散痹汤加减治疗类风湿关节炎肾虚寒湿证的临床研究

评价散痹汤加减治疗类风湿关节炎肾虚寒湿证的疗效及安全性。该试验将168例符合条件的受试者随机分为中药组、西药组和中西药组,每组各56例。分别给予散痹汤加减,甲氨蝶呤,散痹汤加减+甲氨蝶呤,疗程均为16周。观察各组治疗前后健康状况(HAQ)、疾病活动指数(DAS28)、视觉模拟评分(VAS)、中医证候、血沉(ESR)、C反应蛋白(CRP)、抗环瓜氨酸肽(CCP)和类风湿因子(RF)的变化。治疗后中西药组总有效率92.7%,优于中药组79.2%和西药组的82.4%(P0.05);中药组和西药组比较无明显差异,表明散痹汤加减治疗类风湿关节炎肾虚寒湿证具有有效性;中西药组和中药组中医证候评分较西药组改善更为明显(P0.05);其他症状中西药组改善均优于中药组和西药组(P0.05),中药组和西药组比较无明显差异,表明散痹汤加减可有效改善类风湿关节炎肾虚寒湿证的临床症状;不良反应的发生率中药组(3.8%,2/53)中西药组(16.4%,9/55)西药组(33.9%,18/53)(P0.05)。综合以上研究散痹汤加减治疗类风湿关节炎肾虚寒湿证的疗效与甲氨蝶呤无明显差异,具有有效性,且不良反应的发生率较甲氨蝶呤低;散痹汤加减结合甲氨蝶呤片治疗类风湿关节炎肾虚寒湿证具有协同增效的作用,且可降低甲氨蝶呤的不良反应。

Effect of Sanbitang recipe in treatment of rheumatoid arthritis with kidney empty and cold-dampness symptom

To explore the clinical effect of Sanbitang recipe in treatment for the rheumatoid arthritis (RA) with kidney empty and cold-dampness symptom and its safety. A total 168 cases eligible patients were randomly divided into the traditional Chinese medicine (TCM) group, the chemical medicine group and the TCM combined with chemical medicine group, with 56 cases in each group. The TCM group was treated with Sanbitang recipe; The chemical medicine group was given methotrexate tablets; And Sanbitang recipe and methotrexate tablets was adopted in the TCM combined with chemical medicine group. A course of treatment was 16 weeks. Health assessment questionnaire (HAQ), disease activity scores 28-joint counts (DAS28), visual analogue scale (VAS), TCM symptom, erythrocyte sedimentation rate (ESR), C-reactive protein (CRP), cyclic citrullinated peptides (CCP) and rheumatoid factor (RF) were detected. The efficiencies and incidence of adverse reactions in the three groups were compared. The total effective rate of the TCM combined with chemical medicine group was 92.7%, which was higher than 79.2% of the TCM group and 82.4% of the chemical medicine group (P<0.05). There was no statistically significant difference between the TCM group and the chemical medicine group. This suggested that Sanbitang recipe was effective in treating rheumatoid arthritis (RA) with kidney empty and cold-dampness symptom. After treatment, the scores of HAQ, DAS28, VAS, ESR, CRP, CCP and RF of the TCM combined with chemical medicine group were significantly higher (P<0.05) among the three groups. There was no statistically significant difference between the TCM group and the chemical medicine group. This indicated that Sanbitang recipe could effectively alleviate the clinical symptoms of rheumatoid arthritis (RA) with kidney empty and cold-dampness symptom. In terms of efficiency and incidence of adverse reactions, the order from low to high was that the TCM group (3.8%, 2/53)P<0.05). Sanbitang recipe is effective in treating RA with kidney empty and cold-dampness symptom, with no obvious difference from methotrexate tablets and a low incidence of adverse reactions. Sanbitang recipe shows a remarkable effect in treating RA with kidney empty and cold-dampness symptom.