Clinical comprehensive evaluation of Erxieting Granules for treatment of acute pediatric diarrhea(damp-heat diarrhea)
Objective To evaluate the clinical value of Erxieting Granule in treating acute pediatric diarrhea and to provide reference for rational drug use.Methods Through the discussion of experts in the research group,the evaluation indicators in the Clinical Comprehensive Evaluation Index Framework of proprietary Chinese Medicines for Children were selected based on six dimensions including safety,effectiveness and economy,and the evidence was collected based on literature(open/undisclosed),evidential information,clinical questionnaires,etc.,by means of existing statistical data analysis,content analysis,systematic literature review,etc.The evaluation of Erxieting Granules was carried out by using Clinical Comprehensive Evaluation Tool of Children's proprietary Chinese Medicine.Result(1)Security dimension.The incidence of adverse reactions of Erxieting Granules was low,no serious adverse reactions were found,and the safety was good and the risk was controllable,with sufficient evidence,and the score was 24.466 points.(2)Validity dimension.The results of meta-analysis and prospective cohort study both suggested that this product had significant efficacy in the treatment of acute diarrhea in children,ranking second in the efficacy of similar varieties of proprietary Chinese medicines,with a score of 31.94 points.(3)The daily drug cost of this product is 3.1-24.6 yuan,and each additional unit of efficiency costs 0.40-3.14 yuan,which has an economic advantage,and the score is 3.63 points.(4)Suitability dimension.This product has good suitability in terms of drug information and drug use,with a score of 7.87.(5)Accessibility dimension.This product has good accessibility in terms of affordability and availability,scoring 6.34 points.(6)Innovation dimension.In terms of technological innovation,the product has optimized the process,improved and revised the quality standards.And obtained a number of national patents,with good innovation,score 2.73 points.(7)Comprehensive evaluation results.The comprehensive value index of Erxieting Granules is 76.98.Conclusion The comprehensive value index of Erxieting Granules is ≥75,and its clinical comprehensive value is better in the treatment of acute diarrhea in children(damp-heat diarrhea).
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