Construction of the safety evaluation platform related to formula-medicine dose in TCM / 中国药学杂志

ABSTRACT

OBJECTIVE: To put forward a method of construction of the safety evaluation platform related to formula-medicine dose of TCM because of the lack of the dose-effect relationship research and the insufficient of safety monitoring in Chinese medicine. METHODS: Under the guidance of Chinese medicine theory, an ADR (adverse drug reaction)/ADE (adverse drug event) monitoring scale with TCM characteristics was developed based on patients reporting, thus to promote positive and prospective evaluation researches related to formula-medicine dose. On the basis of the ADR/ADE data base, the safety monitoring module will be formed then. RESULTS AND CONCLUSION: The safety evaluation platform related to formula-medicine dose is supposed to be structured.