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目的观察天星健骨方治疗类风湿性关节炎(RA)的临床疗效。方法将220例RA患者随机分为治疗组120例和对照组100例,对照组给予甲氨喋呤片每次10mg,每周1次;来氟米特片每次10mg,每日1次,口服。治疗组在对照组治疗基础上加用天星健骨方胶囊,每次1.35~2.25g,每日3次;两组疗程均为12周。观察两组治疗前后关节肿胀数、关节压痛数、晨僵时间、握力及疼痛水平,并检测类风湿因子(RF)、红细胞沉降率(ESR)、C反应蛋白(CRP)、免疫球蛋白(IgG、IgM、IgA)水平以及安全性指标变化。结果治疗组总有效率为87.5%,对照组67.0%,两组比较差异有统计学意义(P<0.01)。两组患者治疗后关节肿胀数、关节压痛数、晨僵时间、握力及疼痛水平与治疗前比较均有明显改善(P<0.01),治疗组改善均优于对照组(P<0.05或P<0.01)。与治疗前比较,两组患者治疗后ESR、CRP、RF、IgG、IgM明显改善(P<0.01);治疗组治疗后CRP、IgG、IgM比对照组明显降低(P<0.05)。两组不良反应比较差异无统计学意义(P>0.05)。结论天星健骨方治疗RA具有较好疗效,可明显改善其症状和体征,且不良反应明显少于西药。
Objective To observe the clinical efficacy of “Tianxing Jiangu Decoction” in the treatment of rheumatoid arthritis (RA). Methods A total of 220 patients with RA were randomly divided into treatment group (n = 120) and control group (n = 100). The control group was given methotrexate tablets at 10 mg once a week, leflunomide tablets at 10 mg once daily, oral. The treatment group in the control group based on the use of Tianxing Jiangu prescription capsules, each 1.35 ~ 2.25g, 3 times a day; two courses were 12 weeks. The number of joint swelling, joint tenderness, morning stiffness, grip strength and pain were observed before and after treatment. The levels of rheumatoid factor (RF), erythrocyte sedimentation rate (ESR), C reactive protein (CRP), immunoglobulin , IgM, IgA) levels and safety indicators. Results The total effective rate was 87.5% in the treatment group and 67.0% in the control group, with significant difference between the two groups (P <0.01). The joint swelling, joint tenderness, morning stiffness, grip strength and pain were significantly improved in both groups after treatment (P <0.01), and those in the treatment group were better than those in the control group (P <0.05 or P < 0.01). Compared with those before treatment, ESR, CRP, RF, IgG and IgM were significantly improved in both groups after treatment (P <0.01). CRP, IgG and IgM in treatment group were significantly lower than those in control group after treatment (P <0.05). There was no significant difference in adverse reactions between the two groups (P> 0.05). Conclusion Tianxingjilugu Recipe has good curative effect on RA, and can obviously improve the symptoms and signs of asthma. The adverse reactions are obviously less than western medicine.