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酒精性股骨头坏死保髋疗效的相关性研究
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摘要
研究背景:股骨头坏死是一种世界性的难治病,一旦发生,若没有有效的干预,绝大多数病变将呈进行性加重,自行好转的几率微乎其微。病变进展的结局是程度不同的股骨头塌陷,从而影响髋关节功能,多数患者最终需行人工关节置换术。非创伤性ONFH好发于20~50岁的中青年,而中青年患者人工关节置换术的长期疗效仍难预料,相当数量的患者一生将面临两次或更多次的置换,无疑会给患者和社会带来巨大的经济和身心负担。因此,对于股骨头坏死早、中期首选的治疗方法是保髋治疗。
     文献报道非创伤性ONFH患者中10%~74%有长期酗酒史。2004年~2007年在我院髋关节病重点专科住院治疗的非创伤性股骨头坏死患者有529例,其中266例有长期酗酒史,占50.28%,位于第一位。同时,中医辨证分型认为酒精性股骨头坏死是气滞血瘀兼痰湿蕴结型,而激素性股骨头坏死为气滞血瘀兼肝肾亏虚型,两者发病机制存在差异可能影响其保髋疗效。因此我们有必要将酒精性股骨头坏死进行单独研究。
     我们设计了打压植骨支撑术配合中药治疗酒精性股骨头坏死,评价股骨头坏死预后和保髋疗效,分析影响保髋疗效的相关因素,以及“痰瘀同治”对酒精性股骨头坏死患者血脂水平和血液流变学的影响,探讨“痰瘀互结”与酒精性股骨头坏死的发病关系,“痰瘀同治”在酒精性股骨头坏死治疗中的地位。
     研究方法
     1打压植骨支撑术配合中药治疗酒精性股骨头坏死的临床研究
     2004年1月~2007年12月按照设计的诊断标准、纳入标准和排除标准收集在广州中医药大学第一附属医院髋关节病重点专科住院治疗的AIONFH患者93例123髋,采用打压植骨支撑术配合中药。调查各种影响因素:年龄,侧别,分期,正、蛙位分型(坏死部位),正、蛙位分型组合、疼痛指数,骨髓水肿,关节活动度总和,Harris评分,坏死范围,正位、蛙位塌陷程度,疼痛出现时间等。采用EXCEL 2000进行数据录入,SPSS 13.0进行统计分析。计量资料采用t检验、方差分析,计数资料采用卡方检验,等级资料采用秩和检验,双变量相关采用Spearman及Pearson相关分析,多变量相关采用多元线性回归分析,两组数据相关性分析采用典型相关分析,生存曲线分析采用Log-rank检验及Cox比例风险回归分析。
     2“痰瘀同治”对酒精性股骨头坏死患者血液流变学及血脂水平的影响
     2008年7月~2009年2月按照设计的诊断标准、纳入标准和排除标准募集在广州中医药大学第一附属医院髋关节病重点专科住院治疗的AIONFH患者58例,其中创伤性骨坏死17例(对照组),酒精性骨坏死41例(治疗组),酒精性骨坏死采用祛瘀化痰法中药内服。入院后治疗前均晨起空腹抽取外周静脉血检测血脂六项及血液流变学;治疗组服用祛瘀化痰中药2周后再次晨起空腹抽取外周静脉血检测血脂六项及血液流变学。所测值均用SPSS 13.0统计软件进行配对t检验,以均数±标准差((?)±s)表示。
     研究结果
     1打压植骨支撑术配合中药治疗酒精性股骨头坏死的临床研究
     1.1术前、术后各观察指标相关性分析结果:
     ①术前关节活动度越大,则术前Harris评分越高;
     ②术前骨髓水肿程度越重、坏死范围越大,则术前疼痛指数越高;
     ③术前Harris评分越高、术前疼痛指数越轻、坏死范围越小,则术后Harris评分越高;
     ④术前分期较重、术前正位分型为C2、术前蛙位塌陷越重的病人,则术后头臼关系越不和谐、软骨退变越重;
     ⑤年龄越大、术前Harris分级越差,则术后疼痛指数越高;
     ⑥术前分期越重的患者术后疼痛指数越低;
     ⑦术后疼痛指数明显低于术前;
     ⑧术后Harris评分分数及分级显著高于术前。
     1.2股骨头生存曲线分析
     1.2.1以末次随访时间为随访终点计算股骨头存活时间
     平均随访36.4个月,股骨头生存率为82.2%,平均生存时间为56.624个月。
     1.2.2探讨术前及术后各指标对生存率曲线的影响(Log-rank检验)
     结果:
     ①年龄对股骨头生存率曲线有影响,25-35岁、36-45岁年龄阶段的股骨头生存率比46岁以上年龄阶段的股骨头生存率高;
     ②术前蛙位分型对股骨头生存率曲线有影响,术前蛙位分型为C1的股骨头生存率大于蛀位分型为C2的股骨头生存率;
     ③术后多个因素对股骨头生存率曲线有影响,术后疼痛指数越高、术后正位塌陷程度越重、术后蛙位塌陷程度越重、头臼关系不和谐、关节不稳定、软骨退变越严重,股骨头生存率越低。
     ④术前多数因素(侧别、术前疼痛指数、术前骨髓水肿程度、术前总关节活动度、术前分期、术前正位分型、术前正蛙位分型组合、坏死范围、术前正位塌陷值、术前蛙位塌陷值、疼痛出现的时间、术前Harris评分等)对股骨头生存率曲线无影响。
     1.2.3 COX比例风险回归
     术后疼痛指数越高,保髋失败的机率越大;其对应的相对危险度为3.102,说明疼痛指数每增加一个等级,保髋失败的风险是原来的3.102倍。
     2“痰瘀同治”对酒精性股骨头坏死患者血液流变学及血脂水平的影响:
     ①与创伤性股骨头坏死对照,酒精性股骨头坏死与血脂代谢有一定关系,表现为TG、ApoB和ApoB/ApoA升高,而HDL和ApoA减低;
     ②酒精性股骨头坏死患者经治疗后血脂水平有改善,表现为CHOL、HDL、LDL、ApoA、ApoB和ApoB/ApoA减低;
     ③酒精性股骨头坏死患者与创伤性股骨头坏死患者比较,无明显存在血液流变学差异;
     ④酒精性股骨头坏死患者经治疗后血液高凝状态有改善,表现为200/S、30/S、3/S、HCT(X)、Arbe、ηc、EPT、HRV和IR减低,而ESR和K升高。
     结论
     1打压植骨支撑术配合中药治疗酒精性股骨头坏死的临床研究
     ①打压植骨支撑术配合中药治疗酒精性股骨头坏死,临床平均随访36.4个月,股骨头生存率约82.2%,Harris评分为90.99±7.325分,优良率为92.53%,取得令人满意的保髋疗效,说明我们选择的治疗方案和适应症是合理的。
     ②临床上对46岁以上年龄阶段和坏死位于蛙位C2型的股骨头坏死患者,我们建议采用其他保髋方法,甚至可以考虑人工关节置换。
     ③正确把握保髋适应症(包括年龄、分期、坏死部位、坏死范围等)、坚持中西医结合、提高手术技巧、增进医患合作、提高保髋疗效,对减轻患者的经济和精神负担具有重要的社会意义。
     2“痰瘀同治”对酒精性股骨头坏死患者血液流变学及血脂水平的影响
     ①“痰瘀互结”是AIONFH病机病理的关键所在;
     ②“痰瘀同治”能改善患者的高脂血症和血液高粘滞状态。
     ③“痰瘀同治”为“治未病”和“既病防变”提供临床依据。
Background:
     Osteonecrosis of the femoral head is aworldly difficult to treat,in the event,if there is no effective intervention,the vast majority of lesions become heavier to carry out their own little chance of improvement.Outcome of disease is varying degrees of femoral head collapse,thus affecting the hip joint function,most patients need to artificial arthroplasty ultimately. Non-traumatic ONFH occurs in 20 to 50-year-old,and young and middle-aged patients with artificial joint replacement is still difficult to predict the long-term efficacy;a considerable number of patients will face two or more of the replacement in lifetime.Patients will suffer to enormous economic and physical burden undoubtedly.Therefore,early necrosis of the femoral head, medium of choice for treatment is the hip-preserving.
     Reported in the literature,10%-74%of NONFH in patients have long-term history of alcohol abuse.2004-2007 year in the focus of hip disease specialist department of our hospital,there are 529 cases of NONFH treated in patients,266 of which cases have a long history of alcohol abuse,accounting for 50.28 percent.At the same time,TCM Syndrome type of alcohol-induced ONFH is between phlegm and stasis,but steroid-induced ONFH is between deficiency and stasis,there are differences between the pathogenesis of which may affect its hip-preserving efficacy.Therefore,we need to study AIONFH in isolation.
     We designed a minimally invasive bone marrow decompression with pressure bone graft and internal bracket implanting surgery integrating Chinese medicine to treat AIONFH,to evaluate the prognosis of AIONFH and hip-preserving efficacy,analysis the related factors that effect the hip-preserving.Influence "treatment between phlegm and stasis" of AIONFH in patients with blood lipid levels and blood hemorrheology,to explore incidence relations between the "interrelation between phlegm and stasis" and AIONFH, the role in "treatment between phlegm and stasis" of AIONFH.
     Methods:
     1.Clinical study of pressure bone graft and internal bracket implanting surgery integrating Chinese medicine to treat the AIONFH
     93 patients(123 hips) were hospitalized in Department of hip-disease of the ist affiliated hospital of Guangzhou University of Chinese Medicine who were recruited strictly in the light of diagnosis criteria,bringing into criteria and excluding criteria devised in the project from January 2004 to December 200?,who treated with a minimally invasive bone marrow decompression with pressure bone graft and internal bracket implanting surgery integrating Chinese medicine.Investigate the impact of factors including:age,side of other phases is being frog-bit sub-type(necrotic parts),are frog-bit sub-type combinations,the pain index,bone marrow edema,the total range of motion,Harris score,necrotic area,is situated frog-bit collapse the degree of pain and time.EXCEL 2000 for the use of data entry,SPSS 13.0 for statistical analysis.Measurement data using t test,variance analysis,count data using chi-square test,class rank and test data used,two variables related to the use of Spearman and Pearson correlation analysis,multi-variable related to the use of multiple linear regression analysis,two sets of data dependence analysis the use of canonical correlation analysis,survival curve analysis using Log-rank test and Cox proportional hazards regression analysis.
     2.The influence "treatment between phlegm and stasis" of AIONFH in patients with blood lipid levels and blood hemorrheology
     58 patients were hospitalized in Department of hip-disease of the 1st affiliated hospital of Guangzhou University of Chinese Medicine who were recruited strictly in the light of diagnosis criteria,bringing into criteria and excluding criteria devised in the project from July 2008 to February 2009, of which 17 patients of traumatic osteonecrosis(control group),41 patients of AIONFH(treatment group),who take Chinese medicine of eliminating phlegm andstasis.Before treatment all patients were hemospasia detected peripheral lipid and hemorheology in early morning;treatment group was given Chinese medicine of eliminating phlegm and stasis,after two weeks they were hemospasia detected peripheral lipid and hemorheology in early morning again.The measured value of SPSS 13.0 statistical software using paired t inspection to mean±standard deviation((?)±s) indicated.
     Results:
     1 Clinical study of pressure bone graft and internal bracket implanting surgery integrating Chinese medicine to treat the AIONFH
     1.1 Observing correlative analysis before and after operation,results showed that:
     ①Pre-operative greater range of motion,then the higher pre-operative Harris score;
     ②Pre-operative more severe degree of bone marrow edema and necrosis of the greater range,the index of the higher pre-operative pain;
     ③Pre-operative Harris score the higher the index the more pre-operative pain in light,the smaller the necrotic area,the higher score after Harris;
     ④Severe pre-operative staging,pre-operative typing is situated for the C2, frog-bit pre-operative patients with more severe collapse,then the relationship between post-operative acetabular head the more discordant,more severe cartilage degeneration;
     ⑤Older,poorer pre-operative Harris classification,the higher post-operative pain index;
     ⑥Pre-operative staging of patients with more severe post-operative pain index lower;
     ⑦Post-operative pain index was significantly lower than pre-operative;
     ⑧Post-operative Harris scores and the grading score was significantly higher than that pre-operatively.
     1.2 Analysis of survival curve of the femoral head
     1.2.1 the survival time of the femoral head following-up the clinical. The average follow-up of 36.4 months,the survival rate is 82.2%of the femoral head,the average survival time of 56.624 months.
     1.2.2 Discussion of the pre-operative and post-operative indicators of the impact on the survival curve(Log-rank test) We can see:
     ①Survival curves of age on the impact of the femoral head,25 to 35-year-old、36 to 45-year-old age are higher than the age above 46-year-old in the survival rate of the femoral head;
     ②Pre-operative frog-bit sub-type of head impact on the survival rate curve, frog-bit pre-operative classification of the femoral head for the C1 frog survival rate is greater than for the C2-bit sub-type of the survival of the femoral head;
     ③A number of factors after operation affecting the survival curve,the higher post-operative pain index,after the more serious the degree of orthotopic collapse,after collapse of the extent of frog bit more serious,the first disharmony acetabulum,joint instability,cartilage degeneration,the more serious,the lower the survival rate of the femoral head.
     ④Most pre-operative factors(other side,pre-operative pain index,the degree of pre-operative bone marrow edema,pre-operative total range of motion, pre-operative staging,pre-operative typing is situated,before being frog-bit sub-type combination of necrotic area,pre-operative value of orthotopic collapse,collapse pre-operative frog-bit value,pain and time, pre-operative Harris score,etc.) of the femoral head had no effect on the survival rate curve.
     1.2.3 COX proportional hazards regression
     the higher post-operative pain index,the greater probability of failure of the hip;its corresponding relative risk was 3.102 on a pain index for each additional level of security risk of hip failure is 3.102 times the original.
     2.The influence "treatment between phlegm and stasis" of AIONFH in patients with blood lipid levels and blood hemorrheology:
     ①Contrast to traumatic osteonecrosis of the femoral head,to some extent, AIONFH is relationship with lipid metabolism,TG,ApoB and ApoB/ApoA are higher, while HDL and ApoA is reduced;
     ②The patients with AIONFH after treatment is to make better lipid levels, CHOL,HDL,LDL,ApoA,ApoB and ApoB/ApoA are reduced;
     ③The patients with AIONFH contrast to the patients with traumatic ONFH,there is no significant difference in blood hemorrheology;
     ④The patients with AIONFH after treatment with Chinese medicine have improved in the blood hypercoagulable state,200/S,30/S,3/S,HCT(X),Arbe,ηc,EPT,HRV and IR are reduced,while ESR and K are increased.
     Conclusion:
     1 Clinical study of pressure bone graft and internal bracket implanting surgery integrating Chinese medicine to treat the AIONFH
     ①Pressure bone graft and internal bracket implanting surgery integrating Chinese medicine to treat AIONFH,clinical follow-up of 36.4 months,the survival rate of the femoral head is about 82.2%,Harris score was 90.99± 7.325 points,an excellent rate of 92.53%,achieved satisfied with the efficacy of hip-preserving,to verify our choice of treatment options and indications are reasonable.
     ②In clinical,more than 46 years of age and necrosis frog-bit is located in the C2-type in patients,we recommend the use of other methods of hip-preserving,or even artificial hip replacement may be considered.
     ③Grasping correctly on the hip-preserving indication(including age,stage, site of necrosis,necrotic area,etc.),adhere to integrate Chinese medicine with western medicine,to improve the surgical techniques,to enhance patient cooperation in order to enhance hip-preserving efficacy,to reduce the patient's economic and emotional burden with playing an important role on social significance.
     2 The influence "treatment between phlegm and stasis" of AIONFH in patients with blood lipid levels and blood hemorrheology:
     ①"Interrelation between phlegm and stasis" is the key pathological in AIONFH;
     ②"Treatment between phlegm and stasis" is to improve hyperlipidemia and high blood viscosity state.
     ③"Treatment between phlegm and stasis" provide the clinical basis for the "not sick" and "anti-change disease".
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