摘要
目的:探讨益肾蠲痹丸对强直性脊柱炎(Ankylosing Spondylitis,AS)的疗效及安全性。方法:入选67例早中期AS患者,随机分3组:治疗组(益肾蠲痹丸+双氯芬酸片)、阳性对照组(柳氮磺吡啶+双氯芬酸片)和联合治疗组(益肾蠲痹丸+柳氮磺吡啶+双氯芬酸片)。分别观察治疗前、实验中期(治疗3个月)及实验结束(治疗6个月)AS活动指数(BASDAI)、AS测量指数(BASMI)、AS功能指数(BASFI)、血沉(ESR)、C-反应蛋白(CRP)的变化及药物不良反应。结果:实验中期及结束时三组Bath指数和实验室指标比治疗前均有改善,临床症状有所缓解,实验中期3组间疗效无统计学差异(P=0.193),实验结束时联合治疗组效果优于治疗组或阳性对照组,有统计学差异(P=0.023、P=0.026)。各组不良反应以胃肠道反应为主,3组比较无统计学差异(P>0.05)。结论:益肾蠲痹丸联合柳氮磺吡啶治疗早中期活动性AS患者6个月疗效显著,且不良反应轻微。
Objectives：To investigate the efficacy and safety of Yishen luanbi pill on ankylosing spondylitis （ AS ） through a six - month open - label trial. Methods ： 67 cases d early and mid - AS patients were randomly divided into three groups：the treatment group（Yishen Juanbi pill ＋ dMofenae tablets） , the positive control group （sulfasalazine ＋ di- clofenae tablets） , and the combination therapy group （Yishen Juanhi pill ＋ sulfasalazine pills ＋ diclofenae tablets ）. The Bath index such as Bath ankylosing spondylitis disease activity index（BASDAI） ,Bath ankylosing spondylitis measurement index （BASM1） , Bath ankylosing spondylitis functional index （BASFI） , erythmcyte sedimentation rate （ ESR ） , C - reactive protein（CRP） changes and adverse drug reactions were observed at study entry, during the intermediate stage（ 3 months after treatment）and at the end of the experiment（6 months ＇after treatment）. Results：In intermediate stage and at the end of the experiment,both Bath index and laboratory parameters of three groups were improved, and the clinical symptoms had been eased. There was no statistically significant difference in medium stage among three groups （P = 0.193 ）. At the end of the experiment the therapeutic effect of combitaation therapy group was superior to that of the treatment group or positive control group,which had a significant difference （P = 0. 023,P = 0. 026）. The main adverse events of each group was gastrointestinal reactions, but there was no significant difference among three groups （ P 〉 0.05 ）. Conclusion ： The treatment of Yishen Juanbi pill combined with sulfasalazine on active early and mid - AS patients for six months has sig- nificant effects and mild adverse reactions.
出处
《中华中医药学刊》
CAS
2012年第11期2506-2508,共3页
Chinese Archives of Traditional Chinese Medicine
基金
浙江省医学会临床科研基金资助项目(200709)
