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机构地区:[1]北京中医药大学,北京100029 [2]北京中医药大学东方医院风湿科,北京100078
出 处:《北京中医药》2013年第4期265-268,共4页Beijing Journal of Traditional Chinese Medicine
基 金:国家重点基础研究发展计划(973计划)资助项目(2009CB522803)
摘 要:目的评价附子复方治疗寒湿阻络型膝骨性关节炎(KOA)的临床疗效和安全性。方法将60例患者随机分为试验组和对照组各30例,试验组采用中药附子复方治疗;对照组给予口服葡立(盐酸氨基葡萄糖胶囊)治疗。2周为1个疗程,共治疗8周。分别在治疗后第8周随访,评价2组临床疗效和不良反应。结果治疗后中医证候疗效总有效率试验组为92.86%(26/28),对照组为70.37%(19/27),差异有统计学意义(P<0.05)。2组治疗前后疼痛、WOMAC骨性关节炎指数、肿胀、压痛指数、中医症候积分差异均有统计学意义(P<0.05)。其中疼痛视觉模拟评分、WOMAC骨关节炎指数、中医症候积分治疗后2组间比较差异有统计学意义(P<0.05)。全部患者均未见明显的不良反应。结论附子复方治疗寒湿阻络型KOA疗效优于对照组,能够有效改善患者的症状和体征,且胃肠道不良反应少,安全性好,便于患者长期坚持服用,值得推广。Objective To evaluate the clinical efficacy and safety of Fuzi compound prescription on knee osteoarthritis(KOA) in syndrome of cold-dampness obstructing the collaterals.Methods Sixty cases were randomly divided into a treatment group and a control group,30 cases in each one.The Fuzi compound prescription was applied in the treatment group while Puli(glucosamine hydrochloride capsule) was orally administrated in the control group.2 weeks were taken as one treatment course and 8 weeks were required.The follow-up was respectively done after 8 weeks of the treatment.The clinical efficacy and adverse reaction were evaluated in both groups.Results After the treatment,the effective rate of TCM syndrome was 92.68 %(26/28) in the treatment group and 70.37 %(19/27) in the control group,which had significant difference(P < 0.05).There were statistically significant differences in visual analogue scale(VAS),WOMAC osteoarthritis index,swell index,tenderness index and TCM syndrome score in both groups beforeandafterthetreatment(P < 0.05).Ofthem,thereweresignificantbetween-groupdifferencesinVAS,WOMACosteoarthritisindexandTCMsyndromescoreafterthe treatment(P < 0.05).No adverse reaction was observed in all patients.Conclusion The efficacy of Fuzi compound prescription on KOA in syndrome of cold-dampness obstructing the collaterals was superior to that of the control group.It could effectively improve the patients' symptoms and signs with little adverse reaction in the stomach and intestine,having a good safety.Besides,it is convenience for long-term use,worthy of promotion.
关 键 词:膝骨性关节炎 附子复方 盐酸氨基葡萄糖胶囊 临床对照试验
分 类 号:R274[医药卫生—中医骨伤科学]
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