清热活血方治疗类风湿关节炎患者71例临床观察

目的 比较清热活血方和清热活血方联合甲氨蝶呤片(MTX)治疗类风湿关节炎(RA)的临床疗效和安全性.方法 将142例湿热瘀阻证RA患者随机分为中药组71例和中药+MTX组71例,中药组口服清热活血方每次200ml,每日2次;中药+ MTX组在中药组基础上口服MTX,每次10mg,每周1次,两组均治疗24周.分别于治疗0、4、12、24周采用疾病活动性评分(DAS28)、美国风湿病学会(ACR)反应标准为疗效评价指标,并观察不良反应. 结果 治疗12周后两组DAS28评分较治疗前有明显下降(P＜0.05)；治疗24周后两组较治疗4周时的DAS28评分也出现明显下降(P＜0.05).治疗12周中药+ MTX组ACR20、ACR50达标率明显高于中药组(P＜0.05).除C反应蛋白(CRP)、动态红细胞沉降率(ESR)外,两组ACR反应标准中的各项指标随着治疗时间的延长进一步提高(P＜0.05或P＜0.01)；在CRP方面中药+MTX组起效较快,治疗4周后即开始下降(P＜0.01)；在ESR方面两组起效均较慢,治疗12周后才有所降低(P＜0.01).中药组不良反应发生率低于中药+ MTX组.结论 单独应用清热活血方可有效控制疾病活动度、改善风湿病情,较之联合MTX具有更好的安全性;早期建议联合应用MTX,以改善病情.

Clinical Observation on Qingre Huoxue Decoction for 71 Patients with Rhe umatoid Arthritis

Objective To compare the therapeutic effect and saf et y of Qingre Huoxue Decoction(Decoction for Heat-Clearing and Blood-Quickening) alone with methotrexate(MTX) combined for rheum atoid arthritis(RA).Methods Totally 142 RA patients o f damp-heat stasis obstru ction syndrome were randomized into Chinese medicine group and Chinese medicine combined with MTX group,with 71 in each.Chinese medicine group accepted Qingre Huoxue Decoction(Decoction for Heat-Clearing and Blood-Quickening) 200ml eac h time,twice daily.Chines e medicine combined with MTX group accepted MTX 10mg each time,once a week in a d dition.The treatment lasted for 24 weeks.The Disease Activity Score 28(DAS28) and Guidelines for the Management of Rheumatoid Arthritis by American College o f Rheumatology(ACR) was used to observe and analyze the therapeutic effect and adverse effect in the beginning,4th,12th and 24th week of the treatment. Results Comparing with before treatment,the scores by DAS28 were decreased significantly in the 12th week of treatment in both groups(P <0.05).Comparing with 4 weeks after the treatment,the scores by DAS28 were decreased significantly in the 24th week of treatment in both groups(P<0.05).According to ACR20 and ACR50,the standard reaching rate of Chinese medicine combined with MTX group was si gnificantly higher than that of Chinese medicine group in the 12th week of trea tment(P<0.05).With the prolongation of treatment,indexes in both groups were improved except for C reactive protein(CRP) and erythrocyte sedimentation rate (ESR)(P<0.05 or P<0.01).CRP was significantly decreased in the 4th week of tre atment in Chinese medicine combined with MTX group,showing a quicker effect( P <0.01).ESR was significantly decreased in the 12th week of treatment in both groups,showing a slower effect(P<0.01).The incidence of adverse effe ct of Chinese medicine group was lower than that of Chinese medicine combined wi th M TX group.Conclusion Qingre Huoxue Decoction(Decoction for Heat-Clearing and Blood-Quickening) could control the disease activity an d improve the condition of RA patients.It is safer to us e the decoction alone as comparing with MTX combined.But it is suggested to add MTX to improve the condition of RA patients at the earlier stage.