| Objective: To observe the clinical efficacy and safety of TCM decoction prepared by Qinghesanjiao method in the treatment of dampness-heat connotation and toxic-stasis interknot type of Behcet’s disease(BD).Methods: Sixty patients with Dampness-heat connotation and toxic-stasis interknot type of BD conforming to relevant diagnostic criteria were included and randomly divided into control group and treatment group,with 30 cases in each group.The control group was treated with thalidomide tablets,and the treatment group was treated with thalidomide tablets plus TCM decoction.The treatment course of the two groups was 12 weeks.The excellence of the two treatment schemes was evaluated by comparing the laboratory indexes,scores of TCM symptoms and signs,changes of TCM syndrome effective rate and safety indexes of the two groups of patients before and after treatment.Results:1.The general information,laboratory indicators and scores of TCM symptoms and signs before treatment were compared between the two groups,and there were no statistical differences(P > 0.05),indicating comparability.2.After treatment,erythrocyte sedimentation rate(ESR)and C-reactive protein(CRP)could be effectively reduced in both groups(P<0.01),but the reduction was more significant in the treatment group than in the control group(P<0.01).3.The scores of symptoms and signs in the treatment group were improved after treatment compared with those before treatment(P < 0.05).After treatment,the scores of symptoms and signs of oral and genital ulcers,eye lesions,skin lesions,joint swelling and pain,chest distention,irritability,tongue and pulse in control group were significantly improved compared with before treatment(P < 0.05),while foul breath and abnormal bowel movements were not significantly improved(P > 0.05).4.After treatment,the scores of symptoms and signs in the two groups were compared,and the scores of oral and genital ulcers,skin lesions,joint swelling and pain,chest distention,tongue and pulse were improved better in the treatment group than in the control group(P < 0.05),while there was no statistical difference in the scores of eye lesions,foul breath,abnormal bowel movements,and irritability(P > 0.05).The effective rate of TCM syndrome in the treatment group(93.10%)was significantly better than that in the control group(71.43%),with statistical difference(P < 0.05).5.In the course of treatment,the two groups were safe.In the treatment group,1 case showed slight increase of alanine aminotransferase(ALT)and aspartate aminotransferase(AST),while in the control group,1 case showed obvious increase of ALT and AST,which gradually recovered after the addition of hepatoprotective and enzyme-lowering drugs.The incidence of side effects in the treatment group(6.90%)was significantly lower than that in the control group(25.00%),and there was no statistical difference(P >0.05).Conclusion: The combination of Qinghesanjiao formula and thalidomide tablets is safe and effective in the treatment of dampness-heat connotation and toxic-stasis interknot type of BD,which has better effects in improving clinical symptoms and signs,reducing inflammatory response and disease activity than the treatment of thalidomide tablets alone. |