参氏羌活地黄汤治疗类风湿关节炎的疗效：一项随机对照试验

[Efficacy of Shenshi Qianghuo Dihuang Decoction in rheumatoid arthritis: a randomized controlled trial].

作者信息

Chen Zhao-wei, Sun Jian, Li Yu-mei, Chen Yong-qiang

机构信息

Department of Orthopaedics and Traumatology, Shanghai Municipal Hospital of Traditional Chinese Medicine, Shanghai 200071, China.

出版信息

Zhong Xi Yi Jie He Xue Bao. 2010 Jan;8(1):35-9. doi: 10.3736/jcim20100107.

DOI:10.3736/jcim20100107

PMID:20082756

Abstract

BACKGROUND

In China, patients with rheumatoid arthritis (RA) are often treated with traditional Chinese herbal medicine. There are certain advantages of traditional Chinese medicine therapy in treatment of RA.

OBJECTIVE

To assess the efficacy and adverse reaction of Shenshi Qianghuo Dihuang Decoction (SQDD), a compound traditional Chinese herbal medicine, in treatment of RA.

DESIGN, SETTING, PARTICIPANTS AND INTERVENTIONS: This was a 24-week prospective, randomized, controlled trial. Ninety RA patients meeting inclusion criteria from Shanghai Municipal Hospital of Traditional Chinese Medicine were randomly assigned to receive SQDD or methotrexate (MTX) with 45 cases in each group. The patients in SQDD group were orally administered with SQDD twice daily, and the patients in MTX control group were treated by oral administration of 15 mg MTX once a week. All the RA patients were treated for 24 weeks.

MAIN OUTCOME MEASURES

The primary outcome was the number of patients achieving the American College of Rheumatology 20% response. Clinical and laboratory parameters including tender joint count and swollen joint count, patient's global assessment and physician's global assessment (using a 0-10 cm visual analogue scale), duration of morning stiffness, plasma C-reactive protein (CRP) level, erythrocyte sedimentation rate (ESR) and value of anti-cyclic citrullinated peptide (CCP) antibody were assessed.

RESULTS

After 24-week treatment, the response rates in SQDD group and MTX group were 62.53% (24/41) and 67.5% (28/40) respectively, and there was no statistical difference between the two groups (P>0.05). The patient's global assessment and physician's global assessment, morning stiffness, grip strength, tender joint count, swollen joint count and the levels of ESR, CRP and anti-CCP antibody in SQDD and MTX groups were improved significantly as compared with those before treatment, and there were no significant differences between the two groups. The efficacy of MTX in improving rest pain and joint tenderness was better than that of SQDD (P<0.05). The incidence rate of adverse reactions in SQDD group was 9.75%(4/41), significantly lower than 32.5% (13/40) in MTX group (P<0.05).

CONCLUSION

SQDD has a therapeutic effect on RA, and the adverse reactions are less than MTX.

摘要

背景

在中国，类风湿关节炎（RA）患者常接受中药治疗。中医治疗RA有一定优势。

目的

评估复方中药参氏羌活地黄汤（SQDD）治疗RA的疗效及不良反应。

设计、地点、参与者和干预措施：这是一项为期24周的前瞻性、随机、对照试验。从上海市中医医院选取90例符合纳入标准的RA患者，随机分为两组，每组45例，分别接受SQDD或甲氨蝶呤（MTX）治疗。SQDD组患者每日口服SQDD两次，MTX对照组患者每周口服15mg MTX一次。所有RA患者均接受24周治疗。

主要观察指标

主要观察指标为达到美国风湿病学会20%反应的患者数量。评估临床和实验室参数，包括压痛关节数和肿胀关节数、患者整体评估和医生整体评估（使用0 - 10cm视觉模拟量表）、晨僵持续时间、血浆C反应蛋白（CRP）水平、红细胞沉降率（ESR）和抗环瓜氨酸肽（CCP）抗体值。

结果

治疗24周后，SQDD组和MTX组的反应率分别为62.53%（24/41）和67.5%（28/40），两组间差异无统计学意义（P>0.05）。与治疗前相比，SQDD组和MTX组患者的整体评估和医生整体评估、晨僵、握力、压痛关节数、肿胀关节数以及ESR、CRP和抗CCP抗体水平均有显著改善，两组间差异无统计学意义。MTX在改善静息痛和关节压痛方面的疗效优于SQDD（P<0.05）。SQDD组不良反应发生率为9.75%（4/41），显著低于MTX组的32.5%（13/40）（P<0.05）。