OBJECTIVETo explore the clinical efficacy of ulcerative colitis with spleen and kidney yang deficiency by kuijiening plaster and the impacts on IFN-gamma and IL-4 contents, as well as make the comparison with oral medication of sulfasalzine (SASP).

METHODSSixty patients of ulcerative colitis with spleen and kidney yang deficiency were randomized into a Kuijiening plaster group, a SASP group and a combined therapy group, 20 cases in each one. In the Kuijiening plaster group, Kuijiening plaster and oral administration of placebo SASP were applied. The plaster was used at Shangjuxu (ST 37), Tianshu (ST 25), Zusanli (ST 36), Mingmen (GV 4) and Guanyuan (CV 4). In the SASP group, was applied Kuijiening plaster placebo at the points and SASP oral administration was adopted. In the combined therapy group, Kuijiening plaster and SASP oral administration were given. The duration of treatment was 60 days. The follow-up visit was 2 months after treatment. The comprehensive efficacy, the efficacy on TCM syndrome and the changes in serum IFN-gamma and IL-4 before and after treatment were compared among the three groups.

RESULTSThe efficacy on TCM syndrome in the Kuijiening plaster was similar to the SASP group [85.0% (17/20) vs 75.0% (15/20), P > 0.05]. The efficacy on TCM syndrome in the Kuijiening plaster group was superior to the western medicine group [80.0% (16/20) vs 60.0% (12/20), P < 0.05]. The total effective rate of the comprehensive efficacy in the combined therapy group was 95.0% (19/20) and that of TCM syndrome efficacy was 90.0% (18/20), which were all superior to the other two groups (all P < 0.05). The differences in serum IFN-gamma and IL-4 were statistically significant before and after treatment in all of the three groups (all P < 0.05). The treatments in the three groups reduced serum IFN-gamma content and increased serum IL-4 content. The results in the Kuijiening plaster group were superior to the SASP group (P < 0.05) and the results in the combined therapy group were superior to the other two groups (all P < 0.05).

CONCLUSIONKuijiening plaster is effective in the treatment of ulcerative colitis of spleen and kidney yang deficiency, which is not inferior to that of SASP. The efficacy of kuijiening plaster on relieving TCM syndrome and improving body immunity is much superior to SASP. The effect is much better with SASP combined in the treatment.