恒古骨伤愈合剂内外联动治疗寒湿痹阻型膝骨关节炎的疗效观察  

Observation on the Therapeutic Effect of Internal and External Application of Osteoking in Treating Knee Osteoarthritis of Cold-Damp Blockage Type

作　　者：熊逸啸 刘钦岱 白林寒 华盛 汤祖宇 刘科[1] 欧梁 匡建军[2] XIONG Yixiao;LIU Qindai;BAI Linhan;HUA Sheng;TANG Zuyu;LIU Ke;OU Liang;KUANG Jianjun(Hunan University of Chinese Medicine,Changsha 410208 Hunan,China;Hunan Academy of Chinese Medicine,Changsha 410013 Hunan,China)

机构地区：[1]湖南中医药大学,湖南长沙410208 [2]湖南省中医药研究院,湖南长沙410013

出　　处：《广州中医药大学学报》2025年第2期298-308,共11页Journal of Guangzhou University of Traditional Chinese Medicine

基　　金：中国博士后科学基金面上项目(编号:2023M731070);湖南省自然科学基金项目(编号:2023JJ60118);长沙市科技局重点项目(编号:kh2201063);湖南省中医药研究院院级科研项目(编号:202129)。

摘　　要：【目的】观察恒古骨伤愈合剂口服联合定向透药治疗寒湿痹阻型膝骨关节炎(KOA)的临床疗效。【方法】将2022年9月至2023年9月于湖南省中西医结合医院就诊的120例寒湿痹阻型KOA患者按随机数字表法随机分为对照组、口服组、药透组和联合组,每组各30例。其中,对照组给予塞来昔布胶囊口服治疗,口服组给予恒古骨伤愈合剂口服治疗,药透组给予恒古骨伤愈合剂定向透药治疗,联合组给予恒古骨伤愈合剂口服联合定向透药治疗。以12 d为1个疗程,均连续治疗2个疗程。观察各组患者治疗前后中医证候积分、疼痛视觉模拟量表(VAS)评分、西安大略和麦克马斯特大学骨关节炎指数(WOMAC)评分、生活质量健康调查简表(SF-36)评分以及血清白细胞介素1β(IL-1β)、白细胞介素6(IL-6)、肿瘤坏死因子α(TNF-α)水平的变化情况,并评价各组患者的临床疗效与用药安全性。【结果】(1)疗效方面,治疗2个疗程后,联合组的总有效率为96.67%(29/30),高于对照组的73.33%(22/30)及口服组和药透组的70.00%(21/30),组间比较,差异均有统计学意义(P<0.05);而对照组、口服组及药透组的总有效率比较,差异均无统计学意义(P>0.05)。(2)中医证候、疼痛程度和关节功能方面,治疗后,4组患者的中医证候积分、疼痛VAS评分和WOMAC评分均较治疗前降低(P<0.01);组间比较,联合组的中医证候积分、疼痛VAS评分和WOMAC评分均明显低于对照组、口服组及药透组(P<0.05),而对照组、口服组及药透组的中医证候积分、疼痛VAS评分和WOMAC评分比较,差异均无统计学意义(P>0.05)。(3)生活质量方面,治疗后,4组患者SF-36的生理功能(PF)、躯体疼痛(BP)、一般健康(GH)、精力(VT)、生理职能(RP)、社会功能(SF)、情感职能(RE)以及精神健康(MH)等各维度评分均较治疗前明显提高(P<0.01);组间比较,联合组的SF-36各维度评分均明显高于对照组、口服组及药透�Objective To observe the clinical efficacy of oral use combined with targeted transdermal delivery of Osteoking in treating knee osteoarthritis(KOA)of cold-damp blockage type.Methods A total of 120 patients with KOA of cold-damp blockage type who admitted to Hunan Provincial Hospital of Integrated Traditional Chinese And West Medicine from September 2022 to September 2023 were randomly divided into the control group,oral use group,transdermal delivery group and combination group according to the random number table method,with 30 cases in each group.The control group was treated with Celecoxib Capsule orally,the oral use group was treated with Osteoking orally,the transdermal delivery group was treated with Osteoking by targeted transdermal delivery,and the combination group was treated with oral use combined with targeted transdermal delivery of Osteoking.One course of treatment covered 12 days,and all of the four groups were treated for two continuous courses.Before and after treatment,the scores of traditional Chinese medicine(TCM)syndrome,Visual Analogue Scale(VAS)for pain,Western Ontario and McMaster Universities Osteoarthritis Index(WOMAC)for joint function,36-Item Short Form Health Survey(SF-36)for quality of life(QOL),as well as the levels of serum interleukin 1β(IL-1β),interleukin 6(IL-6),and tumor necrosis factorα(TNF-α)were observed in the patients of each group.After treatment,the clinical efficacy and safety of patients in each group were evaluated.Results(1)After two courses of treatment,the total effective rate of the combination group was 96.67%(29/30),which was higher than those of the control group[73.33%(22/30)],oral use group and transdermal delivery group[both being 70.00%(21/30)],and the difference was statistically significant(P<0.05).However,no statistically significant difference of the total effective rate was presented among the control group,oral use group,and transdermal delivery group(P>0.05).(2)After treatment,the scores of TCM syndrome,VAS for pain and WOMAC for joint function

关 键 词：膝骨关节炎 寒湿痹阻 恒古骨伤愈合剂 定向透药疗法 内外联动 炎症因子 关节功能 生活质量 

分 类 号：R274.9[医药卫生—中西医结合]