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目的:研究泛福舒胶囊辅助治疗小儿支气管哮喘(BA)的临床疗效及安全性。方法:选择2014年10月~2015年9月于成都医学院第一附属医院儿科接受治疗的急性发作期BA患儿88例,依照随机数字表法1:1分为泛福舒组(n=44)与对照组(n=44)。对照组在常规治疗的基础上给予布地奈德气雾剂治疗,泛福舒组在对照组的基础上给予泛福舒胶囊治疗。观察和比较两组治疗前后肺功能指标PEF(呼气峰流速)、FEV1,CD3~+、CD4~+、CD8~+、CD4~+/CD8~+T淋巴细胞水平,血清IL-4、IL-5、IL-12、IFN-γ水平以及治疗期间不良反应的发生情况和临床疗效;结果:治疗后,两组PEF、FEV1、CD3~+、CD4~+、CD4~+/CD8~+、IL-12、IFN-γ水平均高于治疗前,CD8~+、IL-4、IL-5水平均低于治疗前,且泛福舒组PEF、FEV1、CD3~+、CD4~+、CD4~+/CD8~+、IL-12、IFN-γ水平均高于对照组,CD8~+、IL-4、IL-5水平均低于对照组,差异均有统计学意义(p<0.05)。泛福舒组总有效率(93.18%)显著高于对照组(75.00%),组间比较有统计学差异(p<0.05)。泛福舒组不良反应发生率(4.55%)与对照组不良反应发生率(0%)无统计学差异。结论:泛福舒胶囊辅助治疗可更有效提高BA患儿的临床疗效,改善其肺功能,增强其免疫防御能力,且安全性较高,值得应用于临床。
Objective: To investigate the clinical efficacy and safety of Pan Fu Shu capsule in adjuvant treatment of pediatric bronchial asthma (BA). Methods: From October 2014 to September 2015, 88 children with BA who were treated in the pediatric department of the First Affiliated Hospital of Chengdu Medical College during the first episode were enrolled in the Panfukang group according to the random number table method (n = 44) and control group (n = 44). The control group was treated with budesonide aerosol on the basis of routine treatment. Pan Fu Shu group was given Pan Fu Shu capsule on the basis of the control group. The levels of PEF, FEV1, CD3 +, CD4 +, CD8 +, CD4 + / CD8 + T lymphocytes in the two groups before and after treatment were observed. The levels of PEF, FEV1, CD3 +, CD4 +, CD4 + / CD8 +, IL-12 and IFN-γ in the two groups were compared between the two groups after treatment. The levels of IL-12 and IFN-γ were significantly higher than those before treatment, and the levels of CD8 +, IL-4 and IL-5 were lower than before treatment, and the levels of PEF, FEV1, CD3 +, CD4 + The levels of CD8 ~ +, IL-4 and IL-5 were lower in the control group than in the control group (P <0.05) . The total effective rate of Pan Fu Shu (93.18%) was significantly higher than that of the control group (75.00%), there was a significant difference between the two groups (p <0.05). The incidence of adverse reactions (4.55%) in panforts and the incidence of adverse reactions in the control group (0%) was not statistically different. Conclusion: Pan Fu Shu capsule adjuvant therapy can be more effective in improving the clinical efficacy of BA children, improve their lung function and enhance their immune defenses, and high safety, it is worth to apply in clinical.