通络生骨方治疗ARCOⅡ期非创伤性股骨头坏死的前瞻性临床研究

Effect of Tongluo Shenggu Prescription on ARCO Stage Ⅱ non-traumatic femoral head necrosis: A prospective study

目的:观察通络生骨方治疗ARCOⅡ期非创伤性股骨头坏死的临床结果及疗效特点。方法:采用前瞻性配对、对照设计方法,对2016年1月~2017年1月的120例ARCOⅡ期非创伤性股骨头坏死的患者进行研究。其中治疗组60例,行通络生骨方治疗;对照组60例,行高能体外冲击波治疗。以影像学稳定率、Harris评分、SF-36评分作为临床疗效指标,随访24个月,统计并分析随访结果。结果:120例患者随访中脱落5例,其余患者均获得随访。两组影像学稳定率比较,差异无统计学意义(P>0.05);治疗组Harris评分明显高于对照组,差异有统计学意义(P<0.05),且治疗组在Harris评分中的疼痛程度、关节功能、关节畸形分值方面优于对照组(P<0.05);SF-36评分中,治疗组生理功能、生理职能、躯体疼痛、总体健康、社会功能、情感职能分值均明显高于对照组,差异具有统计学意义(P<0.05),两组在治疗期间不良事件发生率较低且后期均能自行缓解。结论:通络生骨方在治疗ARCOⅡ期非创伤性股骨头坏死方面疗效肯定,尤其在改善髋关节功能、缓解髋关节疼痛以及提高生活质量方面更为明显。

Objective To observe the clinical efficacy of Tongluo Shenggu Decoction in the treatment of ARCOⅡnon-traumatic femoral head necrosis.Methods A total of 120 patients with ARCOⅡnon-traumatic femoral head necrosis from January 2016 to January 2017 were included in the paired control prospective study.These 60 cases in the treatment group were treated with Tongluo Shenggu Formula.The control group(60 cases)received high energy extracorporeal shock wave therapy.The imaging stability rate,Harris score,and SF-36 score were used as clinical efficacy indicators.All cases were followed up for 24 months,and the follow-up results were statistically analyzed.Results Among these 120 patients,5 patients were lost and the rest were followed up.The imaging stability rate was high,with a similar result between the two groups(78.95%in the treatment group and 72.41%in the control group)(P>0.05).The Harris score of the treatment group was 92.67±8.45,significantly higher than that of the control group(80.39±24.65)(P<0.05).The pain degree,joint function,and joint deformity score of the treatment group were better than those of the control group(P<0.05).The SF-36 score of physiological function,physiological function,physical pain,overall health,social function,and emotional function in the treatment group were significantly higher than those in the control group(P<0.05).The incidence of adverse events of the two groups was low and all patients were relieved later.Conclusions Tongluo Shenggu prescription has a definite curative effect in treating ARCOⅡnon-traumatic femoral head necrosis,especially in improving hip joint function,relieving hip joint pain,and improving quality of life.