Evaluation And Analysis Of The Quality Of Adverse Reaction Report In Clinical Trials Of Traditional Chinese Medicine

Purpose：A retrospective analysis of the quality of Chinese medicine clinicaltrials adverse reaction reports, the evaluation of current medicine adversereactions reported in clinical trials of new drugs, to further standardize theformat and content of Chinese medicine clinical trials adverse reaction reports.Material and method： Screening211pilot projects to remove items adversereactions not mentioned in the statistical analysis included a total of209.The basic situation consolidation project, adverse reactions adverse eventsmentioned valid data, the evaluation criteria of causality of adverse reactionsand adverse conditions such as diagnostics for statistical analysis.Results:1.Chinese medicine clinical trials reported adverse reactions included projectsituation:（1) The international classification of WHO statistics show thatthe development of evaluation criteria: the quality of traditional Chinesemedicine adverse reactions reported in clinical trials in four standard, twoaccounted for the largest proportion of84.9%.(2) National Adverse DrugReaction Testing Center of standard classification statistics: In the fivecriteria, there is no project to achieve the highest standards of four, tothree criteria accounted for the largest proportion of84.9%.(3) NationalAdverse Drug Reaction Monitoring Center " adverse drug reaction case reportsof quality assessment scorecard " Statistics show that: the majority of the71<Score≤80range,95.8%.(4) According to the " Good Clinical Practice"and "Chinese medicine clinical research guidelines " adverse reaction reports,including at least: adverse performance, start time, end time, severity,causation determination, treatment measures, outcomes, and the results theseeight aspects, all of these eight areas mentioned, there are154accounts fora total of86.0%, the main problem is the lack of adverse reactions end time,which lack an aspect has26projects (17.7%). 2Chinese medicine clinical trials adverse selection criteria of causality:Select one of the standard applications up to100projects accounted for47.8%,the selection criteria II accounted for28.2%, nearly six years to apply thestandard has been applied over02-06years increased5%increase, not mentionedstandards fell8%. The clinical diagnosis of causality of adverse drug reactionsis not the same subjects the choice of subjects, although there are many sectionsof the project the majority (>50%) the selection criteria for the determinationof a standard, but some departments such as ENT II project selection criteriathe majority (>50%). And pediatrics, orthopedics in adverse reaction reportsof adverse reactions not mentioned in the causal criteria accounted for50%,which seriously affected the quality of the report, should be paid.3.Adverse reactions diagnosis:(1) to diagnose symptoms and signs, accountingfor71%; laboratory abnormalities accounted for20%; disease diagnosisaccounted for about8%.(2) adverse drug reactions to the drug involveddigestive system adverse reactions of up to diagnose the main symptoms and signs,diagnosis, supplemented by laboratory abnormalities, disease diagnosis mosttimes. The urinary system adverse reactions involved in blood systems baseddiagnostic laboratory abnormalities places.Conclusion:1. The new Chinese medicine adverse reactions reported in clinical trials isan important new drug safety evaluation data medicine work. At present, Chinesemedicine clinical trials for adverse reaction reports no clear qualityevaluation criteria, in accordance with international and domestic most of thelisted criteria for evaluating drug adverse reaction reports new Chinesemedicine TCM drugs reported adverse circumstances. According to the " GoodClinical Practice" and "Chinese medicine clinical research guidelines," Chinesemedicine clinical trials adverse reactions reported at least include: adversereactions performance, start time, end time, severity, causationdetermination, treatment measures, outcomes, The eight aspects of the results. With the passage of time the contents of the report ’s more detailed, but stillneed to be strengthened. Suggested that the state establish relevant evaluationcriteria for the listing of drugs before, in order to improve the quality ofreporting.2. For adverse reactions causality criteria, are expert judgment method ofcausation determination as a method to " Chinese medicine clinical researchguidelines,"2002edition," adverse drug reaction reporting and monitoringmanagement approach" is more commonly used version of the2011. But in Chinesemedicine clinical trials need to be strengthened test designers, professionalresearchers adverse understanding causality criteria should be combined withthe actual reasonable choice.3Currently adverse reactions to the diagnosis of multiple signs and symptomsdiagnosis based, supplemented by laboratory abnormality diagnosis. Researchersare encouraged to try to carry out clinical trials in disease diagnosis basedon symptoms, signs, abnormal laboratory values. For some subtle, adversereactions is not easy to determine, should strengthen monitoring efforts andtimely follow-up, analyze the causes and improve safety in patients taking thedrug.