【摘要】 目的 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 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 (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 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。更多还原

【Abstract】 Objective 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 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 =36. The control group was treated with conventional 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 (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).(5)After 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).(6)There was no statistically significant difference in the maximum dose of pirfenidone used between the two groups(P>0.05).Conclusions 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.更多还原