OBJECTIVE：To compare cli nical effect and safety of different doses of Xuebijing injection combined with Ulinastatin injection in the treatment of sepsis complicated with acute lung injury （ALI）. METHODS ：Totally 115 patients diagnosed as sepsis complicated with ALI were collected from Jul. 2015 to Nov. 2019 in intensive care unit of our hospital. According to therapy method ，the patients were divided into control group （26 cases），low-dose group （29 cases），medium-dose group（30 cases），high-dose group （30 cases）. The control group received Ulinastatin injection 300 thousands u intravenously ，q8 h， for consecutive 5 days，on the basis of routine treatment. On the basis of control group ，low-dose group additionally received intravenous drip of Xuebijing injection 50 mL，bid，for consecutive 7 days；medium-dose group additionally received intravenous drip of Xuebijing injection 100 mL，bid，for consecutive 7 days；high-dose group additionally received intravenous drip of Xuebijing injection 100 mL，qid，for consecutive 7 days. The serum inflammatory factors （IL-6，TNF-α，CRP），respiratory function indexes （PaO2，PaO2/FiO2，ELWI）and related scores （APACEⅡ score and SOFA score ）were compared among 4 groups before and after treatment ，and mechanical ventilation time ，ICU hospitalization time ，28-day mortality rate and adverse reactions during the treatment were recorded. RESULTS ：Before treatment ，there was no statistical significance in serum inflammatory factors，respiratory function indexes or related scores among 4 groups（P＞0.05）. After treatment ，serum inflammatory factors ， ELWI and related scores of 4 groups were decreased significantly ；the low-dose ，medium-dose and high-dose groups were significantly lower than the control group ；the high-dose group was significantly lower than the low-dose and medium-dose groups （P＜0.05）. PaO 2 and PaO 2/FiO2 of 4 groups were increased significantly ，compared with before treatment ；the low-dose ， medium-dose and high-dose groups were significantly higher than the control group ；the high-dose group was significantly higher than the low-dose and medium-dose groups （P＜0.05）. The mechanical ventilation time and ICU hospitalization time in the low-dose，medium-dose and high-dose groups were significantly shorter than control group （P＜0.05），but there was no statistical significance in above indexes among different doses groups （P＞0.05）. There was no statistical significance in 28-day mortality among 4 groups（P＞0.05），and no serious adverse reactions were found. CONCLUSIONS ：Different doses of Xuebijing injection combined with Ulinastatin injection could effectively decrease the level of serum inflammatory factors in patients with sepsis complicated with ALI ，improve lung function and relieve the degree of organ failure ；after combined with high-dose Xuebijing injection，the therapeutic effect is more obvious and does not affect the treatment safety.