九味熄风颗粒(以牡蛎替代龙骨)治疗儿童抽动障碍的随机、双盲、平行对照、多中心、等效性临床试验  

Randomized,double-blind,parallel-controlled,multicenter,equivalence clinical trial of Jiuwei Xifeng Granules(Os Draconis replaced by Ostreae Concha)for treating tic disorder in children

作　　者：蔡秋晗 钟成梁[1,2] 胡思源 李新民[1,2] 徐智春 陈慧[4] 华颖 王俊宏[6] 汤继宏[7] 马丙祥[8] 王秀霞[9] 王爱珍[10] 王孟清[11] 张伟[12] 王淳[13] 滕懿群[14] 单义辉[15] 郭圣璇[1,2] CAI Qiu-han;ZHONG Cheng-liang;HU Si-yuan;LI Xin-min;XU Zhi-chun;CHEN Hui;HUA Ying;WANG Jun-hong;TANG Ji-hong;MA Bing-xiang;WANG Xiu-xia;WANG Ai-zhen;WANG Meng-qing;ZHANG Wei;WANG Chun;TENG Yi-qun;SHAN Yi-hui;GUO Sheng-xuan(First Teaching Hospital of Tianjin University of Traditional Chinese Medicine,Tianjin 300381,China;National Clinical Research Center for Chinese Medicine Acupuncture and Moxibustion,Tianjin 300381,China;Daqing People's Hospital,Daqing 246004,China;the Second Affiliated Hospital of Tianjin University of Traditional Chinese Medicine,Tianjin 300250,China;Wuxi Children's Hospital,Wuxi 214023,China;Dongzhimen Hospital,Beijing University of Chinese Medicine,Beijing 100700,China;Children's Hospital of Soochow University,Suzhou 215025,China;the First Affiliated Hospital of Henan University of Chinese Medicine,Zhengzhou 450003,China;the Second Hospital of Hebei Medical University,Shjiazhuang 050061,China;Taizhou Hospital of Traditional Chinese Medicine,Taizhou 225700,China;the First Hospital of Hunan University of Chinese Medicine,Changsha 410000,China;First Affiliated Hospital,Heilongjiang University of Chinese Medicine,Harbin 150040,China;Deyang People's Hospital,Deyang 618199,China;the Second Hospital of Jiaxing,Jiaxing 314000,China;the Third Hospital of Daqing,Daqing 163712,China)

机构地区：[1]天津中医药大学第一附属医院,天津300381 [2]国家中医针灸临床医学研究中心临床试验中心,天津300381 [3]大庆市人民医院,黑龙江大庆246004 [4]天津中医药大学第二附属医院,天津300250 [5]无锡市儿童医院,江苏无锡214023 [6]北京中医药大学东直门医院,北京100700 [7]苏州大学附属儿童医院,江苏苏州215025 [8]河南中医药大学第一附属医院,河南郑州450003 [9]河北医科大学第二医院,河北石家庄050061 [10]泰州市中医院,江苏泰州225700 [11]湖南中医药大学第一附属医院,湖南长沙410000 [12]黑龙江中医药大学附属第一医院,黑龙江哈尔滨150040 [13]德阳市人民医院,四川德阳618199 [14]嘉兴市第二医院,浙江嘉兴314000 [15]大庆市第三医院,黑龙江大庆163712

出　　处：《中国中药杂志》2025年第6期1699-1705,共7页China Journal of Chinese Materia Medica

基　　金：天津市教委科研计划项目(2021KJ138)。

摘　　要：九味熄风颗粒为已上市中成药,因方中龙骨为一级重点保护古生物化石,拟以牡蛎替代原方龙骨对产品进行改良,为评价改良后产品是否与原方的有效性和安全性一致,开展该项随机、双盲、平行对照、多中心、等效性临床试验。该研究计划纳入288例抽动障碍(TD)患儿,以1∶1随机分为2组,试验组服用九味熄风颗粒(以牡蛎替代龙骨),对照组服用九味熄风颗粒,疗程6周,在治疗满2、4、6周进行访视。主要疗效指标为治疗满6周耶鲁综合抽动严重程度量表-总抽动(YGTSS-TTS)评分与基线的差值,结果组间比较差异无统计学意义;2组差值(试验组-对照组)及95%CI的全分析数据集(FAS)为-0.17[-1.42,1.08]、符合方案数据集(PPS)为0.29[-0.97,1.56],均在等效界值[-3,3],等效性检验成立。次要疗效指标包括抽动疗效总有效率、YGTSS评分及各因子评分、临床总体印象-严重度量表(CGI-S)评分、中医证候疗效、单项症状消失率,其组间比较差异均无统计学意义,与主要疗效指标构成了完整的证据链。该研究共报道6例不良反应,试验组4例(2.82%),对照组2例(1.41%),组间差异无统计学意义;未出现严重可疑非预期不良反应,实验室检查结果未提示需临床特别关注的异常变化。结果表明,支持使用牡蛎替代原方中的龙骨,替代后其疗效和安全性与原方一致。Jiuwei Xifeng Granules have become a Chinese patent medicine in the market.Because the formula contains Os Draconis,a top-level protected fossil of ancient organisms,the formula was to be improved by replacing Os Draconis with Ostreae Concha.To evaluate whether the improved formula has the same effectiveness and safety as the original formula,a randomized,double-blind,parallel-controlled,equivalence clinical trial was conducted.This study enrolled 288 tic disorder(TD)of children and assigned them into two groups in 1∶1.The treatment group and control group took the modified formula and original formula,respectively.The treatment lasted for 6 weeks,and follow-up visits were conducted at weeks 2,4,and 6.The primary efficacy endpoint was the difference in Yale global tic severity scale(YGTSS)-total tic severity(TTS)score from baseline after 6 weeks of treatment.The results showed that after 6 weeks of treatment,the declines in YGTSS-TSS score showed no statistically significant difference between the two groups.The difference in YGTSS-TSS score(treatment group-control group)and the 95%CI of the full analysis set(FAS)were-0.17[-1.42,1.08]and those of per-protocol set(PPS)were 0.29[-0.97,1.56],which were within the equivalence boundary[-3,3].The equivalence test was therefore concluded.The two groups showed no significant differences in the secondary efficacy endpoints of effective rate for TD,total score and factor scores of YGTSS,clinical global impressions-severity(CGI-S)score,traditional Chinese medicine(TCM)response rate,or symptom disappearance rate,and thus a complete evidence chain with the primary outcome was formed.A total of 6 adverse reactions were reported,including 4(2.82%)cases in the treatment group and 2(1.41%)cases in the control group,which showed no statistically significant difference between the two groups.No serious suspected unexpected adverse reactions were reported,and no laboratory test results indicated serious clinically significant abnormalities.The results support the replacement of Os

关 键 词：九味熄风颗粒 龙骨 牡蛎 等效性试验 随机对照试验 

分 类 号：R277.7[医药卫生—中医学]