[1]刘爱峰,王平,张君涛,等.筋骨止痛凝胶外用治疗早期膝骨关节炎肾虚血瘀证的临床研究[J].中医正骨,2025,37(11):1-9.
　LIU Aifeng,WANG Ping,ZHANG Juntao,et al.External application of Jinggu Zhitong Ningjiao(筋骨止痛凝胶)for treatment of early-stage knee osteoarthritis with the syndrome of kidney deficiency and blood stagnation:a clinical study[J].The Journal of Traditional Chinese Orthopedics and Traumatology,2025,37(11):1-9.
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筋骨止痛凝胶外用治疗早期膝骨关节炎肾虚血瘀证的临床研究()

《中医正骨》[ISSN:1001-6015/CN:41-1162/R]

卷:
第37卷
期数:
2025年11期
页码:
1-9
栏目:
临床研究
出版日期:
2025-11-20

文章信息/Info

Title:
External application of Jinggu Zhitong Ningjiao(筋骨止痛凝胶)for treatment of early-stage knee osteoarthritis with the syndrome of kidney deficiency and blood stagnation:a clinical study
作者:
刘爱峰1; 王平1; 张君涛1; 张超1; 翟静波2; 余伟杰1; 刘佳进1; 郭天赐1; 牛朴钰1; 冯汇川1; 梅胜锦1
1.天津中医药大学第一附属医院,天津 300381; 2.天津中医药大学中医药研究院,天津 301617
Author(s):
LIU Aifeng1; WANG Ping1; ZHANG Juntao1; ZHANG Chao1; ZHAI Jingbo2; YU Weijie1; LIU Jiajin1; GUO Tianci1; NIU Puyu1; FENG Huichuan1; MEI Shengjin1
1.First Teaching Hospital of Tianjin University of Traditional Chinese Medicine,Tianjin 300381,China 2.Academy of Traditional Chinese Medicine,Tianjin University of Traditional Chinese Medicine,Tianjin 301617,China
关键词:
骨关节炎; 膝;  肾虚血瘀;  筋骨止痛凝胶;  随机对照试验专题
Keywords:
osteoarthritis; knee;  kidney deficiency and blood stagnation;  Jingu Zhitong Ningjiao;  randomized controlled trials as topic
摘要:
目的:探讨筋骨止痛凝胶外用治疗膝骨关节炎(knee osteoarthritis,KOA)肾虚血瘀证的临床疗效及安全性。方法:将2024年6—12月收治的70例早期KOA肾虚血瘀证患者随机分为2组,每组35例。筋骨止痛凝胶组于膝关节疼痛处外涂筋骨止痛凝胶,安慰剂组于膝关节疼痛处外涂筋骨止痛凝胶模拟剂; 2组均每日2次外涂皮肤,每次3 g,疗程8周。除外涂凝胶外,2组每日均进行股四头肌功能锻炼,共8周。分别于治疗前及治疗4周、8周后记录并比较2组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、膝关节疼痛视觉模拟量表(visual analogue scale,VAS)评分、膝关节活动度及中医证候积分; 分别于治疗前、治疗8周后记录并比较2组患者的膝关节温度、膝关节软骨厚度; 观察并比较2组患者并发症发生情况。结果:①患者退出情况。筋骨止痛凝胶组和安慰剂组各有3例患者退出试验。②WOMAC评分。2组WOMAC评分随时间变化均呈下降趋势,但2组的下降趋势不完全一致(F=131.327,P=0.000; F=139.384,P=0.000); 治疗4周、8周后,筋骨止痛凝胶组WOMAC评分均低于安慰剂组(t=-2.875,P=0.006; t=-5.674,P=0.000)。③膝关节疼痛VAS评分。2组膝关节疼痛VAS评分随时间变化均呈下降趋势,但2组的下降趋势不完全一致(Wald χ2=68.070,P=0.000; Wald χ2=38.281,P=0.000); 治疗4周、8周后,筋骨止痛凝胶组的膝关节疼痛VAS评分均低于安慰剂组(Z=-3.312,P=0.001; Z=-5.708,P=0.000)。④膝关节活动度。2组膝关节活动度随时间变化均呈上升趋势,但2组的上升趋势不完全一致(F=65.954,P=0.000; F=27.821,P=0.000); 治疗8周后,筋骨止痛凝胶组膝关节活动度大于安慰剂组(t=2.304,P=0.000)。⑤中医证候积分。2组中医证候积分随时间变化均呈下降趋势,但2组的下降趋势不完全一致(F=394.671,P=0.000; F=80.072,P=0.000); 治疗4周、8周后,筋骨止痛凝胶组中医证候积分均低于安慰剂组(t=-2.083,P=0.041; t=-6.083,P=0.000)。⑥膝关节温度。治疗8周后,筋骨止痛凝胶组膝关节上内侧区、髌上囊区、膝关节上外侧区、内侧副韧带区、髌骨区、外侧副韧带区、内膝眼穴区、鹅足囊区及犊鼻穴区温度均低于安慰剂组(Z=-6.276,P=0.000; Z=-4.083,P=0.000; t=-3.649,P=0.001; t=-5.413,P=0.000; t=-3.183,P=0.002; t=-2.312,P=0.024; t=-4.112,P=0.000; t=-4.956,P=0.000; Z=-2.754,P=0.006)。⑦膝关节软骨厚度。治疗前及治疗8周后,2组股骨内侧髁软骨厚度、股骨外侧髁软骨厚度、胫骨内侧髁软骨厚度、胫骨外侧髁软骨厚度及髌骨软骨厚度比较,组间差异均无统计学意义。⑧安全性。2组患者并发症发生率比较,差异无统计学意义(P=1.000)。结论:对于早期KOA肾虚血瘀证患者,在行股四头肌功能锻炼的基础上外用筋骨止痛凝胶,能有效缓解膝关节疼痛、降低膝关节局部温度、增加膝关节活动度、改善膝关节功能和中医证候,其疗效优于单纯行股四头肌功能锻炼,但二者在安全性方面相当,且在短期内对软骨形态的改善作用均不明显。
Abstract:
Objective:To investigate the clinical efficacy and safety of external application of Jinggu Zhitong Ningjiao(筋骨止痛凝胶,JGZTNJ)in treatment of early-stage knee osteoarthritis(KOA)with the syndrome of kidney deficiency and blood stagnation.Methods:Se-venty early-stage KOA patients with the syndrome of kidney deficiency and blood stagnation,recruited from June 2024 to December 2024,were enrolled in the study,and randomized into JGZTNJ group and placebo group,with 35 ones in each group.The patients in JGZTNJ group were treated with external application of JGZTNJ at the pain spots of affected knees,while the ones in placebo group with external application of JGZTNJ mimetic agent at the corresponding sites.All patients in the 2 groups were treated twice a day,3 g at a time for consecutive 8 weeks.Furthermore,all patients in the 2 groups were instructed to perform quadriceps functional exercises every day throughout the 8-week treatment period.Outcome measures including the Western Ontario and McMaster Universities osteoarthritis index(WOMAC)score,knee pain visual analogue scale(VAS)score,knee range of motion(ROM),and traditional Chinese medicine(TCM)syndrome score were recorded and compared between the 2 groups before the treatment,after 4- and 8-week treatment,respectively.Additionally,the knee joint temperature and knee cartilage thickness were measured and compared between the 2 groups before the treatment and after 8-week treatment,respectively,and the complications were also monitored and compared between the 2 groups.Results:①Patient withdrawals.Three patients each in the 2 groups withdrew from the trial.②The WOMAC score.The WOMAC score presented a gradual decreasing trajectory over time in the 2 groups,while the 2 groups were inconsistent with each other in the variation tendency(F=131.327,P=0.000; F=139.384,P=0.000).In addition,the WOMAC score was lower in JGZTNJ group compared to placebo group after 4- and 8-week treatment(t=-2.875,P=0.006; t=-5.674,P=0.000).③The knee pain VAS score.The knee pain VAS score presented a gradual decreasing trajectory over time in the 2 groups,while the 2 groups were inconsistent with each other in the variation tendency(Wald χ2=68.070,P=0.000; Wald χ2=38.281,P=0.000).In addition,the knee pain VAS score was lower in JGZTNJ group compared to placebo group after 4- and 8-week treatment(Z=-3.312,P=0.001; Z=-5.708,P=0.000).④The knee ROM.The knee ROM presented a gradual increasing trajectory over time in the 2 groups,while the 2 groups were inconsistent with each other in the variation tendency(F=65.954,P=0.000; F=27.821,P=0.000).In addition,the knee ROM was greater in JGZTNJ group compared to placebo group after 8-week treatment(t=2.304,P=0.000).⑤The TCM syndrome score.The TCM syndrome score presented a gradual decreasing trajectory over time in the 2 groups,while the 2 groups were inconsistent with each other in the variation tendency(F=394.671,P=0.000; F=80.072,P=0.000).In addition,the TCM syndrome score was lower in JGZTNJ group compared to placebo group after 4- and 8-week treatment(t=-2.083,P=0.041; t=-6.083,P=0.000).⑥The knee joint temperature.The temperatures in all nine measured knee regions,e.g.,superior-medial knee region,suprapatellar bursa region,superior-lateral knee region,medial collateral ligament region,patellar region,lateral collateral ligament region,Point Neixiyan(EX LE4)region,pes anserine bursa region and Point Dubi(ST35)region,were lower in JGZTNJ group compared to placebo group after 8-week treatment(Z=-6.276,P=0.000; Z=-4.083,P=0.000; t=-3.649,P=0.001; t=-5.413,P=0.000; t=-3.183,P=0.002; t=-2.312,P=0.024; t=-4.112,P=0.000; t=-4.956,P=0.000; Z=-2.754,P=0.006).⑦The knee cartilage thickness.The cartilage thicknesses of the medial and lateral femoral condyles,medial and lateral tibial condyles,or patella were not significantly different between the 2 groups either before the treatment or after 8-week treatment.⑧Safety.The incidence of complications was comparable between the 2 groups(P=1.000).Conclusion:External application of JGZTNJ combined with quadriceps functional exercises can effectively relieve knee pain,reduce local knee temperature,increase knee ROM,improve knee function,and ameliorate TCM syndromes in early-stage KOA patients with the syndrome of kidney deficiency and blood stagnation,its therapeutic efficacy is superior to that of performing quadriceps exercises alone.However,the both are comparable in safety profiles,and show no significant effect on improving cartilage morphology in the short-term.

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备注/Memo

备注/Memo:
基金项目:国家自然科学基金项目(82474538); 中华中医药学会骨病防治交叉研究项目(2023-GBJC-04); 天津市第二批卫生健康行业高层次人才选拔培养工程(津门医学英才)项目(TJSJMYXYC-D2-028)
通讯作者:刘爱峰 E-mail:draifeng@163.com
更新日期/Last Update: 1900-01-01