<,0.05）. ④ There was no significant difference in lung HRCT semiquantitative score in the two groups before and after treatment （,P,>,0.05）. The TCM score of the two groups was lower than that before treatment （,P,<,0.05）.The TCM score of the TCM group was lower than that of the control group （,P,<,0.05）. ⑤After treatment， the ESR、DAS28-ESR scores、KL-6 and TGF-β1 in the control group and the TCM group were lower than those before treatment （,P,<,0.05）； The ESR、DAS28-ESR scores、KL-6 and TGF-β1 in the TCM group were lower than those in the control group ,（P,<,0.05）. ⑥There was no statistically significant difference in the maximum dose of pirfenidone used between the two groups （,P,>,0.05）.,Conclusions,2,Qingfei Huayu Decoction combined with pirfenidone has a satisfactory therapeutic effect on rheumatoid arthritis-related PF-ILD. Compared with western medicine， Qingfei Huayu Decoction can improve the TCM syndrome of patients better and delay the decline of measured FVC， and the mechanism may be related to the down-regulation of serum TGF-β1 expression level.

关键词

类风湿关节炎间质性肺病肺纤维化清肺化瘀方中医药疗法临床试验

Keywords

rheumatoid arthritisinterstitial lung diseasepulmonary fibrosisQingfei Huayu Decoctiontherapy of traditional Chinese medicineclinic trial

references

WONG A W， RYERSON C J， GULER S A. Progression of fibrosing interstitial lung disease［J］. Respir Res， 2020， 21（1）： 32.

SPAGNOLO P， LEE J S， SVERZELLATI N， et al. The lung in rheumatoid arthritis： focus on interstitial lung disease［J］. Arthritis Rheumatol， 2018， 70（10）： 1544-1554.

HYLDGAARD C， HILBERG O， PEDERSEN A B， et al. A population-based cohort study of rheumatoid arthritis-associated interstitial lung disease： comorbidity and mortality［J］. Ann Rheum Dis， 2017， 76（10）： 1700-1706.

JUGE P A， CRESTANI B， DIEUDE P. Recent advances in rheumatoid arthritis-associated interstitial lung disease［J］. Curr Opin Pulm Med， 2020， 26（5）： 477-486.

姚静慧，潘新，杨光辉，等. 清肺化瘀方对博来霉素诱导的肺纤维化大鼠肺部组织KL-6、IL-6、IL-21、TGF-β1表达的影响［J］. 上海中医药杂志，2021， 55（S1）： 141-145.

COTTIN V， HIRANI N A， HOTCHKIN D L， et al. Presentation， diagnosis and clinical course of the spectrum of progressive-fibrosing interstitial lung diseases［J］. Eur Respir Rev， 2018， 27（150）： 180076.

ALETAHA D， NEOGI T， SILMAN A J， et al. 2010 rheumatoid arthritis classification criteria： an American College of Rheumatology/European League Against Rheumatism collaborative initiative［J］. Ann Rheum Dis， 2010， 69（9）： 1580-1588.

国家中医药管理局. 中医病证诊断疗效标准［M］. 南京：南京大学出版社，1994： 309.

FLAHERTY K R， BROWN K K， WELLS A U， et al. Design of the PF-ILD trial： a double-blind， randomised， placebo-controlled phase Ⅲ trial of nintedanib in patients with progressive fibrosing interstitial lung disease［J］. BMJ Open Respir Res， 2017， 4（1）： e212.

王迁，李梦涛. 2018中国结缔组织病相关间质性肺病诊断和治疗专家共识［J］. 中华内科杂志，2018， 57（8）： 558-565.

HOMMA S， SUGINO K， SAKAMOTO S. Usefulness of a disease severity staging classification system for IPF in Japan： 20 years of experience from empirical evidence to randomized control trial enrollment［J］. Respir Investig， 2015， 53（1）： 7-12.

FUJIMOTO K， TANIGUCHI H， JOHKOH T， et al. Acute exacerbation of idiopathic pulmonary fibrosis： high-resolution CT scores predict mortality［J］. Eur Radiol， 2012， 22（1）： 83-92.

国家药品监督管理局. 中药新药临床研究指导原则（试行）［M］. 北京：中国医药科技出版社，2002： 104.

姚静慧，余小萍. 慢性咳嗽中医PRO量表的研制与条目筛选［J］. 中医药导报， 2018， 24（10）： 23-27.

WOUDE D， HELM-VAN M A. Update on the epidemiology， risk factors， and disease outcomes of rheumatoid arthritis［J］. Best Pract Res Clin Rheumatol， 2018， 32（2）： 174-187.

姜萍，王鹏飞，张艳艳，等. 以肺痹论治结缔组织病相关间质性肺病［J］. 中华中医药杂志，2020， 35（12）： 6170-6173.

周定华，韩明向. 韩明向治疗结缔组织病并发肺间质病变经验［J］. 山东中医杂志，2021， 40（6）： 629-632.

李芊芊，张伟. 痿痹兼顾论治肺间质纤维化探讨［J］. 南京中医药大学学报，2018， 34（3）： 245-247.

姚静慧，潘新，杨光辉，等. 积雪草治疗结缔组织病相关肺疾病的临床及基础研究进展［J］. 上海中医药杂志，2020， 54（10）： 96-100.

何奕坤，杨光辉，胥晓芳，等. 类风湿关节炎继发肺间质病变的中医药治疗进展［J］. 西部中医药，2018， 31（3）： 140-143.

CHANDA D， OTOUPALOVA E， SMITH S R， et al. Developmental pathways in the pathogenesis of lung fibrosis［J］. Mol Aspects Med， 2019， 65： 56-69.

ZHANG T， SHEN P， DUAN C， et al. KL-6 as an immunological biomarker predicts the severity， progression， acute exacerbation， and poor outcomes of interstitial lung disease： a systematic review and Meta-analysis［J］. Front Immunol， 2021， 12： 745233.

HE Q， TANG Y， HUANG J， et al. The value of KL-6 in the diagnosis and assessment of interstitial lung disease［J］. Am J Transl Res， 2021， 13（8）： 9216-9223.

浏览量

257

下载量

CSCD

CNKI被引量

文章被引用时，请邮件提醒。

提交

工具集

关联资源

中西医结合治疗类风湿关节炎继发下肢溃疡验案1则

中药单体化合物调控NF⁃κB信号通路干预类风湿关节炎的研究进展

基于“络病⁃主客交”理论辨治结缔组织疾病相关间质性肺病

基于网络药理学探讨益肾蠲痹丸治疗类风湿关节炎的作用机制

苏励从瘀论治类风湿关节炎的经验