痛宁凝胶外用治疗轻中度膝骨关节炎肾虚筋脉瘀滞证的随机、双盲、安慰剂对照、多中心临床研究  

External application of Tongning(痛宁)gel for treatment of mild-to-moderate knee osteoarthritis with syn-dromes of kidney deficiency and tendon-vessel stasis:a randomized,double-blind,placebo-controlled,multicenter clinical study

作　　者：郑昱新[1] 葛继荣[2] 刘文刚[3] 杨俊兴[4] 何承建[5] 卢敏[6] 沈霖[7] 尹宏[8] 陈永强[9] 李智斌 孙庆[11] 谢利民[12] 詹红生[1] ZHENG Yuxin;GE Jirong;LIU Wengang;YANG Junxing;HE Chengjian;LU Min;SHEN Lin;YIN Hong;CHEN Yongqiang;LI Zhibin;SUN Qing;XIE Limin;ZHAN Hongsheng(Shuguang Hospital Afiliated to Shanghai University of Traditional Chinese Medicine,Shanghai 201203,China;Fujian Academy of Traditional Chinese Medicine,Fuzhou 350003,Fujian,China;The Second Traditional Chinese Medicine Hopital of Guangdong,Guangzhou 510095,Guangdong,China;The First ffiliated Hospital of Guangzhou University of Chinese Medicine,Guangzhou 510405,Guangdong,China;Hubei Provincial Hospital of TCM,wuhan 430061,Hubei,China;The First Hospital of Hunan University of Chinese Medicine,Changsha 410007,Hunan,China;Union Hospital afiliated to Tongji Medical College of Huazhong University of Science and Technology,Wuhan 430022,Hubei,China;Nanjing Hospital of TCM,Nanjing 210022,Jiangsu,China;Shanghai Municipal Hospital of Traditional Chinese Medicine,Shanghai 200071,China;The Affiliated Hospital of Shanxi Univesity of Chinese Medi cine,Xi anyang 712000,Shanxi,China;First Teaching Hospital of Tianjin University of Traditinal Chinese Medicine,Tianjin 300193,China;Guang'anmen Hospital,China Academy of Chinese Medic al Sciences,Beijing 100053,China)

机构地区：[1]上海中医药大学附属曙光医院,上海201203 [2]福建省中医药研究院,福建福州350003 [3]广东省第二中医院,广东广州510095 [4]广州中医药大学第一附属医院,广东广州510405 [5]湖北省中医院,湖北武汉430061 [6]湖南中医药大学第一附属医院,湖南长沙410007 [7]华中科技大学同济医学院附属协和医院,湖北武汉430022 [8]南京市中医院,江苏南京210022 [9]上海市中医医院,上海200071 [10]陕西中医药大学附属医院,陕西咸阳712000 [11]天津中医药大学第一附属医院,天津300193 [12]中国中医科学院广安门医院,北京100053

出　　处：《中医正骨》2022年第6期17-24,共8页The Journal of Traditional Chinese Orthopedics and Traumatology

摘　　要：目的:评价痛宁凝胶外用治疗轻中度膝骨关节炎肾虚筋脉瘀滞证的临床疗效和安全性。方法:采用随机、双盲、安慰剂对照、多中心临床试验,共纳入576例轻中度膝骨关节炎肾虚筋脉瘀滞证患者,痛宁凝胶组432例、安慰剂组144例。痛宁凝胶组于膝关节疼痛处外涂痛宁凝胶,安慰剂组于膝关节疼痛处外涂痛宁凝胶模拟剂;2组均每日2次外涂皮肤,每次3g,疗程3周。分别于治疗前及治疗开始后1周、2周、3周记录并比较2组患者的西安大略和麦克马斯特大学骨关节炎指数(Western Ontario and Mc-Master Universities osteoarthritis index,WOMAC)疼痛评分、僵硬评分、日常活动功能评分及总评分,于治疗开始后3周比较2组患者的综合疗效,观察并比较2组患者并发症发生情况。结果:①受试者退出情况。痛宁凝胶组1例患者因未按要求治疗而退出。②WOMAC疼痛评分。时间因素和分组因素存在交互效应(F=166.662,P=0.000);2组患者WOMAC疼痛评分总体比较,差异有统计学意义,即存在分组效应(F=148.461,P=0.000);治疗前后不同时间点之间WOMAC疼痛评分的差异有统计学意义,即存在时间效应(F=3.823,P=0.022);2组患者WOMAC疼痛评分随时间延长均呈下降趋势,但2组的下降趋势不完全一致[(36.72±12.97)分,(31.93±12.22)分,(26.49±11.50)分,(20.29±11.79)分,F=148.461,P=0.000;(35.47±13.38)分,(33.44±13.11)分,(32.63±13.79)分,(31.61±15.00)分,F=8.574,P=0.000];治疗前及治疗开始后1周,2组患者的WOMAC疼痛评分比较,组间差异均无统计学意义(t=0.994,P=0.322;t=1.262,P=0.207);治疗开始后2周、3周,痛宁凝胶组的WOMAC疼痛评分均低于安慰剂组(t=4.813,P=0.000;t=8.241,P=0.000)。③WOMAC僵硬评分。时间因素和分组因素存在交互效应(F=80.764,P=0.000);2组患者WOMAC僵硬评分总体比较,差异有统计学意义,即存在分组效应(F=57.734,P=0.000);治疗前后不同时间点之间WOMAC僵硬评分的差异无统计学意义Objective:To evaluate the clinical outcomes and safety of external application of Tongning(痛宁,TN)gel for treatment of mild-to-moderate knee osteoarthritis(KOA)with syndromes of kidney deficiency and tendon-vessel stasis.Methods:Five hundred and seventy-six mild-to-moderate KOA patients with kidney deficiency and tendon-vessel stasis syndromes were enrolled in the randomized,double-blind,placebo-controlled,multicenter clinical trial,432 cases in TN gel group and 144 cases in placebo group.The patients in TN gel group were treated with external application of TN gel at the pain spots of affected knee,while the ones in placebo group with external application of TN gel mimetic agent at the pain spots of afected knee.All patients in the 2 groups were treated twicea day,3 g at a time for consecutive 3 weeks.The W estern Ontario and McMaster Universities osteoarthritis index(WOMAC)pain score,siffness score,activity of daily living(ADL)function score and total score were recorded and compared between the 2 groups before the treatment and at 1,2 and 3 weeks ater the beginning of the treatment respectively.Furthermore,the total outcomes were compared between the2 groups at 3 weeks after the beginning of the treatment,and the complications were observed and compared between the 2 groups.Results:①One patient in TN gel group dropped out of the study for failing to be treated as required.②There was interaction between time factor and group factor in WOMAC pain score(F=166.662,P=0.000).There was statistical difference in WOMAC pain scores between the 2 groups in general,in other words,there was group effect(F=148.461,P=0.000).There was statistical difference in WOMAC pain scores between different timepoints before and after the treatment,in other words,there was time effect(F=3.823,P=0.022).The WOMAC pain scores presented a downward trend over time in the 2 groups,while the 2 groups were inconsistent with each other in the variation tendency(36.72±12.97,31.93±12.22,26.49±11.50,20.29±11.79 points,F=148.461,P=0.000;35

关 键 词：骨关节炎 膝 痛宁凝胶 临床试验 

分 类 号：R274.9[医药卫生—中西医结合]