膝痛康治疗肾虚血瘀型膝骨性关节炎疗效评价

Evaluation of Xitongkang Treating Knee Osteoarthritis with Kidney Deficiency and Blood Stasis Syndrome

目的观察膝痛康治疗肾虚血瘀型膝骨性关节炎(knee osteoarthritis,KOA)的临床有效性与安全性,为膝痛康进一步临床推广应用提供依据。方法将3家医院176例合格受试者随机分为试验组88例和对照组88例。试验组采用基础治疗+膝痛康内服,对照组采用基础治疗+安慰剂内服,疗程4周。治疗期间,两组受试者出现不耐受疼痛时均可在医师指导下服用洛索洛芬钠片。试验开始前和结束时,采用NRS评分、WOMAC评分、ADL评分、中医病证诊断疗效量表评分和相关安全性指标检测评价该药的有效性和安全性。结果两组(疗前-疗后)NRS评分、WOMAC评分、ADL评分和中医病证诊断疗效量表评分比较,均有明显统计学意义(P<0.01);两组疗后各评分比较,试验组明显优于对照组(P<0.01);两组各评分有效率组间比较,试验组有效率高于对照组(P<0.01)。结论膝痛康治疗肾虚血瘀型KOA疗效确切,值得临床推广应用。

Objective To observe the efficacy and safety of Xitongkang for the treatment of knee osteoarthritis(KOA) with kidney deficiency and blood stasis syndrome and provide the basis for further clinical application. Methods A total of 176 patients at three hospitals were randomly allocated in equal numbers to receive Xitongkang treatment or placebo control. Each group had 88 patients. The treatment course was 4 weeks. All patients received loxoprofen sodium tablets when they had intolerant pain at the guidance of a doctor. At the beginning and the end of the experiment, NRS,WOMAC,ADL,TCM syndrome evaluation and the patients’ safety indexes were tested. Results The differences of NRS,WOMAC,ADL and TCM syndrome evaluation within groups were statistically significant(P<0.01). The differences between groups after treatment were statistically significant(P<0.01). The efficiency between groups was statistically significant(P<0.01). Conclusion The curative effect of Xitongkang treating KOA with kidney deficiency and blood stasis syndrome is definite and worthy of clinical application.