【作者】 段瑞奇；

【导师】 何伟；

【作者基本信息】 广州中医药大学 ， 中医骨伤科学， 2010， 博士

【摘要】 目的：回顾性研究打压支撑植骨术加中药的治疗方案对围塌陷期ONFH的疗效,客观分析围塌陷期概念在指导临床治疗的意义；比较酒精性和激素性股骨头坏死在临床疗效、影像进展及中医证型等方面的差异；评价ARCO分期分型因素在分期体系中的作用：分析中医辨病、辨证理论在股骨头坏死治疗中的意义。方法：2004年1月至2006年12月,在广州中医药大学第一附属医院髋关节疾病治疗中心住院的ONFH患者,期间接受打压支撑植骨术加中药治疗,并且术后能完成连续性随访2年以上的患者,共83例123髋。男66例(79.5%)99髋(80.5%),女17例(20.5%)24髋(19.5%),激素性坏死35例(42.2%)54髋(43.9%),酒精性48例(57.8%)69髋(56.1%)。ARCOⅡ期47髋(38.2%),Ⅲ期76髋(61.8%)；坏死范围15%～30%的66髋(53.7%),大于30%的57髋(46.3%)；坏死部位B型19髋(15.4%),C1型39骸(31.7%),C2型65髋(52.8%)；术前股骨头未塌陷47髋(38.2%),塌陷小于2mm的26髋(21.1%),塌陷2～4mm的26髋(21.1%),塌陷大于4mm的24髋(19.5%)。随访24～60个月,平均39.35个月。总结末次随访时Harris髋关节功能评分,比较酒精性和激素性ONFH疗效的差异,分别分析ARCO分期系统中的分期、范围、部位及股骨头塌陷的程度等因素对Harris评分及股骨头生存率的影响,对Harris评分的比较,两组比较采用独立样本的t检验,多组比较采用单因素方差分析,生存率分析用Kaplan-Meier法,两两比较采用log-rank检验,将患者手术日期至最后一次随访之间的时间作为生存时间,将Harris评分为差的(<70分)作为失效事件。用Mann-Whitney检验比较酒精性和激素性股骨头坏死的塌陷进展情况。单独研究塌陷前期坏死股骨头(47髋)的生存率,采用Kaplan-Meier法,将塌陷作为失效事件,将术后至股骨头塌陷的随访时间为生存时间,分别分析坏死分期、范围、部位与股骨头塌陷相关性；在对各相关因素进行Linear Regression回归分析。最后,分析中医辨病辨正治疗在股骨头坏死治疗中的作用；根据中医辨正分型,比较各证型Harris评分和股骨头生存率。所有结果采用spss11.5统计软件处理。结果：末次随访Harris评分优34髋(27.6%),良26髋(21.2%),可37髋(30.1%),差25髋(21.1%),临床优良率48.8%,有效率78.9%。共7髋转向全髋关节置换术。通过比较末次随访Harris评分,塌陷进展情况,塌陷前期股骨头生存率及中医证型分布等因素,酒精性和激素性ONFH差异均无统计学意义。ARCO分期分型因素中,坏死分期、范围对临床结果均有显著性影响。坏死部位对临床Harris评分及股骨头生存率方面均有影响,但是C1和C2型之间差异无显著性意义。术前坏死股骨头塌陷的程度对临床疗效有显著性影响,术前塌陷大于4mm的坏死股骨头和其它各组差异有显著性意义,而其它各组无显著性差异。中医证型比较,末次随访Harris评分差异无统计学意义。结论：打压支撑植骨术加中药的治疗方案治疗围塌陷期股骨头坏死具有肯定的临床疗效,股骨头塌陷4mm以下只要髋臼不受影响,均可以纳入保髋治疗范围。在ARCO分期系统的影响因素中,坏死分期、范围在指导治疗方案的选择和判断预后方面具有重要的实用价值。但坏死部位的作用不是不可或缺的,在测量坏死范围的情况下,部位分型在分期系统中可以省略,以简化分期系统。与全髋关节置换相比较,基于Harris评分的髋关节疗效评价标准应该适当放宽,结合本研究的结果,应将Harris评分大于等于70分作为评判疗效的标准。从本研究的结果,还不能认为酒精性和激素性ONFH在临床疗效方面等存在差异。运用中医辨病辨正理论为基础,将中药治疗纳入治疗方案,是为了加快坏死骨的修复,但ONFH的中医证型与临床结果之间没有显著的相关性。更多还原

【Abstract】 Objective:This retrospective study composed four purpose:(1) The effect of the treatment about Impacting Bone Graft combined with traditional Chinese medicine treating Pericollapse Stage ONFH will be evaluated. Then, the concept of Pericollapse Stage was objectively evaluated on guiding treatment. (2) Difference between the alcohol-induced and steriod-induced ONFH will be compared according to clinical effect, radiology progression, and the distribution difference of the syndrome types by TCM theory. (3) The contribution of the factors composed in the ARCO classification system will be analasised in this clinical study. (4) the rerationship between the clinical result and the theory of diease differentiation and syndrome differentiation will be analasised.Methods:From January 2004 to December 2006, There were 83 (123 hips) ONFH cases were treated with Impacting Bone Graft combined with TCM at the hip center of the first hospital of Guangzhou TCM university. All these case were related with alcohol abuse or steriod adminstration, and should be consistently followed up at least for 2 years. there were 66 (79.5%) male and 17 (20.5%) female cases,35 (42.2%) steriod-induced and 48 (57.8%) alcohol-induced. According to ARCO classification, stageⅡ47 (38.2%) hips, stageⅢ76 (61.8%) hips. According to lesion size,66 (53.7%) hips were 15%～30%,57 (46.3%) hips were >30%. According to lesion region,19 (15.4%) hips B type,39 (31.7%) hips C1 type,65 (52.8%) hips C2 type. According to the colleps extent of the femur head,47 (38.2%) hips zero,26 (21.1%) hips<2mm, 26 (21.1%) hips 2～4mm,24 (19.5%) hips >4mm. The follow up time was 24～60 months, average 39.35 months. At the last follow up,the Harris score was collected, the difference of the treatment effect between the AONFH and the SONFH was analysised. The factors, such as lesion stage, size, region and extent of the collaps of the femur head, was analysed one by one with their influence on the Harris score and survival rate. The Independent-Samples T Test procedure Wes used to compare means for two groups of cases based on stage(stageⅡ, stage III), percent involvement (15% to 30%[moderate], or>30%[severe]), and reason(alcohol or steriod). The One-Way ANOVA procedure was used for a quantitative dependent variable based on lesion region(B,C1,C2), extent of the collaps (zero,<2mm,2～4mm,>4mm.). The log rank test was used to compare Kaplan-Meier survival curves for the time from surgery to the last follow up for separate groupings based on stage (stageⅠ, stageⅢ), percent involvement(15% to 30%[moderate], or >30% [severe]), reason(alcohol or steriod), and lesion region(B, Cl, C2), in this procedure, that Harris score less than 70 was seen as failure event. The Mann-Whitney procedure was used to compare progression of the femur head collaps between the AONFH and the SONFH. In the precollaps ONFH group, the log rank test was used to compare Kaplan-Meier survival curves for the time from surgery to the time the femur head collaps happened for separate groupings based on stage(stageⅡ, stage III), percent involvement(15% to 30%[moderate], or>30% [severe]), reason(alcohol or steriod),and lesion region(B, C1, C2), in this procedure, that collaps of the femur head was seen as failure event. Linear Regression was used to compare the factos with regard to their ability to predict the time to progression. Finaly, the clinical effect was evaluated with regard to diease differentiation and syndrome differentiation by TCM theory. According to Harris score, we compared the clinical result and the survival rate of the femur head based on different syndrome types of femoral head necrosis by TCM theory. All of the data was analyzed by the statistical packages SPSS 11.5 for windows.Results:According to Harris score at the last follow up, we got the clinical results:excellent 34 (27.6%) hips, good 26 (21.2%) hips, fair 37 (30.1%) hips, poor 25 (21.1%) hips, and the clinical excellent rate was 48.8%, and the clinical effective rate was 78.9%. Of all the hips, there were 7 hips converted to total hip arthroplasty in the end. Comparing AONFH and SONFH, there wasn’t significant difference based on Harris score, collaps extent of the femur head, survival rate of the precollaps hips, and distribution of syndrome types of femoral head necrosis by TCM theory. With regard to factors in ARCO classification, there was significant difference based on stage(stage II, stageⅢ), percent involvement (15% to 30%[moderate], or>30%[severe]). Though there was statistical difference based on lesion region (B, C1, C2), yet,there was not significant difference between Cl and C2. The collaps extent of the femur head before operation could infuence the clinical result significantly, but the difference just existed between the group>4mm and the other group(zero,<2mm,2～4mm). According to Harris score, there was not significant difference based on distribution of syndrome types of femoral head necrosis by TCM theory.Conclusion:The Impacting Bone Graft combined with TCM is a effective therapeutic regimen for the pericollapse stage ONFH. As long as the collaps of the femur head is not more than 4mm, the hip can be treated with this regimen, considering the factors in the ARCO classification, the stage and lesion size play a important role on chosing therapeutic method and assess prognosis. But the lesion region is not indispensable, if lesion size would be measured,the factor of lesion region can be delected from the classification system, so as to simplify the classification system. Comparing to other similar studies, it looks like the excellent rate(48.8%) and effective rate(78.9%) is lower, but considering the more cases of ARCOⅢand percent involvement (>30% [severe]), maybe the result is better. Comparing to total hip replacement,the Evaluation Criterion for surgery conserving hips based on Harris score should be lower. Refering the results of this study, that the Harris score 70 should be seen as the criterion assigning the effective clinical result. Just based on this study, there is not significant difference between AONFH and SONFH on clinical result. Using the theory of diease differentiation and syndrome differentiation, the TCM was composed to the therapeutic regimen, the purpose for this is to accelerate reparing reaction of the necrosis bone. There is not significant relationship between the syndrome types of femoral head necrosis by TCM theorv and the clinical result.更多还原