青藤碱联合甲氨蝶呤治疗活动性类风湿关节炎临床研究

Clinical study of sinomenine in combination with methotrexate for the treatment of active rheumatoid arthritis

目的观察青藤碱联合甲氨蝶呤治疗活动性类风湿关节炎的临床疗效。方法将90例活动性类风湿关节炎患者随机分为治疗组与对照组,每组45例。治疗组给予青藤碱联合甲氨蝶呤治疗,对照组仅给予甲氨蝶呤治疗。两组疗程均为6个月,观察ACR20、ACR50的达标情况,以及晨僵时间、血沉、C反应蛋白、类风湿因子的变化情况,并监测试验中发生的不良反应。结果①疗程结束后,治疗组ACR20、ACR50达标率分别为86.67%、77.78%,对照组分别为60.00%、57.78%;治疗组ACR20、ACR50达标率高于对照组(P<0.05)。②治疗前后组内比较,两组晨僵时间、ESR、CRP、RF水平差异均有统计学意义(P<0.05);组间治疗后比较,晨僵时间、ESR、CRP、RF水平差异有统计学意义(P<0.05)。③共有90例病例纳入安全性分析。治疗组有7例(15.6%)发生轻度不良反应,对照组有8例(17.8%)发生轻度不良反应;两组不良反应发生率比较,差异无统计学意义(P>0.05)。结论青藤碱联合甲氨蝶呤治疗活动性类风湿关节炎,可显著改善关节疼痛、肿胀等临床症状,减少晨僵时间,且不会显著增加用药不良反应的发生率。

Objective To evaluate the effect of sinomenine （ SIN ） and methotrexate （MTX） in treating active rheumatoid arthritis （RA）. Methods Ninety patients with active RA were randomly divided into treatment group and control group, with 45 cases in each group. Treatment group was treated by SIN and MTX, and control group was treated by MTX, with the course of 6 months. We observed the standards of ACR20 and ACR50 and compared the morning stiffness, erythrocyte sedimentation rate （ESR）, C -reactive protein （CRP） and rheumatoid factor （RF）. The adverse effects were monitored. Results ① In treatment group, the rates of reaching the ACR20 and ACR50 were 86.67% and 77.78% , while in control group the rates were 60.00% and 57.78% respectively; The rates of reaching the ACR20 and ACR50 in treatment group were higher than that of the control group （ P 〈 0.05 ）. ② In each group, there were significant differences in morning stiffness, ESR, CRP and RF between before and after treatment （P 〈 0.05 ）. After treatment, significant differences were found in morning stiffness, ESR, CRP and RF between the two groups （P 〈 0.05 ）. ③ Ninety patients were enrolled for safety analysis. Mild adverse events occurred in 7patients （ 15.6% ） in treatment group, and eight patients （ 17.8% ） in control group developed mild adverse events. There was no difference in the incidence of adverse events between the two groups （ P 〉 0.05 ）. Conclusion Combined SIN and MTX can alleviate clinical symptoms of arthralgia and arthroncus, reduce the duration of morning stiffness in patients with active RA, and would not increase the incidence of adverse events.