The Establishment And Application Of Case Reports Analysis System For Adverse Drug Reactions Of Traditional Chinese Medicine

ObjectiveTo promote the information exploitation degree and standardization of adverse drug reactions (ADR) case reports of traditional Chinese medicine (TCM), to analysis ADR case reports of TCM rapidly, the case reports analysis system for ADR of TCM was built to solve the problem of the insufficient of the exiting ADR reporting system of China. To discuss and compare differences of various measures of quantitative signal detection and their applications in the ADR case reports database of TCM.MethodsBy means of computer technology of Php and Mysql, the ADR case reports database of TCM were created with the ADR case reports of TCM. The relevant standard terminology databases were created with the WHO Adverse Reactions Terminology(WHOART), International Classification of Diseases-Ten Revision(ICD-10) and the Web database of drug information of SFDA. Based on the mentioned databases the functional modules were designed which including data-revise, data-query, statistical analysis, ADR signal detection, case-control study, data management, user and authorization management module. The case reports analysis system for ADR of TCM was built with mentioned functional modules and databases.The information of case reports were filtered and matched with the data of relevant standard terminology databases, and normalize by the built data-revise module. The rules of standardization was created. The statistical analysis of existing case reports were conducted by the statistical analysis module. Base on the dataset of the ADR case reports of TCM, the applications of various measures of quantitative signal detection were discussed and compared by the built ADR signal detection modules.The applicability of.the ADR case reports of TCM was analysised and evaluated further.ResultsThe case reports analysis system for ADR of TCM can be operated simple and applied flexible, with functions of data classification search, automatic data-standardize, flexible statistical outputs, and automatic signal detection. The information of case reports were normalize by the built system.3849rules of ADR name and2210rules of disease name were established.3092rules of generic drugs name were created. A comprehensive statistical analysis of the existing ADR case reports of TCM was carried out to view the distribution of data attributes. The distribution of ADR and drugs was analysised in detail. Rash, anaphylactoid reaction and pruritus are the most frequently reported ADR. Shuanghuanglian injection, Qingkailing Injection and acanthopanax injection are the most frequently reported drugs which the proportion of the reported numbers is more than a third of the total reported number. The results of the signal detection were analysised which include8179Drug-ADR combinations from "all drugs" dataset,22557Drug-ADR combinations from "drug combination" dataset and6344Drug-ADR combinations from "main suspected drug" dataset. The results of various methods of the quantitative signal detection based on the database of ADR case reports of TCM were diffierent but comparable. The recognized ADR signals (hypertension caused by shengmai injection, renal failure acute caused by lianbizhi injection and renal function abnormal caused by lianbizhi injection) were detected effectively by the combined applications of various signal detection measures. ConelusionThe development of the data analysis system based on the ADR case reports of TCM is a effective method which can sift, evaluate and analysis a huge quantity of ADR case reports of TCM with the characteristics of systematic, automatic and simple operated. The built system make the analysis of the information of ADR of TCM more easy and more deep than traditional pharmacovigilance methods. The system can be used to provide better services to explore ADR precaution signals of TCM, promote the efficiency of the monitoring and evaluted benefit and risk of TCM.