Objective,2,To evaluate the safety of supranormal dose of scutellaria barbata and hedyotis diffusa in the treatment of malignant tumor.,Methods,2,A retrospective cohort study was conducted in this study in which 535 patients with malignant tumor were continuously enrolled， including 365 patients in exposure group and 170 patients in non-exposure group. All drugs and adverse events were recorded in detail in the study time window.The adverse event OR values between the exposed group and the non-exposed group were compared. The cumulative exposure values was calculated by weighting the dosage and time of taking medicine， and the incidence of adverse events among different cumulative exposure values in the exposure group was compared.,Results,2,Because of the confounding factors between the two groups， propensity score matching method was further used for 2：1 matching in order to make the baseline data of the two groups relatively balanced.After matching， the difference was not statistically significant between the exposed group and the non-exposed group（,OR,=1.25，95% ,CI, 0.63~2.47，,P,>,0.05）. In the exposure group， with the increase of cumulative exposure， the incidence of adverse events increased（,χ,2,=18.544，,P,<,0.001）. The incidence of adverse events in the high cumulative exposure group was significantly higher than that in the low cumulative exposure group.,Conclusion,2,The data in this study could not support the evidence that supranormal dose of scutellaria barbata and hedyotis diffusa may induce more adverse events in treating malignant tumors.However， the risk of abnormal liver function and gastrointestinal discomfort may be caused by ultra-large dosages and long-term use.