双蚁祛湿通络胶囊治疗强直性脊柱炎临床疗效评价

Therapeutic Evaluation of Shuangyi Qushi Tongluo Capsules in Treating Ankylosing Spondylitis

【目的】评价双蚁祛湿通络胶囊治疗强直性脊柱炎(AS)的有效性及安全性,探讨双蚁祛湿通络胶囊与柳氮磺吡啶联合用药的增效作用。【方法】采用随机、平行对照方法,将80例AS患者随机分为对照组和试验组各40例。对照组给予口服柳氮磺吡啶肠溶片治疗,试验组在对照组的基础上给予口服双蚁祛湿通络胶囊(由黑蚂蚁、黑翅土白蚁、全蝎、人参、黄芪、白术、当归、红花、丹参、牛膝、鸡血藤、淫羊藿、巴戟天等组成)治疗,疗程均为24周。于治疗第4、12、24周分别记录2组患者Bath AS疾病活动性指数(BASDAI)、脊柱痛目视模拟测试表评分(VAS)、患者总体评价(PGA)及夜间痛VAS、脊柱炎症评分、Bath AS功能指数(BASFI)、Bath AS测量指数(BASMI)、生活质量评分、红细胞沉降率(ESR)、C反应蛋白(CRP)等的改变,并观察2组的不良反应发生情况。【结果】(1)与对照组比较,治疗4、12、24周试验组患者达到ASAS 20的比例均显著升高(P<0.05或P<0.01);(2)治疗12、24周后,试验组对各项指标的改善作用均显著优于对照组(P<0.05或P<0.01);(3)对照组1例患者出现轻度的肝功能异常,试验组1例患者出现轻度的胃肠道不适,对照组及试验组的不良反应发生率分别为2.86%、2.63%,差异无统计学意义(P>0.05)。【结论】双蚁祛湿通络胶囊治疗AS疗效确切,且起效时间短,安全性高,与柳氮磺吡啶联合治疗AS有协同作用。

Objective To evaluate the effectiveness and safety of Shuangyi Qushi Tongluo Capsules （ SQTC） in treating ankylosing spondylitis （AS）, and to explore the synergistic action of SQTC combined with sulfasalazine. Methods A randomized and parallel-controlled trial was carried out in 80 AS patients. The enrolled subjects were evenly randomized into testing group and control group. Both groups were given oral use of sulfasalazine enteric-coated tablets, and the testing group was additionally given oral use of SQTC, which is mainly composed of silky ant （Formica Fusca）, black-winged Termitidae, Scorpio, Radix Ginseng, Radix Astragali, Rhizoma Atractylodis Macrocephalae, Radix Angelicae Sinensis, Flos Carthami, Radix Salviae Miltiorrhizae, Radix Achyranthis Bidentatae, Caulis Spatholobi, Herba Epimedii, and Radix Morindae Officinalis. The treatment for the two groups covered 24 weeks. On treatment week 4, 12, 24, we recorded the Bath Ankylosing Spondylitis Disease Activity Index （BASDAI）, visual analog scale （VAS） scores of rachialgia, patients’ general assessment （PGA）, VAS scores of night pain, spondylitis scores, Bath Ankylosing Spondylitis Functional Index （ BASFI） , Bath Ankylosing Spondylitis Metrology Index （ BASMI） , scores of the quality of life （ QOL） , erythrocyte sedimentation rate （ ESR） , C-reactive protein （ CRP）. Moreover, the adverse reaction of the two groups was also monitored. Results （ 1） Compared with the control group, testing group had high ASAS 20 percentage on treatment week 4, 12 and 24 （P〈0.05 or P〈0.01）. （2） After treatment for 12, 24 weeks, the observation indexes were much improved in the testing group （ P〈0.05 or P〈0.01 compared with the control group）. （ 3） In the control group, one case （ 2.86%） had slight abnormal hepatic function, and one case （2.63%） in the testing group had slight gastrointestinal discomfort, the difference being insignificant （P〉0.05）. Conclusion SQTC are effective and safe in treating AS, starting an effect shortly and having synergistic effect on salfasalazine for the treatment of AS.