The Clinical Observation Of Qinzhifugan Granule In The Treatment Of Children With Recurrent Respiratory Tract Infection (Excess-heat Of Lung-stomach Syndrome)

Objective: To observe the clinical efficacy of Qinzhifugan Granule in the treatment of children with recurrent respiratory tract infection due to excess-heat of lung-stomach,and to analyze the effectiveness,safety and advantage.Methods: Eighty children with recurrent respiratory tract infection who met the inclusion criteria and were admitted to the pediatrics department of Hebei Hospital of Traditional Chinese Medicine from February 2018 to February 2019 were selected as the study objects.The patients were divided into observation group and control group by random number table method,with 40 cases in each group.Children in the observation group were treated with Qinzhifugan Granule,while children in the observation group were given Spleen Aminopeptide Oral Lyophilized Powder.The course of treatment was8 weeks,and how many times the respiratory tract infection occurred was recorded at the end of 12 months of follow-up.The total score of TCM syndromes,single symptom score of TCM,serum IgG and T lymphocyte subsets were observed before and after treatment.Statistical methods were used to evaluate the efficacy and safety of the two groups.Results:1.Efficacy of diseaseAfter treatment,the total effective rate was 83.33% in the observation group and 82.86% in the control group,with no significant difference(P>0.05).2.Efficacy of TCM syndromesAt the end of treatment,the effective rate was 97.22% in the observation group and 48.57% in the control group;at the end of follow-up,the effective rate was 91.67% in the observation group and 37.14% in the control group,and the difference between two groups was statistically significant(P<0.05).3.Total score of TCM syndromesAt the end of treatment,the total score of TCM syndromes in the observation group was 3.08±2.048,and that in the control group was7.29±1.824.At the end of follow-up,the total score in the observation group was 3.44±1.963,and that in the control group was 7.49±1.821.The difference between two groups was statistically significant(P<0.05).4.Score of Single TCM symptomAt the end of treatment,the single TCM symptoms in the observation group were improved before and after treatment,and the difference was statistically significant(P<0.05).In the control group,the single TCM symptoms were improved before and after treatment except for halitosis(P<0.05).The comparison between the observation group and the control group showed that the observation group was superior to the control group in improving six TCM symptoms,namely,redness of throat,bad breath,sore tongue,sweating and sticky,restless sleep and dry stool(P<0.05).At the end of follow-up,the scores of single TCM symptoms in the observation group were still decreased compared with those before treatment(P<0.05),while four symptoms in the control group were improved compared with those before treatment(P<0.05),including redness of pharynx,sore tongue,sweating and sticky,and restless sleep at night(P<0.05),but there is no improvement in halitosis and dry stool(P>0.05).5.Serum level of IgGAfter treatment,the serum level of IgG in both groups was higher than that before treatment(P<0.05).However,there was no significant difference between two groups(P>0.05).6.T lymphocyte subsetsAfter treatment,the proportion of CD4+ and CD4+/CD8+ in both groups were higher than that before treatment,and the proportion of CD8+ was lower than before(P<0.05).However,there was no significant difference between two groups(P>0.05).7.Safety indexesDuring the treatment period,the vital signs of both groups were stable,and complete blood routine,urinalysis,stool routine,liver metabolic combination,renal function and electrocardiogram of the two groups were detected before and after treatment and compared.All the records were normal and the difference was not statistically significant(P>0.05).8.Adverse eventsAfter taking medicine,the incidence of adverse events of vomiting in the observation group was 2.8%,and the incidence of adverse events in the control group was 0.There was no significant difference between the two groups(P>0.05).Conclusion:Qinzhifugan granule is effective in treating children with recurrent respiratory tract infection(excess-heat of lung-stomach Syndrome),which can reduce the number of respiratory tract infection in children,improve TCM syndromes,regulate immune function,and has no serious adverse reactions,with good safety.