非创伤性股骨头坏死塌陷前期的临床研究
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摘要
目的:
非创伤性股骨头坏死的塌陷前期是公认的保留股骨头治疗的最佳时机。但是,如何才能达到这个目标远未达成共识。此项研究的目的是评估塌陷前期(ACRO分期中Ⅰ、Ⅱ期)的非创伤性股骨头坏死经过口服复方生脉成骨胶囊辅助负重控制方法治疗后的生存率并评价其临床效果和影像结果,探讨非手术治疗方法的时机及疼痛、坏死分期、坏死范围、坏死部位、骨髓水肿五项危险因素对股骨头生存率的影响。
方法:
1、研究对象:广州中医药大学第一附属医院全国中医髋关节病重点专科1999年1月～2006年3月确诊为非创伤性股骨头坏死塌陷前期(ARCO分期中Ⅰ、Ⅱ期)并采用口服复方生脉成骨胶囊辅助负重控制方法治疗的住院及门诊患者54例(65髋),患者的平均年龄38.39岁(22～69岁),其中男性41例,女性13例;双髋患病49例(占90.07%),单髋患病5例(占9.93%);左侧34髋,右侧31髋;酒精性股骨头坏死24例(占44.44%)28髋,激素性股骨头坏死24例(占44.44%)30髋,特发性股骨头坏死6例(占11.11%)7髋;54例患者(65髋)平均随访37个月。
2、治疗方法:
①药物治疗:口服复方生脉成骨胶囊,4粒/次,每日3次。3个月为1个疗程,共治疗1.5～2年。
②负重控制:A、对坏死范围小、坏死部位位于股骨头非负重区为主、无骨髓水肿、无疼痛者,允许正常行走;B、对坏死范围比较大、坏死部位位于股骨头负重区、无骨髓水肿、无疼痛者,适当限制行走(扶拐杖)3～6月;C、对坏死范围比较大、坏死部位位于股骨头负重区、有骨髓水肿、有或无疼痛者,限制负重行走(坐轮椅)3～6月;所有病例治疗期间严格定期复查。
3、观察影响股骨头生存率的危险因素:
①坏死分期:参照1992年国际骨循环研究会(ARCO)骨坏死的国际分期标准,ARCO分期中Ⅰ期共10髋,其中ⅠA8髋,ⅠB2髋。Ⅱ期共55髋,其中ⅡA9髋,ⅡB14髋,ⅡC32髋。
②疼痛:以髋部腹股沟区疼痛为主,参考主诉疼痛分级法(VRS),将髋关节疼痛分为四级。0级:无疼痛或偶有轻度不适感,共29髋;1级:活动后轻度疼痛但可忍受,不需服止痛药,共18髋;2级:活动后中度疼痛,偶需服止痛药,共14髋;3级:活动后重度疼痛较难忍受,常需服止痛药,共4髋。
③坏死范围:参照Koo计量坏死指数分为3级,≤30%共33髋,＞30%～≤60%共19髋,＞60%共13髋。
④坏死部位:根据2001年日本骨坏死研究分型,MR图像T1加权正中冠状位显示的坏死范围分为四型:A型为坏死区不超过股骨头负重区的内1/3,B型为不超过股骨头负重区的内2/3,C1型为坏死超过负重区的2/3但不超过髋臼外缘,C2型为坏死超过负重区的2/3并超过髋臼外缘。A型7髋,B型20髋,C1型27髋,C2型11髋。
⑤骨髓水肿:依据冠状位扫描的T2W1+脂肪抑制图像股骨上段水肿范围分四级。0级:无骨髓水肿;Ⅰ级:骨髓水肿局限于股骨头区;Ⅱ级:骨髓水肿局限于股骨头及股骨颈区:Ⅲ级:骨髓水肿自股骨头延伸至粗隆下。65髋中0级32髋,Ⅰ级14髋,Ⅱ级11髋,Ⅲ级8髋。
4、疗效评定:
①功能评定:髋关节功能的Harris评分方法。
②塌陷程度的测定:根据X线正位片测股骨头中心点到股骨头顶距离,股骨头塌陷程度=股骨头半径-中心点到股骨头顶距离,塌陷程度共分为3级。A:≤2mm;B:2～4mm;C＞4mm。
③股骨头生存分析:以进行髋关节手术(包括保留髋关节手术或髋关节置换手术)为观察终点Kaplan-Meier股骨头生存分析。
5、随访方法:
随访患者均在治疗后12个月内每3月复查双髋正蛙位X线片1次,坏死修复稳定后,每6个月或12个月复查X线片1次,随访2年以上。如患者在中药治疗期间因塌陷改为手术治疗则随访终止。
6、统计学方法:
采用SPSS13.0软件进行统计。
结果:
以塌陷为观察终点的Kaplan-Meier生存曲线分析:65髋中19髋塌陷,塌陷平均时间11.52个月(1～37个月),生存46髋,生存率为70.77%。以进行手术为观察终点的Kaplan-Meier生存曲线分析:塌陷的19髋中11髋最终行髋关节手术,8髋继续中药治疗,塌陷A级7髋,B级1髋。生存54髋,股骨头的总体生存率为83.08%。随访终期Harris评分平均为89分。分别对疼痛、ARCO分期、坏死指数、坏死部位、骨髓水肿进行分层,以手术为终点的Kaplan-Meier生存曲线分析显示,各组间差异有统计学意义(P＜0.05),无或轻度疼痛,ARCOⅠA、ⅠB、ⅡA、ⅡB期,坏死部位为A型、B型,坏死指数＜30%,无或轻度骨髓水肿,中药治疗后股骨头的生存率达90%以上;坏死部位C1型,坏死指数在30%～60%股骨头的生存率为60%左右;坏死部位C2型股骨头的生存率为38%;中度或重度疼痛,中度或重度骨髓水肿股骨头的生存率低于0.2%。疼痛、ARCO分期、坏死指数、坏死部位、骨髓水肿是预测塌陷前期非创伤性股骨头坏死股骨头生存率的重要指标。与塌陷的相关因素Logistic回归分析结果显示,坏死指数,坏死部位、疼痛与塌陷有统计学意义。
结论:
复方生脉成骨胶囊辅助负重控制是治疗塌陷前期非创伤性股骨头坏死安全简单有效的方法,能阻止或延缓塌陷进展。早期临床结果显示对塌陷前期患者有令人鼓舞的生存率。疼痛、ARCO分期、坏死部位、坏死指数、骨髓水肿是预测股骨头生存率的重要指标。复方生脉成骨胶囊辅助负重控制治疗塌陷前期股骨头坏死的适应症:ARCOⅠA、ⅠB、ⅡA、ⅡB期,坏死部位为A型、B型、无骨髓水肿、无疼痛患者,正常行走。或ARCOⅠC、ⅡC期,坏死部位C型、无骨髓水肿、无疼痛患者,扶双拐3～6月。ARCOⅠC、ⅡC期,坏死部位C型、有骨髓水肿、有股骨头软骨下骨板断裂、有或无疼痛者,建议尽早手术干预,术后配合口服复方生脉成骨胶囊,坐轮椅3～6月。塌陷＜2mm、坏死指数＜30%,坏死部位为A、B型的髋有较高机会塌陷停止,可以不用手术治疗而获得较好的临床疗效。
Objective:Pre-collapse nontraumatic osteonecrosis of the femoral head(NONFH)is the best opportunity for preservation of the femoral head.However,on treatment of pre -collapse NONFH there is significant debate in the orthopaedic community about the best approach to relieving symptoms and halting or delaying disease progression.The purpose of the present study was to review the medical records of pre-collapse NONFH and analyse a series of risk factors with correlating to the survivorship of pre -collapse NONFH,try to search the available methods to predict the survivorship of pre-collapse NONFH.A preliminary clinical study was done to analyse survivorship and radiographic outcome of pre-collapse NONFH were treated with compound Sheng Mai Cheng Gu capsule and protecting weight-bearing method.Discuss nonsurgical treatment options for pre-collapse NONFH.
Methods:
(1)Study objiects:54 patients(65 hips)were diagnosed pre-collapse NONFH from First Affiliated Hospital of Guangzhou University of Traditional Chinese Medicine from January 1999 to March 2006,All of the cases were treated to take compound Sheng Mai Cheng Gu capsule with protecting weight-bearing.There were 41 males and 13 females with a mean age of 38.39 years old(range,22 to.69 years),49 patients with bilateral involvement.With regard to etiology,44.44%(24 patients)of the cases were associated with steroid use,44.44%(24 patients)were associated with alcohol consumption,and 11.11%(6 patients)were idiopathic.
(2)Methods of therapy:①Medication:All of the patients took 12 granule compound Sheng Mai Cheng Gu capsule in everyday,period of treatment was 1.5 to 2 years.②Weight-bearing control method:The patients were allowed to walk in gear when the extent of osteonecrosis of the femoral head was less than 30%,necrotic lesions occupy the medial two-thirds or less of the weight-bearing portion,no bone marrow edema and no pain.The patients were protected to walk with crutch for 3 to 6 months when the extent of osteonecrosis of the femoral head was more than 30%,necrotic lesions occupy more than the medial two-thirds of the weight-beating portion,no bone marrow edema and no pain.The patients were not allowed to walk with wheel-chair for 3 to 6 months when the extent of osteonecrosis of the femoral head was more than 30%,necrotic lesions occupy more than the medial two-thirds of the weight-bearing portion,bone marrow edema was detected and pain was felt or not.
(3)Risk factors for survivorship of pre-collapse NONFH:①Osteonecrosis stage:65 hips were evaluated and classified according to the the grading system of the Association Research Circulation Osseous(ARCO)with the use of plain radiographs and additional application of MRI.10 hips were classified as stageⅠ,8 hips were in stageⅠA and 2 hips were in stageⅠB.55 hips were classified as stageⅡ,9 hips were in stageⅡA among 14 hips were in stageⅡB between 32 hips were in stageⅡC.②Pain: Based on grading scale of pain,pain grading were divided into no pain(grade 0),mild pain(grade 1),moderate pain(grade 2)and severe pain(grade 3).29 hips in grade 0,18 hips in grade 1,14 hips in grade 2 and 4 hips in grade 3.③Necrotic extent:On the basis of the index of necrotic extent method to quantify the extent of osteonecrosis of the femoral head,hips were classified into three categories:grade 1(≤30%),grade 2(30% to 60%),grade 3(＞60%),there were 33 grade-1 hips among 19 grade-2 hips between 13 grade-3 hips.④Necrotic location:According to the 2001 revised criteria from Japanese,necrotic lesions are classified into four types,based on their location on T1-weighted images.Type A lesions occupy the medial one-third or less of the weightbearing portion,7 hips as Type A.Type B lesions occupy the medial two -thirds or less of the weight-bearing portion,20 hips as Type B.Type C1 lesions occupy more than the medial two-thirds of the weight-beating portion but do not extend laterally to the acetabular edge,27 hips as Type C1.Type C2 lesions occupy more than the medial two-thirds of the weight -bearing portion and extend laterally to the acetabular edge, 11 hips as Type C2.⑤Bone marrow edema:According to distribution of bone marrow edema(BME)on T1- and T2-weighted MR images,and fat suppression images,hips were classified into four categories:no BME(grade 0),distributing to femoral head (grade 1),distributing to femoral neck(grade 2),distributing to proximal femoral (grade 3).32 hips in grade 0,14 hips in grade 1,11 hips in grade 2 and 8 hips in grade 3.
(4)Measures of clinical efficacy:Measures of clinical efficacy included radiographic stabilization of osteonecrosis and the Harris hip score.Kaplan-meier survivorship was set that joint-preserving procedures or total hip arthroplasty as the end point,Kaplanmeier survival curves were determined for all hips.
(5)Clinical and radiographic follow-up:Every 3 months,the patients underwent clinical and radiographic examination,and X-ray were obtained at 3-month intervals. Follow-up continued until worsening of pain surgery.All hips were followed up for at least 24 months.The mean clinical and radiographic follow-up period after the initial diagnosis was 37 months(range,24-112 months).
(6)Statistical analysis:Statistical analysis was performed with use of SPSS software (version 13),The Kaplan-meier survivorship was set that joint-preserving procedures or total hip arthroplasty as the end point,and 95%confidence intervals for all hips in each group,Significance was set at P＜0.05.
Results:After the mean duration of clinical and radiographic follow-up of thirty-seven months,the mean baseline Harris hip score for survival hips(n=54)that were not operated was 89(range,80 to 100);there were 19 hips with radiographic progression to collapse,The rate of survival without collapse for all hips was 70.77%(46 hips survivorship in 65 hips)The mean time of collapse after the initial diagnosis was 11.52 months(range,1-37 months).The overall rate of survival without operation for all hips was 83.08%(54 hips survivorship in 65 hips);Kaplan-meier survivorship curve,with joint-preserving procedures or total hip arthroplasty as the end point, survivorship analysis respectively according to pain,osteonecrosis stage,necrotic extent,necrotic location and bone marrow edema showed there was significant difference relatively in every group,P＜0.05.The rate of survival without operation was more than 90%when the patients were not or mild pain,ARCO stage was classified as stageⅠA、ⅠB、ⅡA、ⅡB,necrotic location was type A and type B,the index of necrotic extent was less than 30%,bone marrow edema was no or mild.The rate of survival without operation was about 60%when necrotic location was type C1,the index of necrotic extent was 30%to 60%.The rate of survival without operation was 38%when necrotic location was type C2.The rate of survival without operation was less than 0.2%when the patients were moderate or severe pain,bone marrow edema was moderate or severe.Pain,ARCO stage,necrotic location,necrotic extent and bone marrow edema were important indexs for predicting the rate of survival of precollapse NONFH.
Conclusions:The early clinical results associated with compound Sheng Mai Cheng Gu capsule and protecting weight-beating were encouraging in terms of the survival rates and effective for halting or limiting the progresssion of pre-collapse NONFH.All survivors were rated as good to excellent.We propose that the best strategies to treat pre-collapse with compound Sheng Mai Cheng Gu capsule and protecting weight- bearing is that the patient will be allowed to walk in gear when the patient is not pain, ARCO stage was classified as stageⅠA、ⅠB、ⅡA、ⅡB,necrotic location was type A and type B,bone marrow edema was not detected.The patient will be protected to walk with crutch for 3 to 6 months when the patient is not pain,ARCO stage was classified as stageⅠC、ⅡC,necrotic location was type C,bone marrow edema was not detected.The patient will be suggested to do operation and not allowed to walk with wheelchair for 3 to 6 months postoperation when the patient feels pain,ARCO stage was classified as stageⅠC、ⅡC,necrotie location was type C,bone marrow edema was detected.The analysis indicated that collapse of the femoral head does not necessaryly determine a poor prognosis,and even after collapse occurs,subsequent cessation of collapse can be expected in a certain percentage of hips.Hips with less than 2 mm collapse and necrotic lesions occupying less than the medial 2/3 of the weightbearing area have a high chance of cessation of collapse and improvement of symptoms with no surgical intervention.
非创伤性股骨头坏死的塌陷前期是公认的保留股骨头治疗的最佳时机。但是,如何才能达到这个目标远未达成共识。此项研究的目的是评估塌陷前期(ACRO分期中Ⅰ、Ⅱ期)的非创伤性股骨头坏死经过口服复方生脉成骨胶囊辅助负重控制方法治疗后的生存率并评价其临床效果和影像结果,探讨非手术治疗方法的时机及疼痛、坏死分期、坏死范围、坏死部位、骨髓水肿五项危险因素对股骨头生存率的影响。
方法:
1、研究对象:广州中医药大学第一附属医院全国中医髋关节病重点专科1999年1月～2006年3月确诊为非创伤性股骨头坏死塌陷前期(ARCO分期中Ⅰ、Ⅱ期)并采用口服复方生脉成骨胶囊辅助负重控制方法治疗的住院及门诊患者54例(65髋),患者的平均年龄38.39岁(22～69岁),其中男性41例,女性13例;双髋患病49例(占90.07%),单髋患病5例(占9.93%);左侧34髋,右侧31髋;酒精性股骨头坏死24例(占44.44%)28髋,激素性股骨头坏死24例(占44.44%)30髋,特发性股骨头坏死6例(占11.11%)7髋;54例患者(65髋)平均随访37个月。
2、治疗方法:
①药物治疗:口服复方生脉成骨胶囊,4粒/次,每日3次。3个月为1个疗程,共治疗1.5～2年。
②负重控制:A、对坏死范围小、坏死部位位于股骨头非负重区为主、无骨髓水肿、无疼痛者,允许正常行走;B、对坏死范围比较大、坏死部位位于股骨头负重区、无骨髓水肿、无疼痛者,适当限制行走(扶拐杖)3～6月;C、对坏死范围比较大、坏死部位位于股骨头负重区、有骨髓水肿、有或无疼痛者,限制负重行走(坐轮椅)3～6月;所有病例治疗期间严格定期复查。
3、观察影响股骨头生存率的危险因素:
①坏死分期:参照1992年国际骨循环研究会(ARCO)骨坏死的国际分期标准,ARCO分期中Ⅰ期共10髋,其中ⅠA8髋,ⅠB2髋。Ⅱ期共55髋,其中ⅡA9髋,ⅡB14髋,ⅡC32髋。
②疼痛:以髋部腹股沟区疼痛为主,参考主诉疼痛分级法(VRS),将髋关节疼痛分为四级。0级:无疼痛或偶有轻度不适感,共29髋;1级:活动后轻度疼痛但可忍受,不需服止痛药,共18髋;2级:活动后中度疼痛,偶需服止痛药,共14髋;3级:活动后重度疼痛较难忍受,常需服止痛药,共4髋。
③坏死范围:参照Koo计量坏死指数分为3级,≤30%共33髋,＞30%～≤60%共19髋,＞60%共13髋。
④坏死部位:根据2001年日本骨坏死研究分型,MR图像T1加权正中冠状位显示的坏死范围分为四型:A型为坏死区不超过股骨头负重区的内1/3,B型为不超过股骨头负重区的内2/3,C1型为坏死超过负重区的2/3但不超过髋臼外缘,C2型为坏死超过负重区的2/3并超过髋臼外缘。A型7髋,B型20髋,C1型27髋,C2型11髋。
⑤骨髓水肿:依据冠状位扫描的T2W1+脂肪抑制图像股骨上段水肿范围分四级。0级:无骨髓水肿;Ⅰ级:骨髓水肿局限于股骨头区;Ⅱ级:骨髓水肿局限于股骨头及股骨颈区:Ⅲ级:骨髓水肿自股骨头延伸至粗隆下。65髋中0级32髋,Ⅰ级14髋,Ⅱ级11髋,Ⅲ级8髋。
4、疗效评定:
①功能评定:髋关节功能的Harris评分方法。
②塌陷程度的测定:根据X线正位片测股骨头中心点到股骨头顶距离,股骨头塌陷程度=股骨头半径-中心点到股骨头顶距离,塌陷程度共分为3级。A:≤2mm;B:2～4mm;C＞4mm。
③股骨头生存分析:以进行髋关节手术(包括保留髋关节手术或髋关节置换手术)为观察终点Kaplan-Meier股骨头生存分析。
5、随访方法:
随访患者均在治疗后12个月内每3月复查双髋正蛙位X线片1次,坏死修复稳定后,每6个月或12个月复查X线片1次,随访2年以上。如患者在中药治疗期间因塌陷改为手术治疗则随访终止。
6、统计学方法:
采用SPSS13.0软件进行统计。
结果:
以塌陷为观察终点的Kaplan-Meier生存曲线分析:65髋中19髋塌陷,塌陷平均时间11.52个月(1～37个月),生存46髋,生存率为70.77%。以进行手术为观察终点的Kaplan-Meier生存曲线分析:塌陷的19髋中11髋最终行髋关节手术,8髋继续中药治疗,塌陷A级7髋,B级1髋。生存54髋,股骨头的总体生存率为83.08%。随访终期Harris评分平均为89分。分别对疼痛、ARCO分期、坏死指数、坏死部位、骨髓水肿进行分层,以手术为终点的Kaplan-Meier生存曲线分析显示,各组间差异有统计学意义(P＜0.05),无或轻度疼痛,ARCOⅠA、ⅠB、ⅡA、ⅡB期,坏死部位为A型、B型,坏死指数＜30%,无或轻度骨髓水肿,中药治疗后股骨头的生存率达90%以上;坏死部位C1型,坏死指数在30%～60%股骨头的生存率为60%左右;坏死部位C2型股骨头的生存率为38%;中度或重度疼痛,中度或重度骨髓水肿股骨头的生存率低于0.2%。疼痛、ARCO分期、坏死指数、坏死部位、骨髓水肿是预测塌陷前期非创伤性股骨头坏死股骨头生存率的重要指标。与塌陷的相关因素Logistic回归分析结果显示,坏死指数,坏死部位、疼痛与塌陷有统计学意义。
结论:
复方生脉成骨胶囊辅助负重控制是治疗塌陷前期非创伤性股骨头坏死安全简单有效的方法,能阻止或延缓塌陷进展。早期临床结果显示对塌陷前期患者有令人鼓舞的生存率。疼痛、ARCO分期、坏死部位、坏死指数、骨髓水肿是预测股骨头生存率的重要指标。复方生脉成骨胶囊辅助负重控制治疗塌陷前期股骨头坏死的适应症:ARCOⅠA、ⅠB、ⅡA、ⅡB期,坏死部位为A型、B型、无骨髓水肿、无疼痛患者,正常行走。或ARCOⅠC、ⅡC期,坏死部位C型、无骨髓水肿、无疼痛患者,扶双拐3～6月。ARCOⅠC、ⅡC期,坏死部位C型、有骨髓水肿、有股骨头软骨下骨板断裂、有或无疼痛者,建议尽早手术干预,术后配合口服复方生脉成骨胶囊,坐轮椅3～6月。塌陷＜2mm、坏死指数＜30%,坏死部位为A、B型的髋有较高机会塌陷停止,可以不用手术治疗而获得较好的临床疗效。
Objective:Pre-collapse nontraumatic osteonecrosis of the femoral head(NONFH)is the best opportunity for preservation of the femoral head.However,on treatment of pre -collapse NONFH there is significant debate in the orthopaedic community about the best approach to relieving symptoms and halting or delaying disease progression.The purpose of the present study was to review the medical records of pre-collapse NONFH and analyse a series of risk factors with correlating to the survivorship of pre -collapse NONFH,try to search the available methods to predict the survivorship of pre-collapse NONFH.A preliminary clinical study was done to analyse survivorship and radiographic outcome of pre-collapse NONFH were treated with compound Sheng Mai Cheng Gu capsule and protecting weight-bearing method.Discuss nonsurgical treatment options for pre-collapse NONFH.
Methods:
(1)Study objiects:54 patients(65 hips)were diagnosed pre-collapse NONFH from First Affiliated Hospital of Guangzhou University of Traditional Chinese Medicine from January 1999 to March 2006,All of the cases were treated to take compound Sheng Mai Cheng Gu capsule with protecting weight-bearing.There were 41 males and 13 females with a mean age of 38.39 years old(range,22 to.69 years),49 patients with bilateral involvement.With regard to etiology,44.44%(24 patients)of the cases were associated with steroid use,44.44%(24 patients)were associated with alcohol consumption,and 11.11%(6 patients)were idiopathic.
(2)Methods of therapy:①Medication:All of the patients took 12 granule compound Sheng Mai Cheng Gu capsule in everyday,period of treatment was 1.5 to 2 years.②Weight-bearing control method:The patients were allowed to walk in gear when the extent of osteonecrosis of the femoral head was less than 30%,necrotic lesions occupy the medial two-thirds or less of the weight-bearing portion,no bone marrow edema and no pain.The patients were protected to walk with crutch for 3 to 6 months when the extent of osteonecrosis of the femoral head was more than 30%,necrotic lesions occupy more than the medial two-thirds of the weight-beating portion,no bone marrow edema and no pain.The patients were not allowed to walk with wheel-chair for 3 to 6 months when the extent of osteonecrosis of the femoral head was more than 30%,necrotic lesions occupy more than the medial two-thirds of the weight-bearing portion,bone marrow edema was detected and pain was felt or not.
(3)Risk factors for survivorship of pre-collapse NONFH:①Osteonecrosis stage:65 hips were evaluated and classified according to the the grading system of the Association Research Circulation Osseous(ARCO)with the use of plain radiographs and additional application of MRI.10 hips were classified as stageⅠ,8 hips were in stageⅠA and 2 hips were in stageⅠB.55 hips were classified as stageⅡ,9 hips were in stageⅡA among 14 hips were in stageⅡB between 32 hips were in stageⅡC.②Pain: Based on grading scale of pain,pain grading were divided into no pain(grade 0),mild pain(grade 1),moderate pain(grade 2)and severe pain(grade 3).29 hips in grade 0,18 hips in grade 1,14 hips in grade 2 and 4 hips in grade 3.③Necrotic extent:On the basis of the index of necrotic extent method to quantify the extent of osteonecrosis of the femoral head,hips were classified into three categories:grade 1(≤30%),grade 2(30% to 60%),grade 3(＞60%),there were 33 grade-1 hips among 19 grade-2 hips between 13 grade-3 hips.④Necrotic location:According to the 2001 revised criteria from Japanese,necrotic lesions are classified into four types,based on their location on T1-weighted images.Type A lesions occupy the medial one-third or less of the weightbearing portion,7 hips as Type A.Type B lesions occupy the medial two -thirds or less of the weight-bearing portion,20 hips as Type B.Type C1 lesions occupy more than the medial two-thirds of the weight-beating portion but do not extend laterally to the acetabular edge,27 hips as Type C1.Type C2 lesions occupy more than the medial two-thirds of the weight -bearing portion and extend laterally to the acetabular edge, 11 hips as Type C2.⑤Bone marrow edema:According to distribution of bone marrow edema(BME)on T1- and T2-weighted MR images,and fat suppression images,hips were classified into four categories:no BME(grade 0),distributing to femoral head (grade 1),distributing to femoral neck(grade 2),distributing to proximal femoral (grade 3).32 hips in grade 0,14 hips in grade 1,11 hips in grade 2 and 8 hips in grade 3.
(4)Measures of clinical efficacy:Measures of clinical efficacy included radiographic stabilization of osteonecrosis and the Harris hip score.Kaplan-meier survivorship was set that joint-preserving procedures or total hip arthroplasty as the end point,Kaplanmeier survival curves were determined for all hips.
(5)Clinical and radiographic follow-up:Every 3 months,the patients underwent clinical and radiographic examination,and X-ray were obtained at 3-month intervals. Follow-up continued until worsening of pain surgery.All hips were followed up for at least 24 months.The mean clinical and radiographic follow-up period after the initial diagnosis was 37 months(range,24-112 months).
(6)Statistical analysis:Statistical analysis was performed with use of SPSS software (version 13),The Kaplan-meier survivorship was set that joint-preserving procedures or total hip arthroplasty as the end point,and 95%confidence intervals for all hips in each group,Significance was set at P＜0.05.
Results:After the mean duration of clinical and radiographic follow-up of thirty-seven months,the mean baseline Harris hip score for survival hips(n=54)that were not operated was 89(range,80 to 100);there were 19 hips with radiographic progression to collapse,The rate of survival without collapse for all hips was 70.77%(46 hips survivorship in 65 hips)The mean time of collapse after the initial diagnosis was 11.52 months(range,1-37 months).The overall rate of survival without operation for all hips was 83.08%(54 hips survivorship in 65 hips);Kaplan-meier survivorship curve,with joint-preserving procedures or total hip arthroplasty as the end point, survivorship analysis respectively according to pain,osteonecrosis stage,necrotic extent,necrotic location and bone marrow edema showed there was significant difference relatively in every group,P＜0.05.The rate of survival without operation was more than 90%when the patients were not or mild pain,ARCO stage was classified as stageⅠA、ⅠB、ⅡA、ⅡB,necrotic location was type A and type B,the index of necrotic extent was less than 30%,bone marrow edema was no or mild.The rate of survival without operation was about 60%when necrotic location was type C1,the index of necrotic extent was 30%to 60%.The rate of survival without operation was 38%when necrotic location was type C2.The rate of survival without operation was less than 0.2%when the patients were moderate or severe pain,bone marrow edema was moderate or severe.Pain,ARCO stage,necrotic location,necrotic extent and bone marrow edema were important indexs for predicting the rate of survival of precollapse NONFH.
Conclusions:The early clinical results associated with compound Sheng Mai Cheng Gu capsule and protecting weight-beating were encouraging in terms of the survival rates and effective for halting or limiting the progresssion of pre-collapse NONFH.All survivors were rated as good to excellent.We propose that the best strategies to treat pre-collapse with compound Sheng Mai Cheng Gu capsule and protecting weight- bearing is that the patient will be allowed to walk in gear when the patient is not pain, ARCO stage was classified as stageⅠA、ⅠB、ⅡA、ⅡB,necrotic location was type A and type B,bone marrow edema was not detected.The patient will be protected to walk with crutch for 3 to 6 months when the patient is not pain,ARCO stage was classified as stageⅠC、ⅡC,necrotic location was type C,bone marrow edema was not detected.The patient will be suggested to do operation and not allowed to walk with wheelchair for 3 to 6 months postoperation when the patient feels pain,ARCO stage was classified as stageⅠC、ⅡC,necrotie location was type C,bone marrow edema was detected.The analysis indicated that collapse of the femoral head does not necessaryly determine a poor prognosis,and even after collapse occurs,subsequent cessation of collapse can be expected in a certain percentage of hips.Hips with less than 2 mm collapse and necrotic lesions occupying less than the medial 2/3 of the weightbearing area have a high chance of cessation of collapse and improvement of symptoms with no surgical intervention.
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