Clinical Study And Safety Evaluation On Sanzi Xiangbei Granule In Treatment Of Acute Bronchitis In Children For Phlegm-heat Obstructing In The Lung

Objective: To assess the efficacy and safety of Sanzi Xiangbei granule in treatment of acute bronchitis in children for phlegm-heat obstructing in the lung,and provide evidence to the clinical application of this drug.Methods:(1)Clinical Observation: Sixty child patients with acute bronchitis for phlegm-heat obstructing lungs were selected and divided into observation group(Sanzi Xiangbei Granule group) and control group(Qingfei Huatan Granule in Children) by random grouping method,each group includes 30 children.Both groups continuous treatment for a 5-day treatments and observe a treatment.Record and analyze the syndrome scores of the two groups before and after the treatment.(2)Acute Toxic Test: Elementary observation of Sanzi Xiangbei Granule on toxicity and the death of mice by preliminary test,and evaluate its safety by formal test.Results:(1)Clinical Observation: Sanzi Xiangbei Granule could eliminate or alleviate the symptom of cough, expectoration and other symptoms caused by acute bronchitis in children for phlegm-heat obstructing lungs,and the improvement of diet,stool stem node and other symptoms had advantages.(1)Therapy is a curative method in both groups(P<0.05),were both could eliminate or alleviate the symptoms and signs caused by acute bronchitis in children for phlegm-heat obstructing lungs.(2)In treatment of acute bronchitis in children for phlegm-heat obstructing in the lung,the total effective rate in observation group was 96.7%,and control group was 83.3%, total clinical efficacy of observation group is better than the control group(P<0.05).(3)The effect of the observation group was better than that of the control group in improving the total syndrome and main syndrome(P<0.05),but in improving the secondary syndrome, the two groups of curative is quite(P>0.05).(4)The two group in improving symptoms of rhinobyon,rhinorrhea,thirst,pharynx congestion,tonsillar enlargemen,complexion,and pulmonary signs has effect, and the effect is quite(P>0.05).(5)In the improvement of cough, expectoration,anorexia,and stool stem node,the observation group was better than the control group(P<0.05).(6)Post-treatment cases the curative effect of both groups with improve abnormal Blood Cell Analysis results is equal to each other(P>0.05).(7)No obvious drug adverse reaction was found in two groups of children during this study.(2)Acute Toxic Test: There were no mice dead during the test,and anatomical observation of mice main visceral organ morphology was normal.The maximum administration dose for mice was 107.46 times the clinical dose for an adult to take within 24 hours.Conclusion: By the clinical research and the acute toxicity test, it can confirm that Sanzi Xiangbei Granule in treatment of acute bronchitis in children for phlegm-heat obstructing in the lung is effective and safe,is worth the clinical promotion and the application.