复方雷公藤外敷剂对类风湿关节炎患者关节疼痛的影响

Effect of External Applying Compound Tripterygium wilfordii Hook F.on Joint Pain of Rheumatoid Arthritis Patients

目的观察复方雷公藤外敷剂缓解类风湿关节炎(rheumatoid arthritis,RA)关节疼痛的有效性和安全性。方法采用多中心随机双盲对照试验设计,将174例疾病中度活动的RA患者随机分为外敷剂组(治疗组)和安慰剂组(对照组),每组87例,肿痛关节部位涂抹外用药物,每次20g,每日1次,共8周。以患者报告的关节疼痛缓解做为主要疗效指标,并于治疗前、治疗4周及治疗后评价疼痛视觉模拟量表评分(visual analogue scale for pain,VAS)、28个关节数疾病活动度评分(disease activity score of 28joints,DAS28)、患者健康总体评价,治疗前后检测ESR及hs-CRP。治疗中观察女性月经变化情况,并采用皮肤刺激性强度评价标准对记录试验过程中出现的皮肤刺激进行评价。采用意向性分析进行统计分析。结果治疗组患者关节疼痛缓解率[79例(90.8%)]高于对照组[60例(69.0%),P=0.001]。与本组治疗前比较,两组治疗4周及治疗后疼痛VAS、DAS28评分、总体VAS均改善,差异有统计学意义(P<0.01);治疗组治疗后ESR及hs-CRP水平下降,差异有统计学意义(P<0.05,P<0.01)。两组治疗后疼痛VAS、DAS28评分、患者健康总体评价、ESR及hs-CRP比较差异无统计学意义(P>0.05)。治疗组共发生8例不良事件,其中5例皮肤过敏、1例不能忍受药物气味、2例轻度肝损伤;对照组共发生3例不良事件,其中2例皮肤过敏,1例轻度肝损伤。两组不良事件发生率差异无计学意义(P>0.05)。治疗组未见女性患者报道月经变化。结论复方雷公藤外敷剂外敷是一种有效、安全的缓解RA关节疼痛的治疗方法,可作为缓解RA关节疼痛的辅助方法。

Objective To observe the effectiveness and safety of external applying Compound Tripterygium wilfordii Hook F.（TwHF）in relieving joint pain in rheumatoid arthritis（RA）patients.Methods 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 28joints（DAS28）,VAS for general health（GH）were evaluated before treatment,at week4 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.Results 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（5skin allergy,1intolerance of medical odor,and2 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.Conclusion 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.