[1]张家雯,史宇航,刘嘉淳,等.恒古骨伤愈合剂治疗腰椎间盘突出症的前瞻性、多中心、真实世界研究[J].中国中医骨伤科杂志,2025,33(10):39-44+49.[doi:10.20085/j.cnki.issn1005-0205.251008]
　ZHANG Jiawen,SHI Yuhang,LIU Jiachun,et al.The Osteoking in Treating Lumbar Disc Herniation:A Prospective Multicenter Real-World Study[J].Chinese Journal of Traditional Medical Traumatology & Orthopedics,2025,33(10):39-44+49.[doi:10.20085/j.cnki.issn1005-0205.251008]
点击复制

恒古骨伤愈合剂治疗腰椎间盘突出症的前瞻性、多中心、真实世界研究()

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

卷:
第33卷
期数:
2025年10期
页码:
39-44+49
栏目:
临床研究
出版日期:
2025-10-15

文章信息/Info

Title:
The Osteoking in Treating Lumbar Disc Herniation:A Prospective Multicenter Real-World Study
文章编号:
1005-0205(2025)10-0039-06
作者:
张家雯1; 2; 史宇航1; 2; 刘嘉淳1; 2; 翁习生3; 宓保宏1; 2△; 彭鹏4; 殷咏强5; 高加智6; 郭英7; 杨广杰8; 宋铁兵9; 付伟10; 匡建军11; 张淑云12; 杨少锋13; 陈卫衡1; 2△
1北京中医药大学第三附属医院(北京,100029)
2中医骨伤治疗与运动康复智能化教育部工程研究中心
3北京协和医院
4湖南旺旺医院
5岳阳市人民医院
6潍坊市人民医院
7昆明市中医医院
8河南大学第一附属医院
9西安市中医医院
10西安交通大学第一附属医院长安区医院
11湖南中医药大学第一附属医院
12长沙市第四医院
13湖南省中医药研究院附属医院
Author(s):
ZHANG Jiawen1; 2; SHI Yuhang1; 2; LIU Jiachun1; 2; WENG Xisheng3; MI Baohong1; 2△; PENG Peng4; YIN Yongqiang5; GAO Jiazhi6; GUO Ying7; YANG Guangjie8SONG Tiebing9; FU Wei10; KUANG Jianjun11; ZHANG Shuyun12; YANG Shaofeng13; CHEN Weiheng1; 2△
1The Third Affiliated Hospital of Beijing University of Chinese Medicine,Beijing 100029,China; 2Engineering Research Center of Chinese Orthopaedic and Sports Rehabilitation Artificial Intelligent,Ministry of Education,Beijing 100029,China; 3Peking Union Medical College Hospital,Beijing 100730,China; 4Hunan Want Want Hospital,Changsha 410016,China; 5Yueyang People’s Hospital,Yueyang 414000,Hunan China; 6Weifang People’s Hospital,Weifang 261041,Shandong China; 7Kunming Mulicipal Hospital of Traditional Chinese Medicine,Kunming 650011,China; 8The First Affiliated Hospital of Henan University,Kaifeng 475000,Henan China;...
关键词:
腰椎间盘突出症;  恒古骨伤愈合剂;  病例注册登记研究;  真实世界研究;  倾向性评分匹配
Keywords:
lumbar disc herniation;  osteoking;  case registry study;  real-world study(RWS);  propensity score matching(PSM)
分类号:
R285.6; R681.5
DOI:
10.20085/j.cnki.issn1005-0205.251008
文献标志码:
A
摘要:
目的:研究真实世界中恒古骨伤愈合剂(Osteoking)治疗腰椎间盘突出症(LDH)的临床疗效及安全性。方法:采用前瞻性、观察性、多中心病例注册登记研究方法,对全国10所医院2020年11月至2022年8月共注册登记的490例腰椎间盘突出症患者,观察周期内采用恒古骨伤愈合剂联合常规保守治疗者为观察组,仅常规保守治疗者为对照组。观察组2例因入组后未进行后续观察剔除,最终纳入共488例观察对象,其中观察组359例,对照组129例。采用倾向性评分匹配法,以组别为因变量,以混杂因素为自变量,用1:1最邻近匹配对基线混杂因素进行校正,设置卡钳值为0.1以限制最大匹配距离。主要疗效指标为疼痛视觉模拟量表(VAS)评分,次要疗效指标为日本骨科协会(JOA)下腰痛评分、中医单项疼痛症状(冷痛、热痛、刺痛、隐痛、酸痛)及其他中医症状消失率。分别于病例注册登记时(基线)及登记后第2,4,8周时记录上述指标。采用不良事件发生率评估其安全性。结果:倾向性评分匹配后两组患者各124例,患者性别、年龄、体重指数、病程、基线VAS评分和JOA评分均衡可比,差异无统计学意义(P>0.05)。两组患者在治疗后各时间点(第2,4,8周)VAS评分中位数均显著低于基线,差异有统计学意义(P<0.05); 观察组VAS评分中位数治疗后显著低于对照组(第2周,3.00(2.00,4.00)比4.00(2.00,5.00); 第4周,2.00(1.00,3.00)比2.00(1.00,4.00); 第8周,1.00(0.00,2.00)比1.00(0.00,3.00)),差异有统计学意义(P<0.05)。两组患者治疗后各随访时间点JOA评分中位数较基线均有显著改善,差异有统计学意义(P<0.05)。观察组治疗后JOA评分中位数显著高于对照组(第2周,25.00(21.00,26.25)比22.00(17.75,23.00); 第4周,27.00(24.00,29.00)比24.00(21.00,26.00); 第8周,29.00(27.00,29.00)比24.00(24.00,25.00)),差异有统计学意义(P<0.05)。整理匹配后纳入观察248例患者的基线中医症状量表,筛选频次排列在前5位的中医单项症状,分别是隐痛(76.21%)、刺痛(73.79%)、腰膝酸软(34.68%)、腰身重痛(34.27%)和酸痛(32.26%)。观察组第8周隐痛症状消失率显著高于对照组,差异有统计学意义(84.38%比69.89%,P<0.05),酸痛症状消失率亦呈改善趋势,差异无统计学意义(55.26%比30.95%,P=0.05)。观察组刺痛、腰膝酸软、腰身重痛消失率均高于对照组,但差异无统计学意义(P>0.05)。倾向性评分匹配前两组患者不良事件发生率差异无统计学意义(观察组2.51%比对照组3.08%,P>0.05)),且均为轻度不良反应(如上呼吸道感染、失眠等),未发生严重不良事件。结论:恒古骨伤愈合剂可改善腰椎间盘突出症患者疼痛和功能障碍,且能缓解腰椎间盘突出症患者的隐痛、酸痛中医症状,可作为非手术治疗的重要治疗方案。
Abstract:
Objective:To evaluate the clinical efficacy and safety of the Osteoking,a traditional Chinese herbal preparation,for the treatment of lumbar disc herniation(LDH)through a prospective multicenter real-world study.Methods:This nationwide registry-based observational study enrolled 490 LDH patients from 10 hospitals between November 2020 and August 2022.After excluding 2 cases lost to follow-up,488 participants were analyzed(Osteoking plus conventional therapy,n=359; conventional therapy alone,n=129).Propensity score matching(PSM)with 1:1 nearest neighbor matching(caliper=0.1)was applied to balance baseline characteristics.Primary outcome was pain intensity measured by visual analogue scale(VAS).Secondary outcomes included Japanese orthopedic association(JOA)scores and resolution rates of traditional Chinese medicine(TCM)pain symptoms(cold pain,burning pain,stabbing pain,soreness,heaviness).Assessments were conducted at baseline,weeks 2,4,and 8.Safety was evaluated through adverse event monitoring.Results:After PSM(n=124 per group),baseline characteristics were comparable(all P>0.05).Both groups showed significant VAS reductions from baseline at all timepoints(P<0.05),with superior improvement in the Osteoking group:week 2(3.00 vs 4.00),week 4(2.00 vs 2.00),and week 8(1.00 vs 1.00).JOA scores demonstrated similar trends,with significantly higher median scores in the Osteoking group at all assessments(week 8,29.00 vs 24.00,P<0.05)and superior excellent rates(91.94% vs 47.58%,P<0.05).Analysis of TCM symptoms(n=248)revealed the top five baseline complaints:dull pain(76.21%),stabbing pain(73.79%),lumbar-knee soreness(34.68%),heaviness(34.27%),and general soreness(32.26%).The Osteoking group showed significantly higher resolution rates for dull pain(84.38% vs 69.89%,P<0.05)and marginal improvement in general soreness(55.26% vs 30.95%,P=0.05).Adverse event rates were comparable pre-PSM(2.51% vs 3.08%,P>0.05),with only mild events reported.Conclusion:The Osteoking demonstrates significant benefits in pain relief and functional recovery for LDH patients,particularly in alleviating TCM-identified dull pain and soreness.These real-world findings support its role as a valuable non-surgical therapeutic option.

参考文献/References:

[1] 中华医学会骨科学分会脊柱外科学组,中华医学会骨科学分会骨科康复学组.腰椎间盘突出症诊疗指南[J].中华骨科杂志,2020,40(8):477-487.
[2] 周谋望,岳寿伟,何成奇,等.“腰椎间盘突出症的康复治疗”中国专家共识[J].中国康复医学杂志,2017,32(2):129-135.
[3] DEYO R A,LOESER J D,BIGOS S J.Herniated lumbar intervertebral disk[J].Ann Intern Med,1990,112(8):598-603.
[4] CARLSON B B,ALBERT T J.Lumbar disc herniation:what has the spine patient outcomes research trial taught us?[J].Int Orthop,2019,43(4):853-859.
[5] 国家药典委员会.中华人民共和国药典:一部[M].北京:中国医药科技出版社,2020:1356-1357.
[6] 中华医学会疼痛学分会脊柱源性疼痛学组.腰椎间盘突出症诊疗中国疼痛专家共识[J].中国疼痛医学杂志,2020,26(1):2-6.
[7] 葛龙,李镜,尚文茹,等.非手术疗法治疗腰椎间盘突出症的循证实践指南[J].中国循证医学杂志,2024,24(2):125-148.
[8] 世界中医药学会联合会骨质疏松专业委员会.腰椎间盘突出症中西医结合诊疗专家共识[J].世界中医药,2023,18(7):945-952.
[9] 秦晓宽,孙凯,徐卫国,等.腰椎间盘突出症中医循证实践指南[J].西部中医药,2024,37(5):1-15.
[10] 许文龙.恒古骨伤愈合剂治疗腰椎间盘突出症的疗效观察[J].临床医药文献电子杂志,2018,5(58):31-32.
[11] 曹闲雅,匡浩铭,苏翔,等.恒古骨伤愈合剂治疗腰椎间盘突出症肾虚血瘀证的临床研究[J].湖南中医药大学学报,2020,40(12):1548-1552.
[12] 陈敏,何盈盈,左振芹,等.督脉同心圆刺法配合恒古骨伤愈合剂治疗腰椎间盘突出症的临床观察[J].中国民间疗法,2021,29(23):78-80.
[13] 叶子丰,匡浩铭,沈琳玲,等.恒古骨伤愈合剂口服联合透药治疗腰椎间盘突出症临床研究[J].新中医,2022,54(13):83-87.
[14] 黄振星,杨少锋,郭彦涛,等.恒古骨伤愈合剂治疗瘀血阻络型腰椎间盘突出症的临床疗效[J].中国中医骨伤科杂志,2022,30(3):35-38.
[15] 张在田.恒古骨伤愈合剂治疗腰椎间盘突出症的疗效分析[J].医药前沿,2022,12(9):64-66.
[16] 田峰,谢雁鸣.真实世界研究:中医干预措施效果评价的新理念[J].中西医结合学报,2010,8(4):301-306.
[17] 张强,卢存存,王志飞,等.真实世界观察性研究评估(ArRoWS)工具的介绍[J].中国中医基础医学杂志,2024,30(10):1691-1696.
[18] 王景霞,陈卫衡,陈绍红,等.基于“异病同治”理论探讨恒古骨伤愈合剂在4种骨伤科疾病治疗中的应用[J].中医正骨,2021,33(3):34-39.
[19] 沈金鳌.杂病源流犀烛·腰脐病源流[M].北京:中国中医药出版社,1994.
[20] 戴宁,何青鋆,陆芳.近十年国内药品临床综合评价研究的现状分析与建议[J].中医杂志,2024,65(4):357-361.
[21] 侯吴琼,宗瑛,周方婷,等.恒古骨伤愈合剂对背根节压迫模型大鼠的镇痛作用及机制[J].中国实验方剂学杂志,2023,29(24):30-41.
[22] 袁鑫,武羽洁,角建林,等.彝药恒古骨伤愈合剂的药理作用和临床应用[J].中国现代应用药学,2019,36(3):372-376.
[23] 李振宇,匡浩铭,常裕绅,等.恒古骨伤愈合剂治疗腰椎间盘突出症气滞血瘀证的疗效及对血清代谢物的影响[J].中医药导报,2024,30(4):75-81.
(收稿日期:2025-05-28)

备注/Memo

备注/Memo:
基金项目:北京中医药大学高层次人才科研启动项目(2021-XJ-KYOD-001)
深圳市“医疗卫生三名工程”资助项目(SZZYSM202311020)
△通信作者 E-mail:cor-ai@bucm.edu.cn(宓保宏)
drchenweiheng@bucm.edu.cn(陈卫衡)
更新日期/Last Update: 2025-10-10