金天格胶囊治疗原发性骨质疏松症前瞻性多中心随机双盲对照临床试验  

Clinical Effect of Jintiange Capsule(金天格胶囊)in Treatment of Primary Osteoporosis:A Prospective Multi-Center Randomized Double-Blind Controlled Clinical Trial

作　　者：程金莲[1] 张翔[1] 潘汉升[2] 简小兵[3] 王杰 刘传慧[5] 涂萍 陈少华[7] 王功国[8] 钟树妹[9] 王萧枫 徐涵斌 朱雪琦[1] 雷仲民[1] CHENG Jinlian;ZHANG Xiang;PAN Hansheng;JIAN Xiaobing;WANG Jie;LIU Chuanhui;TU Ping;CHEN Shaohua;WANG Gongguo;ZHONG Shumei;WANG Xiaofeng;XU Hanbin;ZHU Xueqi;LEI Zhongmin(Beijing Hospital of Traditional Chinese Medicine,Capital Medical University,Beijing 100010,China;Ruikang Hospital,Guangxi University of Chinese Medicine,Nanning 530001,Guangxi,China;Guangzhou Hospital of Traditional Chinese Medicine,Guangzhou 510130,Guangdong,China;Shanxi Hospital of Integrated Traditional and Western Medicine,Taiyuan 030013,Shanxi,China;Zhengzhou Orthopedics Hospital,Zhengzhou 45000,Henan,China;The Third Hospital of Nanchang,Nanchang 330009,Jiangxi,China;Qianfoshan Hospital of Shandong Province,Jinan 250014,Shandong,China;Rizhao Hospital of Traditional Chinese Medicine,Rizhao 276800,Shandong,China;People’s Hospital of Ganzhou City,Ganzhou 341000,Jiangxi,China;Integrated Traditional Chinese and Western Medicine Hospital of Wenzhou,Wenzhou 325000,Zhejiang,China;Nanchang Combine Traditional Chinese and Western Medicine Hospital,Nanchang 330006,Jiangxi,China)

机构地区：[1]首都医科大学附属北京中医医院,北京100010 [2]广西中医药大学附属瑞康医院,广西南宁530001 [3]广州市中医医院,广东广州510130 [4]山西省中西医结合医院,山西太原030013 [5]郑州市骨科医院,河南郑州450000 [6]南昌市第三医院,江西南昌330009 [7]山东省千佛山医院,山东济南250014 [8]日照市中医医院,山东日照276800 [9]赣州市人民医院,江西赣州341000 [10]温州市中西医结合医院,浙江温州325000 [11]南昌市中西医结合医院,江西南昌330006

出　　处：《中华中医药学刊》2021年第1期36-41,共6页Chinese Archives of Traditional Chinese Medicine

基　　金：国家“十三五”重大新药创制专项(2019ZX09734001)。

摘　　要：目的评价金天格胶囊(主要成分为人工虎骨粉)治疗原发性骨质疏松症的临床疗效和安全性。方法采用前瞻性分层区组随机方法、双盲双模拟、阳性药平行对照临床研究方法,纳入11家医院471例原发性骨质疏松受试者,以3∶1比例随机分配至试验组和对照组,其中试验组356例,对照组115例。试验组口服金天格胶囊1.2 g/次,3次/d,骨疏康胶囊模拟剂1.28 g/次,2次/d;对照组口服金天格胶囊模拟剂1.2 g/次,3次/d,骨疏康胶囊1.28 g/次,2次/d。两组用药疗程均为24周,干预48周电话随访。干预12周和24周分别评价中医证候积分,以其作为主要结局指标并评价临床疗效;以疼痛VAS评分、单项症状评分和骨密度指改善情况作为次要结局指标。安全性评价包括试验期间骨折发生率,血常规、尿常规、便常规、肝肾功能、心电图等安生性指标。结果(1)试验组12周的总有效率为64.61%(230/356),高于对照组的总有效率50.44%(58/115),差异有统计学意义(χ^(2)=11.580,P=0.000);试验组24周的总有效率为84.55%(301/356),高于对照组的总有效率71.30%(82/115),差异有统计学意义(χ^(2)=13.114,P=0.000);(2)两组24周的中医症状积分均较治疗前降低,差异有统计学意义(W=-26974.5,2775.00;P=0.000,0.000);试验组24周中医症状积分较基线下降的差值大于对照组的差值,差异有统计学意义(Z=2.656,P=0.008);(3)试验组24周腰背疼痛、腰膝酸软无力症状改善优于对照组(χ^(2)=9.940,χ^(2)=10.004;P=0.002,P=0.002),两组24周下肢抽筋、步履艰难和持重困难症状改善差异无统计学意义(χ^(2)=1.501,χ^(2)=3.035,χ^(2)=0.619;P=0.221,P=0.082,P=0.432);(4)试验组24周疼痛VAS评分明显低于对照组,差异有统计学意义(Z=2.644,P=0.008);(5)试验组24周骨密度改善的总有效率为91.98%(298/324),高于对照组的总有效率75.23%(82/109),差异有统计学意义(χ^(2)=17.020,P=0.000);试验组24周腰椎L2、腰椎L3、腰椎L4、腰椎L2-Objective To investigate the clinical effect and safety of Jintiange Capsule(金天格胶囊)in the treatment of primary osteoporosis.Methods A randomized,double-blind,double-simulation,positive-drug parallel control,multicenter clinical study was conducted.A total of 471 patients with primary osteoporosis from 11 hospitals were randomly assigned to the control group(115 cases)and the observation group(356 cases)in a ratio of 3∶1.Patients in the control group were given simulation of Jintiange Capsule(1.2 g per time,three times daily)and Gushukang Capsule(1.28 g per time,twice daily).Patients in the observation group were given Jintiange Capsule(1.2 g per time,three times daily)and simulation of Gushukang Capsule(1.28 g per time,twice daily).Both groups were given 24 weeks as a treatment course,and were followed up by telephone for 48 weeks.Scores of total TCM symptoms were evaluated in 12 and 24 weeks’intervention,and those were taken as primary outcomes to evaluate clinical efficacy.The secondary outcomes included scores of VAS,individual symptom score,and BMD(bone mineral density).Safety outcomes included fracture incidence during test period,and blood routine,urine routine,stool routine,liver and kidney function,electrocardiogram,etc.Results(1)The total effective rate of the observation group at 12 weeks was 64.61%(330/356),higher than that of the control group(50.44%,58/115).The difference was statistically significant(χ^(2)=11.580,P=0.000).The total effective rate of the observation group at 24 weeks was 84.55%(301/356),higher than that of the control group(71.30%,82/115).The difference was statistically significant(χ^(2)=13.114,P=0.000).(2)The TCM symptom scores of both groups at 24 weeks were lower than that before treatment,and the difference was statistically significant(W=-26974.5,2775.00;P=0.000,0.000).The difference of TCM symptom score at 24 weeks from baseline in the observation group was larger than that in the control group,and the difference was statistically significant(Z=2.656,P=0.008).(

关 键 词：金天格胶囊 人工虎骨粉 原发性骨质疏松症 随机对照试验 骨密度 

分 类 号：R269.81[医药卫生—中西医结合]