可乐定透皮贴剂治疗抽动障碍的随机、双盲、安慰剂对照、多中心临床试验  

Randomized,double-blind,multi-centers,clonidine adhesive patch placebo-controlled parallel-designed clinical trial in treating tic disorder

作　　者：杜亚松[1] 李华芳[1] 钟佑泉[2] 焦富勇 于得澧 王惠梅[5] 苏林雁[6] 王民洁[7] 马士薇[8] 顾牛范[1] 

机构地区：[1]上海市精神卫生中心,200030 [2]成都市儿童医院 [3]陕西省儿童医院 [4]哈尔滨市妇幼保健院 [5]山西省儿童医院 [6]中南大学精神卫生研究所 [7]南京脑科医院 [8]上海市儿童医院

出　　处：《上海精神医学》2006年第4期193-198,共6页Shanghai Archives of Psychiatry

摘　　要：目的探讨可乐定透皮贴剂治疗抽动障碍的疗效和安全性。方法对437例符合CCMD-3短暂性抽动障碍、慢性运动或发声抽动障碍及Tourette综合征(发声与多种运动联合抽动障碍)临床诊断标准6-18岁的儿童和青少年,采用可乐定透皮贴剂或安慰剂治疗4周,贴剂1片贴于背部肩胛骨下,每周左右交替。可乐定透皮贴剂与安慰剂比例为3∶1,所用贴剂剂量根据体重高低分别为1.0mg/w,1.5mg/w和2.0mg/w。如耶鲁大体抽动严重程度量表(YGTSS)减分率<30%且CG I-I评分≥4视为无效,在3周末终止试验,并予以泰必利治疗。结果经过4周治疗,试验组YGTSS从治疗前(21.35±8.67)分下降至治疗末的(9.83±7.77)分;对照组从治疗前(22.56±8.79)分下降至(11.84±8.01)分。两组相比在治疗第4周末YGTSS总分修正均数的差异有统计学意义(P<0.05)。治疗4周后,试验组中19.08%(62/325)患者为临床痊愈,49.23%(160/325)患者为显著进步,11.38%(37/325)患者为进步,20.31%(66/325)为无效。治疗4周后对照组中11.71%(13/111)患者为临床痊愈,35.14%(39/111)患者为显著进步,35.14%(39/111)患者为进步,35.14%(39/111)为无效。两组比较疗效差异有统计学意义(2χ=8.5985,P<0.01)。试验组治疗的有效率为68.31%,对照组为46.85%,两组相比差异有显著性(2χ=16.0467,P<0.001)。两组在实验室检查、心电图、生命体征、皮肤反应等方面均无明显异常。试验组中共10例发生不良反应,发生率为3.08%(对照组为7.21%),具体为贴剂处皮肤皮疹1.33%(对照组为5.45%)、谷丙转氨酶升高0.90%(对照组为0)等,和对照组相比总不良反应发生率和各不良反应发生率的差异均无统计学意义(P>0.05)。结论可乐定透皮贴剂用于治疗抽动障碍有效而安全,可乐定透皮贴剂的疗效优于安慰剂,差异有显著性(P<0.05)。Objective： The aim of this study is to evaluate the therapeutic effect and safety of clonidine adhesive patch in treating tic disorder. Methods： Subjects were 437 patients, who should meet CCMD - 3 diagnostic criteria of transient tic disorder,chronic motor or vocal tic disorder or Tourette Syndrome（ combined vocal motor and vocal tic disorder）, 6 to 18 years old. They were divided randomly into two groups ,test group and control group. In the following 4 weeks, subjects in test group were treated by clonidine adhesive patch and subjects in control group were treated by placebo. The patch should be stuck infrascapular left or right on the back each week in turn. The ratio of participants who used clonidine adhesive patch to placebo was 3 to 1. According to patients＇body weight（BW） , the dosage of clonidine adhesive patch was different ,from 1.0mg , 1.5mg to 2.0rag per week . The participant, whose score of YGTSS decreased 〈 30% and the score of CGI - I 〉 = 4, stopped the study at the end of the third week, and then they were treated by tiapride. Results： After 4 weeks＇treatment, YGTSS score in the test group decreased from 21.35 ＋ 8.67 （ at the beginning of the study） to 9.83 ＋ 7.77,while in the control group from 22.56 ＋ 8.79 to 11.84 ＋ 8.01. The difference in YGTSS score between two groups had statistical significance（ P 〈 0.05 ）. After being treated for 4 weeks , 19.08% （62/ 325） of the participants in test group was clinically recovered, 49.23% （160/325）obviously improved, 11. 38% （37/325） improved, 20. 31% （66/325） invalid. In the control group , 11. 71% （ 13/111 ） of the participants was clinically recovered, 35.14% （39/111 ） obviously improved, 35.14% （39/111 ） improved, 35. 14% （39/111 ）invalid, The therapeutic effect difference between two groups had statistical significance. （X^2 = 8. 5985 ,P 〈0.01 ） The effective power in test group was 68.31%, while in control group was 46.85%, the difference between two groups was signific

关 键 词：可乐定透皮贴剂 抽动障碍 疗效 临床研究 

分 类 号：R749.94[医药卫生—神经病学与精神病学]