复方夏天无联合甲氨蝶呤治疗类风湿关节炎的随机开放对照研究

目的观察复方夏天无联合甲氨蝶呤治疗类风湿关节炎的临床疗效及安全性。方法将89例类风湿关节炎患者随机分为治疗组46例及对照组43例,治疗组予常规用药同时加用复方夏天无联合甲氨蝶呤治疗,对照组仅加用甲氨蝶呤。比较治疗前后临床症状、体征及实验室指标(血沉、血小板、类风湿因子、C反应蛋白、抗环瓜氨酸多肽抗体及抗MCV抗体)及血液流变学指标的变化,同时通过比较2组治疗前后P选择素、金属蛋白酶及其抑制物(MMP-3及TIMP-1)等指标变化,探讨药物起效的作用途径,并观察2组不良反应。结果治疗组总有效率89%,对照组为91%,无显著性差异。治疗组及对照组各类临床及实验室指标均有显著改善(P<0.05),且2组无显著性差异。在降低患者血小板、握力改善及血清P选择素下降等方面治疗组优于对照组,不良反应方面治疗组亦优于对照组。结论复方夏天无联合甲氨蝶呤治疗类风湿关节炎安全有效,能有效改善患者临床症状及实验室指标,并具有更高的用药安全性,是中西医结合治疗类风湿关节炎合理的联合治疗方案。

Random open control study of compound recipe Xiatianwu united with Methotrexate on rheumatoid arthritis

Objective It is to observe the clinical curative effect and safety of compound recipe Xiatianwu united with Methotrexate(MTX) on rheumatoid arthritis.Methods 89 patients with rheumatoid arthritis were randomly divided into two groups.46 cases were in treatment group and treated additionally with compound recipe Xiatianwu united with MTX based on routine treatment.The other 43 cases were in control group and only treated additionally with MTX based on routine treatment.The changes of clinical symptoms,signs and laboratory indexes including erythrocyte sedimentation rate,platelet counts,rheumatoid factor,C reactive protein,anti cyclic Citrulline polypeptide and anti-MCV as well as hemorheology indexes in the two groups were compared before and after treatment.The action path of drugs reacted was discuss through comparing the changes of the indexes including P selectin,matrix metalloproteinases-3(MMP-3) and tissue inhibitor of metalloproteinase(TIMP) in the two groups before and after treatment.The untoward reactions in the two groups were observed.Results The total effective rate in treatment group was 89% and that in control group was 91% and there was no significant difference.Various kinds of clinical and laboratory indexes in the two groups were all significantly improved(all P<0.05) but there was no significant difference between the two groups.The curative effects on the aspects of lowering platelet counts,Hand Strength improving and serum P selectin descent in treatment group were outstripped than that in control group.Treatment group was also outstripped than control group on the aspect of untoward reactions.Conclusion It is effective and safe that compound recipe Xiatianwu united with MTX on rheumatoid arthritis.The therapy can effectively improve the clinical symptoms of the patients and laboratory indexes and has higher medication safety.The therapy is reasonable unite therapeutic schedule of rheumatoid arthritis treated with integrated traditional Chinese and western medicine.