| Objective : Asthma is the most common chronic respiratory disease in children. In recent years, the prevalence of asthma in children was entirely on the rise all over the world. The most patients with asthma were found onset before the age of 5,and most of them were in intermittent state. Western Medicine believes that it is unnecessary for such the children to take the long-term control medicine and on-demand inhaled beta2-agonist was enough for them in the asthma attacks. The effective intervention is insufficient. The intermittent asthma belongs to remission stag in Chinese Traditional Medicine(TCM). Traditional Chinese Medicine believes that the essence of asthma is due to the deficiency of lung, spleen and kidney. It is believed that the medicine of strengthening the body resistance should be taken when patient is in asthma relieving stages. Over years, it is a main therapy in TCM to tonify lung,invigorate spleen and reinforce Kidney for patients with asthma at remission stag. And the research showed that the therapy could stop asthma get worse. The aim of this project is to explore the prophylaxis and treatment of TCM Herbs for Supplementing Qi,Replenishing Spleen, Tonifying Kidney to children aged from 2-5 with intermittent asthma, and evaluate the safety of the TCM herbal granule.Methods:The patients in the 60 cases who were aged from 2-5 with intermittent asthma(with non asthma acute attack) were selected from the outpatient of pediatrics of the General Hospital of the Air Force from October 2009 to February 2013.A randomized, single-blind, placebo controlled trial was used in the research. Cases of all enrolled children were filled into condition baseline questionnaire. According to random number table, all children were randomly divided into a treatment group(n= 40) and placebo group(n= 20). The treatment group was treated with TCM herbal granule forSupplementing Qi, Replenishing Spleen, Tonifying Kidney. The placebo group was given to placebo granule, which had the same taste and appearance as that of the TCM herbal granule, free of medicine. And 3 months for a treatment course. Patients were followed up at 1 year after beginning treatment. The attacks of asthma, the duration of the wheezing and coughing in an asthma attack and TCM syndrome scores were recorded at 1 month, 2 months, 3 months and stopping the medicine for 3 months, 6months, 9 months. And the airway resistance and eosinophil cationic protein(ECP) of the two groups were observed before and after 3 months. The results were statistically analyzed. Data were analyzed with SPSS17.0. And P<0.05 was considered statistically significant.Results: ①Among the 60 children with intermittent asthma, 23 presented mild ventilator disorder,and 21 showed abnormally high ECP. ② 55/60 patients finally completed this treatment, including 38 cases from the treatment group and 17 cases from the placebo group, there were 5 cases missing. ③After treatment, the attacks of asthma significantly decreased in the treatment group(P < 0.05), but there was no significant difference in the placebo group(P>0.05). ④For the treatment group, the TCM syndrome scores, the duration of the wheezing and coughing in an asthma attack decreased after 1 month, the scores and the duration of the wheezing and coughing significantly decreased after 2 months and there was also a significant difference in scores and the duration of the wheezing and coughing between the two groups(P<0.05). The difference normally remained after the medicine was stopped for 9 months(P<0.05). ⑤After the 3-month treatment, compared with the placebo group, the airway resistance decreased obviously in the treatment group(P < 0.05). ⑥ No any adverse event was noted in the treatment group.Conclusions:Some children with intermittent asthma(with non asthma acute attack) have airway obstruction and chronic inflammatory disorder of the airway, it proved that the early intervention should be given to children with intermittent asthma.The TCM herbs for Supplementing Qi, Replenishing Spleen, Tonifying Kidney couldreduce the attacks of children aged from 2-5 with intermittent asthma, cut down the duration of the wheezing and coughing in an asthma attack, decrease the TCM syndrome scores and reduce the airway resistance without adverse effects. It could stop progression of the disease. It is a safe and effective drug for treatment of intermittent asthma, and worthy recommending. |