| Objective: The combined treatment of self-prepared traditional Chinese medicine enema and mesalazine sustained release granules(Adisha)was selected to compare with Adisha alone in the treatment of ulcerative colitis(UC)patients,and to observe its clinical efficacy,providing a new idea for the future clinical treatment of ulcerative colitis(UC).Methods: Using random number table method,64 patients included in the clinical trial were divided into treatment group and control group,with 32 patients in each group.The treatment group was given self-made traditional Chinese medicine enema combined with mesalazine sustained release granules(Adisha)integrated traditional Chinese and western medicine,while the control group was given Adisha alone.After the 12-week course of treatment,the efficacy of the two groups was evaluated and compared from both traditional Chinese medicine and western medicine,and the improvement of the quality of life of patients in the two groups was evaluated.Results:(1)Evaluation of single symptom efficacy: T test showed that both treatments could improve the main symptoms of the patients’ clinical manifestations(P < 0.05),but the efficacy of self-prepared traditional Chinese medicine enema combined with Aditha combined with traditional Chinese and western medicine in mucous pus,blood stool and acute diarrhea was better than that of Aditha alone.(2)Evaluation of TCM syndromes efficacy: The efficacy of TCM syndromes in the treatment group was better than that in the control group by rank sum test(P < 0.05).The total effective rate of the treatment group was higher than that of the control group(P <0.05)by chi-square test.It indicates that the efficacy of self-prepared traditional Chinese medicine enema combined with Adisha combined with traditional Chinese and western medicine in the treatment of UC patients with colonic dampness-heat syndrome is better than that of Adisha alone.(3)Clinical efficacy evaluation: The clinical efficacy of the two programs was evaluated by comparing the clinical remission rate,clinical effective rate,endoscopic response rate and mucosal healing rate after treatment between the two groups.The chi-square test showed that the clinical efficacy of the treatment group was better than that of the control group(P < 0.05).It is suggested that the self-designed Chinese medicine enema combined with Aditha combined with traditional Chinese and western medicine treatment scheme can more effectively improve the clinical efficacy of UC patients with colonic dampness-heat syndrome than the use of Aditha alone.(4)Quality of life: The IBDQ scale was used to score patients’ quality of life before and after treatment,so as to evaluate the improvement of patients’ quality of life.By t test,the score of this item was increased in both groups after treatment(P < 0.05).However,the increase rate in treatment group was significantly higher than that in control group(P <0.05).The results indicated that the self-designed Chinese medicine enema combined with Aditha combined with traditional Chinese and western medicine could improve the quality of life of UC patients with colonic dampness-heat syndrome more significantly than the treatment of Aditha alone.Conclusion: Compared with Adisa alone,both self-designed TCM enema combined with Adisa can improve the clinical symptoms of patients with UC colonic dampness-heat syndrome,achieve good clinical efficacy,and improve the quality of life of patients.However,the former has obvious advantages in the evaluation of various indicators,and no adverse events occurred during the trial.The results indicated that the self-prepared traditional Chinese medicine enema is safe and effective in the clinical treatment of UC(dampness-heat syndrome of large intestine),and the combination with western medicine has a better effect. |