吡非尼酮在CPFE患者肺康复治疗中的应用效果及安全性分析

The application effect and safety analysis of pirfenidone in lung rehabilitation treatment of CPFE patients

目的观察吡非尼酮在肺纤维化合并肺气肿(CPEF)患者肺康复治疗后的应用效果及安全性。方法本文为前瞻性研究,病例纳入南阳市第一人民医院2020年1月~2023年5月收治的80例CPEF患者,采用电脑随机分组法将入组患者分为常规组(40例)和试验组(40例),常规组实施常规治疗,试验组采用吡非尼酮配合治疗,比较两组患者的炎症细胞因子、肺纤维化进程、肺动脉血气指标、肺功能改善情况,及用药安全性。结果治疗前,两组患者的炎症指标无统计学差异(P>0.05);治疗后,试验组的转化生长因子-β1(TGF-β1)、基质外金属蛋白酶9(MMP-9)、肿瘤坏死因子-α(TNF-α)分别为(125.35±20.61)ng/L、(30.41±5.16)ng/ml、(3.36±0.27)ng/L,均低于常规组[(140.33±20.36)ng/L、(33.49±5.33)ng/ml、(4.41±1.26)ng/L],差异具有统计学意义(P<0.05)。治疗前,两组患者的肺纤维化进程无统计学差异(P>0.05);治疗后,试验组的细胞间黏附分子-1(ICAM-1)、透明质酸(HA)、肺纤维化评分(Ashcroft)分别为(105.44±20.13)pg/ml、(25.44±5.17)ng/ml、(3.46±0.25)分,均低于常规组[(120.36±20.14)pg/ml、(28.66±5.34)ng/ml、(4.77±1.14)分],差异具有统计学意义(P<0.05)。治疗前,两组患者的肺动脉血气指标无统计学差异(P>0.05);治疗后,试验组的动脉氧分压(PaO_(2))为(85.25±10.31)mmHg,高于常规组(80.33±10.22)mmHg;动脉二氧化碳分压(PaCO_(2))为(40.35±10.27)mmHg,低于常规组(45.77±10.34)mmHg,差异具有统计学意义(P<0.05)。治疗前,两组患者肺功能无统计学差异(P>0.05);治疗后,试验组的第一秒用力呼气容积(FEV1)、用力肺活量(FVC)、呼吸峰值流速(PEF)分别为(60.24±10.11)%、(2.54±0.26)L、(488.75±50.61)L/min,均高于常规组[(54.41±10.23)%、(2.03±0.43)L、(440.24±50.13)L/min],差异具有统计学意义(P<0.05)。在不同治疗方案下,试验组的药物相关副反应发生率为15.00%(6/40),略高于常规组10.00%(4/40),差异无统计学意义(P>0.05)。结论吡非尼酮能抑制CPEF患者炎症因子及肺纤维化进程,对改善其肺动脉血气指标并促进肺功能康复均有积极作用;联合应用此药未明显增加药物相关副反应发生风险,安全性较高。

Objective Observe the efficacy and safety of pirfenidone after pulmonary rehabilitation treatment in patients with CPEF.Methods This article is a prospective study,with cases included from January 2020 to May 2023.The study subjects were 80 patients with CPEF.The enrolled patients were randomly divided into a conventional group(40 cases)and an experimental group(40 cases)using computer randomization.The conventional group received routine lung rehabilitation treatment,while the experimental group received combination therapy with pirfenidone.The inflammatory cytokines,pulmonary fibrosis progression,pulmonary arterial blood gas indicators,and lung function improvement of the two groups of patients were compared,And medication safety.Results Before treatment,the inflammatory indicators of the two groups of patients were similar(P>0.05);After treatment,the TGF of the experimental group-β1.MMP-9,TNF-αThe levels of(125.35±20.61)ng/L,(30.41±5.16)ng/ml,and(3.36±0.27)ng/L were lower than those of the conventional group[(140.33±20.36)ng/L,(33.49±5.33)ng/ml,and(4.41±1.26)ng/L](P<0.05).Before treatment,the progression of pulmonary fibrosis in both groups of patients was similar(P>0.05);After treatment,the ICAM-1,HA,and Ashcroft scores of the experimental group were(105.44±20.13)pg/ml,(25.44±5.17)ng/ml,and(3.46±0.25)points,respectively,which were lower than those of the conventional group[(120.36±20.14)pg/ml,(28.66±5.34)ng/ml,and(4.77±1.14)points](P<0.05).Before treatment,the pulmonary arterial blood gas indicators of the two groups of patients were similar(P>0.05);After treatment,the PaO_(2) of the experimental group was(85.25±10.31)mmHg,which was higher than that of the conventional group(80.33±10.22)mmHg;PaCO_(2) was(40.35±10.27)mmHg,lower than the conventional group(45.77±10.34)mmHg(P<0.05).Before treatment,the lung function of the two groups of patients was similar(P>0.05);After treatment,the FEV1,FVC,and PEF of the experimental group were(60.24±10.11)%,(2.54±0.26)L,and(488.75±50.61)L/min,respectively,which were higher than those of the conventional group[(54.41±10.23)%,(2.03±0.43)L,and(440.24±50.13)L/min](P<0.05).Under different treatment regimens,the incidence of drug-related side effects in the experimental group was 15.00%(6/40),which was similar to 10.00%(4/40)in the conventional group(P>0.05).Conclusion Pifenidone can inhibit inflammatory factors and pulmonary fibrosis progression in CPEF patients,and has a positive effect on improving their pulmonary arterial blood gas indicators and promoting pulmonary function recovery;The combined use of this drug did not significantly increase the risk of drug-related side effects,and its safety was relatively high.