摘要
目的评价可乐定透皮贴治疗儿童抽动障碍（TD）的临床疗效与安全性。方法检索维普科技期刊数据库、万方数据库、中国知网、中国生物医学文献数据库、EMCC、Pub Med、OVID及Cochrance图书馆,搜集可乐定透皮贴治疗TD的RCT和NRCT,检索时间均为建库至2016年8月30日。由2名研究者独立筛选文献、提取资料并评价纳入文献的偏倚风险后,采用Rev Man5.3软件Meta分析。结果最终纳入6篇文献,5篇为RCT,1篇未描述具体随机方法。共纳入1 043例TD患儿,病例组632例,对照组411例。对照组为氟哌啶醇3篇、硫必利2篇和安慰剂2篇。①3篇文献比较了可乐定透皮贴与氟哌啶醇治疗TD的疗效,文献间异质性小,固定效应模型分析,两组的耶鲁综合抽动严重程度量表（YGTSS）减分率差异有统计学意义（P〈0.001）,MD=21.82（95%CI：20.97-22.88）。②2篇文献比较了可乐定透皮贴与硫必利治疗TD的疗效,文献间异质性大,随机效应模型分析,两组YGTSS减分率差异无统计学意义（P=0.43）,MD=10.66（95%CI：-15.67-36.99）。③2篇文献以不同评估方式比较了可乐定透皮贴与安慰剂的疗效,不适宜合并分析,描述性分析显示可乐定透皮贴剂能够有效降低YGTSS的分数。④6篇文献均报道了不良反应的发生情况,可乐定透皮贴主要的不良反应包括：局部皮肤瘙痒、发红（17例）,口干（10例）,头晕（8例）,血压下降（4例）等。3篇文献比较了可乐定透皮贴与氟哌啶醇的不良反应发生率[3.7%（8/218）vs 17.8%（37/208）],差异有统计学意义（P〈0.001）。2篇文献比较了可乐定透皮贴与硫必利的不良反应发生率[15.8%（16/101）vs 31.0%（35/113）],差异有统计学意义（P=0.009）。2篇文献比较了可乐定透皮贴与安慰剂的不良反应发生率[6.2%（24/384）vs 9.3%（12/129）],差异无统计学意义（P=0.24）。结论现有证据表明,可乐定透皮贴与治疗TD的传统药物相比疗效相当,但其不良反应的发生率低,且使用方便。
Objective To evaluate the efficacy and safety of clonidine adhesive patch in the treatment of childhood tic disorders.Methods VIP,Wanfang,CNKI,CBM,EMCC,Pub Med,OVID databases and Cochrance library were searched,in order to collect RCT and non randomized studies which took clonidine adhesive patch therapy,and the retrieval time was from the time that the database was set up to August 30,2016.Two reviewers independently screened the literature,extracted the data and evaluated the risk of bias in the literature.Meta-analysis was conducted by Revman 5.3 software.Results Finally,6 articles were included in this study,5 was RCT,and 1 didn＇t describe whether they used random method or not.A total of 1 043 children with TD were enrolled,including 632 patients in case group and 411 patients in control group.In control group 3 articles were haloperidol,2 articles were tiapride,and the other 2 articles took placebo as control.In 3 articles comparing clonidine adhesive patch with haloperidol in the treatment of TD,the heterogeneity was small,with the fixed effect model,the results showed that the two groups had statistically significant YGTSS reduction rate（P〈0.001）,MD = 21.82（95%CI：20.97 to 22.88）,which suggested that the clonidine adhesive patch was more effective than haloperidol.（2） In 2 articles comparing clonidine adhesive patch with sulfur in the treatment of TD,the heterogeneity between studies was large,so a random effects model was used for meta-analysis,the results showed that the difference of YGTSS reduction rate in two groups was not statistically significant（P = 0.43）,MD = 10.66（95% CI：-15.67 to 36.99）,which suggested that the efficacy of clonidine adhesive patch and tiapride was equivalent.（3） In 2 articles comparing clonidine adhesive patch with placebo in the treatment of TD,in both articles it was found that clonidine adhesive patch could effectivelyreduce YGTSS scores,but the two articles evaluated in different ways,so it was unable to conduct meta-analysis.（4）All 6 articles had reported the occurrence of adverse reaction,the adverse reactions of clonidine adhesive patch mainly included local skin itching and redness（17 cases）,dry mouth（10 cases）,dizziness（8 cases）,blood pressure drop（4 cases）;no serious adverse reactions of cardiac arrhythmia,dysfunction of liver and kidney were reported.In 3 articles comparing the adverse reaction of clonidine adhesive patch with haloperidol [3.7%（8 / 218） vs 17.8%（37 / 208） ],the difference was statistically significant（P〈0.001）,and in 2 articles comparing the adverse reaction of clonidine adhesive patch with tiapride [15.8%（16 / 101） vs 31%（35 / 113） ],the difference was also statistically significant（P = 0.009）,and in 2 articles comparing the adverse reaction of clonidine adhesive patch with placebo [6.2%（24 / 384） vs 9.3%（12 / 129） ],but there was no statistically significant difference（P = 0.24）.Conclusion Clonidine adhesive patch can significantly control the symptoms of TD just like traditional drugs or even better,and with less side effects and can be used conveniently.
出处
《中国循证儿科杂志》
CSCD
北大核心
2016年第6期426-430,共5页
Chinese Journal of Evidence Based Pediatrics
