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）（χ^2=4.171,P=0.034;χ^2=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。
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 Mc Master 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）（ χ^2= 4. 171,P = 0. 034; χ^2= 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 vs26. 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 vs23. 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 vs18. 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 vs81. 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 vs83. 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.
出处
《中医正骨》
2016年第3期14-19,共6页
The Journal of Traditional Chinese Orthopedics and Traumatology
基金
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)
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
femur head necrosis
Gujian Koufuye
arthroplasty
replacement
hip
therapies
investigational
