可乐定透皮贴治疗儿童抽动障碍的有效性与安全性的Meta分析
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摘要
目的:系统评价可乐定透皮贴治疗儿童抽动障碍的有效性与安全性,为临床治疗提供循证依据。方法:计算机检索各数据库自建库起至2018年7月Medline、Embase、Cochrance图书馆、中国知网、维普网、中国生物医学文献数据库、万方数据上发表的可乐定透皮贴(试验组)对比其他治疗(对照组,包括安慰剂组、硫必利组、氟哌啶醇组)治疗儿童抽动障碍的随机对照试验(RCT),对符合纳入标准的文献进行资料提取,并采用Cochrane系统评价手册5.1.0进行质量评价后,采用Rev Man 5.3统计软件对耶鲁综合抽动严重程度量表(YGTSS)减分率(量)、不良事件发生率、有效率等指标进行Meta分析,无法进行Meta分析组别的指标仅进行描述性分析。结果:共纳入8项RCT,合计1 320例患儿。其中2项研究对照组为安慰剂、2项为硫必利、3项为氟哌啶醇、1项同时研究硫必利和氟哌啶醇。Meta分析结果显示,在YGTSS减分率方面,试验组显著高于氟哌啶醇组[MD=21.94,95%CI(21.03,22.86),P<0.001],但与硫必利组比较差异无统计学意义[MD=10.66,95%CI(-15.68,37.00),P=0.43];在不良事件(试验组患儿不良事件主要包括皮肤瘙痒、发红、口干、头晕、血压下降、心电图异常)发生率方面,试验组显著低于硫必利组[OR=0.42,95%CI(0.22,0.82),P=0.01]、氟哌啶醇组[OR=0.17,95%CI(0.09,0.32),P<0.001],但与安慰剂组比较差异无统计学意义[OR=0.61,95%CI(0.29,1.29),P=0.20];在有效率方面,试验组与硫必利组[OR=1.29,95%CI(0.38,4.39),P=0.69]、氟哌啶醇组[OR=1.63,95%CI(0.89,2.96),P=0.11]比较,差异均无统计学意义。描述性分析结果显示,试验组YGTSS减分率(量)显著高于安慰剂组(P<0.05),有效率显著高于安慰剂组(P<0.01)。结论:可乐定透皮贴治疗儿童抽动障碍的YGTSS减分率(量)优于安慰剂、氟哌啶醇,与硫必利相当;有效率优于安慰剂,与硫必利、氟哌啶醇相当;安全性优于硫必利、氟哌啶醇,与安慰剂相当。
OBJECTIVE:To systematically evaluate the efficacy and safety of Clonidine tansdermal patch for child tic disorders in children, and to provide evidence-based reference for clinical treatment. METHODS: Retrieved from Medline, Embase,Cochrane library,CNKI,VIP,CBM and Wanfang database,randomized controlled trials(RCTs) about Clonidine tansdermal patch(trial group)versus other therapies(control group,including placebo group,thiopride group,haloperidol group)for child tic disorders were collected from datbase estallishment to July 2018. The literatures met inclusion criteria were summarized. After quality evaluation with Cochrane system evaluation manual 5.1.0,Meta-analysis of reduction rate(amount) of YGTSS,the incidence of ADR and response rate was performed by using Rev Man 5.3 statistical software. Descriptive analysis was performed on indicators of groups that were unable to perform Meta-analysis. RESULTS:A total of 8 RCTs involving 1 320 patients were included. Among them, 2 RCTs involved placebo in control group;2 RCTs involved thiopride,3 RCTs involved haloperidol, and 1 RCT involved thiopride and haloperidol. Results of Meta-analysis showed that reduction rate of YGTSS in trial group were significantly higher than haloperidol group [MD=21.94,95% CI(21.03,22.86),P<0.001],but there was no statistical significance compared with thiopride group [MD=10.66,95%CI(-15.68,37.00),P=0.43].The incidence of adverse events(mainly including skin itching, redness, dry mouth, dizziness, decreased blood pressure,abnormal electrocardiogram) in trial group were significantly lower than thiopride group [OR=0.42,95% CI(0.22,0.82),P=0.01] and haloperidol group [OR=0.17,95%CI(0.09,0.32),P<0.001],but there was no statistical significance compared with placebo group [OR=0.61,95% CI(0.29,1.29),P=0.20]. There was no statistical significance in response rate of trial group compared with thiopride group [OR=1.29,95%CI(0.38,4.39),P=0.69] and haloperidol group [OR=1.63,95%CI(0.89,2.96),P=0.11]. The results of descriptive analysis showed that reduction rate(amount)of YGTSS in trial group was significantly higher than that of placebo group(P<0.05),and response rate of trial group was significantly higher than that of placebo group(P<0.01). CONCLUSIONS:For child tic disorders in children,Clonidine tansdermal patch is better than placebo and haloperidol in reduction rate(amount)of YGTSS,and is similar to thiopride. Response rate of Clonidine tansdermal patch is better than that of placebo,and is similar to those of thiopride and haloperidol. The safety of Clonidine tansdermal patch is better than those of thiopride and haloperidol,and is similar to that of placebo.
OBJECTIVE:To systematically evaluate the efficacy and safety of Clonidine tansdermal patch for child tic disorders in children, and to provide evidence-based reference for clinical treatment. METHODS: Retrieved from Medline, Embase,Cochrane library,CNKI,VIP,CBM and Wanfang database,randomized controlled trials(RCTs) about Clonidine tansdermal patch(trial group)versus other therapies(control group,including placebo group,thiopride group,haloperidol group)for child tic disorders were collected from datbase estallishment to July 2018. The literatures met inclusion criteria were summarized. After quality evaluation with Cochrane system evaluation manual 5.1.0,Meta-analysis of reduction rate(amount) of YGTSS,the incidence of ADR and response rate was performed by using Rev Man 5.3 statistical software. Descriptive analysis was performed on indicators of groups that were unable to perform Meta-analysis. RESULTS:A total of 8 RCTs involving 1 320 patients were included. Among them, 2 RCTs involved placebo in control group;2 RCTs involved thiopride,3 RCTs involved haloperidol, and 1 RCT involved thiopride and haloperidol. Results of Meta-analysis showed that reduction rate of YGTSS in trial group were significantly higher than haloperidol group [MD=21.94,95% CI(21.03,22.86),P<0.001],but there was no statistical significance compared with thiopride group [MD=10.66,95%CI(-15.68,37.00),P=0.43].The incidence of adverse events(mainly including skin itching, redness, dry mouth, dizziness, decreased blood pressure,abnormal electrocardiogram) in trial group were significantly lower than thiopride group [OR=0.42,95% CI(0.22,0.82),P=0.01] and haloperidol group [OR=0.17,95%CI(0.09,0.32),P<0.001],but there was no statistical significance compared with placebo group [OR=0.61,95% CI(0.29,1.29),P=0.20]. There was no statistical significance in response rate of trial group compared with thiopride group [OR=1.29,95%CI(0.38,4.39),P=0.69] and haloperidol group [OR=1.63,95%CI(0.89,2.96),P=0.11]. The results of descriptive analysis showed that reduction rate(amount)of YGTSS in trial group was significantly higher than that of placebo group(P<0.05),and response rate of trial group was significantly higher than that of placebo group(P<0.01). CONCLUSIONS:For child tic disorders in children,Clonidine tansdermal patch is better than placebo and haloperidol in reduction rate(amount)of YGTSS,and is similar to thiopride. Response rate of Clonidine tansdermal patch is better than that of placebo,and is similar to those of thiopride and haloperidol. The safety of Clonidine tansdermal patch is better than those of thiopride and haloperidol,and is similar to that of placebo.
引文
[1]LECKMAN JF.Tic disorders[J].BMJ,2012.DOI:10.1136/bmj.d7659.
[2]刘智胜.Toumtte综合征共患病的诊治进展[J].中国儿童保健杂志,2010,18(2):94-95,99.
[3]中华医学会儿科学分会神经学组.儿童抽动障碍诊断与治疗专家共识(2017实用版)[J].中华实用儿科临床杂志,2017,32(15):1137-1140.
[4]PRINGSHEIM T,DOJA A,GORMAN D,et al.Canadian guidelines for the evidence-based treatment of tic disorders:pharmacotherapy[J].Can J Psychiatry,2012,57(3):133-143.
[5]ROESSNER V,PLESSEN KJ,ROTHENBERGER A,et al.European clinical guidelines for Tourette syndrome and other tic disorders.PartⅡ:pharmacological treatment[J].Eur Child Adolesc Psychiatry,2011,20(4):173-196.
[6]EHRLICH J,BECK B,THIEDMANN R,et al.Bioequivalence and adhesion evaluation of transdermal clonidine following a change in excipient supplier[J].Int J Clin Pharmacol Ther,2016,54(10):816-824.
[7]American Psychiatric Association.Diagnostic and statistical manual of mental disorders[M].4th edition.Washington:American Psychiatric Association,1994:100-105.
[8]American Psychiatric Association.Diagnostic and statistical manual of mental disorders DSM-IV-TR[M].Washington:American Psychiatric Association,2000:1-943.
[9]中华医学会精神科分会.中国精神障碍分类与诊断标准[M].3版.济南:山东科学技术出版社,2001:35.
[10]LECKMAN JF,RIDDLE MA,HARDIN MT.The Yale global tic severity scale:initial testing of a clinician-rating scale of tic severity[J].J Am Acad Child Adolesc Psychiatry,1989,28(4):566-573.
[11]HIGGINS JPT,GREEN S.Cochrane handbook for systematic reviews of interventions version 5.1.0[EB/OL].[2018-08-17].http://handbook.cochrane.org.
[12]张红宇,林悦,刘美娜,等.可乐定控释贴治疗儿童抽动障碍的临床研究[J].儿科药学杂志,2006,12(6):8-9,16.
[13]钟佑泉,周文智,胡文广,等.可乐定透皮贴治疗儿童抽动障碍的随机双盲对照研究[J].中华儿科杂志,2007,45(10):785-787.
[14]DU YS,LI HF,VANCE A,et.al.Randomized doubleblind multicentre placebo-controlled clinical trial of the clonidine adhesive patch for the treatment of tic disorders[J].Aust N Z J Psychiatry,2008,42(9):807-813.
[15]康华,张月芳,焦富勇,等.可乐定透皮贴治疗儿童抽动-秽语综合征的疗效观察[J].中国当代儿科杂志,2009,11(7):537-539.
[16]吕娟.可乐定透皮贴片和盐酸硫必利治疗抽动障碍的对比研究[D].长春:吉林大学,2015.
[17]JIAO FY,ZHANG X,ZHANG X,et al.Clinical observationon treatment of Tourette syndrome in Chinese children by clonidine adhesive patch[J].Eur J Paediatr Neurol,2016,20(1):80-84.
[18]王健彪,徐晓华,华颖.可乐定透皮贴治疗58例儿童Tourette综合征的临床研究[J].中国儿童保健杂志,2016,24(9):1002-1005.
[19]郭敬民,施晓茜,杨式薇,等.可乐定透皮贴片治疗儿童中重度抽动障碍的临床研究[J].中国当代儿科杂志,2017,19(7):786-789.
[20]LECKMAN JF,DETLOR J,HARCHERIK DF,et al.Short-and long-term treatment of Tourette’s syndrome with clonidine:a clinical perspective[J].Neurology,1985,35(3):343-351.
[21]LECKMAN JF,HARDIN MT,RIDDLE MA,et al.Clonidine treatment of Gilles de la Tourette’s syndrome[J].Arch Gen Psychiatry,1991,48(4):324-328.
[22]Tourette Syndrome Study Group.Treatment of ADHD in children with tics:a randomized controlled trial[J].Neurology,2002,58(4):527-536.
[2]刘智胜.Toumtte综合征共患病的诊治进展[J].中国儿童保健杂志,2010,18(2):94-95,99.
[3]中华医学会儿科学分会神经学组.儿童抽动障碍诊断与治疗专家共识(2017实用版)[J].中华实用儿科临床杂志,2017,32(15):1137-1140.
[4]PRINGSHEIM T,DOJA A,GORMAN D,et al.Canadian guidelines for the evidence-based treatment of tic disorders:pharmacotherapy[J].Can J Psychiatry,2012,57(3):133-143.
[5]ROESSNER V,PLESSEN KJ,ROTHENBERGER A,et al.European clinical guidelines for Tourette syndrome and other tic disorders.PartⅡ:pharmacological treatment[J].Eur Child Adolesc Psychiatry,2011,20(4):173-196.
[6]EHRLICH J,BECK B,THIEDMANN R,et al.Bioequivalence and adhesion evaluation of transdermal clonidine following a change in excipient supplier[J].Int J Clin Pharmacol Ther,2016,54(10):816-824.
[7]American Psychiatric Association.Diagnostic and statistical manual of mental disorders[M].4th edition.Washington:American Psychiatric Association,1994:100-105.
[8]American Psychiatric Association.Diagnostic and statistical manual of mental disorders DSM-IV-TR[M].Washington:American Psychiatric Association,2000:1-943.
[9]中华医学会精神科分会.中国精神障碍分类与诊断标准[M].3版.济南:山东科学技术出版社,2001:35.
[10]LECKMAN JF,RIDDLE MA,HARDIN MT.The Yale global tic severity scale:initial testing of a clinician-rating scale of tic severity[J].J Am Acad Child Adolesc Psychiatry,1989,28(4):566-573.
[11]HIGGINS JPT,GREEN S.Cochrane handbook for systematic reviews of interventions version 5.1.0[EB/OL].[2018-08-17].http://handbook.cochrane.org.
[12]张红宇,林悦,刘美娜,等.可乐定控释贴治疗儿童抽动障碍的临床研究[J].儿科药学杂志,2006,12(6):8-9,16.
[13]钟佑泉,周文智,胡文广,等.可乐定透皮贴治疗儿童抽动障碍的随机双盲对照研究[J].中华儿科杂志,2007,45(10):785-787.
[14]DU YS,LI HF,VANCE A,et.al.Randomized doubleblind multicentre placebo-controlled clinical trial of the clonidine adhesive patch for the treatment of tic disorders[J].Aust N Z J Psychiatry,2008,42(9):807-813.
[15]康华,张月芳,焦富勇,等.可乐定透皮贴治疗儿童抽动-秽语综合征的疗效观察[J].中国当代儿科杂志,2009,11(7):537-539.
[16]吕娟.可乐定透皮贴片和盐酸硫必利治疗抽动障碍的对比研究[D].长春:吉林大学,2015.
[17]JIAO FY,ZHANG X,ZHANG X,et al.Clinical observationon treatment of Tourette syndrome in Chinese children by clonidine adhesive patch[J].Eur J Paediatr Neurol,2016,20(1):80-84.
[18]王健彪,徐晓华,华颖.可乐定透皮贴治疗58例儿童Tourette综合征的临床研究[J].中国儿童保健杂志,2016,24(9):1002-1005.
[19]郭敬民,施晓茜,杨式薇,等.可乐定透皮贴片治疗儿童中重度抽动障碍的临床研究[J].中国当代儿科杂志,2017,19(7):786-789.
[20]LECKMAN JF,DETLOR J,HARCHERIK DF,et al.Short-and long-term treatment of Tourette’s syndrome with clonidine:a clinical perspective[J].Neurology,1985,35(3):343-351.
[21]LECKMAN JF,HARDIN MT,RIDDLE MA,et al.Clonidine treatment of Gilles de la Tourette’s syndrome[J].Arch Gen Psychiatry,1991,48(4):324-328.
[22]Tourette Syndrome Study Group.Treatment of ADHD in children with tics:a randomized controlled trial[J].Neurology,2002,58(4):527-536.