[1]张磊,金红婷,童培建.骨健口服液早期干预非创伤性股骨头坏死的临床研究[J].中医正骨,2016,28(03):14-19.
　ZHANG Lei,JIN Hongting,TONG Peijian.Clinical study on Gujian Koufuye(骨健口服液)for early intervention of nontraumatic osteonecrosis of femoral head[J].The Journal of Traditional Chinese Orthopedics and Traumatology,2016,28(03):14-19.
点击复制

骨健口服液早期干预非创伤性股骨头坏死的临床研究()
分享到：

《中医正骨》[ISSN:1001-6015/CN:41-1162/R]

卷:
第28卷
期数:
2016年03期
页码:
14-19
栏目:
临床研究
出版日期:
2016-03-20

文章信息/Info

Title:
Clinical study on Gujian Koufuye(骨健口服液)for early intervention of nontraumatic osteonecrosis of femoral head
作者:
张磊1; 金红婷2; 童培建3
1.浙江中医药大学第一临床医学院,浙江 杭州 310053;
2.浙江中医药大学骨伤研究所,浙江 杭州 310053;
3.浙江中医药大学附属第一医院,浙江 杭州 310006
Author(s):
ZHANG Lei1; JIN Hongting2; TONG Peijian3
1.First Clinical Medical College of Zhejiang Chinese Medical University,Hangzhou 310053,Zhejiang,China 2.Institute of Traumatology and Orthopedics Affiliated to Zhejiang University of Traditional Chinese Medicine,Hangzhou 310053,Zhejiang,China 3.The First Affiliated Hospital of Zhejiang University of Traditional Chinese Medicine,Hangzhou 310006,Zhejiang,China
关键词:
股骨头坏死;  骨健口服液;  关节成形术; 置换; 髋;  治疗; 临床研究性
Keywords:
femur head necrosis;  Gujian Koufuye;  arthroplasty; replacement; hip;  therapies; investigational
摘要:
目的:观察骨健口服液早期干预非创伤性股骨头坏死(osteonecrosis of the femoral head,ONFH)的临床疗效和安全性。方法:将120例符合要求的SteinbergⅠ、Ⅱ期单侧非创伤性ONFH患者随机分为中药组和常规组,每组60例。2组患者均服用塞来昔布片和维生素D3,并进行局部推拿按摩、电疗及中药外敷等理疗。中药组在上述治疗的基础上服用骨健口服液。分别于治疗前和治疗开始后6、12、18、24个月拍摄X线片观察股骨头塌陷情况,测定西安大略和麦克马斯特大学(Western Ontario and McMaster Universities,WOMAC)骨关节炎指数、髋关节Harris评分,记录治疗开始后24个月内2组患者接受全髋关节置换术的情况。治疗期间每6个月复查1次肝肾功能。结果:至治疗开始后24个月时,中药组失访8例,常规组失访11例,2组均未出现肝肾功能异常者。中药组21例发生股骨头塌陷,12例接受全髋关节置换术; 常规组30例发生股骨头塌陷,26例接受全髋关节置换术。分别以股骨头塌陷和接受全髋关节置换术为观察终点进行生存分析,中药组的股骨头中位生存时间(股骨头塌陷:15个月; 接受全髋关节置换术:15个月)大于常规组(股骨头塌陷:9个月; 接受全髋关节置换术:8个月)(χ2=4.171,P=0.034; χ2=5.280,P=0.022)。治疗前后不同时间WOMAC评分的差异有统计学意义,即存在时间效应(F=137.733,P=0.000)。2组WOMAC评分比较,总体上差异有统计学意义,即存在分组效应(F=28.943,P=0.000); 除治疗前和治疗开始后6个月外,治疗开始后12、18、24个月时中药组的评分均低于常规组[(26.77±2.51)分,(26.79±3.26)分,t=-0.019,P=0.985;(24.42±2.62)分,(25.32±2.36)分,t=-1.219,P=0.229;(21.68±2.60)分,(23.37±1.80)分,t=-2.488,P=0.016;(17.71±1.85)分,(20.74±2.33)分,t=-5.089,P=0.000;(16.19±2.06)分,(18.84±1.89)分,t=-4.553,P=0.000]。时间因素与分组因素不存在交互效应(F=3.581,P=0.364)。治疗前后不同时间髋关节Harris评分的差异有统计学意义,即存在时间效应(F=84.829,P=0.000)。2组髋关节Harris评分比较,总体上差异有统计学意义,即存在分组效应(F=16.235,P=0.000); 除治疗前和治疗开始后6个月外,治疗开始后12、18、24个月时中药组的评分均高于常规组[(79.71±1.77)分,(80.37±2.17)分,t=-1.171,P=0.247;(80.32±1.97)分,(81.11±2.18)分,t=-1.308,P=0.197;(83.68±1.74)分,(81.47±1.90)分,t=4.202,P=0.000;(85.23±1.65)分,(83.74±1.97)分,t=2.880,P=0.006;(87.06±1.63)分,(84.47±1.65)分,t=5.432,P=0.000]。时间因素与分组因素不存在交互效应(F=9.102,P=0.293)。结论:应用骨健口服液早期干预非创伤性ONFH,可以有效缓解髋部症状,改善髋关节功能,延缓病变进展,降低股骨头塌陷率和后期全髋关节置换手术率,而且具有较高的安全性。
Abstract:
Objective:To observe the clinical curative effects and safety of Gujian Koufuye(骨健口服 液,GJKFY)in early intervention of nontraumatic osteonecrosis of femoral head(ONFH).Methods:One hundred and twenty patients with Steinberg phaseⅠandⅡunilateral nontraumatic ONFH enrolled in the study were randomly divided into traditional Chinese medicine(TCM)group and conventional group,60 cases in each group.The patients in the 2 groups were treated with oral application of celecoxib tablets and vitamin D3 and physical treatment including local massage,electrotherapy and external application of Chinese medicine.Moreover,the patients in TCM group were treated with oral application of GJKFY.The collapse of femoral heads were observed by taking X-ray films and western Ontario and McMaster universities(WOMAC)osteoarthritis index and Harris score of hip joint were evaluated before the treatment and at 6,12,18 and 24 months after the beginning of the treatment respectively.Meanwhile,the patients who received total hip arthroplasty(THA)were recored within 24 months after the beginning of the treatment.The hepatorenal functions were tested during the treatment period,once within 6 months.Results:Eight patients in TCM group and 11 patients in conventional group lost to follow-up and no patient developed hepatorenal dysfunction within 24 months after the begining of the treatment.Collapse of femoral head were found in 51 patients(21 in TCM group,30 in conventional group),in which 38 patients underwent THA(12 in TCM group,26 in conventional group).Survival analysis were conducted by using collapse of femoral head and THA as observation endpoints respectively.The median survival time(MST)of femur head was greater in TCM group(15 months for collapse of femoral head,15 months for THA)compared to conventional group(9 months for collapse of femoral head,8 months for THA)(χ2=4.171,P=0.034; χ2=5.280,P=0.022).There was statistical difference in WOMAC scores between different timepoints before and after treatment,in other words,there was time effect(F=137.733,P=0.000).There was statistical difference in WOMAC scores between the 2 groups in general,in other words,there was group effect(F=28.943,P=0.000).The WOMAC scores were lower in TCM group compared to conventional group at 12,18 and 24 months after the beginning of the treatment (26.77+/-2.51 vs 26.79+/-3.26 points,t=-0.019,P=0.985; 24.42+/-2.62 vs 25.32+/-2.36 points,t=- 1.219,P=0.229; 21.68+/-2.60 vs 23.37+/-1.80 points,t=-2.488,P=0.016; 17.71+/-1.85 vs 20.74+/-2.33 points,t=-5.089,P=0.000; 16.19+/-2.06 vs 18.84+/-1.89 points,t=-4.553,P=0.000).There was no interaction between time factor and group factor(F=3.581,P=0.364).There was statistical difference in hip joint Harris scores between different timepoints before and after treatment,in other words,there was time effect(F=84.829,P=0.000).There was statistical difference in Harris hip scores between the 2 groups in general,in other words,there was group effect(F=16.235,P=0.000).The Harris hip scores were higher in TCM group compared to conventional group at 12,18 and 24 months after the beginning of the treatment (79.71+/-1.77 vs 80.37+/-2.17 points,t=-1.171,P=0.247; 80.32+/-1.97 vs 81.11+/-2.18 points,t=- 1.308,P=0.197; 83.68+/-1.74 vs 81.47+/-1.90 points,t=4.202,P=0.000; 85.23+/-1.65 vs 83.74+/-1.97 points,t=2.880,P=0.006; 87.06+/-1.63 vs 84.47+/-1.65 points,t=5.432,P=0.000).There was no interaction between time factor and group factor.Conclusion:In early intervention of ONFH,GJKFY can effectively relieve the hip symptoms,improve the hip function,delay the pathological changes and reduce the probability of femoral head collapse and subsequent THA,meanwhile it has high safety.

参考文献/References:

[1] Min BW,Song KS,Bae KC,et al.Second-generation cementless total hip arthroplasty in patients with osteonecrosis of the femoral head[J].J Arthroplasty,2008,23(6):902-910.
[2] Kamal D,Trǎistaru R,Kamal CK,et al.A case of bilateral aseptic necrosis of the femoral head[J].Curr Health Sci,2014,40(4):289-292.
[3] Disch AC,Matziolis G,Perka C.The management of necrosis-associated and idiopathic bone-marrow oedema of the proximal femur by intravenous iloprost[J].J Bone Joint Surg Br,2005,87(4):560-564.
[4] Dong Y,Li Y,Huang C,et al.Systemic application of teriparatide for steroid induced osteonecrosis in a rat model[J].BMC Musculoskelet Disord,2015,16(1):163.
[5] Lin PC,Wang CJ,Yang KD,et al.Extracorporeal shockwave treatment of osteonecrosis of the femoral head in systemic lupus erythematosis[J].J Arthroplasty,2006,21(6):911-915.
[6] 张鹤山,李子荣.股骨头坏死诊断与治疗的专家建议[J].中华骨科杂志,2007,27(2):146-148.
[7] Steinberg ME,Hayken GD,Steinberg DR.A quantitative system for staging avascular necrosis[J].J Bone Joint Surg Br,1995,77(1):34-41.
[8] Ha YC,Jung WH,Kim JR,et al.Prediction of collapse in femoral head osteonecrosis:a modified Kerboul method with use of magnetic resonance images[J].J Bone Joint Surg Am,2006,88(Suppl 3):35-40.
[9] Mont MA,Zywiel MG,Marker DR,et al.The natural history of untreated asymptomatic osteonecrosis of the femoral head:a systematic literature review[J].J Bone Joint Surg Am,2010,92(12):2165-2170.
[10] Koo KH,Kim R.Quantifying the extent of osteonecrosis of the femoral head. A new method using MRI [J].J Bone Joint Surg Br,1995,77(6):875-880.
[11] Ohzono K,Saito M,Takaoka K,et al.Natural history of nontraumatic avascular necrosis of the femoral head[J].J Bone Joint Surg Br,1991,73(1):68-72.
[12] Chen CH,Wang GJ.Alendronate in the Prevention of Collapse of the Femoral Head in Nontraumatic Osteonecrosis[M].Heidelberg:Springer,2014:265-271.
[13] Nam KW,Kim YL,Yoo JJ,et al.Fate of untreated asymptomatic osteonecrosis of the femoral head[J].J Bone Joint Surg Am,2008,90(3):477-484.
[14] Lee YK,Ha YC,Cho YJ,et al.Does zoledronate prevent femoral head collapse from osteonecrosis?a prospective,randomized,Open-Label,multicenter study[J].J Bone Joint Surg Am,2015,97(14):1142-1148.
[15] 蒋协远,王大伟.骨科临床疗效评价标准[M].北京:人民卫生出版社,2005:275-277.
[16] 刘云鹏,刘沂.骨与关节损伤和疾病的诊断分类及功能评定标准[M].北京:清华大学出版社,2002:275-277.
[17] Aaron RK,Lennox D,Bunce GE,et al.The conservative treatment of osteonecrosis of the femoral head.A comparison of core decompression and pulsing electromagnetic fields[J].Clin Orthop Relat Res,1989, (249):209-218.
[18] Mose K.Methods of measuring in Legg-Calvé-Perthes disease with special regard to the prognosis [J].Clin Orthop Relat Res,1981,(150):103-109.
[19] 成立,童培建,肖鲁伟.骨健口服液治疗股骨头缺血性坏死疗效观察——附136例病例报告[J].中医正骨,2008,20 (5):14-15.
[20] 李朝阳,吴铁,黄连芳,等.黄芪水提液与己烯雌酚对去卵巢大鼠骨代谢的影响[J].中草药,1998,29(1):27-30.
[21] 饶华,胡金家,高书亮,等.成骨样细胞体外培养法筛选杜仲叶防治骨质疏松症的药效成份[J].解剖学研究,2004,26 (2):115-117.
[22] Mitchell DG,Rao VM,Dalinka MK,et al.Femoral head avascular necrosis:correlation of Mr imaging,radiographic staging,radionuclide imaging, and clinical findings[J].Radiology,1987,162(3):709- 715.
[23] Koo KH,Ahn IO,Kim R,et al.Bone marrow edema and associated pain in early stage osteonecrosis of the femoral head:prospective study with serial Mr images[J].Radiology,1999,213(3):715-722.
[24] 张凤瑞.桃红四物汤的研究概况[J].中成药,1994,16(2):42-44.
[25] Min BW,Song KS,Cho CH,et al.Untreated asymptomatic hips in patients with osteonecrosis of the femoral head[J].Clin Orthop Relat Res,2008,466(5):1087-1092.
[26] Shimizu K,Moriya H,Akita T,et al.Prediction of collapse with magnetic resonance imaging of avascular necrosis of the femoral head[J].J Bone Joint Surg Am,1994,76(2):215-223.

相似文献/References:

[1]陈雷雷,张颖.何伟教授采用中医药疗法治疗股骨头坏死的经验[J].中医正骨,2015,27(10):74.
[2]徐西林,赵永兰,张晓峰,等.活骨注射液髋关节腔灌注对兔股骨头坏死模型 血管内皮生长因子表达的动态影响[J].中医正骨,2015,27(08):1.
　XU Xilin,ZHAO Yonglan,ZHANG Xiaofeng,et al.Dynamic effect of intra-articular hip injection of Huogu injection on the expression of vascular endothelial growth factor in rabbit models with femur head necrosis[J].The Journal of Traditional Chinese Orthopedics and Traumatology,2015,27(03):1.
[3]周勇,任菲菲,丰凡翔,等.血管内皮生长因子和骨形态发生蛋白2 在非创伤性股骨头坏死不同区域的表达[J].中医正骨,2015,27(08):7.
　ZHOU Yong,REN Feifei,FENG Fanxiang,et al.Expressions of vascular endothelial growth factor and bone morphogenetic protein 2 in different zones of femoral head with non-traumatic osteonecrosis[J].The Journal of Traditional Chinese Orthopedics and Traumatology,2015,27(03):7.
[4]鲍荣华,王国平,夏晓斌,等.钽棒植入治疗非创伤性股骨头坏死的疗效观察[J].中医正骨,2015,27(02):28.
[5]张兵,马凰富,刘波,等.非创伤性股骨头坏死的舌象定量研究[J].中医正骨,2015,27(04):8.
　ZHANG Bing,MA Huangfu,LIU Bo,et al.Quantitative study on tongue manifestation of patients with nontraumatic osteonecrosis of femoral head[J].The Journal of Traditional Chinese Orthopedics and Traumatology,2015,27(03):8.
[6]李刚,程春生.股骨头坏死血瘀证症状与平乐郭氏正骨方药药物组成 最大频繁关联模式挖掘[J].中医正骨,2015,27(04):21.
　LI Gang,CHENG Chunsheng.Maximal frequent association pattern mining for studying the relationship between BLOOD STASIS syndrome in patients with osteonecrosis of femoral head and drug components of Pingle Guo's orthopedics prescription[J].The Journal of Traditional Chinese Orthopedics and Traumatology,2015,27(03):21.
[7]李文龙,梅沉成,杜贵强,等.微创减压植骨多孔钽棒植入治疗 ARCOⅡ期非创伤性缺血性股骨头坏死[J].中医正骨,2016,28(02):43.
[8]鲍荣华,王国平,夏晓斌,等.直接前入路微创全髋关节置换术治疗晚期股骨头坏死[J].中医正骨,2016,28(03):61.
[9]张超,姚晨,沈计荣.微创髓芯减压打压支撑植骨术结合补肾活血汤口服治疗ARCOⅡ、Ⅲ期股骨头坏死的近期疗效观察[J].中医正骨,2016,28(03):20.
　ZHANG Chao,YAO Chen,SHEN Jirong.[J].The Journal of Traditional Chinese Orthopedics and Traumatology,2016,28(03):20.
[10]唐立明,庞智晖,樊粤光,等.“辨稳论治”微观辨证理念指导下的股骨头坏死围塌陷期分型及其临床应用价值[J].中医正骨,2016,28(05):63.

备注/Memo

备注/Memo:
基金项目:国家自然科学基金项目(81273770); 浙江省自然基金重点项目(2012C13017-2); 浙江省中医药管理局项目 (2016ZA048)
通讯作者:童培建 E-mail:tongpeijian@163.com
更新日期/Last Update: 2016-03-30