Immuno-modulatory effect of somatostatin combined with traditional Chinese medicine on severe acute pancreatitis at early stage: A randomized control trial

OBJECTIVE: To evaluate the immuno-modulatory effect of short course administration of somatostatin (stilamin) continuously at early stage in patients with severe acute pancreatitis (SAP). METHODS: Thirty-nine patients with SAP (22 men, 17 women; the middle age was 49 years)were randomly allocated into control group (20 patients treated with non-surgical integrated traditional Chinese and Western medicine) and treatment group (19 patients treated with somatostatin administered intravenously at a dosage of 250 mug/h for consecutive 72 hours as well as the treatment for the control group). Laboratory parameters, including the expressions of CD(3), CD(4) and CD(8) in lymphocytes (tested by flow cytometry) and C reactive protein (CRP), and indexes of therapeutic effect, including the occurrence of organic dysfunction, local complication and mortality between the two groups were compared. Another group of 30 healthy volunteers (19 men, 11 women; the middle age was 47 years) were recruited for testing the normal levels of CD(3), CD(4) and CD(8). RESULTS: (1) The levels of CD(3), CD(4) and CD(4)/CD(8) in lymphocytes before treatment in both groups were significantly lower than those in the healthy subjects (P<0.05), but there were no statistical differences between the two groups. At the 4th day, CD(3), CD(4) and CD(4)/CD(8) increased significantly in the treatment group (P<0.05) while no changes in the control group; the levels of CD(4) and CD(4)/CD(8) in the treatment group were also higher than those in the control group (P<0.05). (2) The CRP levels of the 2 groups showed no statistical difference before and 4 days after the treatment, but the CRP level in the treatment group was significantly lower than that in the control group at the 7th day (P<0.05). WBC count, serum levels of amylase, lipase, lactate dehydrogenase, aspartate aminotransferase, as well as the score of APACHE II in the treatment group recovered more quickly than those in the control group (P<0.05). (3) The occurrences of organic dysfunctions, local complications and mortality in both groups were not statistically different. CONCLUSION: The short course administration of somatostatin continuously at early stage can reduce the inflammatory response, up-regulate the cell immune function and improve the conditions of the patients with SAP, but its effect on mortality and morbidity needs further study.