评价抽动宁胶囊治疗小儿多发性抽动障碍脾虚痰聚证有效性和安全性的分层区组随机、双盲双模拟、三臂平行对照、多中心、Ⅲ期临床研究  

Efficacy and safety of Choudongning capsule( CDN) in children with Tourette's syndrome of spleen deficiency and phlegm accumulation

作　　者：杨娜[1] 马融[2] 胡思源[2] 刘虹[2] 闫慧敏[3] 向希雄[4] 王雪峰[5] 陈银波[6] 陈玉燕[7] 焦富勇[8] 丁樱[9] 黄皓 王领娣 

机构地区：[1]天津中医药大学,天津300193 [2]天津中医药大学第一附属医院,天津300193 [3]首都医科大学附属北京儿童医院,北京100045 [4]湖北省中医院,湖北武汉430061 [5]辽宁中医药大学附属医院,辽宁沈阳110032 [6]吉林大学第一医院,吉林长春130031 [7]浙江省中医院,浙江杭州310003 [8]陕西省人民医院,陕西西安710068 [9]河南中医学院第一附属医院,河南郑州450099 [10]河南清阳实业有限公司,河南郑州450003 [11]广州博济新药临床研究中心有限公司,广东广州510610

出　　处：《中国中药杂志》2016年第16期3100-3106,共7页China Journal of Chinese Materia Medica

摘　　要：通过对8家中心588例患者的一项分层区组随机、三臂平行对照、双盲双模拟、多中心临床研究,确证评价抽动宁胶囊治疗小儿多发性抽动障碍脾虚痰聚证的有效性和临床应用的安全性。研究将符合纳入标准的患者以3∶1∶1随机分配到试验组、阳性对照组和安慰剂组。试验组口服抽动宁胶囊与泰必利片模拟药、阳性对照组服用泰必利片与抽动宁胶囊模拟药、安慰剂组服用2种药的模拟剂,疗程为6周。有效性观察指标为抽动分级疗效、YGTSS积分及其因子分、社会功能损害程度、中医证候疗效等;安全性指标有临床不良事件/不良反应、生命体征、实验室检测等。结果显示,YGTSS抽动疗效的总有效率,试验组为75.92%,阳性对照组为72.65%,安慰剂组为37.29%,阳性对照组疗效优于安慰剂组,且试验组疗效不劣于阳性对照组。YGTSS抽动积分、运动性抽动、发声性抽动因子分、社会功能损害、中医证候疗效的3组间比较,差异均有统计学意义。试验过程中,试验组出现不良反应5例(1.42%),泰必利组出现10例(8.55%),安慰剂组3例(2.54%),试验组不良反应发生率低于阳性对照组,组间比较差异有统计学意义。根据试验结果可以认为,抽动宁胶囊治疗小儿多发性抽动障碍脾虚痰聚证有效,其疗效不劣于临床常用的泰必利片,且不良反应发生率较泰必利片更低,有临床推广应用价值。To evaluate the efficacy and safety of Choudongning （CDN） capsule in children with Tourette＇s syndrome of spleen defi- ciency and phlegm accumulation through a randomized double-blind three-arm controlled phase Ⅲstudy in 588 patients from 8 hospi- tals. The included patients were randomly divided into test group, positive control group and placebo group at the ratio of 3： 1： 1. Pa- tients in the test group orally took CDN capsules and simulated Tiapridal tablets; the patients in positive control group took Tiapridal tablets and simulated CDN capsules ; whereas the patients in placebo group orally took the simulated agents of the above two drugs. The treatment course was 6 weeks for three groups. The global grading rates, YGTSS scores and its factor scores, the degree of social func- tion damage, as well as traditional Chinese medicine syndrome efficacy were evaluated as the outcome measures on efficacy. The AEs/ ADRs, vital signs and laboratory testing were observed as outcome measures on safety. The total effective rate of YGTSS was 75.92% in the test group, 72. 65% in the positive control group, and 37.29% in the placebo group. Non inferiority test stands between the test group and the positive control group, and they were superior to placebo group in efficacy with statistical difference. Significant differ- ence had also been found among the 3 groups in YGTSS tics score, motor tics score, vocal tics, degree of social function damage and traditional Chinese medicine syndrome efficacy. During the study, there were 5 （1.42%）ADRs in the test group, 10 （8. 55 % ）in the positive control group and 3 （2. 54% ） in the placebo group. The incidence of ADRs in the test group was lower than that in the positive control group, with statistical difference. It is clear to say that CDN capsule can effectively treat the Tourette＇s syndrome of spleen defi- ciency and phlegm accumulation. Its efficacy is not inferior to the commonly used Tiapridal tablets, with even less adverse reactions, so it has clin

关 键 词：抽动宁胶囊 Tourette’s综合征 随机对照试验 三臂试验设计 非劣效检验 Ⅲ期 

分 类 号：R277.7[医药卫生—中医学]