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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 observe the curative effect, safety and quality of life of patients with diffuse systemic sclerosis (ds SSc) treated with LEF and Pred. Methods: A total of 149 patients with ds SSc were randomly divided into control group (n = 71) and observation group (n = 78). LEF + Pred was orally administered to the control group. The observation group was treated with Huoxue Qushi Decoction on the basis of the control group. Treatment for 6 months each. Before treatment and after treatment, Renault phenomenon (RP) was observed in both groups, and skin stiffness, TCM syndrome and quality of life were scored. The erythrocyte sedimentation rate (ESR) and C reactive protein (CRP) were measured to evaluate the clinical efficacy. Adverse reactions. Results: The total effective rate in observation group was higher than that in control group (P <0.05). Compared with the pretreatment group, the incidence of RP was decreased in both groups (P <0.05). Compared with the control group, the incidence of RP in the observation group decreased after treatment (P <0.01). Compared with the group before treatment, the control group had no significant improvement on the skin hardness and TCM syndrome score after treatment, while the skin hardness and TCM syndrome scores decreased in the observation group after treatment (P <0.05) Compared with the control group, the skin hardness and TCM syndrome scores decreased (P <0.05). After treatment, the scores of ESR and CRP decreased (P <0.05), and the scores of ESR and CEP decreased (P <0.05) in the observation group compared with the control group before treatment ). There was no significant difference in the incidence of adverse reactions between the two groups. Conclusion: Fumigating with traditional Chinese medicine can improve symptoms and signs of patients with dsScc, relieve inflammation and improve quality of life, which may be related to improving microcirculation and promoting the absorption of inflammatory cytokines.