宣肺平喘化痰通络方治疗支气管哮喘慢性持续期(痰哮证)的临床研究

Clinical Study on Xuanfei Pingchuan Huatan Tongluo Decoction in Treating Chronic Persistent Bronchial Asthma(Phlegm-asthma Syndrome)

目的评价宣肺平喘化痰通络方治疗支气管哮喘慢性持续期(痰哮证)的临床疗效及对气道炎症和气道高反应性(AHR)的影响。方法将144例患者随机分为对照组和观察组,每组各72例。对照组给予沙美特罗替卡松粉吸入剂和宣肺平喘化痰通络方模拟颗粒治疗,观察组给予沙美特罗替卡松粉吸入剂和宣肺平喘化痰通络方配方颗粒治疗,2组均连续治疗4周。观察2组患者治疗前后肺功能[第1秒用力呼气容积(FEV1)、呼气流量峰值(PEF)、PEF变异率]、气道炎症[嗜酸性粒细胞(EOS)、白细胞介素4(IL-4)、白细胞介素10(IL-10)]、呼出气一氧化氮(FeNO)、痰哮证积分、哮喘控制测试(ACT)评分、血清嗜酸性粒细胞阳离子蛋白(ECP)、血清免疫球蛋白E(IgE)和外周血EOS比例水平的变化,并评价治疗后患者的哮喘控制情况及临床疗效和安全性。结果(1)观察组脱落、失访3例,剔除2例,最后完成研究67例;对照组脱落、失访4例,剔除3例,完成研究65例。(2)观察组临床疗效总有效率为97.01%(65/67),高于对照组的76.92%(50/65),差异有统计学意义(χ^(2)=11.871,P<0.01)。(3)治疗后,2组患者FEV_(1)和FEV_(1)占预计值较治疗前明显增加(P<0.01),PEF变异率较治疗前明显下降(P<0.01),且治疗后观察组FEV_(1)和FEV_(1)占预计值明显高于对照组(P<0.01),PEF变异率低于对照组(P<0.01)。(4)2组患者治疗后痰液中EOS、IL-4水平较治疗前显著下降(P<0.01),IL-10水平较治疗前明显升高(P<0.01);且治疗后观察组改善气道炎症的效果优于对照组(P<0.01)。(5)治疗后2组患者血清中ECP、IgE和外周血EOS比例水平较治疗前显著下降(P<0.01);且治疗后观察组血清中ECP、IgE和外周血EOS比例水平明显低于对照组(P<0.01)。(6)治疗后,2组患者ACT评分较治疗前明显升高(P<0.01),痰哮证积分和FeNO水平均较治疗前明显下降(P<0.01);且治疗后观察组ACT评分显著高于对照组(P<0.01),痰哮证积分和FeNO水平显著低于对照组(P<0.01)。(7)治疗过程中未发现肝、肾功能、尿常规、心电图检测等异常情况及不良反应。结论在西医常规治疗的基础上,采用宣肺平喘化痰通络方内服治疗哮喘慢性持续期痰哮证患者,可减轻患者哮喘症状,改善肺功能,有效地控制哮喘的发作情况,减轻患者气道炎症反应和AHR,临床疗效优于单纯的西医常规疗法,且安全性较好。

Objective To evaluate the clinical efficacy of Xuanfei Pingchuan Huatan Tongluo decoction in the treatment of chronic persistent bronchial asthma(phlegm-asthma syndrome)and its influence on airway inflammation and airway hyperresponsiveness(AHR).Methods One hundred and forty-four patients were randomly divided into a control group and an observation group,with 72 cases in each group.Patients in control group were given salmeterol and ticasone powder inhalation and Xuanfei Pingchuan Huatan Tongluo decoction simulated particles.Patients in observation group were given salmeterol ticasone powder inhalation and Xuanfei Pingchuan Huatan Tongluo prescription granules.Course of treatment for both groups were four consecutive weeks.The lung function(FEV_(1),PEF,PEF variation rate),airway inflammation(EOS,IL-4,IL-10),FeNO,phlegm syndrome score,ACT score,ECP,serum IgE and peripheral blood EOS level were observed before and after treatment.Moreover,asthma control,clinical efficacy and safety were evaluated after treatment.Results(1)In the observation group,three cases were dropped out and lost to follow-up,two cases were eliminated and sixty-seven research cases were completed.In the control group,four cases were dropped out and lost to follow-up,three cases were eliminated and sixty-five research cases were completed.(2)The total effective rate of the disease in the observation group was 97.01%(65/67),which was higher than 76.92%(50/65)in the control group.The difference was statistically significant(χ^(2)=11.871,P<0.01).(3)After treatment,FEV_(1)%and FEV_(1) in the two groups increased significantly when compared to before treatment(P<0.01).The PEF mutation rate was significantly lower than that before treatment(P<0.01).Besides the FEV_(1) and FEV_(1)%in the observation group after treatment were significantly higher than those in the control group(P<0.01),while the PEF variation rate was lower than that in the control group(P<0.01).(4)The levels of EOS,IL-4 in the sputum of the two groups decreased obviously after treatment(P<0.01).The level of IL-10 was significantly higher than that before treatment(P<0.01).After treatment,the observation group was better than the control group in improving airway inflammation(P<0.01).(5)After treatment,serum ECP,IgE and peripheral blood EOS ratio levels in the two groups were significantly lower than those before treatment(P<0.01).The serum ECP,IgE and peripheral blood EOS ratio levels in the observation group were significantly lower than those in the control group(P<0.01).(6)After treatment,the ACT scores of the two groups were significantly higher than those before treatment(P<0.01).The scores of phlegmasthma syndrome and FeNO level were significantly lower than those before treatment(P<0.01).In addition,the ACT score of the observation group was significantly higher than that of the control group(P<0.01)and the phlegmasthma syndrome score and FeNO level were significantly lower than those of the control group(P<0.01).(7)No abnormalities in liver,kidney function,urine routine,and electrocardiogram,etc.were found during the treatment,and no adverse reactions occurred.Conclusion On the basis of conventional western medicine treatment,Xuanfei Pingchuan Huatan Tongluo decoction was taken orally to treat patients with chronic persistent phlegm-asthma syndrome,which can reduce asthma symptoms,improve lung function and effectively control asthma attacks.It also reduced airway inflammation and AHR.The clinical effect was better than that of simple western medicine conventional therapy.The traditional Chinese medicine treatment had better security.