寒痹停片辅助治疗类风湿性关节炎的临床观察

Clinical Observation of Adjunctive Therapy of Hanbiting Tablet in Treatment of Rheumatoid Arthritis

目的:观察寒痹停片辅助治疗类风湿关节炎(RA)寒湿痹阻证的临床疗效以及对关节液和血清白细胞介素-17(IL-17)和前列腺素E2(PGE2)的影响。方法:采用随机按数字表法将114例RA寒湿痹阻证患者分为对照组和治疗组各57例。两组患者均参照《类风湿关节炎诊断及治疗指南》采取非药物治疗;对照组口服甲氨喋呤片,10 mg/次,1次/周,和扶他林片,75 mg/次,1次/d,晚餐后口服。治疗组在对照组治疗的基础上口服寒痹停片,3片/次,3次/d。两组均观察12周。比较两组治疗前后中医症状积分,采取中文版健康调查简表(SF-36)评估两组患者生活质量,分析两组治疗后临床疗效,检测两组治疗前后关节液和血清IL-17及PGE2水平。结果:治疗组治疗后中医症状各项指标积分均明显低于对照组(P<0.01);治疗组治疗后临床总有效率为96.49%,优于对照组的82.46%,比较差异有统计学意义(P<0.05);治疗组治疗后SF-36量表各项评分均明显高于对照组(P<0.01);治疗后治疗组血清和关节液中IL-17及PGE2水平明显低于对照组,比较差异有统计学意义(P<0.01)。结论:寒痹停片辅助治疗RA寒湿痹阻证患者可明显改善临床症状,提高患者生活质量,提高临床疗效,其降低关节液和血清IL-17及PGE2水平可能是发挥上述作用的机制之一。

Objective： To observe clinical efficacy of Hanbiting tablet as an additional therapy for rheumatoid arthritis（RA） patients with cold dampness arthralgia spasm syndrome（CDASS） and its influence on levels of interleukin-17（IL-17） and prostaglandin E2（PGE2） in synovial fluid and serum. Method： One hundred and fourteen RA patients of CDASS were randomly divided into control group and treatment group（57 cases each） by random number table. Two groups were given non-drug treatment on the basis of the Diagnosis and Treatment Guidelines of RA. Patients of control group were given methotrexate tablets（10 mg / time,1 time / week）and emulgel tablets（75 mg / time,qd,oral administration after dinner）. Besides the therapy of control group,patients in treatment group were additionally treated with Hanbiting tablets with oral administration（3 tablets / time,tid）. The course of treatment lasted for 12 weeks for both groups. Scores of traditional Chinese medicine clinical symptoms were compared to evaluated quality of life of patients in two groups by using the Chinese Version of Health Survey Questionnaire Shot Form（SF-36） before and after treatment. The clinical efficacy of both groups were analyzed after treatment,and levels of IL-17 and PGE2 in synovial fluid and serum were detected before and after treatment. Result： Scores of traditional Chinese medicine clinical symptoms in treatment group were all evidently lower than these of control group after treatment（P〈 0. 01）. The clinical effective rate of control group was 96. 49%,which was superior to 82. 46% of treatment group with statistical difference（P 0. 05）. The scores of SF-36 of treatment group were obviously higher than these of control group after treatment（P〈 0. 01）. The levels of IL-17 and PGE2 in the synovial fluid and serum in treatment group were obviously lower than control group with statistical difference（P〈 0. 01）. Conclusion： Hanbiting tablet,as an additional therapy for RA patients with CDASS,could remarkably relieve clinical symptoms and improve the quality of life and clinical efficacy. And its mechanism may be related with reducing levels of IL-17 and PGE2 in synovial fluid and serum.