Jiao Juan, Tang Xiao-po, Yuan Jing, Liu Xu, Liu Hui, Zhang Chun-yan, Wang Li-ying, Jiang Quan
Zhongguo Zhong Xi Yi Jie He Za Zhi. 2016 Jan;36(1):29-34.
To observe the effectiveness and safety of external applying Compound Tripterygium wilfordii Hook F. (TwHF) in relieving joint pain in rheumatoid arthritis (RA) patients.
In this double-blinded, randomized multicenter trial, a total of 174 moderately active RA patients were enrolled and randomly assigned to the treatment group (treated with Compound TwHF, 87 cases) and the placebo control group (87 cases). Compound TwHF or placebo was externally applied in painful joints, 20 g each time, once per day for 8 weeks. Self-reported joint pain relief was taken as a primary effective indicator. Visual analogue scale for pain (VAS), disease activity score of 28 joints (DAS28), VAS for general health (GH) were evaluated before treatment, at week 4 and after treatment. Erythrocyte sedimentation rate (ESR) and hypersensitive C reactive protein (hs-CRP) were tested before and after treatment. Menstrual changes in females were observed during treatment. Skin irritation occurred during the recording process was assessed using skin irritation strength. Intention to treat (ITT) was statistically analyzed.
The joint pain relief rate in the treatment group was 90.8% (79/87 cases), higher than that in the placebo control group (69.0%, 60/87 cases; P = 0.001). VAS pain score, DAS28, VAS for GH score were significantly improved in the two groups at week 4 of treatment and after treatment, as compared with before treatment (P < 0.01). ESR and hs-CRP levels significantly decreased in the treatment group after treatment (P < 0.05, P < 0.01). No difference was found in post-treatment VAS pain score, DAS28, VAS for GH score, ESR, or hs-CRP between the two groups (P > 0.05). Eight adverse events occurred in the treatment group (5 skin allergy, 1 intolerance of medical odor, and 2 mild liver injury), while 3 adverse events occurred in the placebo control group (2 skin allergy, 1 mild liver injury). There was no statistical difference in adverse event between the two groups (P > 0.05). No menstrual change occurred in the treatment group.
External applying Compound TwHF was an effective and safe way to relieve-joint pain of RA patients, which could be taken as an adjuvant therapy.
观察外用复方雷公藤多苷（TwHF）缓解类风湿关节炎（RA）患者关节疼痛的有效性和安全性。
在这项双盲、随机多中心试验中，共纳入174例中度活动期RA患者，随机分为治疗组（87例，采用复方TwHF治疗）和安慰剂对照组（87例）。将复方TwHF或安慰剂外用在疼痛关节处，每次20 g，每天1次，共8周。以患者自我报告的关节疼痛缓解情况作为主要疗效指标。在治疗前、治疗第4周和治疗后评估疼痛视觉模拟量表（VAS）、28个关节疾病活动评分（DAS28）、总体健康状况VAS（GH）。治疗前后检测红细胞沉降率（ESR）和超敏C反应蛋白（hs-CRP）。观察治疗期间女性的月经变化。使用皮肤刺激强度评估记录过程中发生的皮肤刺激情况。采用意向性分析（ITT）进行统计学分析。
治疗组关节疼痛缓解率为90.8%（79/87例），高于安慰剂对照组（69.0%，60/87例；P = 0.001）。与治疗前相比，两组在治疗第4周和治疗后VAS疼痛评分、DAS28、GH评分均显著改善（P < 0.01）。治疗组治疗后ESR和hs-CRP水平显著降低（P < 0.05，P < 0.01）。两组治疗后VAS疼痛评分、DAS28、GH评分、ESR或hs-CRP比较，差异无统计学意义（P > 0.05）。治疗组发生8例不良事件（5例皮肤过敏、1例药物气味不耐受、2例轻度肝损伤），安慰剂对照组发生3例不良事件（2例皮肤过敏、1例轻度肝损伤）。两组不良事件发生率比较，差异无统计学意义（P > 0.05）。治疗组未出现月经变化。
外用复方TwHF是缓解RA患者关节疼痛的一种有效、安全的方法，可作为辅助治疗手段。
