Baseline Model Combination Of Antibiotics And Open Spirit In Qing Injection Adr Signal Detection, The Application Of Research

Objective:Since Traditional Chinese Medicine Injection (TCMI) used in the clinical application, we found that drug combination are universal existed to enhance drug effect, improve cure rate and increase an alternative treatment for the same kinds of diseases. In order to correctly combine drug and reduce the risk of adverse events in clinical applications, we quote the baseline model to mine the risk Adverse Drug Reaction (ADR) signals of TCMI and to promote the progress of the existing mine risk signal methods, only for provide new ideas and a powerful reference of TCMI in the future.Methods:We retrieval the ADR case report literatures of TCM which have been published, and use baseline model to mine the ADR signals of TCMI and screen preliminarily the high risk signals of "Drug A-Drug B and adverse reaction C" combination. With the log-linear regression and linear regression statistically testing suspicious risk signals which have been screened in baseline model, we obtain the exact risk signals of TCMI. We adopt PRRs to mine the ADR signals of TCMI. Then use Kappa consistency check to tests the difference of baseline model (including multiplicative model, additive model), ensure the accuracy and stability of two models, the same to the analysis results of the two research methods are compared by relevant statistical methods.Results:(I) Baseline model and the statistical analysis showed that there are62cases suspicious ADR risk signals, after the statistical analysis find four statistical risk signals groups of "Drug A,-Drug B and ADR" as Qingkailing Injection-Cefotaxime and Shivering, Qingkailing Injection-Cefuroxime and Diarrhea,"Qingkailing Injection-Clindamycin and Hematuria, Qingkailing Injection-penicillin sodium and Pruitus.(II) McNemar test calculations no statistics difference between the two baseline model, and X2=0.1538, P=0.6949, kappa=0.672, it means that the filter results is consistent. The result of McNwmar test is the same to baseline model and PRR, X’=0.200, P=0.6547, kappa=0.4285.Conclusions:With research results under this subject show that the results of detection of the baseline model could use objective risk value and have a superior explain from a public health perspective. At the same time the result of additive model and multiplicative model have a good consistency. The use of signal detection could early mine signals and Contribute to find possible drug safety issues in the early period from a number of adverse reaction data.