[1]孙烨凯,金红婷,何帮剑,等.肾髓同治方治疗膝骨关节炎肝肾亏虚证的临床研究[J].中医正骨,2025,37(09):44-25,43.
　SUN Yekai,JIN Hongting,HE Bangjian,et al.A clinical study of Shensui Tongzhi Fang(肾髓同治方)for treatment of knee osteoarthritis with liver-kidney deficiency syndrome[J].The Journal of Traditional Chinese Orthopedics and Traumatology,2025,37(09):44-25,43.
点击复制

肾髓同治方治疗膝骨关节炎肝肾亏虚证的临床研究()

《中医正骨》[ISSN:1001-6015/CN:41-1162/R]

卷:
第37卷
期数:
2025年09期
页码:
44-25,43
栏目:
膝骨关节炎
出版日期:
2025-09-20

文章信息/Info

Title:
A clinical study of Shensui Tongzhi Fang(肾髓同治方)for treatment of knee osteoarthritis with liver-kidney deficiency syndrome
作者:
孙烨凯1; 金红婷2; 何帮剑2; 胡松峰3; 王萧枫4; 袁文华2
(1.浙江中医药大学第一临床医学院,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; 3.绍兴市中医院,浙江 绍兴 312000; 4.温州市中西医结合医院,浙江 温州 325000)
Author(s):
SUN Yekai1; JIN Hongting2; HE Bangjian2; HU Songfeng3; WANG Xiaofeng4; YUAN Wenhua2
1.The First 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 3.Shaoxing Hospital of Traditional Chinese Medicine,Shaoxing 312000,Zhejiang,China 4.Wenzhou Hospital of Integrated Traditional Chinese and Western Medicine,Wenzhou 325000,Zhejiang,China
关键词:
骨关节炎; 膝;  肝肾亏虚;  消炎药; 非甾类;  肾髓同治方;  非随机对照试验专题
Keywords:
osteoarthritis; knee;  deficiency of liver and kidney;  anti-inflammatory agents; non-steroidal;  Shensui Tongzhi Fang;  non-rando-mized controlled trials as topic
摘要:
目的:观察肾髓同治方治疗膝骨关节炎(knee osteoarthritis,KOA)肝肾亏虚证的临床疗效和安全性。方法:以2023年12月至2024年6月收治的KOA肝肾亏虚证患者为研究对象。根据患者病情和意愿分为肾髓同治方组(肾髓同治方口服)和艾瑞昔布组(艾瑞昔布胶囊口服)。肾髓同治方口服为每日1剂,水煎,早晚各200 mL; 艾瑞昔布胶囊口服为每次0.1 g,每日2次。分别于治疗前和治疗2周后,采用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(包括总分、疼痛评分、僵硬评分及功能评分)评价患膝情况,采用匹兹堡睡眠质量指数(Pittsburgh sleep quality index,PSQI)评分评价患者睡眠情况。观察2组患者不良反应发生情况。结果:共纳入115例患者,肾髓同治方组68例、艾瑞昔布组47例。治疗前,2组患者WOMAC评分和PSQI评分的组间差异均无统计学意义。治疗2周后,肾髓同治方组WOMAC总分、疼痛评分、功能评分及PSQI评分均低于艾瑞昔布组[(50.603±6.591)分,(54.936±8.015)分,t=-3.171,P=0.002;(9.838±2.290)分,(11.128±2.401)分,t=-2.910,P=0.004;(37.397±5.551)分,(40.340±6.545)分,t=-2.597,P=0.011;(6.912±1.891)分,(9.106±2.238)分,t=-5.673,P=0.000]; 2组患者WOMAC僵硬评分的差异无统计学意义。治疗期间,肾髓同治方组未发生不良反应; 艾瑞昔布组2例患者出现恶心、呕吐、食欲下降等不良反应,停药后自行缓解; 2组患者不良反应发生率的差异无统计学意义(P=0.165)。结论:肾髓同治方治疗KOA肝肾亏虚证,在缓解膝关节疼痛、改善膝关节功能及改善患者睡眠质量方面优于艾瑞昔布; 2种药物的安全性相当。
Abstract:
Objective:To observe the clinical efficacy and safety of Shensui Tongzhi Fang(肾髓同治方,SSTZF)in treatment of knee osteoarthritis(KOA)with syndrome of liver-kidney deficiency.Methods:The patients with KOA and liver-kidney deficiency syndrome recruited from December 2023 to June 2024 were selected as the subjects,based on their clinical conditions and preferences,they were treated with oral application of SSTZF(SSTZF group)and imrecoxib capsule(imrecoxib group),respectively.The SSTZF was taken one dose a day in the morning(200 mL)and evening(200 mL),respectively,while,the imrecoxib capsules were taken twice a day,0.1 g at a time.Before the treatment and after 2-week treatment,the affected knee was evaluated using the Western Ontario and McMaster Universities osteoarthritis index(WOMAC)score,including the total score,pain score,stiffness score,and physical function score,and the sleep quality of the patients was assessed using the Pittsburgh sleep quality index(PSQI)score.The adverse reactions were monitored in the 2 groups.Results:One hundred and fifteen patients were enrolled in the study,68 cases in SSTZF group and 47 cases in imrecoxib group.Before the treatment,the WOMAC and PSQI scores showed no significant differences between the 2 groups.After 2-week treatment,the WOMAC total score,pain score,physical function score,and PSQI score were lower in SSTZF group compared to imrecoxib group(50.603±6.591 vs 54.936±8.015 points,t=-3.171,P=0.002; 9.838±2.290 vs 11.128±2.401 points,t=-2.910,P=0.004; 37.397±5.551 vs 40.340±6.545 points,t=-2.597,P=0.011; 6.912±1.891 vs 9.106±2.238 points,t=-5.673,P=0.000),with no significant difference observed in the WOMAC stiffness score between the 2 groups.During the treatment period,no adverse reactions were observed in SSTZF group,whereas,in imrecoxib group,2 patients experienced nausea,vomiting,and decreased appetite,which resolved spontaneously after stopping the medication.There was no statistical difference in the incidence of adverse reactions between the 2 groups(P=0.165).Conclusion:SSTZF is superior to imrecoxib in alleviating knee pain,improving knee joint function,and enhancing sleep quality in patients with KOA and liver-kidney deficiency syndrome,while,both are comparable to each other in the safety.

参考文献/References:

[1] 中国中医药研究促进会骨伤科分会.膝骨关节炎中医诊疗指南(2020年版)[J].中医正骨,2020,32(10):1-14.
[2] 中华中医药学会.膝骨关节炎中西医结合诊疗指南(2023年版)[J].中医正骨,2023,35(6):1-10.
[3] 马勇.膝骨关节炎的辨证分型和中草药治疗——《膝骨关节炎中医诊疗指南(2020年版)》解读[J].中医正骨,2021,33(9):1-2.
[4] 中国中药协会.藤黄健骨片治疗膝骨关节炎临床应用专家共识[J].中医正骨,2021,33(4):4-5.
[5] 李慧,周祥,汪传伟,等.加味补肾活血膏贴敷联合臭氧关节腔灌洗治疗膝骨关节炎(肾虚血瘀证)的临床观察[J].中国中医急症,2025,34(1):102-105.
[6] 卓泽川,侯成志,赵勇,等.补肾活骨汤治疗肾虚血瘀型膝骨关节炎临床研究及药效学验证[J].辽宁中医药大学学报,2024,26(9):16-22.
[7] 吴丛姿,金红婷,童培建.从髓论治膝骨关节炎[J].中医正骨,2021,33(1):52-55.
[8] 胡雪琴,金红婷,肖鲁伟,等.“浙派中医”骨伤学家肖鲁伟辨治“髓系骨病”的学术经验[J].浙江中医药大学学报,2019,43(10):1071-1073.
[9] 胡雪琴,金红婷,施振宇,等.髓病理论及其在骨病学中的应用[J].中医正骨,2018,30(11):39-42.
[10] 汪小健,李少广,王彭禾,等.基于“髓系骨病”理论论治膝骨关节炎[J].中华中医药杂志,2021,36(11):6500-6503.
[11] 中华医学会骨科学分会关节外科学组,中国医师协会骨科医师分会骨关节炎学组,国家老年疾病临床医学研究中心(湘雅医院),等.中国骨关节炎诊疗指南(2021年版)[J].中华骨科杂志,2021,41(18):1291-1314.
[12] 蒋协远,王大伟.骨科临床疗效评价标准[M].北京:人民卫生出版社,2005:275-277.
[13] 刘贤臣,唐茂芹,胡蕾,等.匹兹堡睡眠质量指数的信度和效度研究[J].中华精神科杂志,1996,29(2):103-107.
[14] HUANG H,LUO M,LIANG H,et al.Meta-analysis comparing celecoxib with diclofenac sodium in patients with knee osteoarthritis[J].Pain Med,2021,22(2):352-362.
[15] 程明霞,姑丽尼格尔·艾尼瓦尔,张源,等.艾瑞昔布的适宜性和可及性评价[J].医药导报,2025,44(2):239-245.
[16] 郭宗儒.国家1类新药艾瑞昔布的研制[J].中国新药杂志,2012,21(3):223-230.
[17] 朱晓倩,张思秦,史浩然,等.髓为奇恒之腑的藏象内涵[J].中医正骨,2025,37(5):61-63.
[18] 王玉杭,王煦程,王迪,等.基于“髓系骨病”理论探索Osterix阳性骨髓间充质干细胞维持骨稳态的作用[J].中医正骨,2023,35(1):10-16.
[19] 李记泉,闵冬雨,贾连群,等.基于“心肾髓”理论与骨髓间充质干细胞相关性探索心肌损伤新疗法[J].中华中医药学刊,2020,38(1):90-92.
[20] 翟怀乐.“补肾生髓法”基于PI3K/Akt-Jak1/STAT信号通路促进骨髓间充质干细胞移植治疗肝硬化的机制研究[D].南宁:广西中医药大学,2020.
[21] 张健哲.右归丸加味方治疗膝骨关节炎作用机制的实验研究[D].沈阳:辽宁中医药大学,2024.
[22] 金敏伟,王苏平,童培建,等.肾髓同治方对膝骨关节炎模型小鼠的干预机制研究[J].浙江中西医结合杂志,2024,34(8):708-713.
[23] 王兆全.针刀松解结合关节腔注射透明质酸对膝骨关节炎患者疼痛程度、睡眠质量及关节活动度的影响[J].世界睡眠医学杂志,2023,10(9):2064-2066.
[24] 陈卫红,林红珍.综合放松训练对膝骨关节炎患者睡眠质量的影响[J].世界睡眠医学杂志,2024,11(10):2327-2329.
[25] 吴彬,韩振蕴,胡文悦,等.基于“肾虚肝逆”病机探析失眠辨治思路[J].长春中医药大学学报,2024,40(10):1075-1078.

相似文献/References:

[1]樊庆阳,任凯晶.定制3D打印切模辅助全膝关节置换术治疗 膝骨关节炎合并股骨干骨折畸形愈合[J].中医正骨,2015,27(11):37.
[2]刘晓雅,孙永强,刘国杰.主动快速康复锻炼对全膝关节置换术后关节活动度的影响[J].中医正骨,2015,27(09):73.
[3]郑春松,叶蕻芝,李西海,等.透骨消痛胶囊中补肾柔肝药和活血祛风药治疗 骨关节炎作用方式的计算机模拟比较[J].中医正骨,2015,27(07):6.
　ZHENG Chunsong,YE Hongzhi,LI Xihai,et al.Comparison of the mode of action of Bushen Rougan(补肾柔肝)drugs versus Huoxue Qufeng(活血祛风)drugs contained in Tougu Xiaotong Jiaonang(透骨消痛胶囊)for the treatment of osteoarthritis:A computer simulation study[J].The Journal of Traditional Chinese Orthopedics and Traumatology,2015,27(09):6.
[4]宋兵华,孙俊英,倪增良,等.全膝关节置换术前CT测量股骨后髁角的临床意义[J].中医正骨,2015,27(07):38.
[5]郑春松,叶蕻芝,李西海,等.独活寄生汤含药血清对白细胞介素1β诱导的 退变关节软骨细胞中基质金属蛋白酶 和环氧化酶2表达的影响[J].中医正骨,2015,27(12):1.
　ZHENG Chunsong,YE Hongzhi,LI Xihai,et al.Impact of Duhuo Jisheng Tang(独活寄生汤)medicated serum on expression of matrix metalloproteinase and cyclooxygenase 2 in degenerative articular chondrocytes induced by interleukin-1 beta[J].The Journal of Traditional Chinese Orthopedics and Traumatology,2015,27(09):1.
[6]王金良,孙京涛,李玲,等.骨水泥联合螺钉修复全膝关节置换术中 胫骨平台内侧骨缺损[J].中医正骨,2015,27(12):55.
[7]冯荣,王平,李炳奇,等.铍针刺络拔罐结合中药口服治疗膝骨关节炎合并 原发性血小板增多症1例[J].中医正骨,2015,27(12):73.
[8]蔡云仙.围手术期耳穴按压联合平衡针疗法 在全膝关节置换术后镇痛中的应用[J].中医正骨,2015,27(06):41.
[9]张荣,王健.人工全膝关节置换术的围手术期心理护理[J].中医正骨,2015,27(05):77.
[10]喻长纯,杨明路,王战朝.不同手术方式治疗胫骨平台骨折畸形愈合的体会[J].中医正骨,2015,27(03):37.
[11]孟维娜,明立功,王新德,等.关节镜下清理联合腓骨近1/3段截骨治疗膝骨关节炎[J].中医正骨,2015,27(11):40.
[12]明立功,孟维娜,王新德,等.腓骨近端截骨治疗内侧间室膝骨关节炎的近期疗效观察[J].中医正骨,2015,27(10):25.
[13]张杰,王人彦,张玉柱.膝骨关节炎的治疗进展[J].中医正骨,2015,27(10):68.
[14]梁朝,蔡静怡,闫立,等.针刀疗法改善膝骨关节炎早期疼痛症状的疗效评价[J].中医正骨,2015,27(09):9.
　LIANG Zhao,CAI Jingyi,YAN Li,et al.Evaluation of the curative effect of needle-knife therapy for relieving knee pain in patients with early knee osteoarthritis[J].The Journal of Traditional Chinese Orthopedics and Traumatology,2015,27(09):9.
[15]王建武,党建军,李强,等.四联疗法治疗膝骨关节炎[J].中医正骨,2015,27(08):44.
[16]刘红娟,郭会利,郭树农.云克联合中药治疗膝骨关节炎的护理[J].中医正骨,2015,27(08):75.
[17]陈卫衡.探索建立系统的膝骨关节炎中医临床科研范式 和理论体系[J].中医正骨,2015,27(07):1.
[18]帅波,沈霖,杨艳萍,等.加味青娥丸治疗膝骨关节炎的作用机制研究[J].中医正骨,2015,27(07):15.
　SHUAI Bo,SHEN Lin,YANG Yanping,et al.Study on the mechanism of action of Jiawei Qing'e Wan(加味青娥丸)for the treatment of knee osteoarthritis[J].The Journal of Traditional Chinese Orthopedics and Traumatology,2015,27(09):15.
[19]梅其杰,袁长深,段戡,等.壮药骨痹方烫熨联合运动疗法治疗膝骨关节炎的临床研究[J].中医正骨,2015,27(07):27.
　MEI Qijie,YUAN Changshen,DUAN Kan,et al.Clinical study of the curative effect of hot compressing and rubbing with packet of Gubi Fang(骨痹方)combined with exercise therapy in the treatment of knee osteoarthritis[J].The Journal of Traditional Chinese Orthopedics and Traumatology,2015,27(09):27.
[20]王丹辉,张燕,刘丽娟,等.重组人Ⅱ型肿瘤坏死因子受体-抗体融合蛋白 关节腔注射联合中药薰洗治疗膝骨关节炎的临床研究[J].中医正骨,2015,27(07):31.
　WANG Danhui,ZHANG Yan,LIU Lijuan,et al.Clinical study on intra-articular injection of TypeⅡrecombinant human tumor necrosis factor receptor-Fc fusion protein combined with Chinese herbal steaming and washing therapy for treatment of knee osteoarthritis[J].The Journal of Traditional Chinese Orthopedics and Traumatology,2015,27(09):31.

备注/Memo

备注/Memo:
基金项目:国家自然科学基金项目(82274280); 浙江省科技计划项目(2025C02177); 浙江省基础公益研究计划项目(LR23H270001,LTGY23H270008); 国家中医药管理局科技司-浙江省中医药管理局共建科技计划项目(GZY-ZJ-KJ-23093)
通讯作者:袁文华 E-mail:337979694@qq.com
更新日期/Last Update: 1900-01-01