藤黄健骨片治疗膝关节骨性关节炎肾虚血瘀证的多中心临床观察

目的:观察藤黄健骨片治疗膝关节骨性关节炎肾虚血瘀证的临床疗效。方法:采用多中心、随机对照原则,将符合诊断及纳入标准的本病患者240例按随机数字表法随机分为治疗组120例和对照组120例,治疗组予藤黄健骨片口服,对照组采用西乐葆胶囊口服,4周为1个疗程,观察两组1个疗程后膝骨关节炎WOMAC评分,并评价疗效,进行安全性评价。结果:两组治疗1疗程后膝关节WOMAC评分均较治疗前减少,差异有统计学意义(P<0.01,P<0.05)。治疗组治疗后与对照组在疼痛程度方面比较差异无统计学意义(P>0.05),但在其余各项目比较,差异有统计学意义(P<0.05)。两组疗效比较,差异有统计学意义(P<0.01),治疗组优于对照组,治疗期间治疗组患者均未出现明显不良反应,对照组有5例患者出现胃肠道不适,包括腹痛1例,腹泻1例,消化不良2例,胀气1例。结论:藤黄健骨片治疗膝关节骨性关节炎肾虚血瘀证安全有效。

Multi-center Clinical Observation of Tenghuangjiangu Tablets in the Treatment to Osteoarthritis of the Knee Typed with Diffident Kidney and Blood Stasis

Objective：To observe the clinical efficacy of Tenghuangjiangu tablets in the treatment of osteoarthritis typed with diffident kidney and blood stasis.Methods：240 patients from multi-center met the inclusion criteria were randomly divided into two groups：the control group and the experimental group,120 patients in each group.Patients in the experimental group were treated with Tenghuangjiangu tablets;patients in the control group were treated with Celebrex capsules,four weeks for a course of treatment.WOMAC scores and efficacy were observed and evaluated for the two groups.Results：The WOMAC scores in the two groups after treatment were lower than that in the two groups before treatment（P0.05）;there was significant difference in the clinical efficacy between the two groups after treatment（P〈0.05）.There was no obvious adverse reactions occurred in the treatment group;five patients had gastrointestinal discomfort in the control group,including abdominal pain 1 cases,diarrhea one cases,indigestion two cases and flatulence one cases.Conclusion：It was safe and effective for the Tenghuangjiangu tablets in the treatment of osteoarthritis of the knee typed with diffident kidney and blood stasis.