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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,北京 100029
3.中国中医科学院 中药研究所,北京 100700
4.北京协和医院,北京 100730
Published:20 December 2023,
Published Online:20 September 2023,
Received:20 June 2023,
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全锐,周峻,贾雁等.恒古骨伤愈合剂联合关节腔内注射玻璃酸钠治疗膝骨关节炎的真实世界临床观察[J].中国实验方剂学杂志,2023,29(24):72-79.
QUAN Rui,ZHOU Jun,JIA Yan,et al.A Real-World Clinical Study of Osteoking Combined with Intra-Articular Injection of Sodium Hyaluronate in Treatment of Knee Osteoarthritis[J].Chinese Journal of Experimental Traditional Medical Formulae,2023,29(24):72-79.
全锐,周峻,贾雁等.恒古骨伤愈合剂联合关节腔内注射玻璃酸钠治疗膝骨关节炎的真实世界临床观察[J].中国实验方剂学杂志,2023,29(24):72-79. DOI: 10.13422/j.cnki.syfjx.20231438.
QUAN Rui,ZHOU Jun,JIA Yan,et al.A Real-World Clinical Study of Osteoking Combined with Intra-Articular Injection of Sodium Hyaluronate in Treatment of Knee Osteoarthritis[J].Chinese Journal of Experimental Traditional Medical Formulae,2023,29(24):72-79. DOI: 10.13422/j.cnki.syfjx.20231438.
目的
2
探讨恒古骨伤愈合剂对于发作、缓解期膝骨关节炎患者疗效的改善情况并对其潜在干预机制进行系统挖掘,为提高恒古骨伤愈合剂的临床应用价值、指导其临床合理用药提供一定参考。
方法
2
通过恒古骨伤愈合剂治疗膝骨关节炎的真实世界研究,获得数据资料并录入“恒古骨伤愈合剂治疗膝骨关节炎病例注册登记系统”,在系统中选取2020年5月1日至2021年12月31日来自北京中医药大学第三附属医院、北京协和医院、中国中医科学院望京医院和湖南航天医院等20家医疗机构骨伤科门诊或住院的105例发作、缓解期膝骨关节炎患者,包括60例联用恒古骨伤愈合剂和关节注射治疗的患者,及45例单用关节注射治疗的患者。观察和对比2组患者的西安大略麦克马斯特大学骨关节炎指数(WOMAC)评分、视觉模拟(VAS)疼痛评分、中医单项疼痛症状种类(冷痛、热痛、刺痛、隐痛、酸痛)和其他中医症状,并进行统计学分析。为进一步阐释恒古骨伤愈合剂联用关节注射治疗发作、缓解期膝骨关节炎的潜在分子机制,本研究利用“骨伤交叉数据库(BX-Data,
http://bone-xtrans.com/database
http://bone-xtrans.com/database
)”,收集膝骨关节炎疾病基因集、恒古骨伤愈合剂组方中药材、化学成分、物质基础、候选靶标、玻璃酸钠候选靶标数据进行筛选,构建“疾病靶标”的互作网络。
结果
2
入组的105例膝骨关节炎患者中,发作期患者占15.24%(16/105),缓解期患者占84.76%(89/105),无康复期患者。女性72例(68.57%),多于男性33例(31.43%),105例患者中观察组60例,对照组45例;观察组VAS评分5分患者20例、6分患者19例,共占观察组65.00%;对治疗前后组间VAS评分的比较结果表明,治疗后4周两组评分分别为(4.42±1.01)分、(5.00±1.02)分,治疗后8周分别为(3.12±1.04)分、(3.56±1.08)分,均低于治疗前(6.23±1.28)分、(6.02±1.22)分(
P
<
0.05);对两组疼痛性质的比较结果表明,观察组热痛和刺痛前后改善率分别为3.3%(2/60)、16.7%(10/60),对照组分别为2.2%(1/45)、15.6%(7/45)(
χ
2
=4.034
、
13.583,
P
<
0.05),观察组冷痛改善率为5.0%(3/60)、酸痛改善率为3.3%(2/60),高于对照组;对两组治疗前后的WOMAC评分比较结果表明,观察组的僵硬评分治疗前后差值(1.68±1.42)分,对照组治疗前后得分差值(1.20±1.60)分(
P
<
0.05),且观察组疼痛评分治疗前后差值(3.43±2.88)分、日常活动评分前后差值(12.37±10.21)分和总分治疗前后差值(17.48±12.76)分也均高于对照组[(2.82±3.29)、(10.80±9.63)、(14.82±12.62)分];对于两组治疗前后其他症状改善情况比较结果表明,观察组少寐多梦的改善率为28.3%(17/60),显著高于对照组的2.2%(1/45)(
χ
2
=5.914,
P
<
0.05),观察组渴不欲饮、烦闷不安、口燥咽干、面色晦暗、手足口热5种症状改善率分别为3.3%(2/60)、10.0%(6/60)、8.3%(5/60)、10.0%(6/60)、5.0%(3/60),均高于对照组的-2.2%(1/45)、2.2%(1/45)、2.2%(1/45)、4.5%(2/45)、-6.7%(3/45)。通过网络分析发现,恒古骨伤愈合剂的富集通路主要作用于骨质改善、能量代谢和抗炎镇痛3种作用机制,玻璃酸钠富集通路主要作用于抗炎镇痛机制。
结论
2
恒古骨伤愈合剂联合关节腔内注射玻璃酸钠治疗发作、缓解期膝骨关节炎患者的疗效优于单独使用玻璃酸钠治疗,尤其在抗炎镇痛方面,两药具有协同药效。恒古骨伤愈合剂可能通过改善骨质和调节机体能量代谢途径,发挥其缓解关节僵硬、刺痛、热痛、少寐多梦症状的作用,值得临床推广。
Objective
2
To investigate the improvement of the efficacy of Osteoking in patients with knee osteoarthritis in the onset and remission stage and to systematically explore its potential intervention mechanism, so as to provide a certain reference for improving the clinical application value of Osteoking and guiding its clinical rational drug use.
Method
2
Through the real-world study of the treatment of knee osteoarthritis with Osteoking, the data was obtained and entered into the "Osteoking for the treatment of knee osteoarthritis case registration system", and 105 patients with episodic and remission knee osteoarthritis from the outpatient or inpatient orthopedic department of 20 medical institutions, including the Third Affiliated Hospital of Beijing University of Chinese Medicine, Peking Union Medical College Hospital, Wangjing Hospital of the Chinese Academy of Chinese Medical Sciences and Hunan Aerospace Hospital, from May 1, 2020 to December 31, 2021, were selected in the system. It included 60 patients treated with Osteoking and joint injection, and 45 patients treated with joint injection alone. The WOMAC osteoarthritis index score, visual analogue (VAS) pain score, individual types of pain symptoms (cold pain, hot pain, tingling, dull pain, soreness) and other TCM symptoms were observed and compared between the two groups, and statistically analyzed. In order to further elucidate the potential molecular mechanism of Osteoking combined with joint injection in the treatment of knee osteoarthritis in the treatment of onset and remission, this study used the "Bone Injury Cross Database (
http://bone-xtrans.com/database
http://bone-xtrans.com/database
,BX-Data)" to collect the gene set of knee osteoarthritis disease, the traditional Chinese medicinal materials, chemical composition, material base, candidate target, candidate target, sodium hyaluronate candidate target data for screening, and constructed an interaction network of "disease target".
Results
2
Among the 105 patients with knee osteoarthritis enrolled, 15.24% (16/105) were in the episodic period, 84.76% (89/105) were in remission, and there were no convalescent patients. There were 72 cases (68.57%) in women, 33 cases (31.43%) more than men, 60 cases in the observation group and 45 cases in the control group in 105 patients. There were 20 patients with a VAS score of 5 and 19 patients with a score of 6 in the observation group, accounting for 65.00% of the observation group. The comparative results of VAS scores between groups before and after treatment showed that the scores of the two groups were (4.42±1.01) scores, (5.00±1.02) scores.4 weeks after treatment, and (3.12±1.04) scores and (3.56±1.08) scores,8 weeks after treatment, respectively, which were lower than those before treatment (6.23±1.28) scores,( 6.02±1.22) scores (
P
<
0.05), and the comparative results of the pain properties of the two groups showed that the improvement rates before and after thermal pain and tingling in the observation group were 3.3%(2/60) and 16.7%(10/60), respectively. The control group was 2.2% (1/45)and 15.6%(7/45)[(
χ
2
=4.034、13.583,
P
<
0.05)], respectively, and the improvement rate of cold pain and soreness in the observation group was 5.0%(3/60) and 3.3%(2/60), which was higher than that of the control group . The results of comparing the WOMAC scores before and after treatment of the two groups showed that the difference between the stiffness score before and after treatment in the observation group was (1.68±1.42) scores, the difference between the score before and after treatment in the control group was (1.20±1.60) scores (
P
<
0.05), and the pain score before and after treatment was (3.43±2.88) scores, the difference before and after daily activity score was (12.37±10.21) scores, and the total score before and after treatment was (17.48±12.76) scores, which were also higher than those in the control group (2.82±3.29), (10.80±9.63),(14.82±12.62) scores. The results of comparing the improvement of other symptoms before and after treatment showed that the improvement rate of less sleep and more dreams in the observation group was 28.3%(17/60), which was significantly higher than that of the control group of 2.2%(1/45)(
χ
2
=5.914,
P
<
0.05), and the improvement rates of the five symptoms of thirst and drinking, irritability, dry mouth and pharynx, dull complexion and hand, foot and mouth fever in the observation group were 3.3%(2/60), 10.0%(6/60), 8.3%(5/60), 10.0%(6/60) and 5.0%(3/60), respectively, which were higher than those in the control group -2.2%(1/45), 2.2%(1/45), 2.2%(1/45), 4.5%(2/45), -6.7%(3/45). Through network analysis, it was found that the enrichment pathway of Henggu bone wound healing agent mainly acted on the three mechanisms of bone improvement, energy metabolism and anti-inflammatory and analgesic, and the sodium hyaluronate enrichment pathway mainly acted on the anti-inflammatory and analgesic mechanism.
Conclusion
2
The efficacy of Osteoking combined with intra-articular injection of sodium hyaluronate in the treatment of patients with knee osteoarthritis in attack and remission is better than that of sodium hyaluronate alone, especially in anti-inflammatory and analgesic, and the two drugs have synergistic effect. Osteoking may play its role in relieving the symptoms of joint stiffness, tingling, heat pain, and less sleep and more dreams by improving bone quality and regulating the body's energy metabolism pathways, which is worthy of clinical promotion.
恒古骨伤愈合剂膝骨关节炎临床观察作用机制
Osteokingknee osteoarthritisclinical observationmechanism
陈卫衡.膝骨关节炎中医诊疗指南(2020年版)[J].中医正骨,2020,32(10):1-14.
陈卫衡,刘献祥,童培建,等.膝骨关节炎中医诊疗专家共识(2015年版)[J].中医正骨,2015,27(7):4-5.
中华医学会骨科学分会关节外科学组.骨关节炎诊疗指南(2018年版)[J].中华骨科杂志,2018,38(12):705-715.
吴继昆.恒古骨伤愈合剂治疗157例骨关节炎疗效总结[J].中国现代药物应用,2018,12(24):196-197.
梁志,周峻,全锐, 等. 恒古骨伤愈合剂联合非甾体抗炎药治疗膝骨关节炎的临床研究[J].中国实验方剂学杂志,2023,doi:13422/j.cnki.syfjx.20231644http://dx.doi.org/13422/j.cnki.syfjx.20231644.
李瑞涵,周峻,梁志,等.真实世界恒古骨伤愈合剂治疗膝骨关节炎临床疗效和作用机制分析[J].中国实验方剂学杂志,doi:10.13422/j.cnki.syfjx.20240395http://dx.doi.org/10.13422/j.cnki.syfjx.20240395.
何海军,王荣田,陈志伟,等.膝骨关节炎“从筋论治”的临床研究[J].北京中医药,2016,35(5):451-455.
潘建科,韩燕鸿,黄和涛.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.
李前程,郭永扬,陈祥杰.曲安奈德联合玻璃酸钠关节腔内注射治疗膝骨关节炎的临床疗效及其对骨质代谢的影响[J].临床合理用药杂志,2023,16(3):144-147.
陆艳红,石晓兵.膝骨关节炎国内外流行病学研究现状及进展[J].中国中医骨伤科杂志,2012,20(6):81-84.
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.
王雷,邢祯全.恒古骨伤愈合剂联合玻璃酸钠治疗膝关节骨关节炎的疗效分析[J].中国中医骨伤科杂志,2021,29(3):59-61.
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.
符智虹,李述文,李瑞涵,等.真实世界藤黄健骨片治疗膝骨关节炎缓解期人群用药特征及临床疗效分析[J].中国实验方剂学杂志,2023,29(6):120-127.
李棋,毛云鹤,李箭.玻璃酸钠在骨科和运动医学相关疾病中的应用专家共识(2017年修订版)解读[J].中国医学前沿杂志:电子版,2017,9(11):9-13.
王潇潇,李群,胡智星, 等. 恒古骨伤愈合剂对肌筋膜疼痛综合征大鼠的干预作用[J].中国实验方剂学杂志,2023,doi:10.13422/j.cnki.syfjx.20231144http://dx.doi.org/10.13422/j.cnki.syfjx.20231144.
谭学松,匡浩铭,熊杰,等.恒古骨伤愈合剂治疗肝肾亏虚型膝骨关节炎30例[J].中国中医骨伤科杂志,2021,29(8):44-47.
蒙锡波,邓丽丽.恒古骨伤愈合剂联合活血补肾汤治疗激素性股骨头坏死疗效及对骨密度的影响[J].现代中西医结合杂志,2018,27(1):82-85.
徐涛涛,郑凌歆,孙岩,等.恒古骨伤愈合剂治疗膝骨性关节炎的临床疗效及安全性评价[J].中国中医骨伤科杂志,2022,30(2):8-12.
谢斌,何海军,闫波,等.恒古骨伤愈合剂联合特定电磁波治疗气滞血瘀型膝骨关节炎的多维度疗效分析[J].中国实验方剂学杂志,2022,28(13):130-136.
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