汉防己甲素片联合吡非尼酮治疗肺间质纤维化的临床研究

Clinical study on Tetrandrine Tablets combined with pirfenidone in treatment of pulmonary interstitial fibrosis

目的研究汉防己甲素片联合吡非尼酮胶囊治疗肺间质纤维化的疗效。方法选取2017年8月-2019年8月来郑州大学附属郑州中心医院治疗的80例肺间质纤维化患者为研究对象,所有患者随机分为对照组和治疗组,每组各40例。对照组患者口服吡非尼酮胶囊,200 mg/次,在两周时间内每次增加200 mg最后达到每次维持剂量为600 mg/次,3次/d。治疗组在对照组基础上口服汉防己甲素片,2片/次,3次/d。两组患者持续治疗2个月。观察两组的临床疗效,比较两组临床症状缓解时间、肺功能指标、血清转化生长因子-β(TGF-β1)、血管内皮生长因子(VEGF)、胰岛素生长因子-I(IGF-I)、Ⅲ型胶原(Ⅲ-C)、Ⅳ型胶原(Ⅳ-C)、透明质酸(HA)水平。结果治疗后,治疗组总有效率95.00%,显著高于对照组的77.50%(P<0.05)。治疗后,治疗组胸憋、喘息、气短、咳嗽、咳痰等症状缓解时间明显短于对照组(P<0.05)。治疗后,两组患者最大呼气流量(PEF)、用力肺活量(FVC)、一秒用力呼气容积(FEV1)水平显著升高(P<0.05),且治疗组患者PEF、FVC、FEV1水平升高较多(P<0.05)。治疗后,两组TGF-β1、VEGF、IGF-I水平显著降低(P<0.05);并且治疗组TGF-β1、VEGF、IGF-I水平降低较多(P<0.05)。治疗后,两组Ⅲ-C、Ⅳ-C、HA水平显著降低(P<0.05);并且治疗组Ⅲ-C、Ⅳ-C、HA水平降低较多(P<0.05)。结论汉防己甲素片联合吡非尼酮胶囊治疗肺间质纤维化具有较好的治疗效果,能够改善患者肺功能,缩短临床症状缓解时间,调节血清炎性因子水平,安全性较高,值得在临床上推广应用。

Objective To study the efficacy of Tetrandrine Tablets combined with Pirfenidone Capsules in treatment of pulmonary interstitial fibrosis.Methods Patients(80 cases)with pulmonary interstitial fibrosis in Zhengzhou Central Hospital Affiliated to Zhengzhou University from August 2017 to August 2019 were randomly divided into two groups,and each group had 40 cases.Patients in the control group were po administered with Pirfenidone Capsules,200 mg/time,increased 200 mg each time in two weeks,and finally reached the maintenance dose of 600 mg/time,three times daily.Patients in the treatment group were po administered with Tetrandrine Tablets on the basis of the control group,2 tablets/time,three times daily.Patients in two groups were treated for 2 months.After treatment,the clinical efficacies were evaluated,and clinical symptom relief time,pulmonary function,the levels of TGF-β1,VEGF,IGF-I,Ⅲ-C,Ⅳ-C,and HA in two groups were compared.Results After treatment,the total effective rate of the treatment group was 95%,which was significantly higher than 77.50%of the control group(P<0.05).After treatment,the remission times of chest holding,wheezing,shortness of breath,cough,expectoration and other symptoms in the treatment group was significantly shorter than that in the control group(P<0.05).After treatment,PEF,FVC,and FEV1 in two groups were significantly decreased,and the difference was statistically significant in the same group(P<0.05).And the PEF,FVC,and FEV1 in the treatment group were significantly higher than those in the control group,with significant difference between two groups(P<0.05).After treatment,the levels of TGF-β1,VEGF,and IGF-I in two groups were significantly decreased,and the difference was statistically significant in the same group(P<0.05).And the levels of TGF-β1,VEGF and IGF-I in the treatment group were significantly lower than those in the control group,with significant difference between two groups(P<0.05).After treatment,the levels ofⅢ-C,Ⅳ-C and HA in two groups were significantly decreased(P<0.05).And the levels ofⅢ-C,Ⅳ-C and HA in the treatment group were significantly lower than those in the control group,with significant difference between two groups(P<0.05).Conclusion Tetrandrine Tablets combined with Pirfenidone Capsules has clinical curative effect in treatment of pulmonary interstitial fibrosis,can improve the lung function,reduce the time of clinical symptom relief,and regulate the level of serum inflammatory factors,with good safety,which is worthy of clinical application.