摘要
背景:中医药在国内广泛应用于类风湿关节炎患者中,中医药在该类疾病的治疗中存在一定的优势。目的:观察沈氏羌活地黄汤(Shenshi Qianghuo Dihuang Decoction,SQDD)对类风湿关节炎患者的疗效及不良反应。设计、场所、对象和干预措施:将符合纳入标准、源自上海市中医医院的90例类风湿关节炎患者,随机分配进入SQDD组和甲氨喋呤(methotrexate,MTX)组,两组各45例。SQDD组服用SQDD,分早、晚2次口服;MTX组服用MTX,每周1次,每次15mg。疗程为24周。主要结局指标:治疗12、24周后对患者的下列指标进行评估。休息痛用视觉模拟标尺(visual analogue scale,VAS)0～10分评定,检查晨僵、关节肿胀数和关节压痛数,记录医生评价(VAS0～10)和病人评价(VAS0～10),检测血沉(erythrocyte sedimentation rate,ESR)、C反应蛋白(C-reactive protein,CRP)和抗环瓜氨酸肽(cyclic citrullinated peptide,CCP)抗体等实验室指标。根据美国风湿病学会20%改善标准进行疗效评价,并计算不良反应发生率。结果:治疗24周后SQDD组、MTX组的有效率分别为62.53%(24/41)、67.5%(28/40),均超过50%,两组有效率比较,差异无统计学意义(P>0.05)。两组治疗12或24周后的晨僵、握力、关节肿胀数、关节压痛数、医生评价和病人评价,以及ESR、CRP、抗CCP抗体等指标均较治疗前好转(P<0.05,P<0.01),但两组间差异均无统计学意义(P>0.05);SQDD在改善休息痛以及关节压痛症状上的疗效不如MTX(P<0.05)。SQDD组不良反应发生率为9.75%(4/41),明显低于MTX组的32.5%(13/40),二者比较,差异有统计学意义(P<0.05)。结论:SQDD治疗类风湿关节炎有效,不良反应较MTX轻。
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, controlledtrial. 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 MTXgroup （P〈0.05）.Conclusion： SQDD has a therapeutic effect on RA, and the adverse reactions are less than MTX.
出处
《中西医结合学报》
CAS
2010年第1期35-39,共5页
Journal of Chinese Integrative Medicine
基金
上海市基础研究重点项目(No.08JC1418800)
关键词
类风湿关节炎
沈氏羌活地黄汤
甲氨蝶呤
随机对照试验
rheumatoid arthritis Shenshi Qianghuo Dihuang Decoction methotrexate randomized controlled trial
