Objective To explore effects and clinical efficacy of breviscapine on inflammatory factors and coagulation function in patients with septic acute lung injury (ALI). Methods A total 84 patients with ALI caused by sepsis were assigned to the control group, the low-dose breviscapine group (low-dose group) and the high-dose breviscapine group (high-dose group) according to random digital table, with 28 cases in each group. The control group was treated with conventional Western medicine. The low-dose group was additionally given breviscapine injection (20 mg, one time/d) on the basis of the control group, and the high-dose group was additionally given breviscapine injection (40 mg, one time/d) on the basis of the control group. The three groups were treated for 2 weeks. The clinical efficacy were evaluated in the three groups. Traditional Chinese medicine (TCM) syndrome scores, oxygenation index (PaO2/FiO2), interleukin (IL) -6 and tumor necrosis factor- α (TNF- α) levels, prothrombin time (PT), activated partial thromboplastin time (APTT) and platelet count were compared before and after two weeks of treatment between the three groups. Drug-related adverse events during treatment were recorded in each group. Results The clinical efficacy and total effective rate were better in the low-dose group and the high-dose group compared with those of the control group (P<0.05). After treatment, the TCM syndrome score and levels of IL-6 and TNF-α were decreased than those before treatment in the three groups (P<0.05), and the control group, the low-dose group and the high-dose group were decreased successively. After treatment, PT and APTT were prolonged compared with those before treatment in the three groups, and the control group, the low-dose group and the high-dose group were prolonged successively (P<0.05). After treatment, PaO2/FiO2 and platelet count were increased compared with those before treatment in the three groups, and the control group, the low-dose group and the high-dose group were increased successively (P<0.05). There were no severe adverse drug events during the treatment in the three groups. Conclusion Breviscapine can significantly improve the coagulation dysfunction in sepsis, reduce the abnormal consumption of platelets, inhibit inflammatory response, and has a relatively definite clinical effect on patients with sepsis-induced acute lung injury. [ABSTRACT FROM AUTHOR]