[1]朱本俊,王志洲,严伟,等.骨痿康颗粒联合髓芯减压+纳米羟基磷灰石/聚酰胺66骨诱导活性材料治疗气滞血瘀证股骨头坏死的临床研究[J].中国中医骨伤科杂志,2026,34(04):79-86.[doi:10.20085/j.cnki.issn1005-0205.260413]
 ZHU Benjun,WANG Zhizhou,YAN Wei,et al.[J].Chinese Journal of Traditional Medical Traumatology & Orthopedics,2026,34(04):79-86.[doi:10.20085/j.cnki.issn1005-0205.260413]
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骨痿康颗粒联合髓芯减压+纳米羟基磷灰石/聚酰胺66骨诱导活性材料治疗气滞血瘀证股骨头坏死的临床研究()

《中国中医骨伤科杂志》[ISSN:1005-0205/CN:42-1340/R]

卷:
第34卷
期数:
2026年04期
页码:
79-86
栏目:
临床研究
出版日期:
2026-04-10

文章信息/Info

Title:
文章编号:
1005-0205(2026)04-0079-08
作者:
朱本俊1王志洲1严伟1蔡柯1葛炎炎1姜红江1△
1山东省文登整骨医院(山东 威海,264400)
Author(s):
ZHU Benjun1WANG Zhizhou1YAN Wei1CAI Ke1GE Yanyan1JIANG Hongjiang1△
1Shandong Wendeng Orthopaedic Hospital,Weihai 264400,Shandong China.
关键词:
股骨头坏死 纳米羟基磷灰石/聚酰胺66(nHA/PA66) 骨痿康颗粒 髓芯减压术 中西医结合
Keywords:
osteonecrosis of the femoral head nano-hydroxyapatite/polyamide 66(nHA/PA66) Guweikang granules core decompression integrated Chinese and Western medicine
分类号:
R681.8
DOI:
10.20085/j.cnki.issn1005-0205.260413
文献标志码:
A
摘要:
目的:探讨骨痿康颗粒联合髓芯减压+纳米羟基磷灰石/聚酰胺66(nHA/PA66)骨诱导活性材料治疗气滞血瘀证股骨头坏死的临床疗效与安全性。方法:回顾性分析 2022 年10月至2023 年10 月收治的 ARCO Ⅱ/ⅢA 期股骨头坏死患者32例(32髋),术中髓芯减压并植入nHA/PA66骨诱导活性材料,术后第1天口服骨痿康颗粒,2次/d,2个月为1个疗程,共3个疗程。随访12~18个月(中位数 14 个月),以髋关节Harris评分、中医影像学评分和中医证候评分评估疗效,并记录并发症。结果:手术平均切口长度为(2.63±0.48)cm,手术时间为(37.53±5.30)min,术中出血(50.63±5.83)mL; 无血栓、感染等并发症。末次随访Harris评分为(85.56±9.38)分,显著高于术前(70.81±8.78)分,差异有统计学意义(P<0.05),优良率由 15.6% 提升至 78.1%。影像学评分由2(1,3)分降至1(1,1.25)分,差异有统计学意义(P<0.05)。中医证候评分由术前(18.50±3.66)分降至末次随访(4.81±5.69)分,差异有统计学意义(P<0.05),证候痊愈率为40.6%,总有效率为90.6%。3 例(9.4%)进展为塌陷并转为全髋关节置换。未见药物相关不良反应。结论:骨痿康颗粒联合髓芯减压+nHA/PA66骨诱导活性材料治疗早中期气滞血瘀证股骨头坏死,在缓解疼痛、改善髋关节功能及影像学稳定性方面优于单一髓芯减压或材料植入,且安全性良好,可为临床保髋治疗提供新的中西医结合方案。
Abstract:
Objective:To investigate the clinical efficacy and safety of Guweikang granules combined with a nano-hydroxyapatite/polyamide 66(nHA/PA66)osteoinductive active material in treating osteonecrosis of the femoral head(ONFH)associated with the syndrome of Qi stagnation and blood stasis.Methods:A retrospective analysis of 32 patients(32 hips )with ARCO Ⅱ/ⅢA stage ONFH between October 2022 and October 2023.During the operation,core decompression and implantation of an osteoinductive nHA/PA66 composite were performed.On the first day after surgery,Guweikang granules was administered orally twice daily for a course of 2 months,with a total of 3 courses.The patients were followed up for 1218 months(median 14 months).Efficacy was assessed using the Harris hip score,the traditional Chinese medicine imaging scale,and the traditional Chinese medicine syndrome score,with complications also documented.Results:The average incision length was(2.63±0.48)cm,the operation time was(37.53±5.30)min,and the intraoperative blood loss was(50.63±5.83)mL.There were no complications such as thrombosis and infection.The Harris score at the last follow-up(85.56±9.38)points was significantly higher than that before surgery(70.81±8.78)points(P<0.05),and the excellent and good rate increased from 15.6% to 78.1%.The imaging score decreased from 2(1,3)points to 1(1,1.25)points(P<0.05).The traditional Chinese medicine syndrome score decreased from(18.5±3.66)points preoperatively to(4.81±5.69)points at the last follow-up(P<0.05).The syndrome cure rate was 40.6%,and the overall response rate was 90.6%.Three cases(9.4%)progressed to femoral head collapse and subsequently required to total hip replacement.No drug-related adverse reactions were observed.Conclusion:Guweikang granules combined with core decompression and nHA/PA66 bone-inductive active materials for treating early-to-mid-stage Qi stagnation and blood stasis syndrome in ONFH demonstrated superior efficacy in alleviating pain,improving hip function,and achieving radiographic stability compared to literature reports on core decompression or material implantation alone.With favorable safety profiles,this approach offers a novel,integrated Chinese-Western medicine solution for clinical hip-preserving treatment.

参考文献/References:

[1] 中国医师协会骨科医师分会骨循环与骨坏死专业委员会,中华医学会骨科分会骨显微修复学组,国际骨循环学会中国区.中国成人股骨头坏死临床诊疗指南(2020)[J].中华骨科杂志,2020,40(20):1365-1376.
[2] TAN B,LI W L,ZENG P,et al.Epidemiological study based on China osteonecrosis of the femoral head database[J].Orthopaedic Surgery,2021,13(1):153-160.
[3] 杨小龙,陆欢,朱超,等.骨复生胶囊联合髓芯减压自体髂骨植骨治疗早期股骨头坏死的临床研究[J].中国中医骨伤科杂志,2024,32(1):20-24.
[4] 杨少辉,乔志芬,王光龙.口服骨萎康颗粒治疗股骨头缺血性坏死的临床研究[J].中医正骨,2009,21(10):1-3.
[5] ZHAO D W,ZHANG F,WANG B J,et al.Guidelines for clinical diagnosis and treatment of osteonecrosis of the femoral head in adults(2019 version)[J].Journal of Orthopaedic Translation,2020,21:100-110.
[6] PETEK D,HANNOUCHE D,SUVA D.Osteonecrosis of the femoral head:pathophysiology and current concepts of treatment[J].EFORT Open Reviews,2019,4(3):85-97.
[7] 中华中医药学会.股骨头坏死中医辨证标准(2019年版)[J].中医正骨,2019,31(6):1-2.
[8] 中华医学会骨科分会显微修复学组,中国修复重建外科专业委员会骨缺损及骨坏死学组.成人股骨头坏死诊疗标准专家共识(2012年版)[J].中国骨与关节外科,2012,5(2):185-192.
[9] YUE J A,GUO X Z,WANG R D,et al.Preliminary report of the outcomes and indications of single approach,double-channel core decompression with structural bone support and bone grafting for osteonecrosis of the femoral head[J].BMC Musculoskeletal Disorders,2022,23(1):198.
[10] KAUR G,GANGWANI N,SHARATH H V.A case report on advanced hip tuberculosis:outcomes of combined surgical and rehabilitative intervention[J].Cureus,2024,16(8):e68309.
[11] 陈卫衡.基于X线的股骨头坏死保髋疗效评价方法研究[J/OL].中华关节外科杂志(电子版),2017,11(3):222-227.
[12] 国家食品药品监督管理局.中药新药临床研究指导原则(试行)[M].北京:中国医药科技出版社,2002:353-355.
[13] CHEN Y W,MIAO Y,LIU K X,et al.Evolutionary course of the femoral head osteonecrosis:histopathological-radiologic characteristics and clinical staging systems[J].Journal of Orthopaedic Translation,2022,32:28-40.
[14] BAEK S H,SHIM B J,WON H,et al.Evaluation of safety and efficacy of cell therapy based on osteoblasts derived from umbilical cord mesenchymal stem cells for osteonecrosis of the femoral head:study protocol for a single-center,open-label,phase I clinical trial[J].Pharmaceuticals,2024,17(10):1366.
[15] 钱利海,梁清宇.成人早中期股骨头坏死保髋治疗的最新研究进展[J].实用骨科杂志,2022,28(11):997-1001.
[16] 段瑞蒙,凌昊楠,张蕾蕾,等.股骨颈头颈开窗植骨联合体外冲击波治疗早期股骨头坏死26例[J].中国中医骨伤科杂志,2024,32(8):64-69.
[17] ABDUL HALIM N A,HUSSEIN M Z,KANDAR M K.Nanomaterials-upconverted hydroxyapatite for bone tissue engineering and a platform for drug delivery[J].International Journal of Nanomedicine,2021,16:6477-6496.
[18] MUNIR M U,SALMAN S,IHSAN A,et al.Synthesis,characterization,functionalization and bio-applications of hydroxyapatite nanomaterials:an overview[J].International Journal of Nanomedicine,2022,17:1903-1925.
[19] DIEZ-ESCUDERO A,ESPANOL M,GINEBRA M P.High-aspect-ratio nanostructured hydroxyapatite:towards new functionalities for a classical material[J].Chemical Science,2024,15(1):55-76.
[20] WANG Q,WANG M H,LU X,et al.Effects of atomic-level nano-structured hydroxyapatite on adsorption of bone morphogenetic protein-7 and its derived peptide by computer simulation[J].Scientific Reports,2017,7:15152.
[21] WANG T,GUO S,ZHANG H.Synergistic effects of controlled-released BMP-2 and VEGF from nHAC/PLGAs scaffold on osteogenesis[J].BioMed Research International,2018(1):3516463.
[22] ZHONG W Y,TANG K,QUAN Z X.A novel nanohydroxyapatite/polyamide 66 strut for reducing subsidence after one-level anterior cervical corpectomy and fusion:a finite-element study[J].European Journal of Medical Research,2024,29(1):375.
[23] XIONG Y,REN C,ZHANG B,et al.Analyzing the behavior of a porous nano-hydroxyapatite/polyamide 66(n-HA/PA66)composite for healing of bone defects[J].International Journal of Nanomedicine,2014,9:485-494.
[24] 孟纯阳,安洪,蒋电明,等.新型纳米骨重建和修复材料羟基磷灰石/聚酰胺体内植入的生物相容性及安全性[J].中国临床康复,2004,8(29):6330-6333.
[25] 黄金会.不同降解性高分子复合支架的长期成骨行为对比研究及优化[D].成都:四川大学,2021.
[26] 岳聚安,郭晓忠,王冉东,等.纳米羟基磷灰石/聚酰胺66支撑棒结合同种异体骨治疗ARCOⅢ期股骨头坏死[J].中国组织工程研究,2020,24(28):4485-4491.
[27] 杨明敏,李黛,孙扬.纳米羟基磷灰石复合聚酰胺66材料修复早期股骨头坏死[J].中国组织工程研究,2015,19(34):5463-5467.
[28] YANG P,BIAN C B,HUANG X,et al.Core decompression in combination with nano-hydroxyapatite/polyamide 66 rod for the treatment of osteonecrosis of the femoral head[J].Archives of Orthopaedic and Trauma Surgery,2014,134(1):103-112.
[29] 郭雪峰,任艳玲,于睿,等.基于“久病入络”理论探讨“从虚而始,因虚致瘀,瘀痹骨络”的激素性股骨头坏死核心病机观[J].中华中医药学刊,2024,42(6):191-194.
[30] 田涛涛,石淇允,李无阴,等.补肾活血法治疗创伤性股骨头坏死的理论探析[J].中国中医急症,2020,29(8):1424-1426.
(收稿日期:2025-06-14)

备注/Memo

备注/Memo:
基金项目:山东省中医药科技项目(Z-2023110)
威海市中医药科技项目(2023I-3)
山东省医药卫生科技项目(202304071340)
通信作者 E-mail:boneman@163.com
更新日期/Last Update: 2026-04-15