Jiang Ping, Zhang Lin-ying, Dai Ling-ling, Jiang Xue-mei
Zhongguo Zhong Xi Yi Jie He Za Zhi. 2016 Jan;36(1):24-8.
To observe the auxiliary efficacy and safety of Hebi Recipe (HR)in treating early rheumatoid arthritis (RA).
Totally 63 early RA patients with Gan-Pi disharmony were randomly assigned to the treatment group [32 cases, treated by HR (one dose per day, taken in two portions for 24 successive weeks) plus Methotrexate (MTX)] and the control group (31 cases, treated by MTX alone). The dosage of MTX was increased from 7.5 mg to 12.5 mg, once per week, 24 weeks as one course of treatment. Efficacy for Chinese medical syndromes, American College of Rheumatology 20 (ACR20) improvement rate, disease activity score in 28 joints (DAS28), laboratory related indices [ESR, rheumatoid factor (RF), C-reactive protein (CRP), anti-cyclic citrullinated peptide (CCP)], and related ultrasonic inspection items (synovium thickness, synovium blood flow classification, effusion of joint), and adverse reactions were observed.
The total effective rate (83.9%, 26/31 cases) and ACR20 improvement rate (74.2%, 23/31 cases) were higher in the treatment group than in the control group [60.7% (17/28 cases), 46.4% (13/28 cases); P < 0.05]. Compared with before treatment in the same group, DAS28 score, ESR, RF, CRP, CCP, synovium thickness, synovium blood flow classification, effusion of joint all decreased in the two groups after treatment (P < 0.01, P < 0.05). Compared with the control group after treatment, ACR20 improvement rate, DAS28 score, ESR, RF, CRP, CCP, synovium thickness, synovium blood flow classification, effusion of joint all decreased in the treatment group (P < 0.01, P < 0.05). Liver dysfunction occurred in 1 case of the treatment group. One leucopenia and 2 liver dysfunction occurred in the control group.
HR could effectively improve joints and systemic symptoms of early RA patients with Gan-Pi disharmony.
观察和痹方治疗早期类风湿关节炎(RA)的辅助疗效及安全性。
将63例肝脾不和型早期RA患者随机分为治疗组(32例,采用和痹方治疗,每日1剂,分2次服用,连续服用24周,加用甲氨蝶呤)和对照组(31例,单纯采用甲氨蝶呤治疗)。甲氨蝶呤剂量从7.5 mg增至12.5 mg,每周1次,24周为1个疗程。观察中医证候疗效、美国风湿病学会20(ACR20)改善率、28个关节疾病活动评分(DAS28)、实验室相关指标[血沉(ESR)、类风湿因子(RF)、C反应蛋白(CRP)、抗环瓜氨酸肽(CCP)]、相关超声检查项目(滑膜厚度、滑膜血流分级、关节积液)及不良反应。
治疗组总有效率[83.9%(26/31例)]及ACR20改善率[74.2%(23/31例)]高于对照组[60.7%(17/28例)、46.4%(13/28例);P<0.05]。与同组治疗前比较,两组治疗后DAS28评分、ESR、RF、CRP、CCP、滑膜厚度、滑膜血流分级、关节积液均降低(P<0.01,P<0.05)。与对照组治疗后比较,治疗组ACR20改善率、DAS28评分、ESR、RF、CRP、CCP、滑膜厚度、滑膜血流分级、关节积液均降低(P<0.01,P<0.05)。治疗组出现1例肝功能异常。对照组出现1例白细胞减少和2例肝功能异常。
和痹方可有效改善肝脾不和型早期RA患者的关节及全身症状。