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目的观察益气解毒祛瘀方联合沙利度胺治疗白塞病的临床疗效及安全性。方法将40例气虚瘀毒证白塞病患者随机分为对照组(20例)、治疗组(20例),对照组采用沙利度胺(50 mg/d)治疗,治疗组在对照组治疗基础上同时内服中药益气解毒祛瘀方。疗程均为3个月,观察两组治疗前后临床表现、口腔溃疡发作频次、口腔溃疡间歇时间、血沉(ESR)、C-反应蛋白(CRP)及治疗中不良反应情况。结果治疗组总有效率为95.00%,对照组为85.00%,两组临床疗效比较差异有统计学意义(P<0.05);两组治疗前后口腔溃疡发作情况、炎性指标ESR、CRP水平均有明显改善(P<0.05),治疗后治疗组口腔溃疡间歇时间明显长于对照组(P<0.05),ESR低于对照组(P<0.05);治疗组不良反应发生率为5%,明显低于对照组35%(P<0.05)。结论益气解毒祛瘀方联合沙利度胺治疗白塞病有较好临床疗效,可明显降低血沉及延长口腔溃疡间歇时间,且安全性好。
Objective To observe the clinical efficacy and safety of Yiqi Jiedu Quyu Decoction combined with thalidomide in the treatment of Behcet’s disease. Methods Forty patients with Behcet’s disease were randomly divided into control group (n = 20) and treatment group (n = 20). Patients in control group were treated with thalidomide (50 mg / d) On the basis of oral administration of traditional Chinese medicine qi detoxification stasis side. The course of treatment was 3 months. The clinical manifestation, frequency of oral ulcer attack, oral ulcer intermittent time, erythrocyte sedimentation rate (ESR), C-reactive protein (CRP) and adverse reactions were observed before and after treatment. Results The total effective rate was 95.00% in the treatment group and 85.00% in the control group, with significant difference in clinical curative effect between the two groups (P <0.05). The incidence of oral ulcer and the ESR and CRP levels of inflammatory index in both groups before and after treatment were (P <0.05). The intermittent time of oral ulcer in the treatment group was significantly longer than that in the control group (P <0.05), and the ESR was lower in the treatment group than in the control group (P <0.05). The incidence of adverse reactions in the treatment group was 5% The control group 35% (P <0.05). Conclusions Yiqi Jiedu Quyu Decoction combined thalidomide treatment of Behcet’s disease has a better clinical efficacy, can significantly reduce erythrocyte sedimentation and prolonged oral ulcer intermittent time, and good safety.