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Antidepressant medications: The FDA-approval process and the need for updates 抗抑郁药物:fda批准程序和更新的需要
Pub Date : 2014-12-23 DOI: 10.9740/MHC.N186950
Conor Hanrahan, James P. New
Antidepressant drug development first began in the mid-twentieth century with the discovery of monoamine oxidase inhibitors and tricyclic antidepressants. Soon after, additional molecular targets and drug entities were created, eventually leading to the development of selective serotonin reuptake inhibitors. Today, antidepressants now rank among the top 10 most commonly used medications in the United States (US) and account for over $11 billion in annual sales. To help ensure the safety and efficacy of these commonly used products, in 1977 the US Food and Drug Administration (FDA) created guidelines to standardize antidepressant studies and the approval process. Although many of the recommendations outlined by FDA are still relevant, the document remains vague when describing key aspects of antidepressant trial design and much of the clinical information is outdated by today's standards. This paper will provide a general overview of the FDA-approval process, summarize FDA's position related to antidepress...
随着单胺氧化酶抑制剂和三环抗抑郁药的发现,抗抑郁药物的开发始于20世纪中期。不久之后,更多的分子靶点和药物实体被创造出来,最终导致选择性血清素再摄取抑制剂的发展。如今,抗抑郁药已跻身美国十大最常用药物之列,年销售额超过110亿美元。为了确保这些常用产品的安全性和有效性,1977年,美国食品和药物管理局(FDA)制定了规范抗抑郁药研究和批准程序的指导方针。尽管FDA提出的许多建议仍然具有相关性,但在描述抗抑郁药试验设计的关键方面时,该文件仍然模糊,而且许多临床信息以今天的标准来看已经过时。本文将提供FDA批准过程的总体概述,总结FDA在抗抑郁药物方面的立场。
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引用次数: 11
Utilization of vitamins, herbals, and over-the-counter products to delay progression of dementia 使用维生素、草药和非处方产品来延缓痴呆症的进展
Pub Date : 2014-12-23 DOI: 10.9740/MHC.N204527
Jami L. Butz
Many consumers use alternative preparations such as herbals, vitamins, and over-the-counter products in an attempt to prevent or improve the outcome of dementia. Despite use by almost half of all patients, evidence supporting their utilization is either conflicting or lacking. Omega-3 fatty acids, vitamin B6, vitamin B12, vitamin C, and beta-carotene currently do not have clinical trials showing evidence impacting the progression or treatment of symptoms associated with dementia. In addition, conflicting data exist pertaining to the beneficial utilization of ginkgo biloba and nonsteroidal anti-inflammatory drugs associated with dementia treatment. While a link to the utility of folate associated with areas of improved cognitive functioning has been suggested, further studies are needed. Vitamin E may have some benefit in patients with Alzheimer's disease, however, may also have risks in patients with comorbid diseases such as cardiovascular disease or diabetes mellitus. With limited options still existing...
许多消费者使用替代制剂,如草药、维生素和非处方产品,试图预防或改善痴呆症的结果。尽管几乎有一半的患者使用,但支持其使用的证据要么相互矛盾,要么缺乏。Omega-3脂肪酸、维生素B6、维生素B12、维生素C和β -胡萝卜素目前还没有临床试验显示它们对痴呆症相关症状的进展或治疗有影响。此外,关于银杏叶和非甾体抗炎药与痴呆治疗相关的有益利用,存在相互矛盾的数据。虽然已经提出叶酸与认知功能改善有关,但还需要进一步的研究。维生素E可能对阿尔茨海默氏症患者有一些好处,然而,对患有心血管疾病或糖尿病等共病的患者也可能有风险。选择仍然有限……
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引用次数: 0
Antidepressant management of insomnia disorder in the absence of a mood disorder 无情绪障碍的失眠的抗抑郁药管理
Pub Date : 2014-12-23 DOI: 10.9740/MHC.N188364
P. Nazarian, Susie H Park
Insomnia is the most common sleep disorder, and antidepressants are increasingly being used for its management. This article reviews the existing data concerning the use of antidepressants in the treatment of primary insomnia.
失眠是最常见的睡眠障碍,抗抑郁药被越来越多地用于治疗失眠。本文综述了有关使用抗抑郁药治疗原发性失眠症的现有资料。
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引用次数: 3
Screening, diagnosis, and management of type II diabetes: A review of the 2014 American Diabetes Association guidelines 2型糖尿病的筛查、诊断和管理:2014年美国糖尿病协会指南综述
Pub Date : 2014-12-23 DOI: 10.9740/MHC.N194573
Sweta M Patel, A. Thompson
Individuals with schizophrenia and schizoaffective disorders are at higher risk than the general population for the development of chronic medical conditions, such as type II diabetes. This review article will focus on the 2014 recommendations from the American Diabetes Association for diagnosis, management, and assessment of glycemic control in patients with type II diabetes
患有精神分裂症和分裂情感障碍的个体比一般人群患慢性疾病(如II型糖尿病)的风险更高。这篇综述文章将关注2014年美国糖尿病协会关于II型糖尿病患者血糖控制诊断、管理和评估的建议
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引用次数: 2
Pharmacogenomic testing for treatment resistant depression 治疗难治性抑郁症的药物基因组学检测
Pub Date : 2014-12-23 DOI: 10.9740/MHC.N207183
S. Leckband
The percentage of patients who have failed to completely or partially respond to multiple trials of antidepressants at adequate doses and for an adequate duration of therapy has varied in the literature and is considered substantial. Numerous strategies exist to treat poor antidepressant response, but often medications are selected on a “trial and error” basis. Genetic factors may play a role in poor response or intolerance to treatment with antidepressants which lead to treatment failures. Currently, available genetic testing as well as genetic testing currently under research may help guide clinicians with proper medication and dose selection.
在适当剂量和适当疗程的抗抑郁药的多次试验中,完全或部分无效的患者百分比在文献中有所不同,并且被认为是相当大的。有许多策略可以治疗不良的抗抑郁反应,但通常药物的选择是基于“试错”的基础上的。遗传因素可能在抗抑郁药物治疗反应差或不耐受导致治疗失败方面发挥作用。目前,可用的基因检测以及目前正在研究的基因检测可以帮助指导临床医生正确用药和剂量选择。
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引用次数: 0
Recent changes in the treatment of hypertension 高血压治疗的最新变化
Pub Date : 2014-12-23 DOI: 10.9740/MHC.N197964
Bridget Bradley, L. Carlson
Hypertension affects a large portion of the United States' population and is a significant risk factor for cardiovascular events. A variety of treatment guidelines exist including the American Diabetes Association, European Society of Hypertension/European Society of Cardiology and the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure guidelines. The following is a summary of these guidelines regarding the effective treatment of hypertension.
高血压影响了很大一部分美国人口,是心血管事件的重要危险因素。目前存在多种治疗指南,包括美国糖尿病协会、欧洲高血压学会/欧洲心脏病学会和高血压预防、检测、评估和治疗联合全国委员会指南。以下是关于有效治疗高血压的指南摘要。
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引用次数: 1
A review of the evidence supporting the use of lithium augmentation therapy for the reduction of suicidal behavior in patients with unipolar depression: Revisiting an overlooked benefit of an older medication 对支持使用锂增强疗法减少单极抑郁症患者自杀行为的证据的回顾:重新审视一种被忽视的旧药物的益处
Pub Date : 2014-12-23 DOI: 10.9740/MHC.N207175
Elizabeth Jackson, Rene A. Endow-Eyer
Major depressive disorder is a serious, recurrent condition with significant impact on a person's quality of life and functioning, which carries a significant risk of premature death due to suicide. There is evidence that supports the effectiveness of lithium as an augmentation strategy for treatment-resistant depression, as well as for reducing suicidality in this population. This review introduces several theories regarding the proposed mechanism behind lithium's anti-suicidal effects and summarizes a selection of the pertinent literature supporting lithium's beneficial effects on suicidality.
重度抑郁症是一种严重的、反复发作的疾病,对一个人的生活质量和功能有重大影响,它具有因自杀而过早死亡的重大风险。有证据支持锂作为治疗难治性抑郁症的增强策略的有效性,以及在这一人群中降低自杀率。这篇综述介绍了关于锂抗自杀作用机制的几种理论,并总结了一些支持锂对自杀有益作用的相关文献。
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引用次数: 1
The long-term use of sedative hypnotics in chronic insomnia 长期使用镇静催眠药治疗慢性失眠症
Pub Date : 2014-12-23 DOI: 10.9740/MHC.N190097
Chelsie B. Heesch
Symptoms of insomnia are highly prevalent among adults and insomnia is often a chronic condition which may occur for years. Sedative hypnotics including benzodiazepines (BZDs), zolpidem, eszopiclone, and zaleplon (NBZDs) are commonly used to treat insomnia. The longest controlled studies evaluating the safety and efficacy of NBZDs were 12 months in duration and 2 months in duration for the BZD, temazepam. These studies suggest that NBZDs continue to be effective and safe when used for up to 12 months. The short-term adverse effects are more common and more severe for BZDs than for NBZDs. Despite the current practice of using sedative hypnotics for longer durations, studies have yet to evaluate the long-term adverse effect profile.
失眠的症状在成年人中非常普遍,失眠通常是一种慢性疾病,可能会持续多年。镇静催眠药物包括苯二氮卓类药物(BZDs),唑吡坦,艾司佐匹克隆和扎来普隆(NBZDs)通常用于治疗失眠。评估nbzd安全性和有效性的最长对照研究持续时间为12个月,而BZD替马西泮持续时间为2个月。这些研究表明,nbzd在长达12个月的使用中仍然是有效和安全的。bzd的短期不良反应比nbzd更常见、更严重。尽管目前使用镇静催眠药的时间较长,但研究尚未评估其长期不良影响。
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引用次数: 1
Buprenorphine for opioid dependence: Are there really differences between the formulations? 丁丙诺啡治疗阿片类药物依赖:制剂之间真的有区别吗?
Pub Date : 2014-12-23 DOI: 10.9740/MHC.N186952
Rebecca L. Graham
Buprenorphine and buprenorphine/naloxone sublingual tablets were approved by the FDA in 2002. In 2010, the buprenorphine/naloxone sublingual film was approved to address concerns of diversion, time for tablet dissolution, and unintentional exposure in children with the tablet. This article will compare the buprenorphine sublingual formulations in terms of pharmacokinetics, safety, diversion and misuse, cost, and patient preference. It will explore current data suggesting advantages or disadvantages of the various formulations since conclusive data are minimally available.
丁丙诺啡和丁丙诺啡/纳洛酮舌下片于2002年获得FDA批准。2010年,丁丙诺啡/纳洛酮舌下膜获得批准,以解决片剂转移、片剂溶解时间和片剂儿童意外暴露的问题。本文将比较丁丙诺啡舌下制剂的药代动力学、安全性、转移和误用、成本和患者偏好。它将探讨目前的数据,表明各种配方的优点或缺点,因为结论性数据是最低限度的。
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引用次数: 1
An overview of clinically significant drug interactions between medications used to treat psychiatric and medical conditions 用于治疗精神疾病和医疗状况的药物之间的临床显著药物相互作用的概述
Pub Date : 2014-12-23 DOI: 10.9740/MHC.N197904
D. Hoeft
Prescription rates and polypharmacy are increasing, resulting in a greater potential for drug interactions. Psychiatric patients frequently have co-morbid medical conditions, which further increases the risk of polypharmacy and drug interactions. Drug interactions that affect drugs with narrow therapeutic windowsare of particular concern. This review presents some of these drug interactions and provides strategies for identifying and resolving them.
处方率和多种用药正在增加,导致药物相互作用的可能性更大。精神病患者经常有合并症,这进一步增加了多种用药和药物相互作用的风险。药物相互作用影响药物狭窄的治疗窗口是特别值得关注的。这篇综述介绍了一些药物相互作用,并提供了识别和解决它们的策略。
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引用次数: 6
期刊
Mental Health Clinician
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