• 【对优先选择和设计筛选程序中的建模进行回顾和批评。】 复制标题 收藏 收藏
    DOI:10.3310/hta11520 复制DOI
    作者列表:Karnon J,Goyder E,Tappenden P,McPhie S,Towers I,Brazier J,Madan J
    BACKGROUND & AIMS: OBJECTIVES:To undertake a structured review and critical appraisal of methods for the model-based cost-utility analysis of screening programmes. Also to develop guidelines and an assessment checklist of good practice in the development of screening models. DATA SOURCES:Major electronic databases of healthcare and operational research literatures were searched up to June 2003. REVIEW METHODS:Searches of the literature were undertaken to identify applied and methodological studies of economic evaluations of healthcare screening programmes. All applied screening models were also reviewed in three broad disease areas (cancer, cardiovascular disease and diabetes), as well as antenatal screening. A second-level review focused on particular aspects of the modelling process through case study assessments of screening models for three specific disease areas (colorectal cancer, abdominal aortic aneurysms and antenatal screening for haemoglobinopathies). A separate literature review of studies reporting the utility effects of screening was also undertaken. Guidelines and an assessment checklist for good practice for screening modelling were developed. RESULTS:Few relevant methodological studies were identified, and no studies reporting direct empirical comparisons of alternative methodologies were retrieved. From the review of disease-based screening models, it was apparent that many alternative modelling methods had been applied, including some relatively new approaches that had not been widely disseminated. Natural history modelling is the preferred approach. Alternative modelling approaches were generally only used to extrapolate the observed effects of screening and were unsuitable for evaluating unobserved screening options. More complex model structures may incorporate important additional aspects of the disease natural history, although any benefits should outweigh the consequences of additional unobservable input parameters and increased complexity in implementing the model. No direct comparisons of more detailed and less detailed screening model structures informed areas in which more realistic representations of the disease process may be most beneficial, so only general aspects of good practice could be defined. Two structural aspects that were not well handled by existing screening models included post-diagnosis disease progression and screening uptake. Most models described the former using historical mortality rates, rather than treatment models that are representative of current treatment patterns for different stages of the disease. Constant screening uptake rates were applied to all screening programmes and attendance was not linked to disease incidence or progression. Evidence exists to inform a more detailed representation of screening uptake. The most commonly applied modelling techniques were cohort Markov models and individual sampling simulation models. Individual sampling simulation models may provide more flexibility in their representation of a screening decision problem, but any benefits should outweigh the consequences of the need to assess both variability and uncertainty. Complex mathematical models describing input parameters as continuous variables have analysed the cost-effectiveness of screening; these require further development to estimate the cost-utility of screening directly, or to inform a more detailed representation of the preclinical section of a natural history model (with a traditional state-based model describing pathways' post-clinical presentation). Calibration is a common aspect of screening models, whereby models are fitted to observed data describing outputs of the model in order to populate unobserved input parameters. The review concluded that the estimation of a reference case input parameter set is not recommended. CONCLUSIONS:The review of methods for the model-based cost-utility analysis of screening programmes identified the natural history modelling approach as the preferred general method of evaluation for screening programmes. State transition models have generally been used to represent disease natural histories, with individual sampling models more prevalent than in treatment intervention evaluations. No comparative methodological studies were identified, so no empirical data were available to inform the relative merits of alternative methodologies. The defined guidelines and assessment checklist are informed, therefore, by theoretical interpretations of the impact of alternative approaches to different components of the modelling process when applied to the cost-utility analysis of screening programmes. Further research is needed into methods with the potential to improve the accuracy of screening models, and to respond to the needs of model users.
    背景与目标:
  • 【对可用量表的批评和非人类灵长类动物运动障碍评分量表的表示。】 复制标题 收藏 收藏
    DOI:10.1002/mds.25133 复制DOI
    作者列表:Fox SH,Johnston TH,Li Q,Brotchie J,Bezard E
    BACKGROUND & AIMS: :Levodopa-induced dyskinesia (LID) is a major limitation of long-term management of Parkinson's disease. The roadblocks that have hindered the development of new treatments for levodopa-induced dyskinesia were discussed at a meeting organized by the Michael J. Fox Foundation for Parkinson's research (New York, NY, March 2011). Among these, the lack of consensus methodology and clinical applicability for eliciting and rating LID in 1-methyl-4-phenyl-1,2,3,6-tetrahydropyridine (MPTP)-treated monkeys was highlighted as a particular concern. Here we present an update on the practical use of rating scales for evaluating LID in MPTP-lesioned primate models of PD, with a focus on macaques, and present specifics on the Non-Human Primate Dyskinesia Rating Scale.
    背景与目标: : 左旋多巴诱导的运动障碍 (LID) 是长期治疗帕金森氏病的主要局限性。在迈克尔·J·福克斯帕金森研究基金会 (纽约,纽约,2011年3月) 组织的一次会议上,讨论了阻碍左旋多巴诱发的运动障碍的新疗法开发的障碍。其中,缺乏在1-甲基-4-苯基-1,6-2,3-四氢吡啶 (MPTP) 处理的猴子中引发和评定LID的共识方法和临床适用性被强调为特别关注。在这里,我们介绍了评估量表在MPTP-leed的PD灵长类动物模型中评估LID的实际使用的最新信息,重点是猕猴,并介绍了非人类灵长类动物运动障碍评分量表的细节。
  • 【测量忧郁: 贝克抑郁量表的批判及其在精神卫生护理中的应用。】 复制标题 收藏 收藏
    DOI:10.1111/j.1447-0349.2007.00453.x 复制DOI
    作者列表:Hagen B
    BACKGROUND & AIMS: :The Beck Depression Inventory (BDI) is one of the most commonly used depression measurement instruments. Mental health nurses often utilize the BDI to assess the level of depression in clients, and to monitor the effectiveness of treatments such as antidepressants and electroconvulsive therapy. Despite the widespread use of the BDI in both clinical practice and research, there is surprisingly little nursing literature critically examining the BDI or its use by mental health nurses. This paper reviews the origins, purpose, and format of the BDI, discusses some of the strengths and limitations of the BDI, and concludes with some implications for mental health nursing.
    背景与目标: : 贝克抑郁量表 (BDI) 是最常用的抑郁测量工具之一。精神卫生护士经常利用BDI来评估客户的抑郁水平,并监测抗抑郁药和电惊厥疗法等治疗的有效性。尽管BDI在临床实践和研究中广泛使用,但令人惊讶的是,很少有护理文献严格审查BDI或其精神卫生护士的使用。本文回顾了BDI的起源,目的和形式,讨论了BDI的一些优点和局限性,并总结了对精神卫生护理的一些启示。
  • 【仅紧急血液透析政策: 伦理批评和改革途径。】 复制标题 收藏 收藏
    DOI:10.1177/1073110520958877 复制DOI
    作者列表:Lavingia R,Raghavan R,Morain SR
    BACKGROUND & AIMS: :An estimated 6,500 undocumented immigrants in the United States have been diagnosed with end-stage renal disease (ESRD). These individuals are ineligible for the federal insurance program that covers dialysis and/or transplantation for citizens, and consequently are subject to local or state policies regarding the provision of healthcare. In 76% of states, undocumented immigrants are ineligible to receive scheduled outpatient dialysis treatments, and typically receive dialysis only when presenting to the emergency center with severe life-threatening symptoms. 'Emergency-only hemodialysis' (EOHD) is associated with higher healthcare costs, higher mortality, and longer hospitalizations. In this paper, we present an ethical critique of existing federal policy. We argue that EOHD represents a failure of fiduciary and professional obligations, contributes to moral distress, and undermines physician obligations to be good stewards of medical resources. We then explore potential avenues for reform based upon policies introduced at the state level. We argue that, while reform at the federal level would ultimately be a more sustainable long-term solution, state-based policy reforms can help mitigate the ethical shortcomings of EOHD.
    背景与目标: : 在美国,估计有6,500名无证移民被诊断出患有终末期肾病 (ESRD)。这些人没有资格参加涵盖公民透析和/或移植的联邦保险计划,因此要遵守有关提供医疗保健的地方或州政策。在76% 州,无证移民没有资格接受预定的门诊透析治疗,并且通常仅在出现严重威胁生命的症状时才接受透析。“仅急诊血液透析” (EOHD) 与更高的医疗费用,更高的死亡率和更长的住院时间相关。在本文中,我们提出了对现有联邦政策的道德批评。我们认为,EOHD代表了信托和专业义务的失败,加剧了道德困扰,并破坏了医生成为医疗资源良好管理者的义务。然后,我们根据州一级出台的政策,探索潜在的改革途径。我们认为,尽管联邦一级的改革最终将是一种更可持续的长期解决方案,但基于州的政策改革可以帮助减轻EOHD的道德缺陷。
  • 【[农业问题与公共卫生: 对新自由主义的批判的评论]。】 复制标题 收藏 收藏
    DOI:10.1590/s1413-81232007000100003 复制DOI
    作者列表:Stotz EN
    BACKGROUND & AIMS: -2
    背景与目标: -2
  • 6 Codependency: a critique. 复制标题 收藏 收藏

    【相互依赖: 一种批评。】 复制标题 收藏 收藏
    DOI:10.1080/02791072.1990.10472551 复制DOI
    作者列表:Harper J,Capdevila C
    BACKGROUND & AIMS: :An examination of the origins and development of the codependency concept finds it rooted in an obsolete disturbed-personality hypothesis. Both the current literature and treatment philosophy in the chemical dependency field reflect this perspective and continue to perpetuate a pathogenic view of wives who have chemically dependent husbands. Methods of treatment and the validity of treatment for what remains an unverified diagnostic entity are challenged on the grounds of professional ethics and therapeutic efficacy.
    背景与目标: : 对相互依赖概念的起源和发展的考察发现,它植根于过时的受干扰人格假设。化学依赖领域的当前文献和治疗哲学都反映了这一观点,并继续延续了对具有化学依赖丈夫的妻子的致病观点。基于职业道德和治疗功效,对尚未验证的诊断实体的治疗方法和治疗有效性提出了质疑。
  • 【鼻内催产素对社会认知的影响: 批评。】 复制标题 收藏 收藏
    DOI:10.1016/j.brainres.2013.11.008 复制DOI
    作者列表:Evans SL,Dal Monte O,Noble P,Averbeck BB
    BACKGROUND & AIMS: :The last decade has seen a large number of published findings supporting the hypothesis that intranasally delivered oxytocin (OT) can enhance the processing of social stimuli and regulate social emotion-related behaviors such as trust, memory, fidelity, and anxiety. The use of nasal spray for administering OT in behavioral research has become a standard method, but many questions still exist regarding its action. OT is a peptide that cannot cross the blood-brain barrier, and it has yet to be shown that it does indeed reach the brain when delivered intranasally. Given the evidence, it seems highly likely that OT does affect behavior when delivered as a nasal spray. These effects may be driven by at least three possible mechanisms. First, the intranasally delivered OT may diffuse directly into the CNS where it directly engages OT receptors. Second, the intranasally delivered OT may trigger increased central release via an indirect peripheral mechanism. And third, the indirect peripheral effects may directly lead to behavioral effects via some mechanism other than increased central release. Although intranasally delivered OT likely affects behavior, there are conflicting reports as to the exact nature of those behavioral changes: some studies suggest that OT effects are not always "pro-social" and others suggest effects on social behaviors are due to a more general anxiolytic effect. In this critique, we draw from work in healthy human populations and the animal literature to review the mechanistic aspects of intranasal OT delivery, and to discuss intranasal OT effects on social cognition and behavior. We conclude that future work should control carefully for anxiolytic and gender effects, which could underlie inconsistencies in the existing literature. This article is part of a Special Issue entitled Oxytocin and Social Behav.
    背景与目标: : 在过去的十年中,有大量已发表的研究结果支持以下假设: 鼻内递送催产素 (OT) 可以增强社交刺激的处理并调节与社会情感相关的行为,例如信任,记忆,忠诚和焦虑。在行为研究中使用鼻喷雾剂进行OT已经成为一种标准方法,但是关于其作用仍然存在许多问题。OT是一种无法穿过血脑屏障的肽,并且尚未证明它在鼻内递送时确实会到达大脑。有了证据,OT似乎很可能会以鼻喷雾剂的方式影响行为。这些影响可能由至少三种可能的机制驱动。首先,鼻内递送的OT可能直接扩散到CNS中,在那里它直接与OT受体接合。其次,鼻内递送的OT可能会通过间接外围机制触发增加的中央释放。第三,间接的外围效应可能通过增加中枢释放以外的其他机制直接导致行为效应。尽管鼻内传递的OT可能会影响行为,但关于这些行为变化的确切性质的报道相互矛盾: 一些研究表明OT影响并不总是 “亲社会”,而另一些研究则表明对社会行为的影响是由于更普遍的抗焦虑作用。在这项批评中,我们借鉴了健康人群的工作和动物文献,回顾了鼻内OT递送的机制方面,并讨论了鼻内OT对社会认知和行为的影响。我们得出的结论是,未来的工作应仔细控制抗焦虑和性别影响,这可能是现有文献中不一致的基础。本文是题为催产素和社会行为的特刊的一部分。
  • 【乳腺癌治疗的补充/替代疗法。随机临床试验的系统综述和对当前术语的批评。】 复制标题 收藏 收藏
    DOI:10.1111/j.1524-4741.2006.00340.x 复制DOI
    作者列表:Ernst E,Schmidt K,Baum M
    BACKGROUND & AIMS: :The objectives of this study was to evaluate and critically analyze all randomized clinical trials (RCTs) of ''alternative cancer cures'' (ACCs) for breast cancer. The electronic databases Cochrane Central Register of Controlled Trials, MEDLINE, EMBASE, Allied and Complementary Medicine, Scirus, BIOSIS, CancerLit and CINAHL and for ongoing trials the MetaRegister at http://www.controlled-trials.com/ and the National Research Register at http://www.update-software.com/national/ were searched from their inception. Bibliographies of located studies were scanned. Unpublished or ongoing trials were identified through correspondence with experts in the field. Our own files were hand searched for further RCTs. Review methods included a systematic review of RCTs involving breast cancer patients treated with ACCs, survival, parameters indicative of tumor burden, disease progression, cancer recurrence, and cancer cure. Results were tabulated and summarized. Thirteen RCTs met the inclusion criteria. In most cases their methodological quality is low, with only two RCTs scoring ''4'' and four RCTs scoring ''3'' out of 5 possible points for methodological quality. The treatments tested included various methods of psychosocial support such as group support therapy, cognitive behavioral therapy cognitive existential group therapy, a combination of muscle relaxation training and guided imagery, the Chinese herbal remedy Shi Quan Da Bu Tang, thymus extract, transfer factor, melatonin, and factor AF2. Encouraging but not fully convincing results emerged for melatonin.
    背景与目标: : 这项研究的目的是评估和严格分析乳腺癌 “替代癌症疗法” (ACCs) 的所有随机临床试验 (rct)。电子数据库Cochrane对照试验,MEDLINE,EMBASE,联合和补充医学,Scirus,BIOSIS,CancerLit和CINAHL的中央注册,正在进行的试验的MetaRegister在http:// www.controlled-trials.com/和国家研究注册在http:// www.update-software.com/national/从一开始就被搜索过。扫描了定位研究的书目。通过与该领域专家的通信,确定了未发表或正在进行的试验。我们自己的文件被手工搜索以寻找更多的随机对照试验。审查方法包括对涉及接受ACCs治疗的乳腺癌患者的rct,生存率,指示肿瘤负担的参数,疾病进展,癌症复发和癌症治愈的系统审查。结果被制成表格并进行总结。13个rct符合纳入标准。在大多数情况下,它们的方法学质量较低,在方法学质量的5个可能点中,只有两个rct得分为 “4”,四个rct得分为 “3”。测试的治疗方法包括各种心理社会支持方法,例如团体支持疗法,认知行为疗法,认知存在的团体疗法,肌肉放松训练和指导图像的组合,中草药疗法石泉大补汤,胸腺提取物,转移因子,褪黑激素和因子af2。褪黑激素的结果令人鼓舞,但并不完全令人信服。
  • 【对杰弗里·萨克斯 (Jeffrey D. Sachs) 的《贫困的终结》的批评。】 复制标题 收藏 收藏
    DOI:10.2190/DR5B-3X5T-8AMX-5F3G 复制DOI
    作者列表:Henwood D
    BACKGROUND & AIMS: :Jeffrey Sachs's The End of Poverty is a manifesto and how-to guide on ending extreme poverty around the world; it promotes the U.N. Millennium Development Goals. Sachs achieved fame with his policy package for the "stabilization" of Bolivia (which did nothing to relieve Bolivia's poverty), and became advisor to the Yeltsin government in Russia and to Poland, Slovenia, and Estonia as they began their transitions to capitalism (the last three mixed successes; Russia a thorough disaster). Sachs later became more prominent as a critic of development orthodoxy, and was economic advisor to the Jubilee 2000 movement. The End of Poverty is full of sharp critiques of Western imperialism, but his views on the rest of the development business are more conventional.
    背景与目标: : 杰弗里·萨克斯 (Jeffrey Sachs) 的《贫困的终结》是结束世界各地极端贫困的宣言和指南; 它促进了联合国千年发展目标。萨克斯 (Sachs) 凭借其 “稳定” 玻利维亚的一揽子政策而声名fa起 (这对缓解玻利维亚的贫困没有任何作用),并成为俄罗斯叶利钦政府以及波兰,斯洛文尼亚和爱沙尼亚的顾问,因为他们开始向资本主义过渡 (最后三个成功混合; 俄罗斯是一场彻底的灾难)。萨克斯 (Sachs) 后来成为发展正统的批评家,并成为禧年2000运动的经济顾问。贫困的终结充满了对西方帝国主义的尖锐批评,但他对其他开发业务的看法更为常规。
  • 【临床研究中的合理风险: 综合方法的批评和建议。】 复制标题 收藏 收藏
    DOI:10.1002/sim.2634 复制DOI
    作者列表:London AJ
    BACKGROUND & AIMS: :Before participants can be enrolled in a clinical trial, an institutional review board (IRB) must determine that the risks that the research poses to participants are 'reasonable.' This paper examines the two dominant frameworks for assessing research risks and argues that each approach suffers from significant shortcomings. It then considers what issues must be addressed in order to construct a framework for risk assessment that (a) is grounded in a compelling normative foundation and (b) might provide more operationally precise guidance to the deliberations of various stakeholders. The paper concludes by sketching the outlines of what is referred to as the 'Integrative Approach' to risk assessment and by highlighting some of the ways in which this approach may be more promising than current alternatives.
    背景与目标: : 在参与者可以参加临床试验之前,机构审查委员会 (IRB) 必须确定研究对参与者构成的风险是 “合理的”。本文研究了评估研究风险的两个主要框架,并认为每种方法都存在重大缺陷。然后,它考虑了必须解决哪些问题,以便建立一个风险评估框架,该框架 (a) 基于令人信服的规范基础,(b) 可以为各利益攸关方的审议提供更准确的操作指导。本文最后概述了所谓的风险评估 “综合方法” 的概述,并强调了这种方法可能比当前的替代方法更有希望的一些方式。
  • 【急性冷诱导的大鼠肝脏和大脑中细胞蛋白和核酸的变化; 生化和细胞化学研究的描述和批评。】 复制标题 收藏 收藏
    DOI:10.1016/0014-4827(55)90142-7 复制DOI
    作者列表:GORDON MW,NURNBERGER JI
    BACKGROUND & AIMS: -2
    背景与目标: -2
  • 【对 “阈值在环境影响评估中的重要性: 加拿大的说明性案例研究” 的批评的回应。】 复制标题 收藏 收藏
    DOI:10.1007/s00267-019-01182-7 复制DOI
    作者列表:Singh GG,Lerner J,Clarke Murray C,Wong J,Mach M,Ranieri B,Peterson St-Laurent G,Guimaraes A,Chan KMA
    BACKGROUND & AIMS: :Our paper, "The Insignificance of Thresholds in Environmental Impact Assessment: An Illustrative Case Study in Canada" received a critique that challenged us on a number of grounds. Namely, that we defame EIA practitioners, that we advocate EIAs to become a scientific enterprise, that we do not recognize the complexity inherent in EIA, and that EIA undergo an independent assessment by regulators. We respond to all of these points, and argue that conflict of interest is an institutional issue (not one of corrupt practitioners), and that we critique the science that forms the basis of evidence in EIA. Further, we show that the complexity and uncertainty in the critique cannot explain the findings from our paper that all cases of impact threshold exceedance were determined to be not significant in EIA. Finally, we compare the significance determinations in proponent reports to final regulator decisions and determine that they are overwhelmingly identical (93-95%). Regulators are financially independent of proponents, but their decisions on significant are heavily dependent on the information and analysis provided by the proponent reports. As regulators rely on these reports, environmental impact assessments must be based on rigorous and transparent analysis.
    背景与目标: : 我们的论文 “阈值在环境影响评估中的重要性: 加拿大的说明性案例研究” 受到了批评,以多种理由挑战了我们。也就是说,我们诽谤EIA从业者,我们主张EIA成为科学企业,我们不认识到EIA固有的复杂性,并且EIA经过监管机构的独立评估。我们对所有这些观点都做出了回应,并认为利益冲突是一个制度问题 (而不是腐败的从业者之一),并且我们批评构成EIA证据基础的科学。此外,我们表明,批评中的复杂性和不确定性无法解释我们论文的发现,即所有影响阈值超标的情况都被确定为在EIA中并不重要。最后,我们将支持者报告中的重要性确定与最终监管机构的决定进行比较,并确定它们绝大多数相同 (93-95%)。监管机构在财务上独立于支持者,但其重大决策在很大程度上取决于支持者报告提供的信息和分析。由于监管机构依赖这些报告,因此环境影响评估必须基于严格和透明的分析。
  • 【对外阴疾病当前分类的批判。】 复制标题 收藏 收藏
    DOI:10.1097/00000372-199008000-00009 复制DOI
    作者列表:Kiryu H,Ackerman AB
    BACKGROUND & AIMS: :Several classifications of vulvar diseases have been proposed, but none of them is either consistent internally or applicable clinically and histopathologically. Ambiguous and even inexplicable terms such as "atypical epithelial hyperplasia (dysplasia)", "vulvar dystrophy," "vulvar atypia," "atrophic dystrophy," "mixed dystrophy," and "vulvar intra-epithelial neoplasia" prevent clinicians and histopathologists from communicating effectively with each other. In addition, these terms have different meanings to dermatologists, pathologists, and gynecologists--if indeed they have any meaning at all. If that maelstrom of confusion is to be avoided, diagnoses by histopathologists must be made in the language of clinical medicine. Only then will clinicians be able to understand those diagnoses and thereby manage patients rationally. For example, if findings by conventional microscopy are those of squamous-cell carcinoma in situ of the vulva, the diagnosis of pathologists should be Bowen's disease or bowenoid papulosis and not "vulvar intra-epithelial neoplasia"--a term that is just as applicable to seborrheic keratosis as it is to Bowen's disease and bowenoid papulosis.
    背景与目标: : 已经提出了几种外阴疾病的分类,但它们在内部或临床和组织病理学上都不一致。诸如 “非典型上皮增生 (异型增生)”,“外阴营养不良”,“外阴异型”,“萎缩性营养不良”,“混合性营养不良” 和 “外阴上皮内瘤变” 之类的模棱两可甚至莫名其妙的术语,使临床医生和组织病理学专家无法有效地进行交流。彼此。此外,这些术语对皮肤科医生,病理学家和妇科医生有不同的含义-如果确实有任何含义。如果要避免混乱的漩涡,组织病理学家的诊断必须用临床医学的语言进行。只有这样,临床医生才能理解这些诊断,从而合理地管理患者。例如,如果通过常规显微镜检查发现的是外阴原位鳞状细胞癌,病理学家的诊断应该是Bowen病或bowenoid丘疹病,而不是 “外阴上皮内瘤变”-这个术语适用于脂溢性角化病,也适用于Bowen病和bowenoid丘疹病。
  • 【对医学研究所报告 “药物安全的未来” 的回顾和批评。】 复制标题 收藏 收藏
    DOI:10.1038/sj.clpt.6100083 复制DOI
    作者列表:Benet LZ
    BACKGROUND & AIMS: :In September 2006 an Institute of Medicine (IOM) ad hoc committee on the Assessment of the US Drug Safety System released its report entitled "The Future of Drug Safety: Promoting and Protecting the Health of the Public". The committee's report includes 25 recommendations that "will bring the strengths of the preapproval process (data, regulatory authority, organizational function and capabilities, and resources) to the postapproval phase in order to fulfill a lifecycle approach to the study, regulation, and communication about the risks and benefits of drugs." Copies of the report are available from the National Academies Press (800-624-6242), and the full text is available at http://www.nap.edu.
    背景与目标: : 2006年9月,美国医学研究所 (IOM) 评估美国药物安全体系特设委员会发布了题为 “药物安全的未来: 促进和保护公众健康” 的报告。该委员会的报告包括25项建议,“将把预批准过程的优势 (数据、监管机构、组织职能和能力以及资源) 带到后批准阶段,以实现研究、监管和药物风险和益处沟通的生命周期方法。”该报告的副本可从国家科学院出版社 (800-624-6242) 获得,全文可在http://www.nap.edu获得。
  • 【第二层天然抗抑郁药: 回顾与批评。】 复制标题 收藏 收藏
    DOI:10.1016/j.jad.2010.06.010 复制DOI
    作者列表:Iovieno N,Dalton ED,Fava M,Mischoulon D
    BACKGROUND & AIMS: :The use of Complementary and Alternative Medicine (CAM) for physical and mental problems has increased significantly in the US over the past two decades, and depression is one of the leading indications for the use of CAM. This article reviews some of the lesser-known natural products with potential psychiatric applications that are starting to emerge with some scientific and clinical evidence and may constitute a next wave of natural antidepressants: Rhodiola rosea, chromium, 5-Hydroxytryptophan (5-HTP) and inositol. Background information, efficacy data, proposed mechanisms of action, recommended doses, side effects, and precautions are reviewed. We found some encouraging data for the use of these natural products in specific populations of depressed patients. R. rosea is an adaptogen plant that can be especially helpful in treating asthenic or lethargic depression, and may be combined with conventional antidepressants to alleviate some of their common side effects. Chromium has a beneficial effect on eating-related atypical symptoms of depression, and may be a valuable agent in treating atypical depression and seasonal affective disorder. Inositol may be useful in the treatment of bipolar depression when combined with mood stabilizers. Evidence for the clinical efficacy of 5-HTP is also promising but still preliminary. Although more well-designed and larger controlled studies are needed before any substantive conclusions can be drawn, the available evidence is compelling and these natural products deserve further investigation as a possibly significant addition to the antidepressant armamentarium.
    背景与目标: : 在过去的二十年中,美国对身体和精神问题的补充和替代医学 (CAM) 的使用显着增加,抑郁症是使用CAM的主要适应症之一。本文回顾了一些鲜为人知的具有潜在精神病学应用的天然产品,这些产品已开始出现,并有一些科学和临床证据,可能构成下一波天然抗抑郁药: 红景天,铬,5-羟基色氨酸 (5-HTP) 和肌醇。回顾了背景信息,功效数据,建议的作用机制,推荐剂量,副作用和预防措施。我们发现了一些令人鼓舞的数据,这些天然产物在特定的抑郁症患者人群中使用。R. rosea是一种适应原植物,可特别有助于治疗虚弱或昏睡性抑郁症,并可与常规抗抑郁药联合使用以减轻其某些常见副作用。铬对饮食相关的非典型抑郁症症状具有有益作用,并且可能是治疗非典型抑郁症和季节性情感障碍的有价值的药物。肌醇与情绪稳定剂联合使用可能可用于治疗双相抑郁。5-HTP临床疗效的证据也是有希望的,但仍是初步的。尽管在得出任何实质性结论之前需要进行更精心设计和更大规模的对照研究,但现有证据令人信服,这些天然产物值得进一步研究,作为抗抑郁药军械库的重要补充。

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