OBJECTIVETo investigate whether ulinastatin can alleviate the side effect in patients with gastrointestinal cancer undergoing adjuvant chemotherapy,and to explore the probable mechanism of its protective efficacy.

METHODSForty consecutive patients with gastrointestinal cancer who underwent surgical operations from May 2004 to October 2004 were recruited. The patients were randomly divided into therapeutic group and control group, receiving ulinastatin 150,000 U per day or 250 ml hydrochloric sodium before chemotherapy for 5 continuous days respectively. The prevalence of side effects and the levels IL-6 and TNF-alpha were compared between the two groups.

RESULTSThere were no differences in the clinicopathological characteristics between the two groups. The prevalences of white blood cell decline (41.2% versus 13.1%), pigmentation (23.5% versus 4.3%), baldness (17.6% versus 4.3%) were higher in the control group than those in therapeutic group (all P< 0.05). In therapeutic group, IL-6 level was significantly decreased after ulinastatin treatment, but not in the control group while the levels of TNF-alpha were not changed in the both groups.

CONCLUSIONUlinastatin can reduce the common side effects of chemotherapy, and the mechanism may be associated with the decrease of IL-6.