Objective:To investigate the clinical efficacy and drug safety of the Tiaoshu Huayu Formula in the treatment of pul-monary nodules in patients with blood stasis constitution.Methods:60 patients with pulmonary nodules and blood stasis constitution were selected and divided into the treatment group and the control group according to different treatment methods,with 30 cases in each group.The treatment group was treated with the Tiaoshu Huayu Formula for a treatment period of 3 months,while the control group re-ceived no intervention.Results:Between-group comparison showed that the total effective rate of pulmonary nodules in the treatment group was 33.33%,and the significant improvement rate of TCM syndrome was 66.67%,both of which were superior to those in the control group,with significant differences(P<0.01).Within-group comparison showed that after treatment,the diameter and cross-sec-tional area of pulmonary nodules decreased,and the syndrome score of blood stasis constitution reduced,with significant differences(P<0.01).Multivariate ordinal Logistic regression analysis indicated that disease duration,gender,and the nature of pulmonary nod-ules had significant effects on the therapeutic effect(P<0.05).Drug safety evaluation demonstrated that the Tiaoshu Huayu Formula had good safety.Conclusion:The Tiaoshu Huayu Formula can improve the symptoms related to blood stasis constitution in patients with pulmonary nodules,reduce the area of some pulmonary nodules,and has good safety.