Psychomotor Agitation

精神运动性激动
  • 文章类型: Journal Article
    目的:本研究是一项单盲随机对照试验(RCT),旨在研究电惊厥治疗(ECT)对晚期痴呆患者重度治疗难治性躁动的疗效和安全性。目的是使用科恩-曼斯菲尔德躁动清单(CMAI)评估躁动的减少,评估耐受性和安全性结果,并探索减少躁动的长期稳定性和整体功能。由于在实施过程中遇到的挑战,包括招募障碍和业务困难,将研究设计修改为开放标签格式,并实施其他方案修订.
    方法:最初,RCT将参与者1:1随机分为ECT+常规治疗组或模拟ECT+常规治疗组(S-ECT).当患者入组时,数据来自ECT和模拟ECT(S-ECT)患者.该研究现在在开放标签研究设计中继续进行,所有患者都接受了实际的ECT,将目标样本量从200名减少到50名参与者。
    结果:研究正在进行中,并向注册开放。
    结论:ECT-AD研究设计从RCT到开放标签设计的转变体现了应对现实世界挑战的适应性研究方法。来自研究的RCT和开放标签阶段的数据将为ECT在管理痴呆症的严重治疗难治性躁动中的作用提供独特的视角。可能影响未来的临床实践和研究方法。
    OBJECTIVE: This study began as a single-blind randomized controlled trial (RCT) to investigate the efficacy and safety of electroconvulsive therapy (ECT) for severe treatment-refractory agitation in advanced dementia. The aims are to assess agitation reduction using the Cohen-Mansfield Agitation Inventory (CMAI), evaluate tolerability and safety outcomes, and explore the long-term stability of agitation reduction and global functioning. Due to challenges encountered during implementation, including recruitment obstacles and operational difficulties, the study design was modified to an open-label format and other protocol amendments were implemented.
    METHODS: Initially, the RCT randomized participants 1:1 to either ECT plus usual care or simulated ECT plus usual care (S-ECT) groups. As patients were enrolled, data were collected from both ECT and simulated ECT (S-ECT) patients. The study now continues in an open-label study design where all patients receive actual ECT, reducing the targeted sample size from 200 to 50 participants.
    RESULTS: Study is ongoing and open to enrollment.
    CONCLUSIONS: The transition of the ECT-AD study design from an RCT to open-label design exemplifies adaptive research methodologies in response to real-world challenges. Data from both the RCT and open-label phases of the study will provide a unique perspective on the role of ECT in managing severe treatment-refractory agitation in dementia, potentially influencing future clinical practices and research approaches.
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  • 文章类型: Systematic Review
    目标:40-60%的痴呆患者(PLWD)出现激动和/或攻击症状。需要了解检测PLWD中的激动和/或侵略的最佳方法。我们旨在确定在PLWD背景下根据参考标准进行验证的激动和/或侵略工具。
    方法:我们的研究在PROSPERO注册(CRD42020156708)。我们搜索了MEDLINE,Embase,和PsycINFO截至2024年4月22日。没有语言或日期限制。如果他们使用任何工具或问卷来检测与PLWD参考标准相比的激动或侵略,或任何在人群中比较两种或多种激动和/或侵略工具的研究。所有筛选和数据提取一式两份进行。使用诊断准确性研究质量评估2(QUADAS-2)工具评估研究质量。数据提取由两个独立的作者重复完成。我们提取了人口统计信息,躁动和/或侵略的普遍性,和诊断准确性措施。我们还报道了比较两种或多种激动和/或侵略工具之间相关性的研究。
    结果:6961篇文章在数据库中进行了筛选。包括六篇报告与参考标准相比的诊断准确性测量的文章和30篇报告工具之间相关性测量的文章。西班牙NPI的激动域对西班牙CAMDEX的激动小节表现出最高的敏感性(100%)。发现了常用躁动量表诊断准确性的单一研究证据(BEHAVE-AD,NPI和CMAI)。
    结论:西班牙NPI的激动领域,NBRS,PAS表现出很高的敏感性,并可能是合理的临床实施。然而,这一发现的局限性在于,尽管进行了广泛的搜索,很少有具有诊断准确性测量的研究被确定。最终,需要更多的研究来了解PLWD中躁动和/或攻击检测工具的诊断准确性.
    OBJECTIVE: 40-60% of persons living with dementia (PLWD) experience agitation and/or aggression symptoms. There is a need to understand the best method to detect agitation and/or aggression in PLWD. We aimed to identify agitation and/or aggression tools that are validated against a reference standard within the context of PLWD.
    METHODS: Our study was registered on PROSPERO (CRD42020156708). We searched MEDLINE, Embase, and PsycINFO up to April 22, 2024. There were no language or date restrictions. Studies were included if they used any tools or questionnaires for detecting either agitation or aggression compared to a reference standard among PLWD, or any studies that compared two or more agitation and/or aggression tools in the population. All screening and data extraction were done in duplicates. Study quality was assessed using the Quality Assessment of Diagnostic Accuracy Studies 2 (QUADAS-2) tool. Data extraction was completed in duplicates by two independent authors. We extracted demographic information, prevalence of agitation and/or aggression, and diagnostic accuracy measures. We also reported studies comparing the correlation between two or more agitation and/or aggression tools.
    RESULTS: 6961 articles were screened across databases. Six articles reporting diagnostic accuracy measures compared to a reference standard and 30 articles reporting correlation measurements between tools were included. The agitation domain of the Spanish NPI demonstrated the highest sensitivity (100%) against the agitation subsection of the Spanish CAMDEX. Single-study evidence was found for the diagnostic accuracy of commonly used agitation scales (BEHAVE-AD, NPI and CMAI).
    CONCLUSIONS: The agitation domain of the Spanish NPI, the NBRS, and the PAS demonstrated high sensitivities, and may be reasonable for clinical implementation. However, a limitation to this finding is that despite an extensive search, few studies with diagnostic accuracy measurements were identified. Ultimately, more research is needed to understand the diagnostic accuracy of agitation and/or aggression detection tools among PLWD.
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  • 文章类型: Journal Article
    这篇简短的叙述性综述的目的是评估现有的关于氯胺酮在痴呆症患者中临床使用的文献。尤其是那些有行为障碍的人。PubMed,科克伦,和奥维德(Embase,APAPsycINFO,和MEDLINE)数据库使用搜索词“氯胺酮”和“痴呆症”搜索摘要。“仅包括描述在痴呆症患者中使用氯胺酮的文章。不包括痴呆症患者的文章,没有使用氯胺酮,以一种非英语语言出版,主要描述了动物研究,或者评论被排除在外。3例病例报告符合纳入标准。一个描述了使用皮下氯胺酮治疗抑郁症,一个人描述了肌内氯胺酮用于急性躁动,和一个描述了使用S-氯胺酮作为麻醉在电惊厥治疗抑郁症和紧张症。在任何情况下均未报告明显的不良反应。尽管使用氯胺酮治疗与痴呆相关的抑郁和躁动具有潜力,目前的证据仍然有限。在氯胺酮可用于治疗痴呆症患者的行为障碍之前,需要高质量的前瞻性研究来确认这些病例报告的观察结果。
    The aim of this short narrative review was to evaluate the existing literature regarding the clinical use of ketamine among individuals with dementia, especially those with behavioral disturbances. PubMed, Cochrane, and Ovid (Embase, APA PsycINFO, and MEDLINE) databases were searched for abstracts using the search terms \"ketamine\" AND \"dementia.\" Only articles describing the use of ketamine in individuals with dementia were included. Articles that did not include individuals with dementia, did not use ketamine, were published in a non-English language, primarily described animal studies, or were reviews were excluded. Three case reports met the inclusion criteria. One described the use of subcutaneous ketamine for depression, one described the use of intramuscular ketamine for acute agitation, and one described the use of S-ketamine as anesthesia during electroconvulsive therapy for depression and catatonia. No significant adverse effects were reported in any of the cases. Although the use of ketamine in the treatment of depression and agitation associated with dementia has potential, the current evidence remains limited. High-quality prospective studies are needed to confirm the observations of these case reports before ketamine can be used to treat behavioral disturbances in individuals with dementia.
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  • 文章类型: Journal Article
    这项队列研究检查了急诊科等待住院病床的患者发生谵妄和/或躁动的风险因素。
    This cohort study examines the risk factors for developing delirium and/or agitation in patients in the emergency department waiting for an inpatient bed.
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  • 文章类型: Journal Article
    背景:躁动/谵妄常见于麻醉后的儿童,适当剂量的右美托咪定可以预防这种并发症。本研究旨在探讨不同剂量右美托咪定(DEX)对麻醉患儿躁动/谵妄等并发症的影响。为DEX的剂量建议提供临床证据。
    方法:本研究基于系统评价和荟萃分析(PRISMA)的首选报告项目进行。在Cochrane图书馆进行了系统的搜索,PubMed,WebofScience,和EMBASE。两名独立研究人员进行了文献筛选,数据提取,并评估了方法学质量。使用R和STATA16.0进行数据分析。
    结果:在最终分析中,纳入20项随机对照试验(RCT),涉及2521名儿童。结果表明,与生理盐水相比,1µg/kg,1.5微克/千克,和2µg/kg鼻内DEX显着降低了最有效剂量为2µg/kg(SUCRA=0.91)的儿童麻醉后苏醒期躁动的发生率。与生理盐水相比,1µg/kg,1.5微克/千克,和2µg/kg鼻内DEX减少了患者对术后镇痛的需要,最有效剂量为1.5µg/kg(SUCRA=0.78)。然而,1µg/kgDEX在降低小儿麻醉出现谵妄(PAED)量表评分方面表现最好(SUCRA=0.88)。
    结论:与生理盐水相比,鼻内给药2µg/kgDEX和1.5µg/kgDEX是降低全身麻醉儿童躁动发生率和术后疼痛缓解需要的最佳剂量。鉴于有效性和安全性,鼻内使用1µg/kgDEX似乎是麻醉儿童最有效的剂量。
    BACKGROUND: Agitation/delirium is commonly seen in children after anesthesia, and a proper dose of dexmedetomidine can prevent this complication. This study aimed to investigate the effects of different doses of Dexmedetomidine (DEX) on agitation/delirium and other complications in anesthetized children, providing clinical evidence for dose recommendations of DEX.
    METHODS: This study was conducted based on the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA). A systematic search was conducted in the Cochrane Library, PubMed, Web of Science, and EMBASE. Two independent researchers performed literature screening, data extraction, and assessed the methodological quality. Data analysis was conducted using R and STATA 16.0.
    RESULTS: In the final analysis, 20 randomized controlled trials (RCTs) involving 2521 children were included. The results showed that in comparison to normal saline, 1 µg/kg, 1.5 µg/kg, and 2 µg/kg intranasal DEX significantly reduced the incidence of post-anesthetic emergence agitation in children with the most effective dose being 2 µg/kg (SUCRA = 0.91). Compared with normal saline, 1 µg/kg, 1.5 µg/kg, and 2 µg/kg intranasal DEX reduced patient\'s need for postoperative analgesia, with the most effective dose being 1.5 µg/kg (SUCRA = 0.78). However, 1 µg/kg DEX performed the best in reducing Pediatric Anaesthesia Emergence Delirium (PAED) Scale score (SUCRA = 0.88).
    CONCLUSIONS: Compared with normal saline, intranasal administration of 2 µg/kg DEX and 1.5 µg/kg DEX are the optimal doses to reduce the incidence of agitation and the need for postoperative pain relief in children under general anesthesia. Given effectiveness and safety, intranasal use of 1 µg/kg DEX appears to be the most effective dosage for anesthetized children.
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  • 文章类型: Journal Article
    背景:我们旨在评估右美托咪定(Dex)联合瑞芬太尼对小儿肝脏手术七氟醚麻醉苏醒期苏醒期躁动(EA)的影响。材料与方法前瞻性选取我院肝脏手术患儿60例,随机分为A组(安慰剂+瑞芬太尼+七氟醚)和B组(Dex+瑞芬太尼+七氟醚)。不同时间点的平均动脉压(MAP)和心率(HR),觉醒期间的激动评分,行为状态,疼痛程度,比较两组患者术后不良反应的发生率。结果B组患儿气管拔管后即刻和气管拔管后5min的HR和MAP水平均低于A组。PAED躁动评分,B组PACU入院15min和30min时的CHIPP评分低于A组,B组术后麻醉苏醒时躁动发生率低于A组。使用Dex+瑞芬太尼+七氟醚麻醉可以降低苏醒期EA的发生率,稳定血液动力学水平,减轻术后疼痛,术后不良反应较少,值得临床应用。
    BACKGROUND We aimed to assess the effect of dexmedetomidine (Dex) combined with remifentanil on emergence agitation (EA) during awakening from sevoflurane anesthesia for pediatric liver surgery. MATERIAL AND METHODS Sixty children who underwent liver surgery in our hospital were prospectively selected and randomly allocated into group A (placebo+remifentanil+sevoflurane) or group B (Dex+remifentanil+sevoflurane). Mean arterial pressure (MAP) and heart rate (HR) at different time points, agitation score during awakening, behavioral status, pain level, and the incidence of postoperative adverse effects were compared in both groups. RESULTS Children in group B had lower HR and MAP levels immediately after tracheal extubation and 5 min after tracheal extubation than those in group A. The Aono\'s scores, PAED agitation scores, and CHIPP scores at 15 min and 30 min of admission to the PACU were lower in group B than in group A. The incidence of agitation during postoperative anesthesia awakening was lower in group B in contrast to group A. There was no significant difference in postoperative adverse reactions between group A and group B. CONCLUSIONS In pediatric liver surgery, the use of Dex+remifentanil+sevoflurane anesthesia can reduce the incidence of EA during the awakening period, stabilize hemodynamic levels, and relieve postoperative pain, and has fewer postoperative adverse effects, which warrants clinical application.
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  • 文章类型: Journal Article
    OBJECTIVE: We evaluated impact on length of stay and possible complications of replacing the Clinical Institute Withdrawal Assessment-Alcohol Revised (CIWA-Ar) scale with a slightly modified Richmond Agitation and Sedation Scale (mRASS-AW) to support managing patients admitted with alcohol withdrawal symptoms in a community hospital. Since mRASS-AW is viewed as easier and quicker to use than CIWA-Ar, provided use of mRASS-AW does not worsen outcomes, it could be a safe alternative in a busy ED environment and offer an opportunity to release nursing time to care.
    METHODS: Retrospective time-series analysis of mean quarterly length of stay. All analyses exclusively used our hospital\'s administrative discharge diagnoses database. During April 1st 2012 to December 14th 2014, the CIWA-Ar was used in the ED and in-patient units to guide benzodiazepine dosing decisions for alcohol withdrawal symptoms. After this point, CIWA-Ar was replaced with mRASS-AW. Data was evaluated until December 31st 2020.
    METHODS: mean quarterly length of stay.
    RESULTS: delirium, intensive care unit (ICU) admission, other post-admission complications, mortality.
    RESULTS: N = 1073 patients. No association between length of stay and scale switch (slope change 0.3 (95% CI - 0.03 to 0.6), intercept change, 0.06 (- 0.03 to 0.2). CIWA-Ar (n = 317) mean quarterly length of stay, 5.7 days (95% 4.2-7.1), mRASS-AW (n = 756) 5.0 days (95% CI 4.3-5.6). Incidence of delirium, ICU admission or mortality was not different. However, incidence of other post-admission complications was higher with CIWA-Ar (6.6%) than mRASS-AW (3.4%) (p = 0.020).
    CONCLUSIONS: This was the first study to compare patient outcomes associated with using mRASS-AW for alcohol withdrawal symptoms outside the ICU. Replacing CIWA-Ar with mRASS-AW did not worsen length of stay or complications. These findings provide some evidence that mRASS-AW could be considered an alternative to CIWA-Ar and potentially may provide an opportunity to release nursing time to care.
    UNASSIGNED: BUT: Nous avons évalué l’impact sur la durée du séjour et les complications possibles du remplacement de l’échelle Clinical Institute Withdrawal Assessment- Alcohol Revised (CIWA-Ar) par une échelle d’agitation et de sédation de Richmond légèrement modifiée (mRASS-AW) soutenir la prise en charge des patients admis avec des symptômes de sevrage d’alcool dans un hôpital communautaire. Étant donné que le mRASS-AW est considéré comme plus facile et plus rapide à utiliser que le CIWA-Ar, à condition que l’utilisation du mRASS-AW n’aggrave pas les résultats, il pourrait s’agir d’une solution de rechange sécuritaire dans un environnement de SU occupé et offrir une occasion de libérer du temps pour les soins infirmiers. MéTHODES: Analyse rétrospective de séries chronologiques de la durée moyenne trimestrielle du séjour. Toutes les analyses utilisaient exclusivement la base de données des diagnostics de sortie administrative de notre hôpital. Entre le 1er avril 2012 et le 14 décembre 2014, le CIWA-Ar a été utilisé dans les unités de soins intensifs et de soins aux patients hospitalisés pour guider les décisions de dosage des benzodiazépines pour les symptômes de sevrage de l’alcool. Après ce point, CIWA-Ar a été remplacé par mRASS-AW. Les données ont été évaluées jusqu’au 31 décembre 2020. Résultat principal : durée moyenne trimestrielle du séjour. Résultats secondaires : délire, admission en unité de soins intensifs (USI), autres complications post-admission, mortalité. RéSULTATS: N = 1073 patients. Aucune association entre la durée de séjour et le changement d’échelle (changement de pente 0,3 (IC à 95 % -0,03 à 0,6), changement d’interception, 0,06 (-0,03 à 0,2). CIWA-Ar (n = 317) durée moyenne trimestrielle du séjour, 5,7 jours (95 % 4,2 à 7,1), mRASS-AW (n = 756) 5,0 jours (95 % IC 4,3 à 5,6). L’incidence du délire, de l’admission aux soins intensifs ou de la mortalité n’était pas différente. Cependant, l’incidence d’autres complications post-admission était plus élevée avec CIWA-Ar (6,6%) que mRASS-AW (3,4%) (p = 0,020).
    CONCLUSIONS: Il s’agissait de la première étude à comparer les résultats des patients associés à l’utilisation du mRASS-AW pour les symptômes de sevrage alcoolique en dehors des soins intensifs. Le remplacement de CIWA-Ar par mRASS-AW n’a pas aggravé la durée du séjour ou les complications. Ces résultats fournissent certaines preuves que le mRASS-AW pourrait être considéré comme une alternative au CIWA-Ar et pourrait potentiellement fournir une occasion de libérer du temps de soins infirmiers.
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  • 文章类型: Journal Article
    目的:患者监护系统提供关键信息,但通常会产生响亮的声音,频繁的警报,加剧患者的激动和压力。这可能会增加物理和化学约束的使用,从而影响患者的发病率和自主性。这项研究分析了增加警报阈值如何影响无警报时间的比例以及治疗急性躁动的药物使用频率。
    方法:我们急诊科的患者监测系统于2022年6月28日进行了修改,将心动过速警报阈值从130提高到150,并消除了几种心律失常的警报声音,包括二连性和室性早搏。在该干预之前和之后55天进行了持续55天的pre-post研究。主要结果是每日患者警报数量的变化。次要结果是每天无警报时间和每天服用抗精神病药和苯二氮卓类药物的中位数量。安全性结果是每天转移到复苏区的患者的中位数。我们使用分位数回归比较干预前后的结果,并使用线性回归将无警报时间与服用镇静药物的数量相关联。
    结果:在干预前后,平均每天的警报数量从1332减少到845(-37%)。这主要是由于低优先级心律失常警报从262减少到21(-92%),而每日人口普查中位数没有变化(33比32)。每天无警报的中位小时数从1.0增加到2.4(差异1.4,95%CI0.8-2.1)。每天服用镇静药物的中位数数量从14减少到10(差异-4,95%CI-1至-7),而我们的复苏护理领域的护理水平升级数量没有显着变化。多变量线性回归显示,每天60分钟的无警报时间增加与减少0.8(95%CI0.1-1.4)的镇静药物使用相关,而行为健康普查中的其他患者与0.5(95%CI0.0-1.1)的镇静药物使用相关。
    结论:警报参数设置的合理变化可能会增加患者和医护人员在急诊科度过的时间,而没有警报噪音,在这项研究中,这与服用较少剂量的镇静药物有关。
    OBJECTIVE: Patient monitoring systems provide critical information but often produce loud, frequent alarms that worsen patient agitation and stress. This may increase the use of physical and chemical restraints with implications for patient morbidity and autonomy. This study analyzes how augmenting alarm thresholds affects the proportion of alarm-free time and the frequency of medications administered to treat acute agitation.
    METHODS: Our emergency department\'s patient monitoring system was modified on June 28, 2022 to increase the tachycardia alarm threshold from 130 to 150 and to remove alarm sounds for several arrhythmias, including bigeminy and premature ventricular beats. A pre-post study was performed lasting 55 days before and 55 days after this intervention. The primary outcome was change in number of daily patient alarms. The secondary outcomes were alarm-free time per day and median number of antipsychotic and benzodiazepine medications administered per day. The safety outcome was the median number of patients transferred daily to the resuscitation area. We used quantile regression to compare outcomes between the pre- and post-intervention period and linear regression to correlate alarm-free time with the number of sedating medications administered.
    RESULTS: Between the pre- and post-intervention period, the median number of alarms per day decreased from 1332 to 845 (-37%). This was primarily driven by reduced low-priority arrhythmia alarms from 262 to 21 (-92%), while the median daily census was unchanged (33 vs 32). Median hours per day free from alarms increased from 1.0 to 2.4 (difference 1.4, 95% CI 0.8-2.1). The median number of sedating medications administered per day decreased from 14 to 10 (difference - 4, 95% CI -1 to -7) while the number of escalations in level of care to our resuscitation care area did not change significantly. Multivariable linear regression showed a 60-min increase of alarm-free time per day was associated with 0.8 (95% CI 0.1-1.4) fewer administrations of sedating medication while an additional patient on the behavioral health census was associated with 0.5 (95% CI 0.0-1.1) more administrations of sedating medication.
    CONCLUSIONS: A reasonable change in alarm parameter settings may increase the time patients and healthcare workers spend in the emergency department without alarm noise, which in this study was associated with fewer doses of sedating medications administered.
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  • 文章类型: Case Reports
    皮特-霍普金斯综合征(PTHS)是一种罕见的遗传性疾病,由TCF4基因突变引起,其特征是畸形面部特征,精神运动延迟,智力残疾,呼吸异常,和癫痫发作。偶尔会看到精神病情况。我们提供了一个7岁的PTHS患者焦虑的病例报告,失眠,和激动。我们讨论了该患者的精神药理学干预方案。本案例研究报告了一名患有PTHS的7岁女性,自闭症谱系障碍(ASD),智力残疾。她失眠了,哭泣的咒语和激动的抱怨。对于焦虑症状和激动,利培酮,氟西汀,神经科医生给予氯硝西泮治疗,导致行为抑制,阵发性激动,没有任何好处。入院后,阿立哌唑和羟嗪用于治疗焦虑和ASD相关的易怒。她的改善很小,但换气过度发作仍在进行中。停止了羟嗪,并给予喹硫平以消除睡眠障碍。她的睡眠时间长达11个小时。对于焦虑症状,艾司西酞普兰是处方。她表现出睡眠改善,减少多动症和减少频率的异常呼吸法术。此外,观察到社交沟通技巧的增强,如增加眼神交流和对她的名字的反应。患有遗传综合征的患者可能有各种精神病。对于副作用,应谨慎进行精神药理学干预。
    Pitt-Hopkins syndrome (PTHS) is a rare genetic disorder resulting from TCF4 gene mutations which is characterized by dysmorphic facial features, psychomotor delay, intellectual disability, breathing anomalies, and seizures. Psychiatric conditions are occasionally seen. We present the case report of a seven-year-old PTHS patient with anxiety, insomnia, and agitation. We discuss the psychopharmacological intervention options for this patient. The present case study reports on a 7-year-old female with PTHS, autism spectrum disorder (ASD), and intellectual disability. She had insomnia, crying spells and agitation complaints. For anxiety symptoms and agitation, risperidone, fluoxetine, and clonazepam treatment were given by the neurologist which caused behavioral disinhibition, paroxysmal agitation and no benefit. After admission to our hospital, aripiprazole and hydroxyzine were prescribed for anxiety and ASD-related irritability. She showed a minimal improvement but hyperventilation attacks were still ongoing. Hydroxyzine was stopped, and quetiapine was given to eliminate sleep disturbance. Her sleep period went up to eleven hours. For the anxiety symptoms, escitalopram was prescribed. She showed improvements in sleep, diminished hyperactivity and decreased frequency of abnormal breathing spells. Also, enhancement of social communication skills like increased eye contact and response to her name was observed. Patients with genetic syndromes may have various psychiatric complaints. Psychopharmacological interventions should be administered carefully for the side effects.
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  • 文章类型: Journal Article
    背景:敌意,烦躁,躁动在I型双相情感障碍患者中很常见。事后分析评估了卡利拉嗪对I型双相躁狂症患者这些症状的影响。
    方法:数据来自三个随机分组,双盲,在患有I型双极躁狂/混合发作的成人中进行的卡利拉嗪3期安慰剂对照试验(NCT00488618,NCT01058096,NCT01058668);分析了混合卡利拉嗪剂量(3-12mg/d).根据基线评分将患者分为敌对/易怒和躁动亚组:年轻躁狂量表(YMRS)易怒和破坏性攻击行为项目评分≥2;阳性和阴性综合征量表(PANSS)敌对项目≥2;PANSS兴奋成分(PANSS-EC)总分≥14,≥1个项目得分≥4。评估了从基线到第3周的敌意/刺激性和躁动相关结果的变化。对其他躁狂症状进行了调整,镇静,和静坐不能。
    结果:大多数患者符合亚组纳入标准(YMRS敌意=930;PANSS敌意=841;PANSS-EC躁动=486)。在YMRS子群中,卡利拉嗪与安慰剂相比,在YMRS敌对/易怒相关项目上,基线变化的最小二乘均值差异具有统计学意义(易怒性[-0.93],破坏性攻击行为[-0.79],组合[-1.75];每个P≤0.001),YMRS总分(-5.92,P≤0.0001),和所有单个YMRS项目(-0.25至-0.93,P≤0.0001);在调整其他躁狂症状后,差异仍然显着,镇静,和静坐不能。卡利拉嗪与安慰剂相比,PANSS敌意和PANSS-EC亚组的差异显着(P≤0.001)。
    结论:事后分析。
    结论:卡利哌嗪在躁狂/混合发作的I型双相情感障碍和基线敌意患者中表现出特定的抗敌意/易怒和抗躁动作用,烦躁,或激动。
    BACKGROUND: Hostility, irritability, and agitation are common in patients with bipolar I disorder. Post hoc analyses evaluated the effect of cariprazine on these symptoms in patients with bipolar I mania.
    METHODS: Data were pooled from three randomized, double-blind, placebo-controlled phase 3 cariprazine trials in adults with bipolar I manic/mixed episodes (NCT00488618, NCT01058096, NCT01058668); pooled cariprazine doses (3-12 mg/d) were analyzed. Patients were categorized into hostility/irritability and agitation subgroups by baseline scores: Young Mania Rating Scale (YMRS) irritability and disruptive-aggressive behavior items score ≥ 2; Positive and Negative Syndrome Scale (PANSS) hostility item ≥ 2; PANSS-Excited Component (PANSS-EC) total score ≥ 14 and score ≥ 4 on ≥ 1 individual item. Changes from baseline to week 3 in hostility/irritability- and agitation-related outcomes were evaluated. Adjustments were made for the presence of other manic symptoms, sedation, and akathisia.
    RESULTS: Most patients met subgroup inclusion criteria (YMRS hostility = 930; PANSS hostility = 841, PANSS-EC agitation = 486). In the YMRS subgroup, least squares mean differences in change from baseline were statistically significant for cariprazine versus placebo on YMRS hostility/irritability-related items (irritability [-0.93], disruptive-aggressive behavior [-0.79], combined [-1.75]; P ≤ 0.001 each), YMRS total score (-5.92, P ≤ 0.0001), and all individual YMRS items (-0.25 to -0.93, P ≤ 0.0001); differences remained significant after adjustment for other manic symptoms, sedation, and akathisia. Differences in PANSS hostility and PANSS-EC subgroups were significant for cariprazine versus placebo (P ≤ 0.001).
    CONCLUSIONS: Post hoc analysis.
    CONCLUSIONS: Cariprazine demonstrated specific antihostility/irritability and anti-agitation effects in patients with manic/mixed episodes of bipolar I disorder and baseline hostility, irritability, or agitation.
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