复方丹参注射液治疗风湿性疾病的研究

Effect of Compound Salvia Injection on Rheumatic Diseases

目的观察复方丹参注射液对风湿性疾病的疗效及其机理。方法用复方丹参注射液20ml加入液体中静滴,1次/d,20天1疗程,对124例类风湿性关节炎(RA)、60例强直性脊柱炎(AS)和60例骨性关节炎(OA)患者进行治疗,从显效率和总有效率、症状体征的改善、激素使用率、不良反应发生率和问卷调查等方面观察临床疗效;用大鼠CIA模型,从关节病理、自由基、血粘度、细胞凋亡、细胞因子表达等角度研究疗效机理。结果临床研究发现以该药为主,配合中医辨证治疗,总疗效优于对照组,其中RA显效率、AS显效率和总有效率有显著性差异,对症状体征的缓解明显优于对照组,激素使用率和使用量以及不良反应发生率均明显低于对照组,问卷调查显示疼痛缓解和生存质量均优于对照组;实验研究发现能减轻关节局部炎症反应,升高血清SOD含量和SOD/MDA比值,降低全血粘度,诱导滑膜细胞凋亡,抑制IL-1β、TNF-α及PGE2等炎症介质的生成,下调IL-1βmRNA、IL-6mRNA表达水平,并可下调RA患者滑膜细胞的VEGFmRNA表达。结论复方丹参注射液治疗风湿性疾病有良好的疗效。

Objective To investigate the effects of compound salvia injection on rheumatic diseases and the therapeutic mechanism. Methods Twenty milliliter of compound salvia injection was mixed into liquid infusion and dripped intravenously once a day, 20 days as a course of treatment. Rheumatoid arthritis （RA, n = 124）, ankylosing spondylitis （AS, n = 60） and osteoarthritis （OA, n = 60） were treated with compound salvia injection. Their respective control groups were treated with routine therapy for RA, AS and OA. Questionnaire was used to investigate the clinical effects such as the significantly effective rate, total effective rate, improved signs and symptoms, hormone usage, and incidence of adverse reactions. The CIA model of Wistar rat was intraperitoneally injected with normal saline （0. 8 ml/d）, dexamethasone （0. 09 mg/d） and compound salvia injection （0. 8 ml/d or 0. 4 ml/d） for 3 weeks to study therapeutic mechanism from the joint pathological features, free radicals, blood viscosity, apoptosis and cytokine expression. Results Clinical researches indicated that the therapeutic effect of compound salvia injection combined together with the Traditional Chinese medicine therapy based on differentiation and treatment of symptoms and signs, was better than routine therapy in total effective rate, especially significantly in AS, and the significantly effective rate in RA and AS was of significant statistical difference between the two therapies （P〈0. 05）. In comparison with the control groups, the symptoms and signs in the patients receiving compound salvia injection were improved; the usage of hormone and the incidence of adverse reactions were significantly reduced; pain relief and quality of life were better. Experimental study found compound salvia injection can reduce the local inflammatory response of joint, increase serum levels of SOD and SOD/MDA ratio, decrease blood viscosity, induce apoptosis in synovial cells, restrain the formation of IL-1β, TNF-α, PGE2 and other inflammatory mediators, and reduce the expression levels of VEGF mRNA expression level in synovial cells of RA patients, IL-1α mRNA and IL-6 mRNA. Conclusion Compound salvia injection achieves good therapeutic effect in the treatment of rheumatic diseases.