健脾活骨方治疗早中期非创伤性股骨头坏死的前瞻性临床研究  

Prospective study on Jianpihuogu formula for early- and mid-stage non-traumatic osteonecrosis of femoral head

作　　者：陈卫衡[1] 周宇[1] 何海军[1] 王荣田[1] 王智耀[1] 林娜[2] 

机构地区：[1]中国中医科学院望京医院,北京100102 [2]中国中医科学院中药研究所,北京100700

出　　处：《中华关节外科杂志（电子版）》2013年第3期3-8,共6页Chinese Journal of Joint Surgery(Electronic Edition)

基　　金："十一五"国家科技支撑计划项目(2007BAI20B035);中国中医科学院优势病种课题(CACMS05Y-0029)

摘　　要：目的观察健脾活骨方治疗早中期非创伤性股骨头坏死的有效性及其特色,为早中期股骨头坏死的治疗提供一种可行、有效的方法。方法采用前瞻、配对、对照试验设计方案,将在中国中医科学院望京医院经健脾活骨方治疗的患者作为治疗组,经病灶清除打压植骨术治疗的患者作为对照组。将纳入患者按照ARCO分期相同、坏死面积相近、Harris评分相似、发病原因一致、入院治疗时间相近、体重指数相近、年龄相近的七个配对条件进行1:1配对,共配对120对(240例)。以X线影像稳定率、Harris评分、SF-36评分作为疗效评价指标,配对后进行12个月的随访,分析统计随访结果。结果治疗组影像稳定率为76.28%,与对照组的73.92%结果相当(X2=0.173,P>0.05),治疗组Harris评分为87.67分,高于对照组的83.39分(t=2.658,P<0.05),SF-36评分中,生理功能、生理职能、躯体疼痛、总体健康、社会功能、情感职能分值高于对照组(t=4.28,P<0.01;t=3.675,P<0.01;t=4.28,P<0.01;t=2.62,P<0.05;t=4.92,P<0.01;t=3.17,P<0.05),而活力分值低于对照组(t=-2.339,P<0.05)。不同分期研究显示,治疗组Ⅱ期患者影像稳定率82.02%略高于对照组的78.16%(X2=0.412,P>0.05),而Ⅲ期55.17%的稳定率则略低于对照组的60.71%(X2=0.179,P>0.05);Harris评分方面,两组两期疼痛缓解作用相近,其他方面则治疗组占优;SF-36评分中,治疗组Ⅱ期患者有略好于对照组趋势,而Ⅲ期则区别不明显。治疗组自身对照结果中,Ⅱ期患者影像稳定率为82.02%,高于Ⅲ期的55.17%(X2=8.507,P<0.01),而Ⅱ期患者Harris评分优良率及SF-36总体健康分均低于Ⅲ期。结论健脾活骨方治疗早中期非创伤性股骨头坏死疗效肯定,在改善髋关节功能及提高生活质量方面略优于手术治疗。健脾法在早期比中期更显示出疗效优势,即使中期在影像效果不佳的情况下,中药治疗对缓解症状、改善功能、提高生活质量仍有积极的意�Objective To clarify the efficacy and functional patterns of Jianpihuogu formula on early- and mid-stage non-traumatic osteonecrosis of the femoral head （NONFH） and to provide a feasible and reliable solution for this disease. Methods A scheme of prospective, match-up, control design was adopted in this study. 120 patients treated by Jianpihuogu formula in Wangjing Hospital, China Academy of Chinese Medical Science were set as treatment group, while another 120 patients accepted focal debridement and compact bone grafting surgery were designated as control group. Cases in two groups with similar conditions in terms of ARCO stage, volume of lesion, Harris Hip Score （HHS） , etiology, time of admission, body mass index and age were matched into 120 pairs （240 cases）. Radiographic stable rate of X-ray, HHS, and SF-36 score were used for evaluation of medical condition. A 12-month follow-up was carried out for all of them and statistical data were collected and analyzed. Results For radiographic stable rate, the difference between the treatment group （76. 28% ） and the control group （73.92%） was of no statistical significance （ x^2 = 0. 173, P 〉 0. 05 ）. HHS score of the treatment group （87.67） was higher than that of the control group （ 83.39 ） and the difference was statistically significant （ t = 2. 658, P 〈 0. 05）. The treatment group overmatched its counterpart in parameters of SF-36, including physical function, physical-role, body pain, social function, emotional-role and general heath （ t = 4. 28, P 〈 0. 01 ; t=3.675, P〈0. 01; t=4.28, P〈0.01; t=2.62, P〈0. 05; t=4.92, P〈0. 01; t=3.17, P〈0.05 respectively ）, while the vitality of the treatment group was inferior to the control group （ t = - 2. 339, P 〈 0. 05）. Sub-stage analysis showed that patients in stage 11 of the treatment group had a better radiographic outcome than the control group （82.02% versus 78. 16% ）, which was of no statistical significance （x^2 = 0. 412, P 〉0. 05）. Yet this i

关 键 词：健脾 股骨头坏死 非创伤性 前瞻性研究 临床疗效 

分 类 号：R274.9[医药卫生—中西医结合]