复方丹参注射液治疗活动期类风湿关节炎的临床观察

目的:观察复方丹参注射液治疗活动期类风湿关节炎(RA)临床疗效及安全性。方法:318例活动期RA患者随机分为治疗组(212例)和对照组(106例)。治疗组用复方丹参注射液加常规药物治疗,对照组只用常规药物治疗。分别于治疗前和治疗后20天测定两组患者触痛关节数、肿胀关节数、晨僵时间、双手握力,患者疼痛程度评估、患者对疾病的总体评估、医生对疾病的总体评估、患者的躯体活动功能(HAQ)、28关节病情活动度评分(DAS28)、血沉(ESR)、C反应蛋白(CRP)和类风湿因子(RF)以及两组治疗后ACR20、ACR50和ACR70的改善率,并记录两组治疗中相关的药物不良反应。结果:两组患者治疗后与同组治疗前比较,各项指标均有明显改善(P0.05)。治疗组患者治疗后晨僵时间、双手握力、患者疼痛程度评估、患者对疾病的总体评估、医生对疾病的总体评估、DAS28和HAQ比对照组患者均有明显的改善(P0.05);治疗组患者ACR20改善率(79.72%)明显高于对照组患者(59.43%),(P0.05);两组患者的不良反应及安全性指标无显著性差异(P0.05)。结论:复方丹参注射液治疗活动期RA疗效好,不良反应少。

Clinical Observation of Compound Salvia Injection in Patients With Active Rheumatoid Arthritis

Objective：To observe the efficacy and safety of compound salvia injection in patients with active rheumatoid arthritis（RA）.Methods：The patients with active RA were randomly assigned into the treated group with 212 patients and the treated group with 106 patients.Those in the treated group were treated with compound salvia injection combined with conventional therapy.Those in the control group were treated with conventional therapy.Tender joint count,swollen joint count,time of morning stiffness（TMS）,grip strength,patient′s assessment of pain,patient′s assessment of disease activity,physician′s assessment of disease activity,patient′s assessment of disability（index of the Health Assessment Questionnaire ）,Disease Activity Score in 28 joints（DAS28）,erythrocyte sedimentation rate（ESR）,C reactive protein（CRP） and rheumatoid factor（RF） were tested before treatment and 20 days after treatment.American College of Rheumatology criteria for 20% improvement（ACR20）,50% improvement（ACR50） and 70% improvement（ACR70） were evaluated in patients in the two groups after treatment.The occurrence of adverse events（AEs） and clinical laboratory test abnormalities were recorded.Result：All indexes of patients in the two groups after treatment were significantly improved（P0.05）.Compared with those in the control group,TMS,grip strength,patient′s assessment of pain,patient′s assessment of disease activity,physician′s assessment of disease activity,HAQ and DAS28 of those in the treated group were remarkably improved（P0.05）.The occurrence of AEs and clinical laboratory test abnormalities showed no significant difference between the two groups（P0.05）.Conclusion：Compound salvia injection shows good efficacy with few AEs in treating patients with active RA.