尪痹片不同用药方式治疗膝骨关节炎临床疗效的真实世界研究  

Real-World Study on the Clinical Efficacy of Different Medication Regimens of Wangbi Tablet(尪痹片)in the Treatment of Knee Osteoarthritis

作　　者：张跨越 李超 吴卓耘 董亚炜 郑泽陆 刘毓之 周峻 林嘉铭 陈月峰 宓保宏 陈卫衡 ZHANG Kuayue;LI Chao;WU Zhuoyun;DONG Yawei;ZHENG Zelu;LIU Yuzhi;ZHOU Jun;LIN Jiaming;CHEN Yuefeng;MI Baohong;CHEN Weiheng(The Third Affiliated Hospital of Beijing University of Chinese Medicine,Beijing,100029;Engineering Research Center of Chinese Orthopaedic and Sports Rehabilitation Artificial Intelligent,Ministry of Education;Institute of Orthopedics and Traumatology, Beijing University of Chinese Medicine;National Olympic Sports Center)

机构地区：[1]北京中医药大学第三附属医院,北京市100029 [2]北京中医药大学中医骨伤治疗与运动康复智能化教育部工程研究中心 [3]北京中医药大学骨伤科研究所 [4]国家奥林匹克体育中心

出　　处：《中医杂志》2024年第22期2316-2325,共10页Journal of Traditional Chinese Medicine

基　　金：首都卫生发展科研专项(首发2022-1-7032)。

摘　　要：目的研究真实世界中尪痹片不同用药方式对膝骨关节炎的临床疗效差异,为尪痹片的临床合理用药提供依据。方法采用前瞻性病例注册登记研究方法,观察2019年1月26日至2021年12月17日在全国30家医院注册登记的KOA患者共2999例,根据观察周期内尪痹片的使用情况,将患者分为单用组1507例和联用组1492例,联用组分为尪痹片+中药、尪痹片+西药、尪痹片+中药+西药3个亚组。比较单用组和联用组患者基线资料,包括年龄、性别、体质量、用药时间、临床分期、凯格伦-劳伦斯膝骨关节炎影像分级(K-L分级)等情况;疗效指标包括视觉模拟量表(VAS)评分、西安大略与麦克马斯特大学骨关节炎指数(WOMAC)总分、欧洲五维健康指数量表(EQ-5D)效应值,分别于治疗前及治疗4、8、12周后评价1次,并于治疗4、8、12周后计算治疗前后差值,并将所有患者以上各项指标的基线与治疗12周后差值作为因变量,以性别、年龄、体重指数(BMI)、病程、K-L分级、临床分期等作为自变量,采用多重线性回归探讨疗效的影响因素。同时统计主要症状(包括晨僵、关节肿胀、腰膝酸软、畏风、畏寒)发生情况,并分别于治疗4、8、12周后统计各时间点症状消失情况。结果基线时单用组与联用组的性别、年龄分布差异无统计学意义(P>0.05);单用组中发作期与康复期患者占比高于联用组,而缓解期的占比低于联用组(P<0.05);单用组VAS评分高于联用组,EQ-5D效应值低于联用组(P<0.01),WOMAC总分差异无统计学意义(P>0.05)。与本组治疗前及上一时间点比较,两组患者治疗后各时间点VAS评分、WOMAC总分均明显下降,EQ-5D效应值均明显上升(P<0.05);治疗12周后单用组VAS评分治疗前后差值高于联用组,治疗4、8、12周后联用组WOMAC总分、EQ-5D效应值治疗前后差值均高于单用组(P<0.05)。多重线性回归分析结果显示,治疗前VAS评分对疼痛改善的Objective To investigate the differences in clinical efficacy of different medication regimens of Wangbi Tablets(尪痹片)for knee osteoarthritis(KOA)in a real-world setting,providing a basis for rational clinical use of Wangbi Tablets.Methods A prospective registry study was conducted,involving 2,999 KOA patients registered in 30 hospitals nationwide from January 26th,2019,to December 17th,2021.Based on the use of Wangbi Tablets during the observation period,patients were divided into a monotherapy group(1,507 cases)and a combination therapy group(1,492 cases),and the combination group can be further divided into Wangbi Tablets plus Chinese medicine(CM),Wangbi Tablets plus western medicine(WM),and Wangbi Tablets plus Chinese and western medicine(CM+WM)subgroups.The baseline data of patients in the monotherapy group and the combination group were compared,including age,gender,body weight,medication time,clinical stage,K-L grade,and others.Efficacy indicators included the Visual Analog Scale(VAS)score,Western Ontario and McMaster Universities Osteoarthritis Index(WOMAC)score,and EuroQol five-dimensional(EQ-5D)health index,which were evaluated before and after 4-,8-and 12-week treatment,and the difference before and after treatment was calculated after 4,8 and 12 weeks of treatment.The difference between the baseline and 12 weeks of treatment of all the above indicators was used as the dependent variables,and gender,age,body mass index(BMI),course of disease,K-L grade,and clinical stage were used as independent variables,when multiple linear regression was taken to explore the influencing factors of the efficacy.At the same time,the occurrence of major symptoms(including morning stiffness,joint swelling,soreness of waist and knees,fear of wind,and fear of cold)was counted,and the disappearance of symptoms at each time point was counted after 4,8,and 12 weeks of treatment.Results At baseline,there were no statistically significant differences in gender and age distribution between the monotherapy and combination th

关 键 词：膝骨关节炎 尪痹片 病例注册登记研究 真实世界研究 临床疗效 

分 类 号：R274.9[医药卫生—中西医结合]