Innovative Research TCM ADR Benefit-risk Assessment Based On

Purpose:Based on traditional Chinese medicine characteristics of adverse drugreactions (ADR) of disease severity and adverse drug reactions the establishmentof classification standard, retrospective evaluation, selection risk assessmentmethod, the Delphi method weighting improvement, establish suitable fortraditional Chinese medicine (TCM) ADR benefit risk assessment methodologysystem.Materials and methods:(1) Severity adrs were retrospectively analyzed, based on severityclassification standard (ADR) of TCM;(2)To vial ShuangHuangLian ADR for demonstration, through injection drug useShuangHuangLian (lyophilization) manual (paper), pneumonia caused by exogenouswind hot, upper respiratory tract infection (tonsillitis) disease severityclassification standard;(3) Using the Delphi method and the retrospective analysis and selection, canbe graded by the degree of disease severity and adverse reactions of qualitativeand quantitative indicators, establish suitable for the evaluation of effectsof TCM ADR risk assessment method, Improved-the principle of three-thirdssystem(T-TPOTTS) method;(4) With the national drug supervision and administration of adverse drugreactions/events based on the report content, combining with the characteristicsof injection with ShuangHuangLian adverse reactions and set contains morecontent, effect and risk the survey center for ADR epidemiological survey;(5) Through nested type of adverse reaction cases case-control study and riskassessment of the effect of demonstration, preliminary validation of adversereactions and improve “Improved-the principle of three-thirdssystem(T-TPOTTS)” feasibility of evaluation method. Results:(1) Establish the TCM ADR8qualitative classification standard, supposed thequantitative respectively, finally summarized for traditional Chinese medicinebenefit risk assessment for low and middle level3standards;(2)With demonstration through literature review and preparation manual control,set up fever caused by exogenous wind pneumonia, upper respiratory tractinfection (tonsillitis) grading standards of disease severity level3; Level3was determined by the disease a shorter time, evaluation standard;(3)Establish a suitable for evaluation of effects of TCM ADR risk assessmentmethod, Improved-the principle of three-thirds system(T-TPOTTS) method;method;(4)Completed based on the Improved-the principle of three-thirdssystem(T-TPOTTS) benefits of risk assessment, demonstration preparations forinjection ShuangHuangLian ADR epidemiological survey;(5)Based on epidemiological investigation was complete the necessary ethicalreview form and the design of the informed consent of the relevant content.Conclusion:Based on traditional Chinese medicine (TCM) is established in this paper,according to the characteristics of TCM ADR ADR epidemiological investigationimprovement-the benefit of the principle of three-thirds system risk assessmentmethodology system, targeted strong, easy to control, and facilitatingscientific analysis characteristics and regulation of adverse drug reactionsin the future to provide theoretical reference and reference.