龙香平喘胶囊治疗支气管哮喘临床疗效观察

Observation on Clinical Effects of Longxiang Asthma-relieving Capsules in Treating Bronchial Asthma

目的:观察龙香平喘胶囊治疗支气管哮喘的临床有效性与安全性。方法:按照国家食品药品监督管理总局GCP规范,采用随机双盲、双模拟、阳性药平行对照、多中心研究原则。治疗组109例服用龙香平喘胶囊加模拟剂,对照组108例服用蠲哮片加模拟剂。两组病例进行14天的双盲期治疗,治疗结束后统计疗效。结果:两组治疗后第1秒用力呼气容积/用力肺活量(forced expiratory volume in one second/forced vital capacity,FEV_(1)/FVC)及呼气峰值流量(peak expiratory flow PEF)均比治疗前增高(P<0.01),且两组疗效相当(P>0.05)。治疗后,两组肺功能疗效比较,差异无统计学意义(P>0.05)。两组治疗后第14、21天时证候总积分均较第7天降低(P<0.01),且治疗组治疗第14、21天时证候总积分低于对照组同期(P<0.01)。两组治疗后证候疗效优于治疗前(P<0.01),且治疗组治疗第14、21天证候疗效优于对照组(P<0.01)。显效率、总有效率治疗组分别为55.55%(60/108)、89.81%(97/108),对照组分别为37.04%(40/108)、72.22%(78/108),两组比较,差异有统计学意义(P<0.05)。治疗组喘息、哮鸣音、咳嗽单项症状疗效优于对照组(P<0.05)。治疗组不良反应发生率[0.92%(1/109)]低于对照组[1.85%(2/108)](P<0.01)。结论:龙香平喘胶囊能明显改善支气管哮喘急性发作期患者肺功能,可明显降低“痰瘀阻肺”症状总分,有效改善喘息、哮鸣音、咳嗽单项症状,且用药安全。

Objective:To observe clinical effectiveness and safety of Longxiang asthma-relieving capsules in the treatment of bronchial asthma(BA).Methods:Randomized,double-blinded,double simulated,parallel controlled of positive medicine and multiple centered method was adopted according to the GCP rule of State Food and Drug Administration.All 109 cases of the treatment group took Longxiang asthma-relieving capsules plus simulation agent,and 108 cases of the control group took Juanxiao tablets plus simulation agent,the cases in both groups accepted 14-day double blinded therapy,to perform statistical analysis of clinical effects by the end of therapy.Results:After the treatment,FEV_(1)/FVC and PEF in both groups raised than before the treatment(P<0.01),and therapeutic effects were equivalent in both groups(P>0.05).After the treatment,the difference had no statistical meaning in clinical effects of pulmonary function between both groups(P>0.05).Syndrome integrals at day 14 and 21 after treatment lowered in both groups compared to day seven(P<0.01),and syndrome integrals of the treatment group at day 14 and 21 after treatment were lower than these of the control group over the same period(P<0.01).After the treatment,clinical effects of syndrome in both groups were better than these before the treatment(P<0.01),clinical effects of syndrome of the treatment group at day 14 and 21 after treatment were superior to these of the control group(P<0.01).Marked effective rate and total effective rate of the treatment group were 55.55%(60/108)and 89.81%(97/108)respectively,higher than 37.04%(40/108)and 72.22%(78/108)of the control group,the difference showed statistical meaning between both groups(P>0.05).The treatment group was better than the control group in clinical effects of single symptoms including panting,wheezing rale and cough(P<0.05).The incidence of adverse reaction of the treatment group was[0.92%(1/109)],lower than[1.85%(1/108)]of the control group(P<0.01).Conclusion:Longxiang asthma-relieving capsules could obviously improve lung function in BA patients at exacerbation stage,noticeably decrease total scores of the symptoms of"phlegm and stasis obstructing lung",effectively improve single symptoms including panting,wheezing rale and cough,with safe medication.