Clinical Study And Safety Evaluation On Sangsha Granule In Treatment Of Acute Trachea-bronchitis In Children For Wind-dryness Hurting The Lung

Objective: To objectively assess the efficacy and scientifically evaluate safety of Sangsha granule in treatment of acute trachea-bronchitis in children for wind-dryness hurting the lung,and finally provide proofs to the clinical application of such drug.Methods:(1)Clinical Observation: children patients who meet the standards of acute trachea-bronchitis for wind-dryness hurting the lung were picked out and divided into observer group(Sangsha Granule)and contrast group(Sangju Ganmao Granule)by randomized method,and each group had 30 children at last.Two groups accept continuous course for six day.Record,analyze and compare the symptom scores of both groups pre-test and post-test.(2)Acute Toxic Test: On the basis of abortively detecting the LD50 of mice by pre-test,formal test were designed to proof safety of Sangsha Granule.Results:(1)Clinical Observation: Sangsha Granule not only remove or relieve the main syndromes of cough,expectoration and throat itching caused by acute trachea-bronchitis in children for wind-dryness hurting the lung,but also obviously improve the subordinate syndromes of throat congestion,antiadoncus and diet.(1)Therapies of two groups could remove or eliminate the many symptoms and signs caused by acute trachea-bronchitis in children for wind-dryness hurting the lung(P<0.05).(2)Under the treatment of acute trachea-bronchitis in children for wind-dryness hurting the lung,the total clinical effective rate of observer group was 90%,and the contrast group was 86.7%,had not statistically significant(P>0.05).(3)Comparing with the contrast group,The efficacy of the observer group had advantage in improving the main syndromes(P<0.05),but about the total syndromes and subordinate syndromes,the efficacy of two groups showed fairly(P>0.05).(4)The effect of two groups in improvement of symptoms of pharyngalgia,physical sign of lung,stuffy nose,running nose,tongue sign,and dry stool were fairly(P>0.05).(5)The observer group was more superior than the contrast group in improving cough,expectoration,throat itching,throat congestion,antiadoncus and diet(P<0.05).(6)After treatment the efficacy of two groups in improving abnormal Blood Routine Examination had not statistically significant(P>0.05).(7)Sixty children of two groups had no obviously adverse drug effect during the whole study.(2)Acute Toxic Test: There was no mice dead during drug test,and their main visceral organs appearance were normal.The maximum dosage of mice was 120 times higher than an adult's clinical dose.Conclusion: Through the clinical study and the acute toxic test,it could demonstrate that Sangsha Granule is effective and safe in remeding acute trachea-bronchitis in children for wind-dryness hurting the lung,and worthy of the clinical application and generalization.