组织病理学同行评议的GLP要求及关注点探讨

目的：探讨组织病理学同行评议的GLP要求及关注点。方法：简要介绍药物非临床安全性评价领域组织病理学同行评议的指导原则、目的、GLP要求、GLP符合性要求、种类、地点、病理工作组、同行评议病理学家和专题病理学家的职责、动物数量的选择、建议归档文件、同行评议声明以及使用数字扫描全切片图像进行同行评议等内容。结果：组织病理学同行评议可核实并提高病理诊断和病理解释的准确性、一致性及完整性,提高病理报告的质量;同时,可作为毒性病理学家继续教育的重要组成部分。结论：本文探讨组织病理学同行评议的GLP要求及关注点,以期为我国药物非临床安全性评价领域更好地开展符合GLP的组织病理学同行评议提供一些参考。     

应用全切片图像进行毒性病理学同行评议的研究进展

全切片图像是通过数字切片扫描仪将整个组织切片扫描生成的二维图像，近年来已广泛应用于病理学教学、组织切片讨论、科研等领域。参照美国毒性病理学会（STP）对全切片图像在诊断中的应用建议、经济合作与发展组织（OECD）和美国食品药品管理局（FDA）关于使用全切片图像进行病理学同行评议的指导原则，对药物非临床研究质量管理规范（GLP）条件下应用全切片图像进行毒性病理学同行评议的工作流程、内容和要求进行相关总结。同时结合中国合同研究组织（CRO）采用全切片图像开展毒性病理学评价进行概述，以期提升我国毒性病理学评价和病理学同行评议工作的规范性与专业水平。     

Fractionated delivery systems for difficult to treat clinical applications: acne scarring, melasma, atrophic scarring, striae distensae, and deep rhytides

Fractional resurfacing or laser therapy (FLT) represents a technology that seeks to address the limitations of both ablative resurfacing and nonablative treatments. Many companies now offer versions of fractionated erbium or carbon dioxide lasers. The purpose of this paper is to examine FLT for difficult to treat applications such as melasma, acne scarring, atrophic scarring, striae distensae, and deep rhytides. Fractional laser therapy is a truly novel approach to many conditions, especially those with dermal pathology. Although published peer review data is limited, the ability to effectively and safely treat these conditions in all skin types appears to have been significantly enhanced with this new modality. We are early in our scientific explorations of what is possible with FLT.     

α-常春藤皂苷一氧化氮供体衍生物的合成及其抗肿瘤活性研究

目的合成并表征α-常春藤皂苷一氧化氮供体衍生物,并对其抗肿瘤活性进行研究。方法采用苯硫酚作为起始原料,以不同长度的二醇作为连接臂,将α-常春藤皂苷的28位羧基和呋咱氮氧化物连接在一起得到α-常春藤皂苷一氧化氮供体衍生物;并采用MTT法对目标化合物进行体外抗乳腺癌活性研究。结果合成了4个α-常春藤皂苷一氧化氮供体衍生物,其结构均通过1H-NMR和MS确证。生物活性结果测试表明其抗肿瘤活性均优于阳性对照药α-常春藤皂苷。结论α-常春藤皂苷一氧化氮供体衍生物抗肿瘤活性明显,具有很好的开发价值。     

Publication of presented abstracts at annual scientific meetings: a measure of quality?

One measure of the quality of research presented at the annual scientific meeting is publication of the data presented in a peer review journal. This allows for a more rigorous review of design, methodology and conclusions. To determine the rate of subsequent publication, MEDLARS searches were performed on the 269 presented abstracts at the 1984 and 1986 meetings of the American Association of Poison Control Centers, The American Academy of Clinical Toxicology, The American Board of Medical Toxicology and the Canadian Association of Poison Control Centers. Of the 296 presented abstracts, 134 (49.8%) were published. There was no difference in the eventual publication rate between the 1984 and 1986 meeting. There were 38 non-reviewed symposia publications and 96 peer-reviewed articles. Publications of 35.7% of presented abstracts in peer review journals compares poorly with the percentage of peer-reviewed publication from other scientific meetings. If publication in a peer-review journal is important, steps should be taken to improve the percentage of presented abstracts that are accepted by peer-review journals.     

Peer Supports for Tobacco Cessation for Adults with Serious Mental Illness: A Review of the Literature

OBJECTIVE: A relatively new approach to addressing tobacco use in mental health settings is the involvement of consumers or peers, defined as other individuals with mental health conditions, as service providers. This review examines the literature describing peer delivered supports for tobacco cessation for adults with serious mental illness. METHODS: The authors conducted a review of online databases to identify reports of tobacco cessation interventions in which peers play a key role in the provision of services to help other adults with serious mental illness to reduce or quit using tobacco. RESULTS: Our review yielded reports of four tobacco cessation interventions for persons with serious mental illness that include peer providers. The roles of peers in these interventions include that of co-leaders of an educational smoking cessation group, individual counselors as part of a multi-faceted tobacco treatment program, and as outreach tobacco cessation advocates. CONCLUSIONS: The roles of peers in these interventions are promising; however, more detail about the selection and experience of the peer providers, as well as the services they deliver in tobacco cessation interventions, would be helpful. In addition, rigorous research is needed to evaluate the impact of peer providers on reducing tobacco use in this population.     

组织病理学评估及同行评议的原始数据及GLP符合性解读

组织病理学评估是药物非临床安全性评价的重要环节，组织病理学同行评议不仅可以确保诊断术语的一致性和准确性，而且可以提高病理诊断的准确性和病理学报告的质量。因为GLP质量体系的核心是原始数据，所以要确保最终病理学报告能够真实反映原始数据。组织病理学评估和同行评议的原始数据是病理学报告重建和保证报告质量的基础。本文对国内外GLP法规对原始数据的定义、美国FDA对病理学原始数据的规定、国内外监管机构对组织病理学同行评议中原始数据的规定、不同类型组织病理学同行评议中的原始数据以及组织病理学同行评议的GLP符合性进行分析，希望为我国GLP机构更好地开展组织病理学评估及同行评议提供一定参考。     

美国FDA《非临床毒理学研究病理学同行评议指南草案》关注点探讨

目的:探讨美国食品药品监督管理局于2019年7月发布的《非临床毒理学研究病理学同行评议指南草案》内容,以期为我国药物非临床安全性评价更好地开展病理学同行评议提供借鉴。方法:对《非临床毒理学研究病理学同行评议指南草案》的制定背景、有关非临床毒理学研究的病理学同行评议的计划、管理、记录和报告的建议进行分析,并与经济合作与发展组织分别于2012年颁布的《长期毒性和致癌性实验的设计和实施》指导性文件第116号和2014年颁布的第16号文件《组织病理学同行评议GLP要求指导原则》进行比较。结果:从与病理学同行评议相关的8个方面内容对《非临床毒理学研究病理学同行评议指南草案》进行梳理,有关病理学同行评议的定义、同行评议病理学家的资质、病理学同行评议的时间及类型分别与OECD第16号文件中相应内容一致。而关于在非GLP机构进行GLP研究病理学同行评议的要求、病理学同行评议过程的记录、病理学同行评议声明的内容及签署、如何确保专题病理学家的解释结果不会受到过度影响,以及解决专题病理学家和同行评议病理学家分歧的程序与OECD第16号文件中相应内容存在差异。结论:《非临床毒理学研究病理学同行评议指南草案》的...     

A peer review quality assurance program in drug information

The development and implementation of a peer review quality assurance program for a drug information service is described. Eight drug information centres across Canada initially agreed to participate as peer reviewers. Critera were developed to select drug information requests that would qualify for the program. Peer review responses were compared to the centre's response by a panel of four drug information pharmacists. Thirteen of 14 requests sent to peer reviewers were returned and there was agreement between the conclusions and recommendations provided in the responses by our drug information centre and the peer review pharmacist in 11 cases. Peer reviewer pharmacists tended to prepare more in depth responses. This represents the first report of a peer review quality assurance program for a drug information service.     

Radiologist review versus group peer review of claimed responses in a phase II study on high-dose ifosfamide in advanced soft tissue sarcomas of the adult: a study of the EORTC Soft Tissue and Bone Sarcoma Group

The Soft Tissue and Bone Sarcoma Group (STBSG) of the EORTC ran a phase II study to assess the therapeutic activity of high-dose ifosfamide in patients with advanced soft tissue sarcomas by means of response rate (RR). Investigators claiming a response submitted the relevant chest radiographs (CXR) or scans to two other members of the STBSG for peer review. The reviewers completed a questionnaire indicating overall response or reasons for rejecting the claimed responses. An independent radiologist also reviewed the cases and he was blinded to the results of the peer review until the study was concluded. Twenty-two patients were reviewed by the radiologist and peer review, and the completed questionnaires were retrospectively reviewed. Two differences were noted, one partial responder (PR) was regarded as stable disease by the radiologist and one PR by peer review was determined a complete response by the radiologist. The radiologist found subsequent evidence of progressive disease in three patients who initially showed a PR, whilst the review group noted only one. This study suggests peer review in this tumor type is a satisfactory method of achieving an accurate, objective RR.     

Self-determination,perceived approval,and drinking: Differences between Asian Americans and Whites

The present research assessed racial differences in the associations among controlled orientation, injunctive norms, and increased drinking by White and Asian American college students. Previous research has noted racial differences in drinking, but reasons have not been considered in the context of individual differences in self-determination or responses to social influences. The authors evaluated perceived parental and peer injunctive norms as mediators of the relationship between controlled orientation and number of drinks consumed per week. The association between controlled orientation and drinking was further expected to be moderated by race. This study consisted of 534 White and 198 Asian American participants who had at least one heavy drinking episode in the month prior to assessment. Participants completed self-report measures assessing self-determination, perceived parental/peer injunctive norms, and drinking. Results indicated that peer injunctive norms served as a mediator between controlled orientation and greater number of drinks consumed per week for Whites only. Although Asian Americans were significantly higher in controlled orientation than Whites, they drank less and perceived their peers to be less approving of drinking. In contrast, Whites who were high in controlled orientation viewed their friends as being significantly more approving of alcohol and consumed significantly more drinks per week. Results provide unique considerations for understanding cultural differences in drinking among White and Asian American young adults.     

The national toxicology program chemical nomination selection and testing process

The NTP is an interagency program of the Federal Government which coordinates toxicological programs at the NIH (NIEHS), FDA (NCTR), and CDC (NIOSH) with input from NCI, NIH, OSHA, CPSC, EPA, and ATSDR. The NTP has the capability to completely characterize the toxicologic profile of a chemical, including studies of chemical disposition, genetic toxicity, immunotoxicity, teratology, reproductive toxicity, carcinogenicity, neurotoxicity, and specific organ toxicity. The NTP encourages nominations of chemicals of human health concern from all sectors of the public, including industry, labor, and the general public. The specific process of nomination, evaluation, and selection of chemicals for testing by the NTP is described. It is a multicomponent system with several evaluations and a public peer review step to assure adequate consideration of all nominated chemicals. The results of NTP studies are all peer reviewed and available to the general public as well as to the scientific community.     

Prevention Counseling and Student Assistance Programs: A Review of the Literature

Substance abuse prevention counseling can be found in two venues: school counseling and student assistance programs (SAPs). School prevention counseling is based on school psychology and guidance counseling. The authors of this article did not find any empirical studies of prevention counseling. Six criteria were used to assess the published research on SAPs: research designs, sampling methods, measures, procedures, analyses, and peer review of results. SAP studies reviewed were placed in one of three levels: Rigorous (N = 3; met all inclusion criteria), Informative (N = 2; met all criteria except peer review), and Evaluative (N = 5; weak design, but explicit in describing methods). The Rigorous Studies found a decrease in substance use or risk factors. The two Informative Studies found a decrease in substance use. The Evaluative Studies demonstrated the prevention of increases in substance use.     

The Initial Use of Drugs in a Sample of Pre-teenage Schoolchildren: the role of choice, pressure and influence

The traditional assumption that young people are introduced to illegal drugs as a result of peer pressure has been increasingly challenged in recent years with a number of authors arguing that peer selection and individual choice are more important influences. The present paper seeks to further our understanding of this issue by examining the accounts which a sample of pre-teenage children gave of their initial use of drugs. While peer pressure, a desire to conform to the group, and other attempts to influence them were found to be involved in a proportion of the cases, the dominant factors in initial use were personal choice and curiosity. It was also clear that curiosity, external influences and a desire to conform were not mutually exclusive and would often interact as part of a complex dynamic. The paper concludes by discussing the implications of the findings for drugs education.     

Exogenous endoscopy-related infections,pseudo-infections,and toxic reactions: clinical and economic burden

ABSTRACT

Objectives: The objective of this study was to analyze the characteristics and costs of exogenous endoscopy-related infections, pseudo-infections, and toxic reactions in the US.

Methods: A systematic review of the scientific literature published between 1966 and 2005 was conducted in Medline. Data collection was based on a prospective protocol developed by the authors.

Results: The literature review included 70 outbreaks described in 64 scientific articles. Bronchoscopy accounted for half of all reported outbreaks. Inadequate decontamination practices were the leading cause of contamination; equipment malfunction became the second leading cause of contamination during the period 1990–2004. More than 91% of the infections identified could be prevented by health care providers if quality control systems are improved and implemented. The available economic information concerning exogenous endoscope related events is very limited. A model for the analysis of the economic burden of exogenous endoscopy-related events is proposed.

Conclusions: Proper decontamination practices, the use of protective sheaths, and the improvement of surveillance systems could reduce the clinical and economic burdens associated with exogenous endoscopy-related events.