骨蚀宁胶囊联合唑来膦酸治疗早中期股骨头坏死的临床疗效观察

Clinical Effect of Gushining Capsule Combined with Zoledronic Acid in Treatment of Early-and Middle-stage Femoral Head Necrosis

目的评估骨蚀宁胶囊联合唑来膦酸治疗早中期股骨头坏死的临床疗效。方法将股骨头坏死(早中期)患者64例随机分为对照组和观察组,每组32例,其中观察组38髋,对照组35髋。对照组予以唑来膦酸静脉滴注,口服骨化三醇及碳酸钙D3治疗;观察组在对照组治疗的基础上予以中药骨蚀宁胶囊口服。治疗1年后通过门诊随访调查患者治疗后髋关节Harris评分、基于X线片评分的疗效。结果两组临床疗效比较,差异有统计学意义(P<0.05)。与治疗前比较,两组治疗1年后髋关节功能、畸形、活动度和疼痛评分均显著升高(P<0.05);观察组治疗1年后髋关节功能、疼痛、活动度评分均显著高于对照组(P<0.05)。结论骨蚀宁胶囊联合唑来膦酸、骨化三醇及碳酸钙D3能更显著改善股骨头坏死症状,延缓股骨头进一步塌陷。

Objective To investigate the clinical effect of Gushining Capsule combined with zoledronic acid in the treatment of early-and middle-stage femoral head necrosis.Methods A total of 64 patients with early-and middle-stage femoral head necrosis were randomly divided into control group and observation group,with 32 patients in each group(38 hips in the observation group and 35 hips in the control group).The patients in the control group were given intravenous drip of zoledronic acid and oral administration of calcitriol and calcium carbonate D3,and those in the observation group were given oral administration of the traditional Chinese medicine Gushining Capsule in addition to the treatment in the control group.After 1 year of treatment,the patients were followed up at the outpatient service to observe Harris hip score and clinical outcome based on X-ray score.Results There was a significant difference in clinical outcome between the two groups(P<0.05).After 1 year of treatment,both groups had significant increases in the scores of hip joint function,deformity,range of motion,and pain(P<0.05),and compared with the control group,the observation group had significantly higher scores of hip joint function,pain,and range of motion(P<0.05).Conclusion Gushining Capsule combined with zoledronic acid,calcitriol,and calcium carbonate D3 can significantly improve the symptoms of femoral head necrosis and delay the further collapse of the femoral head.