白芍总苷胶囊治疗类风湿关节炎疗效和安全性的临床研究

目的　研究TGP治疗RA的疗效和安全性。方法　将RA患者随机分为TGP、MTX、TGP +MTX、TGP +SSZ、SSZ +MTX共 5组 ,于 0W、4W、12W、2 4W、36W时观察患者关节疼痛 (VAS)、关节压痛数、关节压痛指数、关节肿胀数 ,关节肿胀指数、晨僵时间、握力改善情况及有关实验室检查和药物的副作用。结果　TGP组在治疗 12W时有效率为 6 8.2 % ,显著低于其他各组治疗 12W时有效率 (P <0 .0 5 ) ,但在 2 4W (77.3% )及 36W (76 .2 % )时与MTX组和MTX +TGP组比较差异无显著性 ,但低于SSZ +MTX组 (分别为 85 .7%和 92 .9% )和SSZ +TGP组 (分别为 86 .9%和 86 .4 % ) ,其中 2 7例出现副作用 ,发生率为 2 1.8% ,以稀便例次最多。结论　TGP是一种安全有效治疗RA的慢作用药物。

The Clinical Study on Curative Effect and Safety of TGP in Rheumatoid Arthritis

Objective The study of the curative effect and safety of total glucosides of paeony capsules (TGP) in rheumatoid arthritis.Methods All of the patients were randomly divided into 5 groups:namely TGP,MTX,TGP+MTX,TGP+SSZ and SSZ+MTX Diseaes activity was assessed baseline and after 4w,12w,24w and 36w of therapy with the following variables :VAS(0--3),tender joint count ,swollen joint count pain on visual analogue scale ,morning stiffness time, hand-grip stress and acute phase veactants and adverse event assessments about the drugs ,Monitoring included naematological indices and liver functional tests.Results The patients on TGP showed significant improvement compared with others at 24w and 36w,improvement response rate( 77.3%,76.2% SSZ+TGP86.9%,86.4%;SSZ+MTX 85.7%,92.9% respectively ).27 patients expectal adverse events(21.8%), diarrhoea were frequent with continuoustreatment.Conclusion These long term data confirmed that TGP is an effective and safe slow acting antirheumatic drug.