加减丹栀逍遥散和阿维A胶囊随机对照治疗寻常型银屑病肝经郁热证的疗效观察

Efficacy of Modified Danzhixiaoyaosan(丹栀逍遥散)and Acitretin Capsules in Treating Psoriasis Vulgaris with Ganjingyure(肝经郁热)Syndrome:A Randomized Controlled Trial

目的:观察加减丹栀逍遥散和阿维A胶囊随机对照治疗寻常型银屑病肝经郁热证的临床疗效。方法:210例患者采用随机数字表法随机分为3组,各70例。中药组给予加减丹栀逍遥散,西药组给予阿维A胶囊,联合组给予加减丹栀逍遥散联合阿维A胶囊,疗程4周。分析3组临床指标,血清和皮损组织中CD4+T淋巴细胞亚群百分比、生长因子、炎性指标的差异。比较3组临床疗效、复发率及安全性。结果:联合组总有效率为98.6%,高于中药组的82.1%(P<0.05)和西药组的80.3%(P<0.05)。与治疗前比较,中药组和联合组治疗后银屑病皮损面积及严重性指数(PSAI),皮肤病生活质量指数(DLQI),皮损厚度,中医证候评分、Th1、Th17、Th22、神经生长因子(NGF)、转化生长因子-β1(TGF-β1)、血管内皮生长因子(VEGF)、降钙素原(PCT)、CC趋化因子受体6(CCR6)、核因子-κB(NF-κB)、单核细胞趋化蛋白4(MCP-4)含量明显降低(P<0.05),Treg、表皮生长因子(EGF)含量明显升高(P<0.05);西药组PSAI、DLQI、皮损厚度、中医证候评分、NGF、TGF-β1、VEGF、PCT、NF-κB含量降低(P<0.05),EGF含量升高(P<0.05);治疗后,联合组PSAI、DLQI、皮损厚度、NGF、TGF-β1、VEGF、PCT、NF-κB、MCP-4含量较中药组明显降低(P<0.05),EGF含量较中药组升高(P<0.05);联合组PSAI、DLQI、皮损厚度、中医证候评分、Th1、Th17、Th22、NGF、TGF-β1、VEGF、PCT、CCR6、NF-κB、MCP-4含量较西药组降低(P<0.05),Treg、EGF含量较西药组升高(P<0.05)。复发率比较:联合组<中药组<西药组(P<0.05)。不良反应比较:中药组<联合组<西药组(P<0.05)。结论:加减丹栀逍遥散可有效减轻寻常型银屑病肝经郁热证患者的皮损程度,改善血清和皮损组织中CD4+T淋巴细胞亚群百分比,生长因子,炎性指标的水平,复发率低,安全性高。加减丹栀逍遥散联合阿维A胶囊具有增效减毒的作用。

Objective:To observe the clinical efficacy of modified Danzhixiaoyaosan(丹栀逍遥散)and acitretin capsules in the treatment of psoriasis vulgaris due to Ganjingyure(肝经郁热)syndrome.Methods:A total of 210 patients were randomized into 3 groups(n=70)by the random number table method.The traditional Chinese medicine(TCM),western medicine,and combination groups were treated with modified Danzhixiaoyaosan,acitretin capsules,and modified Danzhixiaoyaosan+acitretin capsules,respectively,for 4 weeks.The clinical indicators,percentages of CD4~+T lymphocyte subsets,growth factors,and inflammation indicators in the serum and skin tissue were determined.The clinical efficacy,recurrence rate,and safety were compared among the three groups.Results:The total response rate was 98.6%in the combination group,which was higher than that in the TCM group(82.1%)and the western medicine group(80.3%)(P<0.05).Compared with those before treatment,the treatment in the TCM group and combination group lowered the psoriasis area and severity index(PASI)dermatology life quality index(DLQI),lesion thickness of skin,TCM syndrome scores,Th1,Th 17,Th22,nerve growth factor(NGF),transforming growth factor-β_1(TGF-β_1),vascular endothelial growth factor(VEGF),procalcitonin(PCT),chemokine(C-C-motif)receptor 6(CCR6),nuclear factor kappa-κB(NF-κB),and monocyte chemotactic protein 4(MCP-4)levels(P<0.05),while it elevated the Treg and epidermal growth factor(EGF)levels(P<0.05).The treatment in the western medicine group lowered the PSAI,DLQI,lesion thickness of skin,TCM syndrome scores,NGF,TGF-β_1,VEGF,PCT,and NF-κB levels and elevated the EGF level(P<0.05).After treatment,the combination group had lower PSAI,DLQI,lesion thickness of skin,NGF,TGF-β_1,VEGF,PCT,NF-κB,and MCP-4 levels and higher EGF level than the TCM group(P<0.05).Moreover,the combination group had lower PSAI,DLQI,lesion thickness of skin,TCM symptom scores,Th1,Th17,Th22,NGF,TGF-β_1,VEGF,PCT,CCR6,NF-κB,and MCP-4 levels and higher Treg and EGF levels than the western medicine group(P<0.05).The recurrence rate followed the trend of combination group.