注射用甲磺酸齐拉西酮治疗双相障碍Ⅰ型急性躁狂发作的疗效和安全性
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- 英文论文题名：The efficacy and safety of Intramuscular Ziprasidone Mesylate for treatment of acute manic episodes of bipolar disorder type Ⅰ
- 论文作者：顾成宇 ; 钱丽菊 ; 沈芳 ; 王鹤秋 ; 邢葆平 ; REN Zhibin
- 英文论文作者：GU Chengyu ; QIAN Liju ; REN Zhibin ; WANG Heqiu ; XING Baoping ; Tongde Hospital of Zhejiang Province
- 年：2014
- 作者机构：浙江省立同德医院浙江省精神卫生中心,浙江中医药大学附属省立同德医院;济宁市精神病防治院;
- 论文关键词：注射用甲磺酸齐拉西酮 ; 氟哌啶醇注射液 ; 躁狂发作 ; 冲动 ; 激越
- 英文论文关键词：Intramuscular Ziprasidone Mesylate ; Haloperidol Injection ; manic episode ; irritation ; agitation ; impulsiveness
- 会议召开时间：2014-11-20
- 会议录名称：2014浙江省医学会精神病学分会学术年会、浙江省医师协会精神科医师分会第七届年会论文汇编
- 语种：中文
- 分类号：R749.4
- 学会代码：ZJKX
- 会议名称：2014浙江省医学会精神病学分会学术年会、浙江省医师协会精神科医师分会第七届年会
- 会议地点：中国浙江湖州
- 主办单位：浙江省医学会精神病学分会（The Society of Psychiatry ; ZJMA）、浙江省医师协会精神科医师分会
- 学会名称：浙江省科学技术协会
- 页数：5
- 文件大小：379k
- 原文格式：O
- 会议级别：地方
摘要
目的:探讨注射用甲磺酸齐拉西酮治疗双相障碍Ⅰ型躁狂发作的疗效和安全性。方法:本研究为随机双盲对照研究。选取41例符合DSM-ⅣV双相障碍Ⅰ型躁狂发作诊断标准的患者,按照1:1随机分为注射用甲磺酸齐拉西酮研究组(简称研究组,n=21),和氟哌啶醇注射液对照组(简称对照组,n=20),分别接受72小时注射用甲磺酸齐拉西酮或氟哌啶醇注射液治疗。在入组时和2小时、6小时、24小时、48小时和72小时,评估患者CGI-BP-S和YMRS量表。在入组时和治疗第2、6、24、48、72小时采用治疗需处理的不良反应量表(TESS)、锥体外系副反应量表(SAS)评定药物的副反应。在治疗前和治疗第72小时进行实验室和心电图检查。结果:研究组双相障碍大体症状量表评分(CGIBP-S)在第72小时总分均低于对照组[(2.10±0.44)VS(2.60±0.88),P<0.05)];研究组在治疗第2小时、第6小时、第24小时、第48小时、第72小时,CGI-BP-S总分低于基线[(3.95±0.80)VS(5.38±0.80),P<0.01)、[(3.29±0.90)VS(5.38±0.80),P<0.01)]、[(2.67±0.73)VS(5.38±0.80),P<0.01)]、[(2.14±0.57)VS(5.38±0.80),]P<0.01)][(2.10±0.44)VS(5.38±0.80),P<0.01)]。对照组研究组在治疗第2小时、第6小时、第24小时、第48小时、第72小时,CGI-BPS总分低于基线[(3.95±0.80)VS(5.45±0.89),P<0.01)、[(4.05±3.00)VS(5.45±0.89),P<0.01)]、[(3.30±1.13)VS(5.45±0.89),P<0.01)]、[(3.15±0.88)VS(2.35±0.67),P<0.01)][(2.60±0.88)VS(5.45±0.89),P<0.01)]。在治疗72小时后,对照组量表评分在活动减少、肌强直、震颤、静坐不能方面均较研究组高(P<0.01)。结论:注射用甲磺酸齐拉西酮适用于治疗急性躁狂发作患者的急性兴奋、冲动、激越症状,且和传统的氟哌啶醇注射液相比具有疗效更好、副反应更少等特点,值得临床应用。
Objective:Few controlled trials of Intramuscular Ziprasidone Mesylate intervention in patients with acute manic episodes of bipolar disorder type I have been reported,and there is uncertainty about the usefulness of putative treatments and the assessment methodologies.The author evaluated the efficacy and safety of T Intramuscular Ziprasidone Mesylate intervention in patients with acute manic episodes.Methods:Prospective,parallel-group,randomized,double-blind,placebo-controlled study conducted between October,2013,and September2014,at the Tongde Hospital of Zhejiang Province and the JINING mental health center.Inpatients who met the critea of DSM-IV for acute manic episodes.After assessment they were randomly assigned to a 72-hours treatment trial with Intramuscular Ziprasidone Mesylate(N=21),Haloperidol Injection-controlled group(N=20).Outcomes were assessed by using CGI-BP-S、 YMRS and HAMD-17 for efficacy and TESS and SAS for side effects at the basehhe,in the 2~(nd) hour,the 6~(th) hour,the 24~(th) hour,the 48~(th) hour and the 72~(th) hour.Results:While the Intramuscular Ziprasidone Mesylate treated inpatients did reveal significantly greater improvements in irritation,agitation,impulsiveness those in the Haloperidol Injection-controlled group in the 2nd hour,the 6th hour,the 24 th hour,the 48 th hour and the 72 th hour.And the Intramuscular Ziprasidone Mesylate treated inpatients did appear significantly greater improvements in irritation,agitation,impulsiveness than those at the baseline in the 2nd hour,the 6th hour,the 24 th hour,the 48 th hour and the 72 th hour.The inpatients of the Haloperidol Injection controlled group did report significantly greater improvements in the 2nd hour,the 6 hour,the 24 hour,the 48 hour and the 72 hour.There were statistically significant differences among the two groups in side effects.Condusions:Intramuscular Ziprasidone Mesylate was effective in ameliorating acute manic episodes of bipolar disorder type I.And its side effects were mild and quickly disappeared.
Objective:Few controlled trials of Intramuscular Ziprasidone Mesylate intervention in patients with acute manic episodes of bipolar disorder type I have been reported,and there is uncertainty about the usefulness of putative treatments and the assessment methodologies.The author evaluated the efficacy and safety of T Intramuscular Ziprasidone Mesylate intervention in patients with acute manic episodes.Methods:Prospective,parallel-group,randomized,double-blind,placebo-controlled study conducted between October,2013,and September2014,at the Tongde Hospital of Zhejiang Province and the JINING mental health center.Inpatients who met the critea of DSM-IV for acute manic episodes.After assessment they were randomly assigned to a 72-hours treatment trial with Intramuscular Ziprasidone Mesylate(N=21),Haloperidol Injection-controlled group(N=20).Outcomes were assessed by using CGI-BP-S、 YMRS and HAMD-17 for efficacy and TESS and SAS for side effects at the basehhe,in the 2~(nd) hour,the 6~(th) hour,the 24~(th) hour,the 48~(th) hour and the 72~(th) hour.Results:While the Intramuscular Ziprasidone Mesylate treated inpatients did reveal significantly greater improvements in irritation,agitation,impulsiveness those in the Haloperidol Injection-controlled group in the 2nd hour,the 6th hour,the 24 th hour,the 48 th hour and the 72 th hour.And the Intramuscular Ziprasidone Mesylate treated inpatients did appear significantly greater improvements in irritation,agitation,impulsiveness than those at the baseline in the 2nd hour,the 6th hour,the 24 th hour,the 48 th hour and the 72 th hour.The inpatients of the Haloperidol Injection controlled group did report significantly greater improvements in the 2nd hour,the 6 hour,the 24 hour,the 48 hour and the 72 hour.There were statistically significant differences among the two groups in side effects.Condusions:Intramuscular Ziprasidone Mesylate was effective in ameliorating acute manic episodes of bipolar disorder type I.And its side effects were mild and quickly disappeared.
引文
[1]Robet E.Hales,MD.,MBA.Stuart C.Yudofsky.MD.Glen O.Gabbard.MD.the American Psychiatric Publishing Textbook of Psychiatry.chapter 11.
[2]Keck P E Jr,Versiani M,Potkin S,et al.Ziprasidone in the treatment of acute bipolar mania:a three-week,placebocontrolled,double-blind,randomized trial[J].Am—J-Psychiatry,2003,160(4):741—748.
[3]Sernyak MJ,Griffin RA,Johnson RM,et al.Neuroleptic exposure following inpatient treatment of acute manic with lithium and neuroleptie[J].AnO Psychiatry,1994,151:133—136.
[4]Neborsky R,Janowsky D,Munson E,et al.Rapid treatment of acute psychotic symptoms with high—and low—dose haloperid01.Behavioral considerations[J].Arch Gen Psychiatry,1981,38(2):195—199.
[5]Stahl精神药理学精要:神经科学基础与临床应用(第3版)[M].人民卫生出版社.第4章.
[6]Hongyan Zhang,MD,Gang Wang,MDJingping Zhao,etal.Intramuscular Ziprasidone Versus Haloperidol for Managing Agitation in Chinese Patients With Schizophrenia.Clin Psychopharmacol 2013;33:178-185.
[7]Shamima S.Khan,M.D.,1 and Lisa M.Mican,Pharm.D.ANaturalistic Evaluation of Intramuscular Ziprasidone Versus Intramuscular Olanzapine for the Management of Acute Agitation and Aggression in Children and Adolescents[J]JOURNAL OF CHILD AND ADOLESCENT PSYCHOPHARMACOLOGY,2006,16(6)671-677.
[8]Shlomo Brook,Jeorg Walden,Isma Benattia,etal.Ziprasidone and haloperidol in the treatment of acuteexace rbation of schizophrenia and schizoaffective disorder:comparison of intramuscular and oral formulations in a 6-week,randomized,blinded-assessment study[J].Psychopharmacology,2005(178):514-523.
[9]Miceli JJ,Tensfeldt TG,Shiovitz T,et al.Effects of high-dose ziprasidone and haloperidol on the QTc interval after intramuscular administration:a randomized,single-blind,parallel-group study in patients with schizophrenia or schizoaffective disorder.Clin Ther.2010;32:472-491.
[10]李乐华,赵靖平,许秀峰,等.国产齐拉西酮与氟哌啶醇注射液治疗精神分裂症急性激越症状的对照研究[J]。中华精神科杂志,2006.11,39(4):216-219.
[2]Keck P E Jr,Versiani M,Potkin S,et al.Ziprasidone in the treatment of acute bipolar mania:a three-week,placebocontrolled,double-blind,randomized trial[J].Am—J-Psychiatry,2003,160(4):741—748.
[3]Sernyak MJ,Griffin RA,Johnson RM,et al.Neuroleptic exposure following inpatient treatment of acute manic with lithium and neuroleptie[J].AnO Psychiatry,1994,151:133—136.
[4]Neborsky R,Janowsky D,Munson E,et al.Rapid treatment of acute psychotic symptoms with high—and low—dose haloperid01.Behavioral considerations[J].Arch Gen Psychiatry,1981,38(2):195—199.
[5]Stahl精神药理学精要:神经科学基础与临床应用(第3版)[M].人民卫生出版社.第4章.
[6]Hongyan Zhang,MD,Gang Wang,MDJingping Zhao,etal.Intramuscular Ziprasidone Versus Haloperidol for Managing Agitation in Chinese Patients With Schizophrenia.Clin Psychopharmacol 2013;33:178-185.
[7]Shamima S.Khan,M.D.,1 and Lisa M.Mican,Pharm.D.ANaturalistic Evaluation of Intramuscular Ziprasidone Versus Intramuscular Olanzapine for the Management of Acute Agitation and Aggression in Children and Adolescents[J]JOURNAL OF CHILD AND ADOLESCENT PSYCHOPHARMACOLOGY,2006,16(6)671-677.
[8]Shlomo Brook,Jeorg Walden,Isma Benattia,etal.Ziprasidone and haloperidol in the treatment of acuteexace rbation of schizophrenia and schizoaffective disorder:comparison of intramuscular and oral formulations in a 6-week,randomized,blinded-assessment study[J].Psychopharmacology,2005(178):514-523.
[9]Miceli JJ,Tensfeldt TG,Shiovitz T,et al.Effects of high-dose ziprasidone and haloperidol on the QTc interval after intramuscular administration:a randomized,single-blind,parallel-group study in patients with schizophrenia or schizoaffective disorder.Clin Ther.2010;32:472-491.
[10]李乐华,赵靖平,许秀峰,等.国产齐拉西酮与氟哌啶醇注射液治疗精神分裂症急性激越症状的对照研究[J]。中华精神科杂志,2006.11,39(4):216-219.