目的将调查 Artemisia annua L 的摘录的互补使用的效果和安全。(EAA ) 在对待活跃风湿性关节炎(RA ) 上。使随机化的控制临床的试用被执行的方法。159 与活跃 RA 参与的所有随机用隐藏的随机的分配方法被分到控制组(80 个案例) 和 EAA 组(79 个案例) 。在控制组,病人们与 leflflunomide 和 methotrexate 被药物治疗 48 个星期;并且在 EAA 组的病人与 leflflunomide 被管理,加 EAA (30 g/d ) 的 methotrexate。在 0 , 12 , 24 和 48 个星期的时间点,临床的结果测量,包括客观疼痛分数,温柔分数,痛苦的关节的数字,肿的关节的数字,为生活的质量的健康评价问询表( HAQ )分数,浆液的层次风湿病的因素( RF ),反周期的 citrullinated 蛋白质抗体( CCP-Ab ),红血球沉积率( ESR ), C 反应蛋白质( CRP ),为疼痛(管)的视觉类似物分数,和外套 effificacy 被检测并且记录。在 24 个星期的客观疼痛分数,在 12 个星期的痛苦的关节和 ESR 的数字,温柔分数和 HAQ ,和温柔获得的结果, painfull 关节的数字,肿的关节的数字, HAQ , CRP ,在 48 个星期的 RF 和 CCP-Ab signifificantly 与控制组相比在 EAA 组被改进( P < 0.01 或 P < 0.05 )。在 24 和 48 个星期, EAA 组的全面 effificacy 比控制组 signifificantly 高(P < 0.01 ) 。与控制组相比有在处理以后的 12 个星期和在 EAA 组的不利效果的更低的发生率以内的 corticosteroids 的 signifificantly 更高的退却率(P < 0.01 或 P < 0.05 ) 。结论 EAA 正 methotrexate 和 leflflunomide 在活跃 RA 的处理比 methotrexate 和 leflflunomide 的平淡的使用更有效、安全。
Objective:To investigate the effect and safety of the complementary use of the extract of Artemisia annua L.(EAA) on treating active rheumatoid arthritis(RA). Methods:A randomized controlled clinical trial was performed. All the 159 participates with active RA were randomly assigned to the control group(80 cases) and EAA group(79 cases) using concealed random allocation method. In the control group, patients were medicated with leflunomide and methotrexate for 48 weeks; and patients in the EAA group were administrated with leflunomide, methotrexate plus EAA(30 g/d). At the time points of 0, 12, 24 and 48 weeks, the clinical outcome measures, including objective pain score, tenderness score, number of painful joints, number of swollen joints, health assessment questionnaire(HAQ) score for quality of life, levels of serum rheumatoid factor(RF), anti-cyclic citrullinated protein antibodies(CCP-Ab), erythrocyte sedimentation rate(ESR), C reactive protein(CRP), visual analogue score for pain(VAS), and the overall efficacy were detected and recorded. Results:The objective pain score, number of painful joints and ESR at 12 weeks, tenderness score and HAQ at 24 weeks, and the tenderness score, number of painfull joints, number of swollen joints, HAQ, CRP, RF and CCP-Ab at 48 weeks were significantly improved in the EAA group compared with the control group(P〈0.01 or P〈0.05). At 24 and 48 weeks, the overall efficacy of the EAA group was significantly higher than the control group(P〈0.01). There were significantly higher withdrawal rate of corticosteroids within 12 weeks post-treatment and lower incidence rate of adverse effects in the EAA group compared with the control group(P〈0.01 or P〈0.05). Conclusion:EAA plus methotrexate and leflunomide were more effective and safer than the routine use of methotrexate and leflunomide in the treatment of active RA.