活血祛瘀汤熏洗联合西药治疗弥漫性系统性硬化症

Effect of Blood Stasis-removing Huoxue Quyu Decoction Fumigation in Treatment of Systemic Sclerosis with Diffuse Scleroderma

目的:观察活血祛瘀方熏洗联合来氟米特(LEF)及泼尼松(Pred)治疗弥漫性系统性硬化症(ds SSc)疗效、安全性及对患者生活质量的影响。方法:将149例ds SSc患者随机分为对照组(71例)和观察组(78例),对照组口服LEF+Pred,观察组在对照组的基础上采用活血祛瘀方熏洗,两组治疗各进行6个月。在治疗前及治疗后,分别观察两组雷诺现象(RP),并进行皮肤硬度、中医证候及生活质量评分,检测红细胞沉降率(ESR),C反应蛋白(CRP),评价临床疗效,观察不良反应。结果:观察组临床总有效率较对照组提高(P<0.05)。与本组治疗前比较,两组患者RP发生率均降低(P<0.05);治疗后与对照组比较,观察组RP发生率降低(P<0.01)。与本组治疗前比较,对照组治疗后患者皮肤硬度、中医证候积分无改善;而观察组治疗后,患者皮肤硬度、中医证候积分均较下降(P<0.05);治疗后与对照组比较,观察组皮肤硬度、中医证候积分均下降(P<0.05)。与本组治疗前比较,两组治疗后患者生活质量积分均提高,ESR,CRP下降(P<0.05);治疗后与对照组比较,观察组生活质量积分提高,ESR,CEP下降(P<0.05)。两组不良反应发生率无统计学差异。结论:活血祛瘀方熏洗可改善ds SSc患者症状、体征,减轻炎症损伤,提高生活质量,其作用可能与改善微循环、促进炎症因子吸收有关。

Objective： To study the therapeutic efficacy and safety of blood stasis-removing Huoxue Quyu decoction fumigation combined with leflunomide（ LEF） and prednisone（ Pred） in treatment of systemic sclerosis with diffuse scleroderma（ ds SSc）. Method： Totally 149 patients of ds SSc were divided into two groups in random： control group（ LEF and Pred,71 cases） and observation group（ Huoxue Quyu decoction fumigation combined with LEF and Pred,78 cases）,and treated for 6 months. Before and after treatment,efforts were made to observe Raynaud＇s Phenomenon（ RP）,hardness of skin,symptoms of traditional Chinese medicine（ TCM）,quality of life of two groups,detect erythrocyte sedimentation rate（ ESR） and C reactive protein（ CRP）,and evaluate clinical efficacy and adverse reactions. Result： Compared with control group,observation group showed increase in total effective rate（ P〈0. 05）. Compared with the same group before treatment,incidence of RP reduced in both groups（ P〈0. 05）. Compared with control group after treatment,incidence of RP reduced in observation group（ P〈0. 01）. Compared with the same group before treatment,control group showed no change in hardness of skin and symptoms of TCM after treatment,whereas observation group showed decreases in hardness of skin and symptoms of TCM after treatment,Compared with control group after treatment,observation group showed decreases in hardness of skin and symptoms of TCM（ P〈0. 05）. Compared with the same group before treatment,both groups showed increase in quality of life,and decreases in ESR and CRP（ P〈0. 05）. Compared with the control group after treatment,observation group showed increase in quality of life,and decreases in ESR and CRP（ P〈0. 05）. Both groups had no statistically significant difference in adverse reaction rate. Conclusion： The blood stasis-removing Huoxue Quyu fumigation combined with LEF and Pred has a better effect than the administration with single western medicine in treatment of ds SSc,and is worth promoting in clinic.