| Objective: The purpose of this study was to observe the clinical efficacy and safety of Kechuanping Granule in the treatment of bronchitis with cold shuts the lung type, and to evaluate TCM syndrome scores and comprehensive efficacy. At the same time, the levels of IL-4 and IL-17 in peripheral blood to detected and a preliminary study on the mechanism of Kechuanping Granule in the treatment of bronchiolitis that it is to provide the theoretical basis for the clinical treatment of bronchiolitis.Methods: 60 children with bronchiolitis were selected according to the criteria of this study. The patients were randomly divided into observation group and control group with 30 cases in each group. The two groups were given routine treatment of Western medicine, in which the observation group was added to Kechuanping Granule orally on the basis of the conventional treatment. The two groups were treated with a course of 7 days. After the end of the one course of treatment, which it to observed the scores of TCM symptom, comprehensive efficacy and drug safety. At the same time, the levels which its were to detected before and after treatment of IL-4 and IL-17 in peripheral blood, blood routine, liver and kidney function, urine and stool routine. A preliminary study on the mechanism and safety of Kechuanping Granule in the treatment of bronchiolitis.Results:1. Total efficacy comparison: The total effective rate was 96.67% in the observation group and 80.00% in the control group. The total effective rate of the two groups was statistically significant (p<0.05),indicating that both groups were able to significantly improve the clinical efficacy of children with cold shuts the lung type of bronchiolitis,and the observation group was superior to the control group.2. Comparison of total score of TCM syndromes : The total score of TCM syndromes in the two groups after treatment were lower than before treatment, and the difference was statistically significant (p<0.05). After treatment, there was a significant difference between the two groups (p<0.05), indicating that both groups after treatment can improve the clinical symptoms and signs of children with bronchiolitis, and the observation group was superior to the control group.3. Comparison of the main syndromes of TCM: The scores of the main symptoms of the two groups were lower than before treatment, and the differences were statistically significant (p<0.01 or 0.05). Besides, the three main syndromes of asthma,cough and phlegm of comparison after treatment in the two groups, the observation group was superior to the control group (p<0.05).4. Comparison of the minor syndromes of TCM: The scores of the minor symptoms of the two groups were lower than before treatment, and the differences were statistically significant (p<0.01 or 0.05). Besides, the three minor syndromes of nasal flaring and cyanotic lips of comparison after treatment in the two groups, the observation group was superior to the control group (p<0.05).5. Comparison of the levels of IL-4 and IL-17 in peripheral blood serum : After treatment the levels of serum IL-4 and IL-17 in the two groups were significantly lower than before treatment, and the difference was statistically significant(p<0.05),indicating that both groups after treatment can reduce the levels of serum IL-4 and IL-17 of children with bronchiolitis, and the observation group was superior to the control group(p<0.05).6. Observation of safety: In this study, 60 patients had no serious adverse reactions,there were only 2 cases of children in the control group had a transient diarrhea,vomiting, and symptoms disappeared quickly after untreatment. The safety index was detected of before and after treatment. The results showed that blood routine, liver function, renal function, urine routine, stool routine were not abnormal. This study shows that the safety and reliability of Kechuanping Granule in the treatment of bronchiolitis with cold shuts the lung type.Conclusion:1. Kechuanping Granule can significantly improve the TCM syndrome scores of bronchitis with the cold shuts the lung type, enhance physical fitness, improve the overall efficacy.2. Kechuanping Granule can reduce the level of serum IL-4 and IL-17 in peripheral blood of bronchitis with the cold shuts the lung type, and the levels of serum IL-4 and IL-17 were significantly decreased in peripheral blood of children. And it can significantly reduce the relapse after the withdrawal of the situation and good security,it is worth in the clinical promotion, children with asthma, suggesting that the mechanism may be to regulate Th1/Th2 balance disorders and reduce airway inflammation.3. It is safe and worthy to be popularized in clinical application for Kechuanping Granule. |
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