真实世界藤黄健骨片联合非甾体抗炎药治疗膝骨关节炎临床研究  

Tenghuang Jiangu Tablets Combined with Non-steroidal Anti-inflammatory Drugs for Osteoarthritis of Knee:A Real-world Study

作　　者：李述文 李瑞涵 贾雁 朱瑞征 李翔宇 符智虹 梁志 高帅 颜炎 翁习生[2] 林娜[3] 陈卫衡 LI Shuwen;LI Ruihan;JIA Yan;ZHU Ruizheng;LI Xiangyu;FU Zhihong;LIANG Zhi;GAO Shuai;YAN Yan;WENG Xisheng;LIN Na;CHEN Weiheng(The Third Affiliated Hospital of Beijing University of Chinese Medicine,Beijing 100029,China;Peking Union Medical College Hospital,Beijing 100730,China;Institute of Chinese Materia Medica,China Academy of Chinese Medical Sciences,Beijing 100700,China)

机构地区：[1]北京中医药大学第三附属医院,北京100029 [2]北京协和医院,北京100730 [3]中国中医科学院中药研究所,北京100700

出　　处：《中国实验方剂学杂志》2023年第15期110-118,共9页Chinese Journal of Experimental Traditional Medical Formulae

基　　金：首都卫生发展科研专项重点攻关项目(2022-1-7032);北京中医药大学高层次人才科研启动项目(2021-XJ-KYQD-001)。

摘　　要：目的:基于真实世界数据探讨藤黄健骨片联合口服非甾体抗炎药治疗膝骨关节炎的临床疗效及其适用的分期,为藤黄健骨片的临床合理用药提供依据。方法:从2019年9月至2021年1月收录的“藤黄健骨片治疗膝骨关节炎病例注册登记系统”中,纳入采用藤黄健骨片联合口服非甾体抗炎药的病例共218例并设为试验组,单独采用口服非甾体抗炎药的病例126例设为对照组,将两组患者的性别、年龄、体质量指数、膝关节凯尔格-伦劳伦斯分级(K-L分级)、膝关节疼痛视觉模拟评分(VAS评分)、膝关节“西安大略和麦克马斯特大学关节炎指数”评分(WOMAC评分)K-L分级、VAS评分、WOMAC评分、肿胀分级、关节怕冷评分、腰酸乏力评分、不良事件/不良反应发生情况等项目,采用差值检验法进行全数据集疗效分析;采用倾向性评分匹配法排除组间混杂因素的影响,建立子数据集,并用重复测量资料的方差分析进行子数据集的疗效分析。访视点为登记注册时,登记注册后4周、8周。用Excel 2019和SPSS 23.0对数据进行统计分析。结果:试验组女性占比66.06%(144/218),多于对照组的58.73%(74/126)(χ^(2)=1.846);平均年龄(61.12±7.01)岁,大于对照组的(59.38±5.99)岁(W=19918.50,P<0.05);试验组缓解期占比98.17%(214/218);K-L分级比较,试验组Ⅱ级占比64.22%(144/218),Ⅲ级占比25.23%(55/218)。入组和用药8周的全数据集疗效分析显示,试验组VAS评分平均下降(3.27±1.24)分,优于对照组[(2.75±1.20)分,W=34179.00,P<0.05];总WOMAC评分平均下降(23.43±11.46)分,优于对照组[(16.71±8.86)分,W=32387.00,P<0.05];肿胀分级平均下降(0.63±0.64)级,优于对照组[(0.33±0.59)级,W=33847.50,P<0.05];关节怕冷评分平均下降(1.90±1.84)分,优于对照组[(1.40±1.28)分,W=35165.00,P<0.05];腰酸乏力评分平均下降(2.02±1.64)分,优于对照组[(1.10±1.28)分,W=32986.50,P<0.05]。入组、用药4周、用药8周的子数据集�Objective:To investigate the clinical efficacy of Tenghuang Jiangu tablets(THJGT)combined with oral non-steroidal anti-inflammatory drugs(NSAIDs)in the treatment of osteoarthritis of the knee and its applicable stage based on real-world data,and provide a basis for the rational clinical use of THJGT.Method:A total of 218 cases treated with THJGT combined with oral NSAIDs included in the"THJGT for knee osteoarthritis case registry"from September 2019 to January 2021 were selected as the observation group,and 126 cases treated with oral NSAIDs alone as the control group(CG).The data of gender,age,body mass index,Kellgren-Lawrence grading scale(K-L scale)score,visual analogue score(VAS score),Western Ontario and McMaster Universities Osteoarthritis Index(WOMAC)score,swelling grade,joint fear of cold score,back pain and weakness score,and occurrence of adverse events/reactions of the patients in both groups were used for the evaluation of efficacy with full analysis set.The propensity score matching method was used to exclude the influence of confounding factors between groups,and the sub-data sets were established,with which the repeated measures analysis of variance(ANOVA)was carried out to evaluate the efficacy.Visit points were at registration,4 weeks and 8 weeks after registration.The data were statistically analyzed in Excel 2019 and SPSS 23.0.Result:The proportion of females in the observation group was 66.06%(144/218),which was higher than that(58.73%,74/126)in the control group(χ^(2)=1.846).The average age in the observation group was(61.12±7.01)years,which was higher than that[(59.38±5.99)years]in the control group(W=19918.50,P<0.05).The remission rate in the observation group was 98.17%(214/218).In the observation group,the proportions of the patients at K-L gradesⅡandⅢwere 64.22%(144/218)and 25.23%(55/218),respectively.The effect analysis of the whole data set for enrollment and treatment for 8 weeks showed that the VAS score of the experimental group decreased by(3.27±1.24)points on average,which

关 键 词：膝骨关节炎 藤黄健骨片 病例注册登记系统 倾向性评分匹配法 真实世界研究 

分 类 号：R2-0[医药卫生—中医学] R33R684.3R285.6R969.4R274