藏族药如意珍宝丸治疗膝骨关节炎的多中心、随机、双盲、安慰剂、平行对照临床试验  

A Multicenter,Randomized,Double-blind,and Placebo-parallel Controlled Trial of Tibetan Medicine Ruyi Zhenbaowan in Treatment of Knee Osteoarthritis

作　　者：孙春全 谢雁鸣[1] 高景华[3] 陈卫衡 王连心[1] 王尚全[3] 田向东 徐祖健 郑昱新[6] 周明旺[7] 李春根 徐展望[9] 郭珈宜[10] 杜双庆[11] 陈奇刚[12] 纪泉[13] 白志强 肖京[15] 齐万里[16] 杨伟毅[17] 张景肖[18] SUN Chunquan;XIE Yanming;GAO Jinghua;CHEN Weiheng;WANG Lianxin;WANG Shangquan;TIAN Xiangdong;XU Zujian;ZHENG Yuxin;ZHOU Mingwang;LI Chungen;XU Zhanwang;GUO Jiayi;DU Shuangqing;CHEN Qigang;JI Quan;BAI Zhiqiang;XIAO Jing;QI Wanli;YANG Weiyi;ZHANG Jingxiao(Institute of Basic Research in Clinical Medicine,China Academy of Chinese Medical Sciences,Beijing 100700,China;Tsinghua University Yuquan Hospital(Integrated Chinese and Western Medicine Hospital of Tsinghua University),Beijing 100040,China;Wangjing Hospital,China Academy of Chinese Medical Sciences,Beijing 100102,China;Beijing University of Chinese Medicine Third Affiliated Hospital,Beijing 100029,China;The Affiliated Traditional Chinese Medicine Hospital of Southwest Medical University,Luzhou,646099,China;Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine(TCM),Shanghai 201203,China;Gansu Provincial Hospital of TCM,Lanzhou 730050,China;Beijing Hospital of TCM,Capital Medical University,Beijing 100010,China;The Affiliated Hospital of Shandong University of TCM,Jinan 250011,China;Luoyang Orthopedic-Traumatological Hospital of Henan Province,Luoyang 471002,China;Hebei Provincial Hospital of TCM,Shijiazhuang 050013,China;Kunming Municipal Hospital of Chinese Medicine,Kunming 650599,China;Beijing Hospital,Beijing 100005,China;Beijing First Hospital of Integrated Chinese and Western medicine,Beijing 100026,China;Xiyuan Hospital,China Academy of Chinese Medical Sciences,Beijing 100091,China;Affiliated Hospital of Changchun University of TCM,Changchun 130021,China;Guangdong Provincial Hospital of Chinese Medicine,Guangzhou 510120,China;School of Statistics,Renmin University of China,Beijing 100044,China)

机构地区：[1]中国中医科学院中医临床基础医学研究所,北京100700 [2]清华大学玉泉医院(清华大学中西医结合医院),北京100040 [3]中国中医科学院望京医院,北京100102 [4]北京中医药大学第三附属医院,北京100029 [5]西南医科大学附属中医医院,泸州646099 [6]上海中医药大学附属曙光医院,上海201203 [7]甘肃省中医院,兰州730050 [8]首都医科大学附属北京中医医院,北京100010 [9]山东中医药大学附属医院,济南250011 [10]河南省洛阳正骨医院,洛阳471002 [11]河北省中医院,石家庄050013 [12]昆明市中医医院,昆明650599 [13]北京医院,北京100005 [14]北京市第一中西医结合医院,北京100026 [15]中国中医科学院西苑医院,北京100091 [16]长春中医药大学附属医院,长春130021 [17]广东省中医院,广州510120 [18]中国人民大学统计学院,北京100044

出　　处：《中国实验方剂学杂志》2024年第24期57-67,共11页Chinese Journal of Experimental Traditional Medical Formulae

基　　金：青海省重大科技专项(2020-SF-A3-2)。

摘　　要：目的:通过前瞻性的多中心、随机、双盲、安慰剂、平行对照临床试验,评价藏族药如意珍宝丸治疗初、早期膝骨关节炎(KOA)的临床疗效。方法:2021年10月13日至2021年12月25日期间于中国中医科学院望京医院等15个分中心共纳入符合纳排标准的KOA受试者240例,随机分为观察组与对照组,每组各120例。观察组受试者的干预措施为如意珍宝丸+健康宣教,对照组受试者的干预措施为如意珍宝丸安慰剂+健康宣教。两组受试者的干预周期均为4周,结束干预后随访4周。主要结局指标为西安大略和麦克马斯特大学骨关节炎指数评分(WOMAC评分)总积分,次要结局指标为视觉模拟(VAS)疼痛评分的应答率、WOMAC子项目积分(关节疼痛、关节僵硬、关节功能)、生活质量(SF-12)评分、中医证候评分。结果:(1)疗效评价。边际模型结果显示,如意珍宝丸治疗膝骨关节炎改善WOMAC总分、WOMAC疼痛评分方面,观察组优于对照组,差异具有统计学意义(P<0.05)。两组在改善VAS评分应答率、WOMAC功能评分、WOMAC僵硬评分、生活质量-躯体健康(SF12-PCS)评分、生活质量-精神健康(SF12-MCS)评分、中医证候评分方面,差异无统计学意义。(2)亚组分析。(1)在VAS评分应答率方面,基线VAS评分为[4,5]的受试者,观察组应答率高于对照组,差异具有统计学意义(P<0.05)。(2)在中医证候评分方面,年龄段在[56,60]岁、[61,65]岁的受试者,观察组中医证候总分的降幅优于对照组,差异具有统计学意义(P<0.05)。结论:藏族药如意珍宝丸对KOA初、早期轻型患者,在改善WOMAC总分、VAS评分应答率、WOMAC疼痛评分、WOMAC功能评分、中医证候评分方面具有较好的临床疗效,可以填补藏族药如意珍宝丸治疗KOA循证证据的不足,为民族医药的传承与发展做出了示范研究。Objective:This study aimed to evaluate the clinical efficacy of Ruyi Zhenbaowan(RYZBW)in the treatment of initial and early knee osteoarthritis(KOA)through a prospective multicenter,randomized,double-blind,and placebo-parallel controlled trial.Method:From October 13th,2021 to December 25th,2021,240 KOA subjects meeting the acceptance criteria were enrolled in 15 sub-centers including Wangjing Hospital,Chinese Academy of Chinese Medical Sciences,and they were randomly divided into observation group and control group,with 120 cases in each group.The intervention measures for the observation group were RYZBW+health education,and the intervention measures for the control group were RYZBW placebo+health education.The intervention period in both groups was four weeks,and they were followed up for four weeks after the intervention.The primary outcome measure was the total score of Western Ontario and McMaster University Osteoarthritis Index score(WOMAC score),and the secondary outcome measures were the response rate of visual scale(VAS)pain score,WOMAC sub item scores(joint pain,joint stiffness,and joint function),quality of life(SF-12)score,and traditional Chinese medicine(TCM)syndrome score.Result:(1)Efficacy evaluation.The marginal model results showed that the observation group was better than the control group in improving the WOMAC total score and WOMAC pain score in the treatment of KOA with RYZBW,and the difference was statistically significant(P<0.05).There was no significant difference between the two groups in improving VAS score response rate,WOMAC function score,WOMAC stiffness score,SF12-PCS(quality of life-physical health)score,SF12-MCS(quality of life-mental health)score,and TCM syndrome score.(2)Subgroup analysis.(1)In terms of VAS score response rate,the response rate of the observation group was higher than that of the control group for subjects with baseline VAS score of(4,5),and the difference was statistically significant(P<0.05).(2)In terms of TCM syndrome score,for subjects aged[56,60]and[61,65],

关 键 词：藏族药 如意珍宝丸 临床试验 膝骨关节炎 

分 类 号：R2-0[医药卫生—中医学] R285.5R2-031R274.9