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Cerebral Anoxia in an 18-year-old Patient Being Treated for Major Depressive Disorder: How Forensic Detective Work Uses Medical Knowledge Including Clinical Pharmacology to Solve Cases. 一名接受重度抑郁症治疗的 18 岁患者的脑缺氧:法医侦探工作如何利用包括临床药理学在内的医学知识破案。
IF 1.3 4区 医学 Q3 Medicine Pub Date : 2024-05-01 DOI: 10.1097/PRA.0000000000000780
Sheldon H Preskorn, David D Masolak

This column is the first of a 3-part series illustrating the importance of medical knowledge, including clinical pharmacology, in a forensic context. This first case involved an 18-year-old high school student who suffered an anoxic brain injury and remained in a state of permanent decorticate posture, unresponsive except for grunts and primitive movements until he died several years later. Our investigation began by ruling out plausible causes that were suggested by the defense in the malpractice suit. Once those possibilities were eliminated, the focus was on what accounted for the damage to the patient using general medical knowledge and clinical pharmacology. The 4 Ds of forensic psychiatry (duty, damages, dereliction, and direct cause) are the 4 elements that the plaintiff is required to prove in civil court to prevail in a malpractice suit and are applied to this case with a special focus on dereliction and direct cause. This catastrophic outcome was due to 3 factors. First, the patient had physiologically significant dehydration to the point that he had developed a reflex tachycardia to maintain his blood pressure. Second, the patient had been switched from extended to immediate-release quetiapine, resulting in a doubling of the peak concentration of the drug, which produced higher occupancy of alpha-1 adrenergic, histamine-1, and dopamine-2 receptors, causing a further drop in his blood pressure as well as increased sedation and impairment of his gag reflex. These effects occurred quickly because of the faster absorption of the IR formulation of the drug. Third, the patient had gone to sleep in a reclining chair so that his brain was above his heart and his lower extremities were below his heart, resulting in an increased "steal" of cardiac output going to his brain. These 3 factors together led the patient to aspirate and suffer a hypoxic brain injury after an episode of vomitus. This column explains the process by which the cause of this sad outcome was determined, how it was related to a dereliction of duty to the patient, and how other proposed causes were ruled out.

本专栏是三部分系列文章中的第一篇,说明医学知识(包括临床药理学)在法医鉴定中的重要性。第一个案例涉及一名 18 岁的高中生,他因缺氧性脑损伤而处于永久性去皮质状态,除了呼噜声和原始动作外没有任何反应,直到几年后死亡。我们的调查首先排除了被告方在渎职诉讼中提出的可能原因。一旦排除了这些可能性,我们就开始利用医学常识和临床药理学,重点研究是什么原因造成了病人的损伤。法医精神病学的 4 D(责任、损害、失职和直接原因)是原告在民事法庭上胜诉时需要证明的 4 个要素,适用于本案例,尤其侧重于失职和直接原因。造成这一灾难性后果的原因有 3 个。首先,病人生理性严重脱水,以至于出现反射性心动过速来维持血压。其次,患者从缓释喹硫平换成了速释喹硫平,导致药物的峰值浓度增加了一倍,从而使α-1肾上腺素能、组胺-1和多巴胺-2受体的占据率升高,导致血压进一步下降,镇静作用增强,吞咽反射受损。由于红外制剂药物吸收更快,这些影响很快就会出现。第三,病人是在躺椅上入睡的,因此他的大脑位于心脏上方,而下肢位于心脏下方,从而增加了流向大脑的心输出量的 "窃取"。这三个因素加在一起,导致病人在一次呕吐后吸入气体,造成缺氧性脑损伤。本专栏解释了造成这一悲惨结果的原因是如何确定的,它与对病人的失职是如何相关的,以及如何排除其他拟议原因的。
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引用次数: 0
Alzheimer Disease-Link With Major Depressive Disorder and Efficacy of Antidepressants in Modifying its Trajectory. 阿尔茨海默病与重度抑郁症的联系以及抗抑郁药对改变其发病轨迹的疗效。
IF 1.9 4区 医学 Q3 Medicine Pub Date : 2024-05-01 DOI: 10.1097/PRA.0000000000000779
Nour Fakih, Marc Fakhoury

Alzheimer disease (AD) is a devastating neurodegenerative disorder that affects millions of individuals worldwide, with no effective cure. The main symptoms include learning and memory loss, and the inability to carry out the simplest tasks, significantly affecting patients' quality of life. Over the past few years, tremendous progress has been made in research demonstrating a link between AD and major depressive disorder (MDD). Evidence suggests that MDD is commonly associated with AD and that it can serve as a precipitating factor for this disease. Antidepressants such as selective serotonin reuptake inhibitors, which are the first line of treatment for MDD, have shown great promise in the treatment of depression in AD, although their effectiveness remains controversial. The goal of this review is to summarize current knowledge regarding the association between AD, MDD, and antidepressant treatment. It first provides an overview of the interaction between AD and MDD at the level of genes, brain regions, neurotransmitter systems, and neuroinflammatory markers. The review then presents current evidence regarding the effectiveness of various antidepressants for AD-related pathophysiology and then finally discusses current limitations, challenges, and future directions.

阿尔茨海默病(AD)是一种破坏性神经退行性疾病,影响着全球数百万人,目前尚无有效的治疗方法。主要症状包括学习和记忆力减退,无法完成最简单的任务,严重影响患者的生活质量。在过去几年中,有关注意力缺失症与重度抑郁症(MDD)之间联系的研究取得了巨大进展。有证据表明,重度抑郁障碍通常与注意力缺失症有关,而且可以成为这种疾病的诱发因素。选择性血清素再摄取抑制剂等抗抑郁药是治疗 MDD 的一线药物,它们在治疗 AD 抑郁症方面显示出了巨大的前景,但其有效性仍存在争议。本综述旨在总结目前关于AD、MDD和抗抑郁治疗之间关联的知识。综述首先从基因、大脑区域、神经递质系统和神经炎症标志物等层面概述了AD与MDD之间的相互作用。然后,综述介绍了当前各种抗抑郁药对AD相关病理生理学的有效性证据,最后讨论了当前的局限性、挑战和未来方向。
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引用次数: 0
Psychosocial Impairment in Older Patients With Bipolar I Disorder. 老年双相情感障碍 I 患者的社会心理障碍。
IF 1.9 4区 医学 Q3 Medicine Pub Date : 2024-03-01 DOI: 10.1097/PRA.0000000000000767
Berkay Vahapoğlu, Cana Aksoy Poyraz, Armağan Özdemir

Background: The goal of this study was to assess psychosocial functioning in older patients with bipolar I disorder compared with healthy subjects and to identify the psychopathological factors associated with poor functioning in patients.

Methods: We recruited 68 euthymic patients with bipolar I disorder from the outpatient unit and 89 healthy controls who were older than 50 years of age. In addition to clinical variables, we used other standardized measures, including the Young Mania Rating Scale, the Hamilton Depression Rating Scale, the Hamilton Anxiety Rating Scale, the Functional Assessment Short Test, and the Montreal Cognitive Assessment.

Results: Older patients with bipolar I disorder had poorer psychosocial functioning in general and in the domains of occupation, autonomy, and cognition than the healthy controls on the basis of previously defined Functional Assessment Short Test cutoff scores. We found that 35.3% (95% CI: 23%-47%) of the patients did not have clinically significant functional impairment, 38.2% (95% CI: 26%-50%) had mild impairment, and 26.5% (95% CI: 16%-37%) had moderate impairment. Depressive symptoms and impaired cognition were associated with poor overall functioning.

Conclusions: The level of psychosocial functioning was heterogeneous among the patients. Subsyndromal depressive symptoms, even at low levels, and impaired cognition predicted poor functioning in euthymic middle-aged and older patients with bipolar I disorder.

研究背景本研究的目的是评估老年双相情感障碍 I 患者与健康人相比的社会心理功能,并确定与患者功能低下相关的心理病理因素:我们从门诊部招募了 68 名躁狂症 I 患者和 89 名年龄在 50 岁以上的健康对照者。除临床变量外,我们还使用了其他标准化测量方法,包括青年躁狂评定量表、汉密尔顿抑郁评定量表、汉密尔顿焦虑评定量表、功能评估短测试和蒙特利尔认知评估:结果:与健康对照组相比,根据之前定义的功能评估简短测试临界分数,双相情感障碍 I 老年患者的总体社会心理功能以及职业、自主性和认知领域的社会心理功能均较差。我们发现,35.3%(95% CI:23%-47%)的患者没有明显的临床功能障碍,38.2%(95% CI:26%-50%)的患者有轻度功能障碍,26.5%(95% CI:16%-37%)的患者有中度功能障碍。抑郁症状和认知能力受损与整体功能低下有关:结论:患者的社会心理功能水平参差不齐。抑郁症状(即使程度较轻)和认知功能受损预示着躁狂症 I 型中老年患者的功能较差。
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引用次数: 0
Navigating the Discussion of Mental Illness With Vietnamese Americans. 与美籍越南人讨论精神疾病的导航。
IF 1.9 4区 医学 Q3 Medicine Pub Date : 2024-03-01 DOI: 10.1097/PRA.0000000000000770
Carter Do, Thinh H Le, Emily Nguyen, Thomas K Pak

Approaching mental health issues in the Vietnamese community is challenging due to the distinct cultural practices, the stigma of mental illness, and the language barrier. These complexities are compounded by additional stressors experienced by many Vietnamese Americans stemming from war trauma and the demands of immigration. In this article, the authors discuss the implications that Vietnamese cultural practices have on the perception of mental health in Vietnamese American communities. Specifically, the discussion encompasses mood disorders, particularly depression, and schizophrenia, 2 prevalent mental health conditions that often intersect with cultural nuances. Shedding light on this often-overlooked aspect, the authors provide insight into understanding the specific challenges Vietnamese Americans with depression and schizophrenia face. At the end of this article, a helpful table of commonly used mental health terms, their Vietnamese translations, and explanations in Vietnamese are presented. Beyond linguistics, the article extends its guidance to mental health providers seeking to engage in productive discussion about mental health with their patients. By offering practical tips tailored to cultural context, the article aims to foster a more inclusive approach to mental health in Vietnamese American communities.

由于独特的文化习俗、精神疾病的耻辱感和语言障碍,在越南社区解决心理健康问题具有挑战性。许多越南裔美国人因战争创伤和移民需求而承受着额外的压力,这些复杂因素使问题变得更加复杂。在本文中,作者讨论了越南文化习俗对美籍越南人社区心理健康观念的影响。具体而言,文章讨论了情绪障碍,尤其是抑郁症和精神分裂症,这两种普遍存在的心理健康问题往往与文化的细微差别交织在一起。作者对这一经常被忽视的问题进行了深入探讨,帮助我们了解患有抑郁症和精神分裂症的美籍越南人所面临的具体挑战。在文章末尾,作者还提供了一份有用的表格,列出了常用的心理健康术语、其越南语翻译以及越南语解释。除了语言之外,文章还为心理健康服务提供者提供了指导,帮助他们与患者就心理健康问题进行富有成效的讨论。通过提供适合文化背景的实用技巧,文章旨在促进美国越南裔社区采用更具包容性的方法来处理心理健康问题。
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引用次数: 0
Clinical Experience on the Use of a Single-day, Two-injection Start Initiation Regimen of Aripiprazole Once Monthly in Patients With Schizophrenia in Spain: SaTISfy Study. 西班牙精神分裂症患者使用阿立哌唑单日两次注射起始方案(每月一次)的临床经验:SaTISfy 研究。
IF 1.9 4区 医学 Q3 Medicine Pub Date : 2024-03-01 DOI: 10.1097/PRA.0000000000000776
Miquel Bioque, María José Moreno, Susana Gómez-Lus, María Isabel Ramos

Objective: The two-injection start (TIS) initiation regimen was recently approved for aripiprazole once monthly 400 mg (AOM400), with potential benefits in adherence. The SaTISfy study described in this article analyzed Spanish psychiatrists' perspectives on hospitalization lengths of stay, schizophrenia management, and the use of AOM400-TIS.

Methods: The authors describe an ecological study of aggregated data collected using a 41-question survey. Fifty psychiatrists were asked to provide their perceptions of their patients with schizophrenia and treatment with AOM400.

Results: The psychiatrists reported that lack of treatment adherence was the main reason for hospitalization for 58.3% of their patients diagnosed with schizophrenia. Aripiprazole, in any formulation, was the most commonly prescribed therapeutic option, being prescribed for a mean (SD) of 2.5 (0.9) out of 5 patients, while 98% of psychiatrists chose AOM400-TIS for patients who failed to adhere to previous treatments. Patients with schizophrenia, regardless of their treatment, were hospitalized for an average of 17.7 (3.93) days versus patients with schizophrenia treated with AOM400-TIS, who were hospitalized for an average of 14.2 (4.18) days, a reduction of 3.5 (3.86) days. Patients treated with AOM400-TIS showed a reduction of 5 (4.18) days compared with the mean national duration of hospitalization for acute patients in psychiatry units in Spain (19.18 d). The surveyed psychiatrists reported that AOM400-TIS improved safety and tolerability. Most of the psychiatrists were satisfied with the administration and results of AOM400-TIS. Most of the psychiatrists (90%) also reported that fewer health care resources were consumed with AOM400-TIS, mainly due to a reduction in hospitalization days and in the use of concomitant medications.

Conclusions: AOM400-TIS was considered to have a positive impact on the duration of hospitalization and thus on the use of health care resources. There was a positive perception of adherence, safety, and tolerability with the use of AOM400-TIS in patients with schizophrenia.

目的:阿立哌唑每月注射一次,每次 400 毫克(AOM400),最近被批准采用两次注射起始(TIS)方案,这可能对患者的依从性有好处。本文所述的 SaTISfy 研究分析了西班牙精神科医生对住院时间、精神分裂症管理和 AOM400-TIS 使用情况的看法:作者介绍了一项通过 41 个问题的调查收集汇总数据的生态研究。50名精神科医生被要求提供他们对精神分裂症患者和AOM400治疗的看法:结果:精神科医生表示,在他们诊断出的精神分裂症患者中,58.3%的患者住院的主要原因是缺乏治疗依从性。阿立哌唑(任何剂型)是最常见的处方治疗方案,平均(标清)5名患者中有2.5名(0.9名)接受了阿立哌唑的治疗,而98%的精神科医生选择AOM400-TIS来治疗之前未能坚持治疗的患者。接受AOM400-TIS治疗的精神分裂症患者平均住院17.7(3.93)天,而接受AOM400-TIS治疗的精神分裂症患者平均住院14.2(4.18)天,缩短了3.5(3.86)天。与西班牙全国精神科急症患者的平均住院时间(19.18 天)相比,接受 AOM400-TIS 治疗的患者的住院时间缩短了 5 (4.18) 天。接受调查的精神科医生表示,AOM400-TIS提高了安全性和耐受性。大多数精神科医生对 AOM400-TIS 的使用和效果表示满意。大多数精神科医生(90%)还表示,AOM400-TIS减少了医疗资源的消耗,主要原因是住院天数和同时使用的药物减少了:结论:AOM400-TIS被认为对住院时间有积极影响,因此对医疗资源的使用也有积极影响。精神分裂症患者对使用AOM400-TIS的依从性、安全性和耐受性有积极的看法。
{"title":"Clinical Experience on the Use of a Single-day, Two-injection Start Initiation Regimen of Aripiprazole Once Monthly in Patients With Schizophrenia in Spain: SaTISfy Study.","authors":"Miquel Bioque, María José Moreno, Susana Gómez-Lus, María Isabel Ramos","doi":"10.1097/PRA.0000000000000776","DOIUrl":"10.1097/PRA.0000000000000776","url":null,"abstract":"<p><strong>Objective: </strong>The two-injection start (TIS) initiation regimen was recently approved for aripiprazole once monthly 400 mg (AOM400), with potential benefits in adherence. The SaTISfy study described in this article analyzed Spanish psychiatrists' perspectives on hospitalization lengths of stay, schizophrenia management, and the use of AOM400-TIS.</p><p><strong>Methods: </strong>The authors describe an ecological study of aggregated data collected using a 41-question survey. Fifty psychiatrists were asked to provide their perceptions of their patients with schizophrenia and treatment with AOM400.</p><p><strong>Results: </strong>The psychiatrists reported that lack of treatment adherence was the main reason for hospitalization for 58.3% of their patients diagnosed with schizophrenia. Aripiprazole, in any formulation, was the most commonly prescribed therapeutic option, being prescribed for a mean (SD) of 2.5 (0.9) out of 5 patients, while 98% of psychiatrists chose AOM400-TIS for patients who failed to adhere to previous treatments. Patients with schizophrenia, regardless of their treatment, were hospitalized for an average of 17.7 (3.93) days versus patients with schizophrenia treated with AOM400-TIS, who were hospitalized for an average of 14.2 (4.18) days, a reduction of 3.5 (3.86) days. Patients treated with AOM400-TIS showed a reduction of 5 (4.18) days compared with the mean national duration of hospitalization for acute patients in psychiatry units in Spain (19.18 d). The surveyed psychiatrists reported that AOM400-TIS improved safety and tolerability. Most of the psychiatrists were satisfied with the administration and results of AOM400-TIS. Most of the psychiatrists (90%) also reported that fewer health care resources were consumed with AOM400-TIS, mainly due to a reduction in hospitalization days and in the use of concomitant medications.</p><p><strong>Conclusions: </strong>AOM400-TIS was considered to have a positive impact on the duration of hospitalization and thus on the use of health care resources. There was a positive perception of adherence, safety, and tolerability with the use of AOM400-TIS in patients with schizophrenia.</p>","PeriodicalId":16909,"journal":{"name":"Journal of Psychiatric Practice","volume":null,"pages":null},"PeriodicalIF":1.9,"publicationDate":"2024-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10962426/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140207101","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Increasing the Acceptability of Lethal Means Safety Counseling for Firearms: Tips and Scripts. 提高致命手段对枪支安全咨询的可接受性:提示和脚本。
IF 1.9 4区 医学 Q3 Medicine Pub Date : 2024-03-01 DOI: 10.1097/PRA.0000000000000773
Gabriela K Khazanov, Shimrit Keddem, Katelin Hoskins, Hal S Wortzel, Joseph A Simonetti

In lethal means safety counseling (LMSC), clinicians encourage patients to limit their access to common and lethal means of suicide, especially firearms. However, previous studies have shown that clinicians may hesitate to deliver this evidence-based intervention, in part because of concerns that patients might not find such discussions acceptable. Based on a published review of 18 qualitative studies examining diverse perspectives on LMSC, we discuss strategies that may help clinicians increase the acceptability of LMSC among their patients and present supporting scripts, rationales, and resources. The studies included in the review examined the perspectives of clinicians, patients, firearm owners, and other relevant groups across a wide range of clinical settings on LMSC for firearms. The authors of these studies recommend that clinicians approach LMSC in a nonjudgmental manner with awareness of their own biases, demonstrate cultural competency by acknowledging the role of firearms in patients' lives, and adapt LMSC to patients' previous experiences with firearms, safety, and injury. Clinicians may also want to contextualize and provide a rationale for LMSC, decide whether or not to directly ask about access to firearms, and recommend a range of storage options tailored to the patient. Free locking devices or discount coupons for purchasing such devices may increase the acceptability and efficacy of these discussions. The strategies recommended in this paper are the first to be based on a comprehensive set of relevant studies. Future research is needed to examine whether these strategies do in fact increase the acceptability of LMSC and promote other outcomes such as increased feasibility and efficacy.

在致命手段安全咨询(LMSC)中,临床医生鼓励患者限制使用常见的致命自杀手段,尤其是枪支。然而,以往的研究表明,临床医生在实施这种循证干预时可能会犹豫不决,部分原因是担心患者可能无法接受这种讨论。基于已发表的 18 项定性研究对 LMSC 不同观点的审查,我们讨论了可帮助临床医生提高患者对 LMSC 可接受性的策略,并提供了支持性脚本、理由和资源。综述中的研究考察了临床医生、患者、枪支所有者和其他相关群体在各种临床环境下对枪支 LMSC 的看法。这些研究的作者建议,临床医生应以不带偏见的方式对待 LMSC,并意识到自己的偏见,通过承认枪支在患者生活中的作用来展示文化能力,并根据患者之前在枪支、安全和伤害方面的经验来调整 LMSC。临床医生可能还需要说明 LMSC 的来龙去脉并提供其理由,决定是否直接询问是否可以接触枪支,并推荐一系列适合患者的存储选项。免费的锁定装置或购买此类装置的折扣券可能会提高这些讨论的可接受性和有效性。本文所建议的策略是首次以一整套相关研究为基础提出的。今后还需要进行研究,以探讨这些策略是否确实提高了 LMSC 的可接受性,并促进了其他成果的实现,例如提高了可行性和有效性。
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引用次数: 0
Psychotic and Somatic Symptoms Are Frequent in Refugees With Posttraumatic Stress Disorder: A Narrative Review. 患有创伤后应激障碍的难民经常出现精神和躯体症状:叙述性综述。
IF 1.9 4区 医学 Q3 Medicine Pub Date : 2024-03-01 DOI: 10.1097/PRA.0000000000000772
Matthieu Gasnier, Anthony Aouizerat, Kenneth Chappell, Thierry Baubet, Emmanuelle Corruble

Objective: In 2021, 89.3 million refugees were vulnerable to posttraumatic stress disorder (PTSD) after exposure to multiple and repeated traumatic experiences. The recent war in Ukraine provoked 7 million refugees to flee their homes. Specific clinical presentations of PTSD in refugee populations may not be familiar to most physicians. The goal of this review is to describe the diagnosis and specific clinical features of PTSD in refugees.

Methods: This narrative review of 263 articles explores 3 PTSD diagnoses that are frequently described in refugee populations and that have been observed in our clinical practices: complex PTSD, PTSD with psychotic symptoms, and PTSD with somatic symptoms.

Results: While complex PTSD does not seem to be related to individuals' culture and origin, the other 2 diagnoses have been specifically described in refugee populations. PTSD with somatic manifestations appears to be the most frequently described and commonly acknowledged form in refugee populations, whereas PTSD with psychotic symptoms remains more controversial due to its clinical variability and association with comorbid disorders.

Conclusions: The difficulty of identifying PTSD with psychotic symptoms and PTSD with somatic symptoms in refugee populations may lead to misdiagnosis and explain the moderate effectiveness of care delivered to these populations. Appropriate diagnosis is essential to provide optimal psychiatric care to refugee populations.

目标:2021 年,8930 万难民在遭受多重、反复的创伤经历后容易患上创伤后应激障碍(PTSD)。最近的乌克兰战争导致 700 万难民逃离家园。大多数医生可能并不熟悉难民群体中创伤后应激障碍的具体临床表现。本综述旨在描述难民创伤后应激障碍的诊断和具体临床特征:这篇263篇文章的叙事性综述探讨了在难民人群中经常被描述的3种创伤后应激障碍诊断,这些诊断在我们的临床实践中也被观察到:复杂性创伤后应激障碍、伴有精神病性症状的创伤后应激障碍和伴有躯体症状的创伤后应激障碍:结果:复杂性创伤后应激障碍似乎与个人的文化和出身无关,但其他两种诊断在难民群体中有具体描述。具有躯体表现的创伤后应激障碍似乎是在难民群体中最常被描述和普遍承认的形式,而具有精神症状的创伤后应激障碍由于其临床变异性和与合并症的关联性,仍然存在较多争议:结论:在难民群体中,难以识别伴有精神症状的创伤后应激障碍和伴有躯体症状的创伤后应激障碍可能会导致误诊,这也是为这些群体提供的护理效果一般的原因。适当的诊断对于为难民提供最佳的精神治疗至关重要。
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引用次数: 0
How the Food and Drug Administration Drug Approval Process Relates to the Potential Approval of Intravenous Racemic Ketamine for Treatment-resistant Major Depression. 美国食品和药物管理局的药物审批程序如何与可能批准静脉注射消旋氯胺酮治疗耐药性重度抑郁症相关联。
IF 1.9 4区 医学 Q3 Medicine Pub Date : 2024-03-01 DOI: 10.1097/PRA.0000000000000768
Sheldon H Preskorn

This column focuses on the status of intravenous racemic ketamine for the treatment of patients suffering from a form of major depressive disorder that does not respond to trials of currently available biogenic amine antidepressants. To provide context, the column reviews the 3 pivotal elements of the usual Food and Drug Administration (FDA) drug approval process: (1) the unmet medical need (ie, the indication) for which the drug is being developed, (2) the efficacy of the drug for that condition, and (3) the safety/tolerability of the drug. This column is based on the author's 45-year history of drug development work and is not a statement of the FDA. There are typically 3 phases in the drug development process: (1) studies done in normal volunteers, (2) typically small-scale proof of concept studies, and (3) large-scale registration trials. This third phase is critical in determining the efficacy, safety, and tolerability of the drug in a manner that most closely follows the clinical use of the drug. This column focuses specifically on whether generally small-scale studies done in academic centers are sufficient for drug approval, and it briefly reviews lithium and clozapine as examples of psychiatric medications that had such academic research in the literature, as well as clinical use in other countries. Those data supported the unique value of these medications in patients with bipolar disorder and treatment-resistant schizophrenia (ie, the unmet medical need), respectively, and the findings led American psychiatrists to advocate for FDA approval of these medications. Their efforts led to the needed registration trials for FDA approval of these medications. This column reviews the key features of registration trials and the reason that they are critical for FDA approval, and it discusses 2 special considerations related to the intravenous administration of racemic ketamine. First, racemic ketamine is not esketamine but, instead, it contains R-ketamine in addition to S-ketamine (ie, esketamine). The second consideration is that differences between intravenous and intranasal administration may affect the safety of the drug. While safety concerns were specifically addressed in the registration trials for esketamine, comparable research remains to be done for intravenous racemic ketamine. Understanding how the FDA's drug approval process works is important for prescribers, their patients, and the public.

本专栏主要介绍静脉注射外消旋氯胺酮治疗重度抑郁症患者的情况,这种患者对目前可用的生物胺类抗抑郁药试验无反应。为了提供背景资料,本专栏回顾了美国食品和药物管理局(FDA)通常药物审批程序的三个关键要素:(1)正在开发的药物尚未满足的医疗需求(即适应症);(2)药物对该病症的疗效;以及(3)药物的安全性/耐受性。本专栏基于作者 45 年的药物开发工作经验,并非 FDA 的声明。药物开发过程通常分为 3 个阶段:(1)在正常志愿者中进行的研究;(2)典型的小规模概念验证研究;(3)大规模注册试验。第三阶段对于以最贴近临床用药的方式确定药物的疗效、安全性和耐受性至关重要。本专栏特别关注在学术中心进行的一般小规模研究是否足以作为药物审批的依据,并简要回顾了锂和氯氮平作为精神科药物的例子,这些药物在文献中进行了此类学术研究,并在其他国家进行了临床使用。这些数据分别支持了这些药物在双相情感障碍和耐药性精神分裂症患者中的独特价值(即未满足的医疗需求),这些研究结果促使美国精神科医生倡导美国食品药物管理局批准这些药物。他们的努力促成了 FDA 批准这些药物所需的注册试验。本专栏回顾了注册试验的主要特点以及注册试验对 FDA 批准至关重要的原因,并讨论了与外消旋氯胺酮静脉注射有关的两个特殊注意事项。首先,外消旋氯胺酮不是艾司氯胺酮,而是除了 S-氯胺酮(即艾司氯胺酮)外还含有 R-氯胺酮。第二个考虑因素是静脉注射和鼻内注射的不同可能会影响药物的安全性。虽然在埃斯氯胺酮的注册试验中专门讨论了安全性问题,但对于静脉注射外消旋氯胺酮仍有待进行类似的研究。了解美国食品和药物管理局的药物审批程序对处方者、患者和公众都很重要。
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引用次数: 0
Formulary Coverage of Esketamine and Ketamine for Depression in Ohio Health Insurance Marketplace and Medicaid Plans. 俄亥俄州健康保险市场和医疗补助计划中治疗抑郁症的 Esketamine 和 Ketamine 的处方覆盖范围。
IF 1.9 4区 医学 Q3 Medicine Pub Date : 2024-03-01 DOI: 10.1097/PRA.0000000000000766
Brian S Barnett

For more than 2 decades, intravenous ketamine has been demonstrated to have rapid antidepressant effects. However, access to this generic drug is limited due to insurers claiming it is "experimental" because ketamine does not have a Food and Drug Administration indication for depression. In contrast, intranasal esketamine, an enantiomer of ketamine, is approved by the Food and Drug Administration for depression and is still under patent. The goal of this column is to provide a clearer understanding of formulary coverage of these similar medications by insurers. Formularies of all 2023 Ohio Health Insurance Marketplace and Medicaid plans were reviewed to determine the inclusion status of intravenous ketamine and intranasal esketamine for depression. This review found that intravenous ketamine was not covered by any Marketplace or Medicaid plan for depression, while intranasal esketamine was on 72.7% and 100% of formularies, respectively. Thus, members of the analyzed insurance plans can more easily access intranasal esketamine than intravenous ketamine for depression, despite the latter being more cost-effective and possibly more efficacious.

二十多年来,静脉注射氯胺酮已被证明具有快速抗抑郁作用。然而,由于保险公司声称氯胺酮是 "试验性 "药物,因此这种非专利药物的使用受到了限制,因为氯胺酮并没有获得美国食品药品管理局的抑郁症适应症。与此相反,氯胺酮的对映体--鼻内注射用艾司氯胺酮已被美国食品药品管理局批准用于治疗抑郁症,并且仍在专利期内。本专栏旨在让读者更清楚地了解保险公司对这些类似药物的处方覆盖范围。我们审查了 2023 年俄亥俄州健康保险市场和医疗补助计划的所有医保目录,以确定静脉注射氯胺酮和鼻内注射艾司氯胺酮治疗抑郁症的纳入情况。审查发现,静脉注射氯胺酮未被任何市场或医疗补助计划纳入抑郁症治疗范围,而鼻内注射艾司氯胺酮则分别被纳入 72.7% 和 100% 的医保目录。因此,与静脉注射氯胺酮相比,分析的保险计划的成员更容易获得鼻内注射艾司氯胺酮治疗抑郁症,尽管后者更具成本效益,疗效也可能更好。
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引用次数: 0
Prodromal or Factitious Psychosis: A Cautionary Tale in the Era of Increasing Social Media Use by Vulnerable Individuals. 前驱性或假性精神病:在弱势群体越来越多地使用社交媒体的时代,一个值得警惕的故事。
IF 1.9 4区 医学 Q3 Medicine Pub Date : 2024-03-01 DOI: 10.1097/PRA.0000000000000771
Leo Bastiaens, Stephanie Cristofano-Casella, Jesse Bastiaens

Research on the prodromal phase of schizophrenia has been ongoing for several decades and, more recently, findings from this research are being incorporated into everyday psychiatric practice, such as the use of interviews to evaluate prodromal symptomatology. This evolution is happening in the midst of an explosion of social media use by teenagers and young adults, increasing the exposure of youth to portrayals of psychiatric experiences. For example, reports from around the world of "TIK-TOK tics" emphasize the role of social media in the "creation" of psychiatric symptoms. This case report highlights the importance of a full psychiatric evaluation in acute care settings where quick treatment of psychotic symptoms is the norm. A 15-year-old patient was initially diagnosed with prodromal schizophrenia but, after a more extensive evaluation during a second admission, she was diagnosed with borderline personality disorder. Her antipsychotic treatment regimen was stopped and appropriate education and treatment were started, without the recurrence of "psychotic symptoms" during follow-up. It may be that patients with borderline personality disorder, a frequent condition on inpatient units, are at particular risk of assimilating symptoms as represented on social media.

对精神分裂症前驱期的研究已经持续了几十年,最近,这项研究的结果正在被纳入日常的精神科实践中,例如使用访谈来评估前驱期症状。这一演变是在青少年使用社交媒体激增的背景下发生的,社交媒体增加了青少年接触精神科经历的机会。例如,世界各地关于 "TIK-TOK 抽搐 "的报道强调了社交媒体在 "创造 "精神症状中的作用。本病例报告强调了在急症护理环境中进行全面精神评估的重要性,因为在急症护理环境中,快速治疗精神病症状是一种常态。一名 15 岁的患者最初被诊断为前驱型精神分裂症,但在第二次入院接受更全面的评估后,她被诊断为边缘型人格障碍。她的抗精神病治疗方案被停止,并开始接受适当的教育和治疗,但在随访期间没有再出现 "精神病症状"。边缘型人格障碍是住院病房的常见病,边缘型人格障碍患者可能特别容易吸收社交媒体上的症状。
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引用次数: 0
期刊
Journal of Psychiatric Practice
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