To study the efficacy of long-term methotrexate (MTX) in the treatment of ulcerative colitis (UC) with azathioprine (AZA) ineffective intervention.

Ninety-two patients with UC ineffective in the treatment of AZA, were randomly divided into two groups, forty-six cases in each group. The control group was given intramuscular injection of MTX for one year. The control group was treated with placebo for half a year after having finished intramuscular injection of MTX for six months. We Compare the differences of clinical efficacy in two groups, and analyze the level of hemoglobin (HB), albumin (ALB), blood sink (ESR), C-reactive protein (CRP), platelet (PLT) in two groups, and learn the incidence of adverse reactions in the two groups.

There was no significant difference in clinical curative effect between the two groups after six months (χ²=0.045; P>0.05).The total effective rate in the observation group after one year was higher than that for six months and that in control group (χ² = 11.683 and 17.692 respectively; P<0.05). The levels of HB and ALB were increased, and CRP, ESR and PLT were decreased during the treatment (t=4.181, 4.599, 10.789, 16.959, 62.326, 7.950, 9.756, 22.270, 23.002, 75.209, 3.637, 5.180, 16.339, 9.553, 11.515 respectively; P<0.05).The levels of HBsAg and ALT were significantly higher in the control group than those before treatment, and the levels of CRP, ESR and PLT were significantly lower than those before treatment (t=4.465, 4.405, 10.743, 17.248, 61.852, 3.942, 3.321, 9.670, 15.893, 60.567 respectively, P<0.05).There was no significant difference between the six months of treatment and the treatment for 1 year (t=0.496, 1.150, 1.200, 0.233, 0.312 respectively, P>0.05). After 1 year of treatment, HB and ALB in the observation group were significantly higher than those in the control group, CRP, ESR and PLT were significantly lower than those in the control group (t=3.893, 6.240, 17.009, 9.971, 11.662 respectively, P<0.05). There was no significant difference in the incidence of adverse reactions between the two groups (χ²=1.848, P>0.05).

MTX treatment of UC, which is ineffective in the treatment of azathioprine (AZA), can improve the nutritional status of the body, coagulation function, and reduce the body′s inflammatory response. It can control the disease and has high safety with a good clinical value.