The Programming And Application Of Analysis System For Traditional Chinese Medicine Adverse Drug Reactions

Purpose: In order to strengthen the monitoring of traditional Chinese medicine's adverse drug reactions (ADR) , promote the standardization and the information availabiliy of the existing ADR data, and because of problems and insuffierency of China's ADR reporting system, the ADR data processing system for traditional Chinese medicine should be established. According to the needs of the grassroot monitor organization routine work on analyzes.evaluation and feedback, the system should posses functions of monitor information assistance, data automatic standard,nimble statistical output.Method: Cases of the traditional Chinese medicine ADR of Shandong province were abstracted, and the traditional Chinese medicine ADR database was built by means of the Microsoft Access database technology. ADR terminology standard database based on WHO, the drug's standard nomenclature database, the enterprise name standard database and the medical institution standard database were established. Linked with standard databases above, the data of ADR cases reported was standardized. The traditional Chinese medicine ADR data analysis system which includes the data standardized module, the retrieval module, the statistical module, the analysis module was programmed. In this system, the ADRs could be retrieved and analysed automatically remainning the primitive data unchanged.The ADR cases of traditional Chinese medicine in 2003-2005 collected from Shandong Province had been analysized to evaluate the serviceability of this analysis system.Result: The traditional Chinese medicine ADR data analysis system which includes the data standardized module, the retrieval module, the statistical module, the analysis module was programmed.The traditional Chinese medicine ADR data analysis system which could standardize, analyse the ADR data automatically was designed. The Chinese traditional medicine ADR database in 2003-2005 was contained in this system and the ADR information about Shandong province could be provided. With this system, the data analysis efficiency in ADR monitoring and the ability to find pharmacovigilance signal was greatly enhanced. Carried on the analysis using the system to the database content, the ADR caused by the injection of traditional Chinese medicine was in the forefront. Among this, the percentages of Shuanghuanglian injection and Herba Houttuyniae injection are 11.13% and 8.32%, respectively, and the serious ADR cases have achieved 10. In the serious ADR, the allergic reaction was primarily. Shuanghuanglian injection and Herba Houttuyniae injection caused 2 death cases. From the data, it is obvious that the ADR was caused by the same batch.Conclusion: The traditional Chinese medicine ADR data analysis system which contains of the traditional Chinese medicine ADR cases in 2003-2005 from Shandong province and posses the function of retrieval, statistics and analysis was built. This analysis system filled up the deficiency of the current ADR report software and the reports. It has provided the specialized standard database such as the ADR terminology, the drug name, the production enterprise name etc. The analysis system focuses on the group events and problems in the enterprise. It affords advantage to discover the pharmacovigilance signal effectively, carry out the key monitoring, reducing the serious events, maintain the safety in medication. This analysis system has the advantage of little volume, low costs, maintaining easily and updating quickly. Evaluating the traditional Chinese ADR data of Shandong province with this system, the pharmacovigilance signal of the injection of traditional Chinese is obvious.