目的 观察保肺康治疗气阴两虚、痰瘀阻络型慢性阻塞性肺疾病合并肺间质纤维化(chronic obstructive pulmonary disease with pulmonary interstitial fibrosis,COPD-PIF)患者的临床疗效.方法 将符合纳入标准的COPD-PIF患者按照随机数字表法分为 2 组,治疗组予以中药保肺康联合西医综合治疗,对照组予以中药安慰剂联合西医综合治疗,疗程共 3 个月.观察并比较 2组患者治疗有效率,以及治疗前后中医证候积分、肺功能、动脉血氧分压(partial pressure of oxygen in arterial blood,PaO2)、慢阻肺患者自我评估测试(COPD assessment test,CAT)评分、改良英国医学研究学会(modified British medical research council,mMRC)呼吸困难指数评分、急性加重次数等指标的变化.结果 治疗组患者中医证候总积分、主要症状积分、第 1 秒用力呼气容积(forced expiratory volume in one second,FEV1)占预计值百分比(FEV1%pred)、PaO2、CAT评分、mMRC评分、急性加重次数较治疗前均有改善(P<0.05),且疗效优于对照组.相关性分析显示中医证候积分的改善与CAT评分、mMRC评分呈显著正相关,与FEV1%pred、肺一氧化碳弥散量(diffusing capacity of the lung for carbon monoxide,DLCO)占预计值百分比(DLCO%pred)呈显著负相关.结论 中药保肺康不仅可以显著改善 COPD-PIF 患者的主要症状(喘息、胸闷、气短、咳嗽、咯痰、乏力),且能降低 CAT 评分、mMRC评分,改善患者氧合与肺功能,减少急性加重次数,临床疗效显著,且未见明显不良反应,值得临床推广应用.
Clinical Efficacy Evaluation of Baofei Kang in the Treatment of Chronic Obstructive Pulmonary Disease with Pulmonary Interstitial Fibrosis
Objective To observe the clinical efficacy of Baofei Kang in treating patients with chronic obstructive pulmonary disease with pulmonary interstitial fibrosis(COPD-PIF)of Qi Yin deficiency and phlegm stasis obstruction syndrome.Methods The COPD-PIF patients who met the inclusion criteria were divided into two groups according to the random number table method,and the treatment group was given the combination of traditional Chinese medicine Baofei Kang and Western medicine treatment,while the control group was given the combination of traditional Chinese medicine placebo and Western medicine treatment,and the treatment course was 3 months.Observe and compare the treatment efficacy rates,as well as the changes of TCM syndrome scores,lung function,partial pressure of oxygen in arterial blood(PaO2),COPD assessment test(CAT)score,modified British medical research council(mMRC)score,and the times of exacerbation in the two groups before and after treatment.Results The treatment group showed improvement(P<0.05)in total score of TCM syndrome,main symptom score,forced expiratory volume in one second(FEV1)%pred,PaO2,CAT score,mMRC score,and times of acute exacerbation,while the curative efficacy was better than that of the control group.Correlation analysis showed that the improvement of TCM syndrome score was significantly positively correlated with CAT score,mMRC score and significantly negatively correlated with FEV1%pred and diffusing capacity of the lung for carbon monoxide(DLCO)%pred.Conclusion Baofei Kang can effectively improve the symptoms of COPD-PIF patients such as wheezing,chest tightness,shortness of breath,cough,expectoration,and fatigue,reduce the CAT score,mMRC score,improve PaO2,improve the patients'pulmonary function,reduce the times of acute exacerbation.It has significant clinical efficacy,and do not show any adverse effects,which deserves to be promoted.
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