【作者】 张书钦；

【导师】 陈卫衡；

【作者基本信息】 中国中医科学院 ， 中医骨伤科学， 2010， 硕士

【摘要】 股骨头坏死(Osteonecrosis of the Femoral Head, ONFH)是由于某些原因导致股骨头无菌性炎症、坏死的一种病理过程,临床以疼痛、跛行、功能障碍为特征,病情呈进行性加重,致残率极高,疗效差,严重影响人们的生活健康。随着对股骨头坏死临床研究的不断深入,许多方法开始结合应用,在临床上并取得了很好的疗效,显示出其巨大的潜力和广阔的前景。而中医药对股骨头坏死的早期治疗,在某些方面也体现了比较明显的优势。目的：通过中、西医治疗股骨头坏死的回顾性研究,观察其近中期疗效和中医证候特点,分析中、西医治疗股骨头坏死的优势,以便于指导股骨头坏死的临床治疗。方法：拟定本研究方案；选取2002年1月至2008年12月在中国中医科学院望京医院接受治疗的股骨头坏死患者；设计CRF表,根据纳入标准与剔除标准,对采用中、西医保守治疗方法且随访在1年至三年的患者填写CRF表,同时收集各阶段影像材料；整理入组患者的临床资料和影像评定资料,建立数据库；选取合适的统计学方法对数据进行统计分析。结果：1.一般情况2002年1月至2008年12月股骨头坏死病例共487例,满足随访病例共421例,686髋,随访率86.45%。其中男性274例,451髋,女性147例,235髋。最大年龄75岁,最小年龄15岁,平均40.46±11.34。获得了平均20.3个月的随访。随访一年病例434髋,随访两年病例183髋,随访三年及以上病例69髋。中药多途径治疗406髋,植骨+中药治疗182髋,综合保守治疗98髋。Ⅰ期32髋,Ⅱ期453髋,Ⅲ期190髋,Ⅳ期11髋。(表1)中药多途径治疗后随访一年病例261髋，随访两年病例100髋，随访三年病例45髋；植骨+中药治疗后随访一年病例106髋，随访两年病例54髋，随访三年病例22髋；综合保守治疗后随访一年病例67髋，随访两年病例29髋，随访三年病例2髋。Ⅰ期治疗后随访一年病例21髋，随访两年病例7髋，随访三年病例4髋；Ⅱ期治疗后随访一年病例278髋，随访两年病例127髋，随访三年病例48髋；Ⅲ期治疗后随访一年病例126髋，随访两年病例47髋，随访三年病例17髋；Ⅳ期治疗后随访一年病例9髋，随访两年病例2髋。(表2)2．总体结果2．1 Harris髋关节功能评价按Harris效性标准，686髋股骨头坏死病例总有效率达到80．61％。2．2影像学评价按影像学效性指标，686髋股骨头坏死病例影像稳定率为80．47％。3单因素分层结果3．1按治疗方法3．1．1 Harris髋关节功能评价三种治疗方法的总体稳定率分别为62．24％、83．25％、79．67％。不同治疗方法间Harris功能评价的总有效率差异无统计学意义(P>0．05)。3．1．2影像学评价三种治疗方法的影像稳定率分别为84．69％、81．28％、80．22％。不同治疗方法间影像学稳定率差异无统计学意义(P>0．05)。3．2按ARCO分期3.2.1 Harris髋关节功能评价Ⅰ、Ⅱ、Ⅲ、Ⅳ期的总有效率分别为90.63%、83.44%、73.16%、36.36%。不同分期的股骨头坏死病例的总有效率差异显著,有统计学意义(P<0.05)。3.2.2影像学评价Ⅱ、Ⅲ、Ⅳ期的影像稳定率分别为82.78%、80.53%、90.91%,不同分期的股骨头坏死病例的影像稳定率差异有统计学意义(P<0.05)。3.3按随访时间3.3.1 Harris髋关节功能评价随访三个时间点的总有效率分别为79.49%、84.70%、76.81%,不同随访时间股骨头坏死病例的总有效率差异显著,有统计学意义(P<0.05)。3.3.2 Harris评分比较随访一年病例总体Harris评分为78.04±11.80；随访两年病例总体Harris评分为80.54±11.68；随访三年病例总体Harris评分为81.50±8.00。ANOVA分析检验结果：随访两年及三年Harris评分高于随访一年Harris评分,有统计学意义(P<0.05)；随访三年Harris评分高于随访两年Harris评分,无统计学意义(P>0.05)。3.3.2影像学评价按影像学效性标准,三个随访时间点的影像稳定率分别为82.26%、77.60%、76.81%。不同随访时间股骨头坏死病例的影像稳定率无统计学意义(P>0.05)。4两因素分层4.1按治疗方法-随访时间4.1.1 Harris评分比较ANOVA分析检验结果：与中药多途径给药治疗后一年相比,治疗后两年Harris评分提高,有统计学意义(p<0.05)。4.1.2 Harris髋关节功能评价综合保守治疗后随访一年、两年的临床显效率分别为8.96%、17.24%,有效率分别为50.75%、48.28%。卡方检验结果差异无统计学意义(P>0.05)。中药多途径给药治疗后随访一年、两年、三年的临床显效率分别为16.48%、21.00%、15.56%,有效率分别为67.82%、61.00%、64.44%。卡方检验结果差异无统计学意义(P>0.05)。植骨+中药治疗后随访一年、两年、三年的临床显效率分别为16.04%、24.07%、18.18%,有效率分别为61.32%、61.32%、68.18%。卡方检验结果差异无统计学意义(P>0.05)。4.1.3影像学评价综合保守治疗后随访一年、两年的稳定率分别为89.55%、72.41%。卡方检验结果差异无统计学意义(P>0.05)。中药多途径给药治疗后随访一年、两年、三年的稳定率分别为82.76%、79.00%、77.78%。卡方检验结果差异无统计学意义(P>0.05)。植骨+中药治疗后随访一年、两年、三年的稳定率分别为78.30%、81.48%、81.82%。卡方检验结果差异无统计学意义(P>0.05)。4.2按治疗方法-随访时间4.2.1 Harris评分比较ANOVA分析检验结果：Ⅲ期病例中,与治疗后一年的Harris评分比较,治疗后两年和三年均有所提高,,有统计学意义(p<0.05)。4.2.2 Harris髋关节功能评价Ⅰ期病例治疗后随访一年、两年、三年的临床显效率分别为33.33%、42.86%、50.00%,有效率分别为52.38%、57.14%、50.00%。卡方检验结果差异无统计学意义(P>0.05)。Ⅱ期病例治疗后随访一年、两年、三年的临床显效率分别为16.19%、19.69%、14.58%,有效率分别为68.71%、62.99%、62.50%。卡方检验结果差异无统计学意义(P>0.05)。Ⅲ期病例治疗后随访一年、两年、三年的临床显效率分别为16.67%、27.66%、11.76%,有效率分别为55.56%、48.94%、58.82%。卡方检验结果差异有统计学意义(P<0.05)。4.2.3影像学评价Ⅰ期病例治疗后随访一年、两年、三年的稳定率均为100%。卡方检验结果差异无统计学意义(P>0.05)。Ⅱ期病例治疗后随访一年、两年、三年的稳定率分别为84.53%、81.10%、77.08%。卡方检验结果差异无统计学意义(P>0.05)。Ⅲ期病例治疗后随访一年、两年、三年的稳定率分别为83.33%、76.60%、70.59%。卡方检验结果差异有统计学意义(P<0.05)。Ⅳ期病例治疗后一年、两年的稳定率分别为88.89%。5证候特点在421例股骨头坏死患者中,气滞血瘀证(A组)患者55例,占13.06%；痰瘀阻络证(B组)患者168例,占49.90%；经脉痹阻证(C组)患者109例,占25.89%,肝肾亏虚证(D组)患者89例,占21.14%。三个证型分别采用中药多途径给药治疗、植骨+中药治疗和综合保守治疗的例数之间差异有统计学意义(P<0.05)。关节疼痛、晨僵、体倦乏力、关节屈伸不利等常见症状或体征与证候分型的关系：关节疼痛及晨僵在气滞血瘀证、痰瘀阻络证及经脉痹阻证中常见,肝肾亏虚证常见有体倦乏力的表现,而股骨头坏死患者中功能普遍较差,关节屈伸不利。结论：1.股骨头坏死的中、西医保髋治疗不仅必要,且疗效确切,具有可行性；2.中药多途径给药治疗具有操作简单、药物作用充分、副作用小、安全性高的优点,更易于被患者接受；3.在植骨的基础上,应用中药内服外用治疗在功能恢复和作用持久方面能发挥更大作用。更多还原

【Abstract】 Objective:Through retrospective clinical study on osteonecrosis of the femoral head(ONFH) with integrated traditional Chinese and Western medicine treatment, observe the short-term effectiveness and traditional Chinese medicine syndrome and analyse its superiority so as to guide the clinical treatment.Method:Screen the cases of femoral head necrosis (ONFH) for conservative treatment in Wangjing hospital of China Acadamy of Chinese Medicine Science from January 2002 to December 2008, and follow-up to a year or more, collect the case report form(CRF) and image material of each stage, then establish a database, apply image and Harris score for efficacy evaluation. Analyse statistically by stratifing according to the three factors:treatment method, ARCO stage and follow-up time.Results:1 General informationThere’s 487 ONFH cases received conservative treatment from January 2002 to December 2008.421 cases of patients (686 hips)met the follow-up, up to 86.45%. 274 cases(451 hips) were male,147 cases (235 hips) female. The age range was 15-75 years old, mean 40.46±11.34. Received an average of 20.3 months of follow-up.434 hips were followed up for one year,183 hips for two years,69 hips for three years or more.406 hips with traditional Chinese medicine multi-way treatment(Method 1) were followed up,182 hips with grafting bone+traditional Chinese medicine(TCM) treatment(Method 2), and 98 hips with synthesis conservative treatment(Method 3).32 hips of ONFH patients ARCOⅠwere followed up,453 hips of ARCOⅡ, 190 hips of ARCOⅢ,11 hips of ARCOⅣ. (Table 1) After Method 1 treatment,261 hips were followed up for one year,100 hips for two years,45 hips for three years; after Method 2 treatment 106 hips were followed up for one year,54 hips for two years,22 hips three-year’s; after Method 3 treatment, 67 hips were followed up for one year,29 hips for two years,2 hips for three years.Ⅰperiod of ONFH patients after treatment,21 hips were followed up for one year,7 hips for two years,4 hips for three years;Ⅱperiod of ONFH patients after treatment,287 hips were followed up for one year,129 hips for two years,48 hips for three years;Ⅲperiod of ONFH patients after treatment,126 hips were followed up for one year,47 hips for two years,17 hips for three years;Ⅳperiod of ONFH patients after treatment,9 hips were followed up for one year,2 hips for two years.2 Overall Results2.1 Harris hip joint function appraisalAccording to the Harris titre standard, total effectiveness of 686 ONFH hips achieves 80.61%.2.2 Image resultAccording to the image titre standard,686 ONFH hips’phantom index of stability is 80.47%.3 Stratified the results of single factor3.1 Stratified according to treatment3.1.1 Harris hip joint function appraisalOverall index of stability of the three treatment methods is respectively 62.24%, 83.25%,79.67%. The total effective rate of the Harris function appraisal among different treatment methods is no significant difference (P>0.05).3.1.2 Image resultThe image stable rate of three methods is respectively 84.69%,81.28%,80.22%. Different methods in the treatment have no significant difference in image stable rate (P> 0.05).3.2 Stratified according to ARCO Stage3.2.1 Harris hip joint function appraisalThe total effective rate of ARCOⅠ,Ⅱ,Ⅲ,Ⅳis respectively 90.63%,83.44%, 73.16%,36.36%. The total efficiency in different stages has significant difference statistically (P<0.05).3.2.2 Image resultThe image stable rate of ARCOⅡ,Ⅲ,Ⅳis respectively 84.69%,81.28%, 80.22%. Different stages in the treatment have significant difference in image stable rate(P<0.05).3.3 Stratified according to follow-up time3.3.1 Harris hip joint function appraisalThe total effective rate of the three time points is respectively 79.49%,84.70%, 76.81%. The total efficiency in different follow-up time has significant difference statistically (P<0.05).3.3.2 Harris score comparisonOverall Harris score followed up a year was 78.04±11.80; up two cases, the score was 80.54±11.68; up three cases was 81.50±8.00. ANOVA analysis of test results:two-and three-year follow-up Harris score was higher than the one-year’s, statistically significant (P<0.05); three-year follow-up Harris score was higher than the two-year’s, no statistical significance(P> 0.05).3.3.3 Image resultThe image stable rate of the three time points is respectively 82.26%,77.60%, 76.81%. Different follow-up time has no statistical difference in image stable rate (P> 0.05).4 Stratified the results of two factors 4.1 Stratified according to treatment-follow-up time4.1.1 Harris score comparisonANOVA analysis of test results:compared to one year after treatment with Method 1, Harris score after treatment for two years increased significantly (p<0.05).4.1.2 Harris hip joint function appraisalAccording to Harris evaluation criteria, with Method 1 treatment,16.48% clinical excellence and 67.82% efficiency for follow-up one year,21.00% and 61.00% for two years,15.56% and 64.44% for three years. Chi-square test results showed no significant difference (P> 0.05).According to Harris evaluation criteria, with Method 2 treatment,16.04% clinical excellence,61.32% efficiency for follow-up one year,24.07% and 61.32% for two years,18.18% and 68.18% for three years. Chi-square test results showed no significant difference (P> 0.05).According to Harris evaluation criteria, with Method 3 treatment,8.96% clinical excellence,50.75% efficiency for follow-up one year,17.24% and 48.28% for two years. Chi-square test results showed no significant difference (P> 0.05).4.1.3 Image resultBy image evaluation criteria, with Method 1 treatment,82.26% stable for follow-up one year; 79.00% stable for two years; 77.78% stable for three years. Chi-square test results showed no significant difference (P> 0.05).By image evaluation criteria, with Method 2 treatment,78.30% stable for follow-up one year; 81.48% stable for two years; 81.82% stable for three years. Chi-square test results showed no significant difference (P> 0.05).By image evaluation criteria, with Method 1 treatment,89.55% stable for follow-up one year; 72.41% stable for two years. Chi-square test results showed no significant difference (P> 0.05).4.2 Stratified according to treatment-follow-up time4.2.1 Harris score comparisonANOVA analysis of test results:compared with stageⅢfor one year, Harris score increased for two years and three years after treatment with statistical significance (p<0.05).4.2.2 Harris hip joint function appraisalAccording to Harris evaluation criteria, in StageⅠcases,33.33% clinical excellence,52.38% efficiency for follow-up one year,42.86% and 57.14% for two years,50.50% and 50.00% for three years. Chi-square test results showed no significant difference (P> 0.05).According to Harris evaluation criteria, in StageⅡcases,16.19% clinical excellence,68.71% efficiency for follow-up one year,19.69% and 62.99% for two years,14.58% and 62.50% for three years. Chi-square test results showed no significant difference (P> 0.05).According to Harris evaluation criteria, in StageⅢcases,16.67% clinical excellence,55.56% efficiency for follow-up one year,27.66% and 48.94% for two years.11.76% and 58.82% for three years. Chi-square test results significantly (P <0.05).According to Harris evaluation criteria, in StageⅣcases,33.33% efficiency for follow-up one year,50.00% clinical excellence for two years. Chi-square test results showed no significant difference (P> 0.05).4.2.3 Image resultBy image evaluation criteria, in StageⅠcases,100.00% stable for the three time points.By image evaluation criteria, in StageⅡcases,84.53% stable for follow-up one year; 81.10% stable for two years; 77.08% stable for three years. Chi-square test results showed no significant difference (P> 0.05).By image evaluation criteria, in StageⅢcases,83.33% stable for follow-up one year; 76.60% stable for two years; 70.59% stable for three years. Chi-square test results showed no significant difference (P> 0.05).By image evaluation criteria, in StageⅣcases,88.89% stable for follow-up one year.5 Syndromes characteristic In 421 cases of ONFH patients, stagnancy of qi and blood stasis type(气滞血瘀证, Type A) were 55 cases, accounting for 13.06%; the stagnation of phlegm and blood stasis in collateral branch of the large channel type (痰瘀阻络型, Type B) 168 cases, accounting for 49.90%, blockage of channels type (经脉痹阻型, Type C) 109 cases, accounting for 25.89%, liver-yin and kidney-yin type (肝肾亏虚型, Type D) 89 cases, accounting for 21.14%.Relationship between common adverse symptoms or signs (such as Joint pain, morning stiffness, body tired fatigue, joint flexion and extension) and syndrome type: joint pain and morning stiffness in Type A, Type B and Type C, Type D common with the performance of weak body tired. but the function of the ONFH patients are generally bad joint flexion and extension negative accompanied.Conclusion:1. ONFH as a worldwide difficult treatment disease at high rate of deformity, the Chinese and Western medical hip-preserving treatment is not only necessary but also effective and feasible.2. Chinese medicine treatment of multi-channel delivery is simple, drugs function full, small side effects, the advantages of high security, more easily acceptable by the patients.3. The application of topical treatment of Chinese Herbs based on the bone graft can play a greater role in the function and sustainable.更多还原