發(fā)布時間：2019-05-15 22:39

【摘要】：目的評價可樂定透皮貼治療兒童抽動障礙(TD)的臨床療效與安全性。方法檢索維普科技期刊數(shù)據(jù)庫、萬方數(shù)據(jù)庫、中國知網(wǎng)、中國生物醫(yī)學文獻數(shù)據(jù)庫、EMCC、Pub Med、OVID及Cochrance圖書館,搜集可樂定透皮貼治療TD的RCT和NRCT,檢索時間均為建庫至2016年8月30日。由2名研究者獨立篩選文獻、提取資料并評價納入文獻的偏倚風險后,采用Rev Man5.3軟件Meta分析。結(jié)果最終納入6篇文獻,5篇為RCT,1篇未描述具體隨機方法。共納入1 043例TD患兒,病例組632例,對照組411例。對照組為氟哌啶醇3篇、硫必利2篇和安慰劑2篇。13篇文獻比較了可樂定透皮貼與氟哌啶醇治療TD的療效,文獻間異質(zhì)性小,固定效應(yīng)模型分析,兩組的耶魯綜合抽動嚴重程度量表(YGTSS)減分率差異有統(tǒng)計學意義(P0.001),MD=21.82(95%CI:20.97~22.88)。22篇文獻比較了可樂定透皮貼與硫必利治療TD的療效,文獻間異質(zhì)性大,隨機效應(yīng)模型分析,兩組YGTSS減分率差異無統(tǒng)計學意義(P=0.43),MD=10.66(95%CI:-15.67~36.99)。32篇文獻以不同評估方式比較了可樂定透皮貼與安慰劑的療效,不適宜合并分析,描述性分析顯示可樂定透皮貼劑能夠有效降低YGTSS的分數(shù)。46篇文獻均報道了不良反應(yīng)的發(fā)生情況,可樂定透皮貼主要的不良反應(yīng)包括:局部皮膚瘙癢、發(fā)紅(17例),口干(10例),頭暈(8例),血壓下降(4例)等。3篇文獻比較了可樂定透皮貼與氟哌啶醇的不良反應(yīng)發(fā)生率[3.7%(8/218)vs 17.8%(37/208)],差異有統(tǒng)計學意義(P0.001)。2篇文獻比較了可樂定透皮貼與硫必利的不良反應(yīng)發(fā)生率[15.8%(16/101)vs 31.0%(35/113)],差異有統(tǒng)計學意義(P=0.009)。2篇文獻比較了可樂定透皮貼與安慰劑的不良反應(yīng)發(fā)生率[6.2%(24/384)vs 9.3%(12/129)],差異無統(tǒng)計學意義(P=0.24)。結(jié)論現(xiàn)有證據(jù)表明,可樂定透皮貼與治療TD的傳統(tǒng)藥物相比療效相當,但其不良反應(yīng)的發(fā)生率低,且使用方便。
[Abstract]:Objective to evaluate the clinical efficacy and safety of clonidine transdermal patch in the treatment of children with tic disorder (TD). Methods the database of Weipu sci-tech journals, Wanfang database, China knowledge network, Chinese biomedical literature database, EMCC,Pub Med,OVID and Cochrance library were searched. The RCT and NRCT, of clonidine transdermal paste in the treatment of TD were collected. The retrieval time is from the establishment of the database to August 30, 2016. After two researchers independently screened the literature, extracted the data and evaluated the bias risk of the literature, the Rev Man5.3 software Meta was used to analyze the literature. Results six literatures were included, 5 of which were RCT,1 articles without description of specific random methods. A total of 1043 children with TD were included, 632 cases in the case group and 411 cases in the control group. In the control group, there were 3 haloperidol, 2 thiopride and 2 placebo. Thirteen articles compared the efficacy of clonidine transdermal paste and haloperidol in the treatment of TD, the heterogeneity between the literature was small, and the fixed effect model was analyzed. There was significant difference in (YGTSS) score reduction rate between the two groups (P0.001), MD=21.82 (95%CI:20.97~22.88). 22 articles compared the efficacy of clonidine transdermal patch and thiopride in the treatment of TD. There was no significant difference in YGTSS score reduction rate between the two groups (P 鈮，

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