“宝根1号方”治疗儿童哮喘缓解期(肺脾气虚证)的多中心随机对照临床研究

“Baogen-Ⅰ Decoction” in the treatment of children with asthma in remission stage(syndrome of lung and spleen qi-deficiency):A multicenter randomized controlled clinical study

目的:观察"宝根1号方"治疗儿童哮喘临床缓解期(肺脾气虚证)的临床疗效。方法:将156例儿童哮喘临床缓解期(肺脾气虚证)患儿按照多中心、随机、平行对照的原则分为治疗组78例和对照组78例。对照组患儿给予沙美特罗替卡松雾化吸入+孟鲁司特钠口服,治疗组患儿在对照组治疗基础上给予"宝根1号方"颗粒口服,两组疗程均为2个月。观察并比较两组患儿的临床疗效、肺功能及中文版儿童哮喘控制测试问卷(Ch-CACT)评分的变化,检测两组患儿的嗜酸性粒细胞计数(EOS)、Ig A、Ig G、Ig M、Ig E及干扰素-γ(IFN-γ)、白介素-4(IL-4)的水平。结果:治疗后,治疗组和对照组的临床总有效率分别为89.47%和87.02%,两组疗效比较差异无统计学意义(P>0.05)。治疗后,两组患儿的Ig A、Ig G、Ig M水平较治疗前均显著升高(P<0.05),Ig E水平较治疗前明显降低(P<0.05),且治疗组患儿的Ig E水平明显低于对照组(P<0.05);两组患儿的EOS、IL-4水平较治疗前均显著降低(P<0.05),IFN-γ水平较治疗前显著升高(P<0.05),且治疗组患儿的EOS、IL-4水平低于对照组(P<0.05),IFN-γ水平高于对照组(P<0.05)。治疗后,两组患儿的第1秒用力呼气量占预计值百分比(FEV1%)、最大呼气峰流量(PEF)水平及Ch-CACT评分均显著升高(P<0.05),但组间比较,上述指标的差异均无统计学意义(P>0.05)。结论:"宝根1号方"能明显改善支气管哮喘缓解期儿童的免疫功能,对其哮喘具有一定的预防作用。

Objective: To observe the clinical efficacy of"Baogen-I Decoction"in the treatment of children with asthma in remission stage( lung and spleen qi-deficiency syndrome). Methods: One hundred and fifty-six children with asthma in remission stage( lung and spleen qi-deficiency syndrome) were divided into the treatment group( 78 cases) and the control group( 78 cases) according to the multicenter randomized parallel-controlled principles. The children in the control group were treated with salmeterol and fluticasone propionate by inhalation and montelukast sodium by oral administration,and the children in the treatment group were orally treated with"Baogen-I Decoction"Granule based on the treatment for the control group,with a course of 2 months. The clinical efficacy,lung function and score of Chinese-Childhood Asthma Control Test( Ch-CACT) in both groups were observed and compared,and the levels of EOS,Ig A,Ig G,Ig M,Ig E,IFN-γ and IL-4 were detected. Results: After treatment,the total clinical effective rates of the treatment group and the control group were 89.47% and 87.02% respectively,with no statistical difference between the two groups( P>0.05). After treatment,the levels of Ig A,Ig G and Ig M in both groups were obviously increased( P<0.05),the level of Ig E was obviously decreased( P<0.05),and the level of Ig E of the treatment group was lower than that of the control group( P<0.05); the levels of EOS and IL-4 in both groups were obviously decreased( P<0.05),the level of IFN-γ was obviously increased( P<0.05),and the levels of EOS and IL-4 of the treatment group were lower than those of the control group( P<0.05),the level of IFN-γ was higher than that of the control group( P<0.05). After treatment,the levels of FEV1% and PEF and the score of Ch-CACT in both groups were significantly increased( P<0.05),but there were no statistical differences on above indexes between the two groups( P>0.05). Conclusion: "Baogen-I Decoction"can significantly improve the immune function of children with bronchial asthma in remission stage and shows certain preventive effect on asthma.