抽动宁胶囊治疗小儿多发性抽动症脾虚痰聚证有效性和安全性的多中心II期临床研究  

Efficacy and safety of Choudongning Capsule in children with Tourette's syndrome of spleen deficiency and phlegm accumulation in phase II clinic

作　　者：郭圣璇 胡思源[2] 刘虹[2] 陈玉燕[3] 王雪峰[4] 李伟伟[5] 何平[6] 黄浩 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]浙江省中医院,浙江杭州310003 [4]辽宁中医药大学附属医院,辽宁沈阳110032 [5]广西中医药大学第一附属医院,广西南宁530000 [6]云南中医学院第一附属医院,云南昆明650000 [7]河南清阳实业有限公司,河南郑州450003 [8]广州博济新药临床研究中心有限公司,广东广州510610

出　　处：《中草药》2018年第4期891-896,共6页Chinese Traditional and Herbal Drugs

摘　　要：目的初步评价抽动宁胶囊治疗小儿多发性抽动症脾虚痰聚证的有疗效性和安全性。方法采用分层区组随机、阳性药平行对照、双盲双模拟、多中心临床研究的方法。纳入240例患儿。按照1∶1的比例随机分为试验组和阳性对照组。试验组口服抽动宁胶囊和泰必利片模拟药,阳性对照组服用泰必利片和抽动宁胶囊模拟药,疗程为6周。观察耶鲁综合抽动严重程度量表(YGTSS)抽动症状的临床疗效、YGTSS抽动症状总积分、运动性抽动和发声性抽动因子积分、社会功能损害、中医证候疗效,并对其安全性进行评价。结果 YGTSS抽动症状临床疗效的总有效率,试验组为71.19%,阳性对照组为67.50%,经非劣效检验,试验组患者抽动症状疗效不劣于阳性对照组。YGTSS抽动症状总积分、运动性抽动和发声性抽动因子积分、社会功能损害、中医证候疗效的组间比较,差异均无统计学意义。试验过程中,试验组出现不良反应2例(1.67%),阳性对照组出现6例(5%),组间比较差异无统计学意义,且试验组不良反应发生率低于阳性对照组。结论抽动宁胶囊治疗小儿多发性抽动症脾虚痰聚证有效,且疗效不劣于泰必利,不良反应发生率低,安全性良好。Objective To evaluate the efficacy and safety of Choudongning （CDN） Capsule in children with Tourette＇s syndrome of spleen deficiency and phlegm accumulation. Methods A stratified-block randomized, parallel-controlled, double-blind, double- dummy, multi-center trials were designed for clinical study. A total of 240 patients were enrolled and separated randomly into experimental group and positive control group in the rate of 1 ; 1. Patients in the experimental group orally took CDN Capsule andsimulated Tiapridal Tablets; The patients in positive control group took Tiapridal Tablets and simulated CDN Capsule. Treatment course lasted for 6 weeks. The clinical efficacy and integrals of YGTSS twitch, the factor scores of motor tics and vocal tics, YGTSS social function damage, traditional Chinese medicine syndrome efficacy were observed to evaluate its security. Results The total effective rate of YGTSS twitch clinical efficacy was 71.19% in the experimental group and 67.50% in the positive control group, respectively. The results of non-inferiority test indicated that the efficacy of experimental group was not worse than that in the positive control group. There was no significant difference between two groups in YGTSS twitch integrals, motor tics and vocal tics＇ factor scores, YGTSS social function damage, and traditional Chinese medicine syndrome efficacy, Only two ADRs （1.67%） in the experimental group and six ADRs （5%） in the positive control group were observed during clinical trials. The incidence of ADRs in the experimental group was lower than that in the positive control group with no statistical difference. Conclusion CDN Capsule have similar efficacy on the treatment of Tourette＇s syndrome of spleen deficiency and phlegm accumulation contrast to Tiapridal Tablets, with lower adverse reactions and better safety.

关 键 词：抽动宁胶囊 小儿多发性抽动症 随机对照试验 II期临床 泰必利 分层区组随机 阳性药平行对照 双盲双模拟 

分 类 号：R97[医药卫生—药品]