[1]曹依珊,金钊锴,童培建,等.自体基质血管组分联合骨健口服液治疗早中期膝骨关节炎肾虚髓亏证的临床研究[J].中医正骨,2025,37(07):33-40.
　CAO Yishan,JIN Zhaokai,TONG Peijian,et al.Autologous stromal vascular fraction combined with Gujian(骨健)peroral liquids for treatment of early- to mid-stage knee osteoarthritis with marrow depletion due to kidney deficiency:a clinical study[J].The Journal of Traditional Chinese Orthopedics and Traumatology,2025,37(07):33-40.
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自体基质血管组分联合骨健口服液治疗早中期膝骨关节炎肾虚髓亏证的临床研究()

《中医正骨》[ISSN:1001-6015/CN:41-1162/R]

卷:
第37卷
期数:
2025年07期
页码:
33-40
栏目:
临床研究
出版日期:
2025-07-20

文章信息/Info

Title:
Autologous stromal vascular fraction combined with Gujian(骨健)peroral liquids for treatment of early- to mid-stage knee osteoarthritis with marrow depletion due to kidney deficiency:a clinical study
作者:
曹依珊1; 金钊锴2; 童培建2; 金红婷2; 应俊2
1.浙江中医药大学第三临床医学院,浙江 杭州 310053; 2.浙江中医药大学附属第一医院/浙江省中医院,浙江 杭州 310006
Author(s):
CAO Yishan1; JIN Zhaokai2; TONG Peijian2; JIN Hongting2; YING Jun2
1.The Third Clinical Medical College of Zhejiang Chinese Medical University,Hangzhou 310053,Zhejiang,China 2.The First Affiliated Hospital of Zhejiang Chinese Medical University(Zhejiang Provincial Hospital of Chinese Medicine),Hangzhou 310006,Zhejiang,China
关键词:
骨关节炎; 膝;  肾虚髓亏;  基质血管成分;  注射; 关节内;  骨健口服液;  随机对照试验专题
Keywords:
osteoarthritis; knee;  marrow depletion due to kidney deficiency;  stromal vascular fraction;  injections; intra-articular;  Gujian peroral liquids;  randomized controlled trials as topic
摘要:
目的:观察自体基质血管组分(stromal vascular fraction,SVF)联合骨健口服液治疗早中期膝骨关节炎(knee osteoarthritis,KOA)肾虚髓亏证的临床疗效和安全性。方法:将2022年7月至2024年6月收治的60例早中期KOA肾虚髓亏证患者随机分为2组,每组30例。SVF组采用自体SVF关节腔注射治疗; 联合组在自体SVF关节腔注射后,连续口服4周骨健口服液。治疗前及治疗开始后2周、4周、8周,测定患者的西安大略和麦克马斯特大学骨关节炎指数(Western Ontario and McMaster Universities osteoarthritis index,WOMAC)评分和膝关节疼痛视觉模拟量表(visual analogue scale,VAS)评分; 治疗前及治疗开始后1 d、2周,测定患者的血清C反应蛋白(C-reactive protein,CRP)、血清白细胞介素-6(interleukin-6,IL-6)水平等炎症指标; 治疗前和治疗开始后 8周,采用Qualisys Oqus700+三维步态分析系统进行膝关节步态运动学参数检测,包括步行过程中患侧膝关节屈曲最大角度、最小角度,以及步速和步长。观察试验期间2组患者的并发症发生情况。结果:①一般情况。试验过程中,SVF组1例患者失访,联合组2例患者退出试验。②WOMAC评分。时间因素与分组因素不存在交互效应(F=0.542,P=0.654)。2组患者的WOMAC评分总体比较,差异无统计学意义,即不存在分组效应(F=-1.833,P=0.068)。治疗前后不同时间点之间WOMAC评分的差异有统计学意义,即存在时间效应(F=10.531,P=0.000)。2组患者的WOMAC评分随时间变化均呈降低趋势(F=3.371,P=0.021; F=7.662,P=0.000),且2组的降低趋势完全一致。③膝关节疼痛VAS评分。时间因素与分组因素不存在交互效应(F=0.983,P=0.401)。SVF组患者的膝关节疼痛VAS评分高于联合组,即存在分组效应(F=-2.853,P=0.005)。治疗前后不同时间点之间膝关节疼痛VAS评分的差异有统计学意义,即存在时间效应(F=70.171,P=0.000)。2组患者的膝关节疼痛VAS评分随时间变化均呈降低趋势(F=33.852,P=0.000; F=40.014,P=0.000),且2组的降低趋势完全一致。④血清CRP水平。时间因素与分组因素存在交互效应。2组患者的血清CRP水平随时间变化均呈先升高后降低的趋势(F=200.982,P=0.000; F=270.709,P=0.000); 治疗前和治疗开始后1 d,2组患者的血清CRP水平比较,组间差异均无统计学意义(t=-0.172,P=0.869; t=1.241,P=0.217); 治疗开始后2周,联合组的血清CRP水平低于SVF组(t=-3.223,P=0.002)。⑤血清IL-6水平。时间因素与分组因素存在交互效应。2组患者的血清IL-6水平随时间变化均呈先升高后降低的趋势(F=94.442,P=0.000; F=86.361,P=0.000); 治疗前和治疗开始后1 d,2组患者的血清IL-6水平比较,组间差异均无统计学意义(t=-0.212,P=0.831; t=0.884,P=0.378); 治疗开始后2周,联合组的血清IL-6水平低于SVF组(t=-2.463,P=0.015)。⑥患侧膝关节屈曲最大角度。治疗开始后8周,SVF组的患侧膝关节屈曲最大角度与治疗前的差异无统计学意义(t=-1.991,P=0.052),联合组的患侧膝关节屈曲最大角度较治疗前增大(t=-5.233,P=0.000),2组患者患侧膝关节屈曲最大角度的差异无统计学意义(t=-2.001,P=0.050)。⑦患侧膝关节屈曲最小角度。治疗开始后8周,2组患者的患侧膝关节屈曲最小角度均较治疗前减小(t=11.522,P=0.000; t=16.648,P=0.000),联合组的患侧膝关节屈曲最小角度小于SVF组(t=2.372,P=0.021)。⑧步速。治疗开始后 8周,2组患者的步速均较治疗前增加(t=-3.421,P=0.001; t=-5.502,P=0.000),联合组的步速高于SVF组(t=-2.274,P=0.027)。⑨步长。治疗开始后8周,SVF组的步长与治疗前的差异无统计学意义(t=-2.001,P=0.051),联合组的步长较治疗前增大(t=-3.322,P=0.002),2组患者步长的差异无统计学意义(t=-0.948,P=0.348)。⑩并发症。2组患者均未发生膝关节肿胀、感染以及肝肾损伤等并发症。结论:采用自体SVF联合骨健口服液治疗早中期KOA肾虚髓亏证,可明显减轻机体炎症反应和膝关节疼痛症状、改善膝关节功能,在减轻炎症反应和提高步速方面疗效优于单纯自体SVF关节腔注射治疗,而且安全性较高。
Abstract:
Objective:To observe the clinical efficacy and safety of autologous stromal vascular fraction(SVF)combined with Gujian(骨健,GJ)peroral liquids in treatment of early- to mid-stage knee osteoarthritis(KOA)with marrow depletion due to kidney deficiency.Methods:Sixty early- to mid-stage KOA patients with marrow depletion due to kidney deficiency admitted from July 2022 to June 2024 were randomized into SVF group and combination group,with 30 ones in each group.The patients in SVF group were treated with intra-articular injection of autologous SVF,while the ones in combination group with intra-articular injection of autologous SVF followed by oral application of GJ peroral liquids for consecutive 4 weeks.The Western Ontario and McMaster Universities osteoarthritis index(WOMAC)score and knee pain visual analogue scale(VAS)score were measured before the treatment and at 2,4 and 8 weeks after initiation of the treatment,respectively,and the serum C-reactive protein(CRP)and interleukin-6(IL-6)levels were detected before the treatment,and at 1 day and 2 weeks after initiation of the treatment,respectively.Furthermore,the knee gait kinematic parameters,including the maximum flexion angle and minimum flexion angle of the affected knee,stride velocity,and stride length during walking,were quantified using the Qualisys Oqus700+ 3D motion capture system before the treatment and at 8 weeks after initiation of the treatment,respectively,and the complications were observed and recorded throughout the trial.Results:①General condition.During the trial,1 patient in the SVF group was lost to follow-up,and 2 patients in the combination group withdrew from the trial.②WOMAC score.No interaction effect was observed between time factor and group factor(F=0.542,P=0.654).There was no statistical difference in the WOMAC score between the 2 groups in general,indicating absence of group effect(F=-1.833,P=0.068); While,the WOMAC score differed significantly across different time points before and after the treatment,demonstrating a significant time effect(F=10.531,P=0.000).The WOMAC score presented a decreasing trajectory over time in the 2 groups(F=3.371,P=0.021; F=7.662,P=0.000),with the identical trends.③Knee pain VAS score.No interaction effect was observed between time factor and group factor(F=0.983,P=0.401).The knee pain VAS score was higher in SVF group compared to combination group,indicating a significant group effect(F=-2.853,P=0.005); Moreover,the knee pain VAS score differed significantly across different time points before and after the treatment,demonstrating a significant time effect(F=70.171,P=0.000).The knee pain VAS score presented a decreasing trajectory over time in the 2 groups(F=33.852,P=0.000; F=40.014,P=0.000),with the identical trends.④Serum CRP level.A significant interaction effect was observed in serum CRP level between time factor and group factor.The serum CRP level presented a biphasic trajectory of initial increase followed by decrease over time in the 2 groups(F=200.982,P=0.000; F=270.709,P=0.000).The comparison of serum CRP level between the 2 groups revealed no significant differences before the treatment and at 1 day after initiation of the treatment(t=-0.172,P=0.869; t=1.241,P=0.217),while,at 2 weeks after initiation of the treatment,the serum CRP level was lower in combination group compared to SVF group(t=-3.223,P=0.002).⑤Serum IL-6 level.A signi-ficant interaction effect was observed in serum IL-6 level between time factor and group factor.The serum IL-6 level presented a biphasic trajectory of initial increase followed by decrease over time in the 2 groups(F=94.442,P=0.000; F=86.361,P=0.000).The comparison of serum IL-6 level between the 2 groups revealed no significant differences before the treatment and at 1 day after initiation of the treatment(t=-0.212,P=0.831; t=0.884,P=0.378),while,at 2 weeks after initiation of the treatment,the serum IL-6 level was lower in combination group compared to SVF group(t=-2.463,P=0.015).⑥Maximum flexion angle of the affected knee.The maximum flexion angle of the affected knee showed no significant change in SVF group(t=-1.991,P=0.052),while it increased in combination group(t=-5.233,P=0.000)at 8 weeks after initiation of the treatment compared to pre-treatment,however,no significant difference in the maximum flexion angle was detected between the 2 groups(t=-2.001,P=0.050).⑦Minimum flexion angle of the affected knee.The minimum flexion angle of the affected knee decreased at 8 weeks after initiation of the treatment compared to pre-treatment in the 2 groups(t=11.522,P=0.000; t=16.648,P=0.000),with smaller values observed in combination group compared to SVF group(t=2.372,P=0.021).⑧Stride velocity.The stride velocity increased at 8 weeks after initiation of the treatment compared to pre-treatment in the 2 groups(t=-3.421,P=0.001; t=-5.502,P=0.000),with higher values observed in combination group compared to SVF group(t=-2.274,P=0.027).⑨Stride length.The stride length did not change significantly in SVF group,but it increased in combination group at 8 weeks after initiation of the treatment compared to pre-treatment(t=-2.001,P=0.051; t=-3.322,P=0.002),however,no significant difference in the stride length was detected between the 2 groups(t=-0.948,P=0.348).⑩No patients experienced the complications such as knee swelling,infection,liver injury,or kidney injury in the 2 groups.Conclusion:Combination of autologous SVF with GJ peroral liquids can significantly ameliorate the systemic inflammatory response,alleviate the knee pain symptoms,and improve the knee joint function in treatment of early- to mid-stage KOA with marrow depletion due to kidney deficiency.Its therapeutic effect is superior to that of intra-articular injection of autologous SVF alone in reducing inflammatory response and improving stride velocity,with a favorable safety profile.

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备注/Memo

备注/Memo:
基金项目:国家自然科学基金项目(82104889); 浙江省中医药科技计划项目(2024ZR011); 浙江省国际联合实验室建设项目(浙江-美国中医药骨伤联合实验室)(浙科发〔2024〕42号)
通讯作者:应俊 E-mail:yincyivan@163.com
更新日期/Last Update: 1900-01-01