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[1]張磊,金紅婷,童培建.骨健口服液早期干預(yù)非創(chuàng)傷性股骨頭壞死的臨床研究[J].中醫(yī)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.
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骨健口服液早期干預(yù)非創(chuàng)傷性股骨頭壞死的臨床研究()
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《中醫(yī)正骨》[ISSN:1001-6015/CN:41-1162/R]

卷:
第28卷
期數(shù):
2016年03期
頁碼:
14-19
欄目:
臨床研究
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:
張磊1; 金紅婷2; 童培建3
1.浙江中醫(yī)藥大學(xué)第一臨床醫(yī)學(xué)院,浙江 杭州 310053;
2.浙江中醫(yī)藥大學(xué)骨傷研究所,浙江 杭州 310053;
3.浙江中醫(yī)藥大學(xué)附屬第一醫(yī)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
關(guān)鍵詞:
股骨頭壞死;  骨健口服液;  關(guān)節(jié)成形術(shù); 置換; 髖;  治療; 臨床研究性
Keywords:
femur head necrosis;  Gujian Koufuye;  arthroplasty; replacement; hip;  therapies; investigational
摘要:
目的:觀察骨健口服液早期干預(yù)非創(chuàng)傷性股骨頭壞死(osteonecrosis of the femoral head,ONFH)的臨床療效和安全性。方法:將120例符合要求的SteinbergⅠ、Ⅱ期單側(cè)非創(chuàng)傷性O(shè)NFH患者隨機(jī)分為中藥組和常規(guī)組,每組60例。2組患者均服用塞來昔布片和維生素D3,并進(jìn)行局部推拿按摩、電療及中藥外敷等理療。中藥組在上述治療的基礎(chǔ)上服用骨健口服液。分別于治療前和治療開始后6、12、18、24個(gè)月拍攝X線片觀察股骨頭塌陷情況,測定西安大略和麥克馬斯特大學(xué)(Western Ontario and McMaster Universities,WOMAC)骨關(guān)節(jié)炎指數(shù)、髖關(guān)節(jié)Harris評分,記錄治療開始后24個(gè)月內(nèi)2組患者接受全髖關(guān)節(jié)置換術(shù)的情況。治療期間每6個(gè)月復(fù)查1次肝腎功能。結(jié)果:至治療開始后24個(gè)月時(shí),中藥組失訪8例,常規(guī)組失訪11例,2組均未出現(xiàn)肝腎功能異常者。中藥組21例發(fā)生股骨頭塌陷,12例接受全髖關(guān)節(jié)置換術(shù); 常規(guī)組30例發(fā)生股骨頭塌陷,26例接受全髖關(guān)節(jié)置換術(shù)。分別以股骨頭塌陷和接受全髖關(guān)節(jié)置換術(shù)為觀察終點(diǎn)進(jìn)行生存分析,中藥組的股骨頭中位生存時(shí)間(股骨頭塌陷:15個(gè)月; 接受全髖關(guān)節(jié)置換術(shù):15個(gè)月)大于常規(guī)組(股骨頭塌陷:9個(gè)月; 接受全髖關(guān)節(jié)置換術(shù):8個(gè)月)(χ2=4.171,P=0.034; χ2=5.280,P=0.022)。治療前后不同時(shí)間WOMAC評分的差異有統(tǒng)計(jì)學(xué)意義,即存在時(shí)間效應(yīng)(F=137.733,P=0.000)。2組WOMAC評分比較,總體上差異有統(tǒng)計(jì)學(xué)意義,即存在分組效應(yīng)(F=28.943,P=0.000); 除治療前和治療開始后6個(gè)月外,治療開始后12、18、24個(gè)月時(shí)中藥組的評分均低于常規(guī)組[(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]。時(shí)間因素與分組因素不存在交互效應(yīng)(F=3.581,P=0.364)。治療前后不同時(shí)間髖關(guān)節(jié)Harris評分的差異有統(tǒng)計(jì)學(xué)意義,即存在時(shí)間效應(yīng)(F=84.829,P=0.000)。2組髖關(guān)節(jié)Harris評分比較,總體上差異有統(tǒng)計(jì)學(xué)意義,即存在分組效應(yīng)(F=16.235,P=0.000); 除治療前和治療開始后6個(gè)月外,治療開始后12、18、24個(gè)月時(shí)中藥組的評分均高于常規(guī)組[(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]。時(shí)間因素與分組因素不存在交互效應(yīng)(F=9.102,P=0.293)。結(jié)論:應(yīng)用骨健口服液早期干預(yù)非創(chuàng)傷性O(shè)NFH,可以有效緩解髖部癥狀,改善髖關(guān)節(jié)功能,延緩病變進(jìn)展,降低股骨頭塌陷率和后期全髖關(guān)節(jié)置換手術(shù)率,而且具有較高的安全性。
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.

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備注/Memo

備注/Memo:
基金項(xiàng)目:國家自然科學(xué)基金項(xiàng)目(81273770); 浙江省自然基金重點(diǎn)項(xiàng)目(2012C13017-2); 浙江省中醫(yī)藥管理局項(xiàng)目 (2016ZA048)
通訊作者:童培建 E-mail:[email protected]
更新日期/Last Update: 2016-03-30