| The clinical safety research on post-marketing medicines should carry out the multi-dimensional design of the real world study, and fully consider the data, evidence from multiple sources, and fully consider the evidence integration. This paper reported the clinical safety research design of Xianling Gubao capsule, reported the analysis of spontaneous reporting system data, hospital information system data, and literature data. Through the integration of safety data and evidence, it was found that the general ADR of Xianling Gubao capsule is mainly gastrointestinal system damage, which is manifested as nausea, vomiting, dry mouth, constipation and diarrhea, etc.; serious ADR is mainly manifested in liver and gall system damage, which is manifested in liver function abnormality, liver enzyme elevation, liver cell damage, etc.; anaphylaxis is sometimes manifested in general ADR, sometimes in serious ADR; liver function abnormality has gender difference, and the proportion of women is on the high side; liver function abnormality occurs in 3～7 days, 15 days and two peak periods, suggesting that there may be different pathogenesis. Nausea, vomiting and gastric dysfunction are the ADR warning signals of Xianling Gubao capsule. The paper further discussed the support of retrospective data for prospective research design, initially clarified the advantages and disadvantages of the main data sources in the security real world multi-dimensional research design, and analyzed the complementarity between the data and the timing of the corresponding research from the perspective of security evidence. |
