固本防哮饮联合定喘敷贴膏治疗儿童哮喘缓解期疗效评价

Therapeutic Evaluation of Gubenfangxiao Decoction Combined with Dingchuanfutie Paste on Remission Stage of Asthmatic Children

目的:评价固本防哮饮联合定喘敷贴膏治疗儿童哮喘缓解期肺脾气虚证的疗效。方法:采用中心随机、平行分组对照,多中心临床研究,4个中心共263例哮喘缓解期患儿完成本次研究,其中试验组132例、对照组131例,试验组采用固本防哮饮口服联合定喘敷贴膏穴位敷贴;对照组用普米克都保(布地奈德)吸入,疗程均为12个月。结果:1)主要疗效指标评价:治疗6个月和12个月时,2组患儿哮喘发作次数、呼吸道感染次数均较治疗前有显著减少(P<0.01),其中12个月时呼吸道感染次数试验组显著低于对照组(P<0.05)。2)中医证候疗效指标评价:试验组和对照组对中医证候疗效指标均有明显改善效果,但试验组在改善鼻痒喷嚏、流涕、咳嗽、出汗、大便、舌象等症状和总症状积分方面要优于对照组(P<0.01,P<0.05)。2组证候总疗效比较,试验组总有效率为93.08%、对照组总有效率为82.31%,试验组明显优于对照组(P<0.05)。结论:固本防哮饮联合定喘敷贴膏治疗儿童哮喘缓解期安全有效。

Objective： To evaluate the efficacy of Gubenfangxiao decoction（ GBFXD） combined with Dingchuanfutie Paste（ DCFTP）on remission stage of asthmatic children who have syndrome of lung-spleen qi deficiency. Methods： A central randomized,parallel controlled,4-center clinical study was carried out on 263 cases of asthmatic children of remission stage. There were 132 cases in test group and 131 cases in control group. Children were orally administered GBFXD combined with DCFTP in the test group and inhaled Pulmicort Turbuhaler in the control group,and the treating period was 12 months. Results： 1） Main outcome indicators evaluation： Compared to baseline,the frequency of asthma attack and respiratory infection were significantly reduced after 6 months of treatment and 12 months of treatment（ P〈0. 01）. What is more,after 12 months,the frequency of respiratory infection in test group was notably lower than control group（ P〈0. 05）. 2） TCM syndrome outcome indicators evaluation： Compared to baseline,the TCM syndrome outcome indicators were all effectively improved no matter in test group or control group after 12 months. However the indicators of itchy nose and sneezing,running nose,cough,sweatiness,stool,and tongue manifestation were markedly improved than control group（ P〈0. 01,P〈0. 05）. The total syndrome therapeutic effective rate was 93. 08% in test group,82. 31% in control group. The advantage of test group is remarkable（ P〈0. 05）. Conclusion： The treatment of oral administration GBFXD combined with DCFTP on remission stage of asthmatic childrenwas safe and effective.