肾痹汤加减联合双氯芬酸钠治疗股骨头坏死肾虚血瘀证的临床观察

Clinical Observation of Shenbitang Combined with Diclofenac Sodium for Osteonecrosis of Femoral Head Caused by Kidney Deficiency and Blood Stasis

目的：探讨。肾痹汤加减联合双氯芬酸钠缓释片治疗早中期股骨头坏死肾虚血瘀证的临床疗效，探讨其作用机制。方法：将106例早中期股骨头坏死肾虚血瘀证患者按就诊顺序随机分为对照组和观察组，每组各53例。对照组患者给予仙灵骨葆胶囊联合双氯芬酸钠缓释片，观察组患者给予肾痹汤加减联合双氯芬酸钠缓释片，连续治疗6个月，随访12个月。治疗前后分别观察患者的Harris量表，健康调查简表（sF-36），中医证候量表和影像学评分；检测血浆黏度（PV），红细胞电泳时间（EPT），红细胞沉降率（ESR），红细胞比容（HCT）的变化；比较两组患者的有效率、复发率及安全性指标。结果：研究期间对照组患者脱落2例，观察组患者脱落4例。观察组总有效率97．9％，高于对照组的82．4％（P〈0．05）；随访12个月观察组复发率8．1％，低于对照组的35．5％（P〈0．05）。与对照组治疗后比较，观察组患者Harri量表，sF-36量表和髋关节影像学评分明显升高（P〈0．05），中医证候量表评分，PV，EPT，ESR，HCT水平明显降低（P〈0．05）。观察组不良反应发生率12．2％，低于对照组的35．5％（P〈0．05）。治疗组血、尿常规异常发生率分别为15．9％，9．8％，低于对照组的30．6％，18．4％（P〈0．05）。结论：肾痹汤加减联合双氯芬酸钠缓释片治疗早中期股骨头坏死肾虚血瘀证，患者的临床症状和PV，EPT，ESR，HCT水平明显改善，复发率和不良反应发生率低。

Objective： To explore the therapeutic effect of Shenbitang combined with diclofenac sodium for early-to-middle stage osteonecrosis of the femoral head caused by kidney deficiency and blood stasis. Method： A total of 106 cases eligible patients were randomly divided into the control group （53 cases） and the observation group （53 cases）. The patients in control group were treated with Xianling Gubao capsules combined with diclofenac sodium release tablets; Shenbitang combined with diclofenac sodium release tablets was adopted in the observation group, with a treatment course of 6 months and a follow-up of 12 months in both groups. The Harris scale, SF-36, the traditional Chinese medicine （TCM） syndromes scale and imaging scores were observed before and after treatment. The changes of plasma viscosity （PV） , electrophoresis （EPT） , erythrocyte sedimentation rate （ESR）, erythrocyte deposition （HCT） were detected. The effective rates, recurrence rates and safety indexes werecompared between two groups. Result： The 2 cases in control group and 4 cases in observation group withdrew from the study. The total effective rate was 97.9% in observation group, higher than 82.4% in control group （P 〈 0.05）. The recurrence rate was 8.1% in observation group, lower than 35.5% in control group in follow-up for 12 months （P 〈 0.05）. As compared with the control group after treatment, the Harris scores, the SF-36 scores, and hip imaging scores were significantly higher in observation group （P 〈 O. 05） , and the TCM syndrome scores, PV, EPT, ESR, and HCT indexes were significantly lower （P 〈 0.05）. The incidence of adverse reactions was 12.2% in observation group, lower than 35.5% in control group （P 〈 0.05）. The incidence rate of abnormal indexes in routine blood test and urine test was 15.9% and 9.8% respectively in observation group, lower than 30.6% and 18.4% in control group （P 〈 0.05）. Conclusion： Shenbitang combined with diclofenae sodium release tablets could significantly improve the clinical symptoms and PV, EPT, ESR and HCT indexes, and reduce the recurrence rate and incidence of adverse reactions in the treatment of early-to-middle stage osteonecrosis of the femoral head caused by kidney deficiency and blood stasis.