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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
Published:20 December 2023,
Published Online:02 November 2023,
Received:20 June 2023,
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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观察[J].中国实验方剂学杂志,2023,29(24):80-86.
LIANG Zhi,ZHOU Jun,QUAN Rui,et al.Clinical Study of Osteoking Combined with Non-Steroidal Anti-inflammatory Drugs in Treatment of Knee Osteoarthritis[J].Chinese Journal of Experimental Traditional Medical Formulae,2023,29(24):80-86.
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观察[J].中国实验方剂学杂志,2023,29(24):80-86. DOI: 10.13422/j.cnki.syfjx.20231644.
LIANG Zhi,ZHOU Jun,QUAN Rui,et al.Clinical Study of Osteoking Combined with Non-Steroidal Anti-inflammatory Drugs in Treatment of Knee Osteoarthritis[J].Chinese Journal of Experimental Traditional Medical Formulae,2023,29(24):80-86. DOI: 10.13422/j.cnki.syfjx.20231644.
目的
2
基于真实世界数据探讨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疗效,为临床用药提供依据。
方法
2
从2020年5月至2021年12月采用注册登记研方法收集了1 002例未行膝关节置换术的膝骨关节炎患者,最终纳入952例,其中口服恒古骨伤愈合剂联合口服非甾体抗炎药的病例共133例并设为观察组,单独口服非甾体抗炎药病例共73例设为对照组,将两组患者的基线资料、视觉模拟评分(VAS评分)、西安大略和麦克马斯特大学骨关节炎指数评分(WOMAC评分)等项目进行统计学分析。访视点为登记注册时、登记注册后第4周、8周。为了进一步阐释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疗效,并通过网络药理学方法,检索骨伤交叉数据库、TCMSP等数据库,获取恒古骨伤愈合剂的有效成分、非甾体抗炎药与膝骨关节炎的相关基因集,将相关基因集进行Venn分析,构建蛋白质-蛋白质相互作用(PPI)网络图,再筛选出关键核心靶点,进行基因本体(GO)及京都基因与基因组百科全书(KEGG)富集分析。
结果
2
观察组第4周VAS评分平均下降(-2.79±1.206)分,优于对照组[(-2.73±1.575)分,
P
<
0.05],观察组第8周VAS评分平均下降(-3.97±1.308)分,优于对照组[(-3.89±1.822)分,
P
<
0.05],观察组第8周WOMAC总评分平均下降(-52.07±21.677)分,显著优于对照组[(-46.75±25.368)分,
P
<
0.05],观察组第8周WOMAC(疼痛)评分平均下降(-10.99±4.229)分,优于对照组[(-10.03±5.535)分,
P
<
0.05],观察组第4周WOMAC(僵硬)评分平均下降(-1.49±2.901)分,优于对照组[(-0.92±1.998)分,
P
<
0.05],观察组第8周WOMAC(僵硬)评分平均下降(-1.90±3.200)分,优于对照组[(-1.26±2.230)分,
P
<
0.05],观察组第8周WOMAC(关节功能)评分平均下降(-39.17±16.562)分,明显优于对照组[(-35.47±20.098)分,
P
<
0.05]。网络药理学分析结果,恒古骨伤愈合剂治疗膝骨关节炎的核心网络靶点是经过信号传导转录激活因子3(STAT3)、血管内皮生长因子A(VEGFA)、肿瘤坏死因子(TNF)等信号通路的调节进而调控细胞信号传导、血管生成、软骨细胞的增殖与迁移、炎性细胞从而来抑制炎性反应,减少损害,延缓疾病的进一步发展。
结论
2
恒古骨伤愈合剂联合非甾体抗炎药治疗膝骨关节炎后4周、8周的疗程后,其缓解疼痛、关节僵硬、改善关节功能的疗效均优于单独使用非甾体抗炎药,在网络药理学中恒古骨伤愈合剂治疗膝骨关节类通过参与调节炎性因子、代谢反应相关生物过程、调控软骨细胞的增值与凋亡等,从而产生抗炎阵痛、改善关节活动度、关节僵硬的效果,值得临床推广与应用。
Objective
2
To explore the clinical efficacy of Osteoking combined with non-steroidal anti-inflammatory drugs in the treatment of knee osteoarthritis based on real-world data and provide a basis for clinical medication.
Method
2
From May 2020 to December 2021, the data of a total of 1 002 patients with knee osteoarthritis who did not undergo knee joint replacement surgery was collected through the registration method. 952 patients were ultimately included, including 133 cases orally taking Osteoking combined with non-steroidal anti-inflammatory drugs as the observation group and 73 cases orally taking non-steroidal anti-inflammatory drugs alone as the control group. Statistical analysis was conducted on the baseline data, VAS scores, WOMAC scores, and other items. The visit point is the 4
th
and 8
th
weeks after registration. In order to further elucidate the clinical efficacy of Osteoking combined with non-steroidal anti-inflammatory drugs in the treatment of knee osteoarthritis, the effective components of Osteoking and the relevant gene sets of non-steroidal anti-inflammatory drugs and knee osteoarthritis were obtained through network pharmacology methods and retrieval in bone injury cross database, TCMSP, and other databases. Venn analysis was performed on the relevant gene sets, and a PPI network diagram was constructed. Then key core targets were screened out, and enrichment GO and KEGG enrichment analyses were conducted.
Result
2
The VAS score of the observation group decreases by an average of (-2.79±1.206) scores in the 4
th
week, which is better than the control group [(-2.73±1.575) scores,
P
<
0.05]. The VAS score of the observation group decreases by an average of (-3.97±1.308) scores in the 8
th
week, which is better than the control group [(-3.89±1.822) scores,
P
<
0.05]. The total WOMAC score of the observation group decreases by an average of (-52.07±21.677) scores points in the 8
th
week, which is significantly better than the control group [(-46.75±25.368) scores,
P
<
0.05]. The observation group has an average decrease of (-10.99±4.229) scores in WOMAC (pain) score in the 8
th
week, which is better than the control group [(-10.03±5.535) scores,
P
<
0.05]. The observation group has an average decrease of (-1.49±2.901) in WOMAC (stiffness) score in the 4
th
week, which is better than the control group [(-0.92±1.998) scores,
P
<
0.05], and the observation group has an average decrease of (-1.90±3.200) scores in WOMAC (stiffness) score in the 8
th
week, which is better than the control group [(-1.26±2.230) scores,
P
<
0.05]. The observation group shows an average decrease of (-39.17±16.562) scores in WOMAC (joint function) score in the 8
th
week, which is significantly better than the control group [(-35.47±20.098) scores,
P
<
0.05]. According to network pharmacology analysis, the core network target of Osteoking in treating knee osteoarthritis is manifested as regulating signal pathways such as signal transduction transcription activator 3(STAT3), vascular endothelial growth factor A(VEGFA), tumor necrosis factor (TNF) to regulate cell signaling, angiogenesis, chondrocyte proliferation and migration, and inflammatory cells, thereby inhibiting inflammatory reactions, reducing damage, and delaying the development of the disease.
Conclusion
2
After a 4-week and 8-week course of treatment for knee osteoarthritis with Osteoking combined with non-steroidal anti-inflammatory drugs, there is a significant therapeutic effect on relieving pain and joint stiffness and improving joint function. In network pharmacology, Osteoking is involved in regulating inflammatory factors, metabolic response-related biological processes, the proliferation and apoptosis of chondrocytes, etc. in the treatment of knee osteoarthritis, resulting in anti-inflammatory and analgesic effects and improving joint mobility and joint stiffness. Therefore, it is worthy of clinical promotion and application.
膝骨关节炎恒古骨伤愈合剂临床观察作用机制真实世界研究
knee osteoarthritisOsteokingtclinical observationmechanismreal-world research
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