Research Of Text-based Active Monitoring Technology For Allergic ADE And Module Development

Background:Adverse drug reaction monitoring plays the key role of drug safety surveillance in post-market drug assessment. Automatic monitoring, as a new method of drug post-market drug safety research, has a good development prospects. The hospital ADE automatic monitoring system that is developed by PLA General Hospital has achieved remarkable results in lab-results reuse. But the system was in need of further development of extracting comprehensive clinical information from unstructured clinical notes in electric health records.Objective:The purpose of our work was to resolve the technical problems in text-based allergic reaction active monitoring and develop a module of allergic reaction discovery for the system. In order to improve the efficiency of medical data utilization, standardizing operating procedures was also an important part of the research.Methods:(1) Exploring naturel language processing technology for text-based ADE automatic monitoring. In order to build the module for skin allergic reaction and module for allergic shock, we established lexicons and annotated corpora, and trained the automatic record classifier.(2) For multi-center drug evaluation research application, combining pre-work basis with practice experience, we developed automatic monitoring system standardized operation process, and drawn the flow chart.(3) On the basis of the above study, we applied the system on automatic monitoring practice of roxatidine hydrochloride acetate for injection, containing thrombocytopenia, hemoglobin reduction, leukopenia, liver damage, renal impairment, trypsin abnormalities, skin allergic reaction, allergic shock and arrhythmia.Results:(1) The developed allergic reaction module followed the automatic monitoring system and achieved the design requirements. In the following module testing process, we got the real world incidence of ceftriaxone induced skin allergic reaction (0.33%) from 14042 drug users and haemocoagulase agkistrodon induced skin allergic reaction (0.065%) from 13818 drug users. And we got the incidence of tanshinone ? A induced systemic anaphylaxis (0.025%)from 11969 drug users, cinepazide induced systemic anaphylaxis form 11281 drug users and ceftriaxone induced systemic anaphylaxis form 25280 drug users(2) Developed a standardized operation process for the automatic monitoring system, and finished a detailed monitoring flow chart.(3) Finished the drug safety research of 9284 cases roxatidine user, the real world incidence of ADRs were liver damage (0.93%-1.04%), hemoglobin reduction (0.20%-0.23%),leukopenia (0.13%-0.15%), thrombocytopenia (0.11%-0.12%), renal impairment (0.28%),trypsin abnormalities (0.01%), skin allergic reaction (0.05%), arrhythmia (0.08%). The total incidence was 1.79% (95%CI: 1.62%-2.06%). None allergic shock was detected in this research. The results indicated that the overall risk of roxatidine was small under the clinical guideline, but the duration of medication and the age of patients were ADR risk factors that should be concerned.Conclusions:The text classification performance of the bayesian network and the decision tree classification used in the monitoring module were good and met the needs drug safety active monitoring. And the sensitivities and accuracy of skin allergens detection reached a high level. The standardized operation process reduced the difficulty of using the system and ensured the stability of the research results quality and contributed to real-world drug safety assessment in large sample.