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目的观察清养透解合剂联合西药治疗系统性红斑狼疮(SLE)患者的临床疗效及其对血管损伤的影响。方法采用前瞻性单盲随机对照的方法,将42例SLE阴虚证患者随机分为治疗组22例和对照组20例,并设健康体检者12名作为健康组。治疗组在西医基础治疗同时加用清养透解合剂,每天1剂;对照组在西医基础治疗同时加用安慰剂,每天1剂,两组均治疗6个月。观察两组治疗前后狼疮活动性评分(SLEDAI)、中医证候积分、泼尼松用量及不良反应;并与健康组比较人可溶性血栓调节蛋白(sTM)、血管假性血友病因子(vWF)的表达。结果与本组治疗前比较,两组治疗后SLEDAI评分、中医证候积分、泼尼松片用量均明显降低(P<0.01);治疗后治疗组SLEDAI评分、中医证候积分、泼尼松片用量均明显低于对照组(P<0.01或P<0.05)。治疗前治疗组及对照组与健康组比较血清vWF、sTM水平均明显升高(P<0.01);治疗组治疗后较治疗前血清vWF、sTM水平明显降低(P<0.01)。治疗组不良反应例数明显少于对照组(P<0.01)。结论清养透解合剂联合西药能改善SLE阴虚证患者临床症状,减少激素用量,明显降低血管损伤因子vWF、sTM的表达,从而减轻血管损伤。
Objective To observe the clinical efficacy of Qingjiantoujie Mixture combined with western medicine in the treatment of patients with systemic lupus erythematosus (SLE) and its effect on vascular injury. Methods Forty-two patients with SLE Yin Deficiency Syndrome were randomly divided into treatment group (n = 22) and control group (n = 20), and 12 healthy subjects were selected as healthy group by prospective single-blind randomized controlled trial. The treatment group in the Western medicine treatment plus clearing and clearing and clearing the mixture agent, a day; the control group in the Western medicine treatment plus placebo, day 1, both groups were treated for 6 months. The levels of SLEDAI, TCM syndromes, prednisone dosage and adverse reactions were observed before and after treatment. The levels of soluble sTM, vWF, expression. Results Compared with before treatment, SLEDAI score, TCM syndrome score and prednisone dosage were significantly decreased in both groups after treatment (P <0.01). After treatment, SLEDAI score, TCM syndrome score, prednisone tablet The dosage was significantly lower than the control group (P <0.01 or P <0.05). The levels of serum vWF and sTM in treatment group and control group before treatment were significantly higher than those in healthy group (P <0.01). The serum levels of vWF and sTM in treatment group were significantly lower than those before treatment (P <0.01). The number of adverse reactions in the treatment group was significantly less than that in the control group (P <0.01). Conclusion Qingzuruntangjie decoction combined with western medicine can improve the clinical symptoms, reduce the dosage of hormones, reduce the expression of vascular injury factors vWF and sTM, and thus reduce the vascular injury.