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青蒿提取物治疗活动期类风湿关节炎的效果:一项随机对照试验。

Effect of Artemisia annua extract on treating active rheumatoid arthritis: A randomized controlled trial.

作者信息

Yang Min, Guo Ming-Yang, Luo Yong, Yun Ming-Dong, Yan Jiao, Liu Tao, Xiao Chang-Hong

机构信息

Department of Traditional Chinese Medicine, Rheumatology Center of Integrated Traditional and Western Medicine, General Hospital of Chengdu Military Area Command PLA, Chengdu, 610083, China.

Department of Internal Medicine, School of Traditional Chinese Medicine, Southern Medical University, Guangzhou, 510515, China.

出版信息

Chin J Integr Med. 2017 Jul;23(7):496-503. doi: 10.1007/s11655-016-2650-7. Epub 2016 Dec 29.

Abstract

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 leflflunomide and methotrexate for 48 weeks; and patients in the EAA group were administrated with leflflunomide, 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 effificacy 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 signifificantly improved in the EAA group compared with the control group (P<0.01 or P<0.05). At 24 and 48 weeks, the overall effificacy of the EAA group was signifificantly higher than the control group (P<0.01). There were signifificantly 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 leflflunomide were more effective and safer than the routine use of methotrexate and leflflunomide in the treatment of active RA.

摘要

目的

探讨青蒿提取物(EAA)辅助治疗活动性类风湿关节炎(RA)的疗效及安全性。

方法

进行一项随机对照临床试验。采用隐匿随机分配法将159例活动性RA患者随机分为对照组(80例)和EAA组(79例)。对照组患者服用来氟米特和甲氨蝶呤48周;EAA组患者服用来氟米特、甲氨蝶呤加EAA(30克/天)。在0、12、24和48周时,检测并记录临床结局指标,包括客观疼痛评分、压痛评分、疼痛关节数、肿胀关节数、健康评估问卷(HAQ)生活质量评分、血清类风湿因子(RF)水平、抗环瓜氨酸肽抗体(CCP-Ab)、红细胞沉降率(ESR)、C反应蛋白(CRP)、疼痛视觉模拟评分(VAS)以及总体疗效。

结果

与对照组相比,EAA组在12周时的客观疼痛评分、疼痛关节数和ESR,24周时的压痛评分和HAQ,以及48周时的压痛评分、疼痛关节数、肿胀关节数、HAQ、CRP、RF和CCP-Ab均有显著改善(P<0.01或P<0.05)。在24周和48周时,EAA组的总体疗效显著高于对照组(P<0.01)。与对照组相比,EAA组治疗后12周内糖皮质激素的撤药率显著更高,不良反应发生率更低(P<0.01或P<0.05)。

结论

在治疗活动性RA方面,EAA联合甲氨蝶呤和来氟米特比常规使用甲氨蝶呤和来氟米特更有效、更安全。

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