Objective To explore the efficacy and potential mechanism of Shenfu Injection（ 参附注射液） in treating intestinal mucosal barrier dysfunction in sepsis. Methods One hundred and sixteen patients with sepsis and intestinal mucosal barrier dysfunction were randomized into a control group and a treatment group

with 58 cases in each group. Both groups were given routine western medicine treatment

and in addition to the routine western treatment

the treatment group was given 60 ml of Shenfu Injection through intravenous infusion once a day for 2 weeks.The levels of intestinal fatty acid binding protein（ I-FABP）

soluble CD14 subtypes

malondialdehyde（ MDA） and superoxide dismutase（ SOD） in both groups were measured before treatment and on the 7 th day and the 14 th day after the first treatment

and the patients’ acute physiology and chronic health status scores（ APACHE） II and 28-day survival status were observed. Results On the 7 th day and the 14 th day after first treatment

the levels of I-FABP

soluble CD14 subtypes and MDA in the two groups were lower than those before treatment

while the level of SOD increased significantly（ P < 0. 05）

and the improvement on the 14 th day was better than that on the 7 th day（ P <0. 05）. On the 7 th day and the 14 th day after first treatment

serum levels of I-FABP

soluble CD14 subtypes and MDA were lower

and the SOD activity was higher in the treatment group than those in the control group（ P < 0. 05）.The 28-day survival rate in the treatment group was 77. 58%（ 45/58）

which was significantly higher than that in the control group（ 58. 62%

34/58）（ χ2= 4. 802

P = 0. 028）. The serum level of I-FABP in patients with sepsis were positively correlated with APACHE II score（ r = 0. 243

P = 0. 009）. Conclusion Shenfu Injection combined with routine western medicine treatment may be more effective than routine western medicine treatment in sepsis patients with functional impairment of intestinal mucosal barrier. This combination treatment could reduce the serum levels of I-FABP

soluble CD14 subtypes

and MDA

and increase SOD activity

thereby reducing mortality rate.