孟鲁司特致神经精神不良反应文献分析

目的了解孟鲁司特致神经精神不良反应发生的相关规律、特点,寻找风险因素,为临床安全用药提供参考。方法在新乡医学院第一附属医院中国医院药物警戒系统(CHPS v2.0)的药品评价系统中,通过医嘱检索、病历检索这两个检索维度,检索2019年1月—2020年2月使用孟鲁司特过程中发生"兴奋""焦虑""抑郁""迷失方向或混乱""注意力不集中""噩梦""幻觉""失眠""震颤""烦躁""易怒""梦游""自杀""强迫症""不安""口吃""肌肉不自主运动"等神经精神症状的病例;同时检索万方数字化期刊全文库、中国学术期刊(网络版)、中文科技期刊全文数据库(维普)中孟鲁司特相关神经精神不良反应报道,合并文献病例与院内病例,回顾性统计分析患者性别、年龄、原患疾病、用药剂量、合用用药、不良反应表现、发生时间、严重程度、治疗和转归等项目。结果收集院内病例15例,文献检索获得病例12例,合计入选病例27例。关联性评价结果显示,"可能有关"4例(14.8%),"很可能"有23例(85.2%);院内病例统计神经精神不良反应发生率0.33%;40～65岁年龄段不良事件发生率最高;13例不良反应无使用孟鲁司特的用药指征;未发现给药剂量与不良反应发生的相关性;不良反应表现为焦虑、噩梦、烦躁/激动/言语多、攻击性强较多,也可见遗尿、头痛头胀、肢体麻木等;发生时间多在用药后7 d以内,最快的0.5 h,也有延至数周后的可能;停药后绝大多数可以恢复正常且恢复较快。结论孟鲁司特可能导致神经精神不良反应,临床应用时需严格把握用药指征,加强用药监护,在儿童患者的临床应用中应更加引起关注,一旦发生不良反应要立即停止使用,特别是在服药开始后一周内要加强临床观察。相关神经精神不良反应停药后多数可以恢复。     

Was It Worth Introducing Health Economic Evaluation of Innovative Drugs in the French Regulatory Setting? The Case of New Hepatitis C Drugs

Objective

This paper constitutes the first attempt to draw lessons from the recent uptake of health economic evaluation of innovative drugs in the French regulatory framework.

人工智能在肿瘤领域应用现状及发展前景

综述人工智能在肿瘤领域的技术方法和应用现状，包括肿瘤风险评估、诊断、治疗、护理等方面，探讨其面临的机遇与挑战，以期为人工智能助力肿瘤诊疗和照护提供参考，推动人工智能在肿瘤领域应用进一步发展。     

药品审评检查机构质量管理体系建设实践探索

目的:贯彻国务院强化质量管理、落实全国药监部门完善自身质量管理体系工作部署,梳理山东省药品审评检查机构质量管理体系建设情况,总结经验、查找不足,加强审评检查质量管理。方法:调研药品审评检查机构导入质量管理体系的现实意义,剖析山东省药品审评检查机构质量管理体系建设的实践经验,思考存在的问题。结果:行之有效的质量管理体系对药品审评检查机构规范化建设和药品审评检查发展起到了积极的推动作用。结论:药品审评检查机构推进质量管理体系建设,对规范自身建设、提高工作质量、降低业务风险、服务医药产业发展具有重要作用,也是必然要求,药品审评检查机构质量管理体系需要持续改进,逐渐与国际接轨。     

Use of Checklists in Reviews of Health Economic Evaluations, 2010 to 2018

Objective

It is useful for reviewers of economic evaluations to assess quality in a manner that is consistent and comprehensive. Checklists can allow this, but there are concerns about their reliability and how they are used in practice. We aimed to describe how checklists have been used in systematic reviews of health economic evaluations.

中医外治法治疗过敏性鼻炎的临床研究近况

参照近10年相关文献,对治疗过敏性鼻炎的中医外治法进行了梳理分析,总结了临床常用的外治法有针刺疗法、灸法、穴位贴敷、穴位注射、穴位埋线、推拿疗法、特色疗法、局部给药及综合疗法,并分析了各自的优势及有效性,以期为临床治疗过敏性鼻炎提供借鉴。     

Closing the evidence-practice gaps in aphasia management: are we there yet? Where has a decade of implementation research taken us? A review and guide for clinicians

Background: There are evidence-practice gaps in all areas of aphasia management across the continuum of care. Despite the recognition that effective implementation strategies are needed to improve the consistency of speech pathologists’ aphasia management practices, there have been few studies investigating this important issue. Therefore, little is known about the effectiveness of implementation strategies in the field of aphasiology. In light of the developing field of knowledge translation, it is important to review the aphasia implementation literature to highlight current trends, draw together findings, and determine future implementation research needs.

Aims: To critically review, summarise, and discuss the implementation literature in the field of aphasiology to date, in order to guide clinical aphasiologists to work towards closing the evidence-practice gaps in aphasia management.

Main contribution: A review of the literature in this developing area of expertise in the field of aphasiology, with examples of practical applications.

Conclusions: Only six implementation studies have been published in aphasia (related to conversation partner training, discourse analysis, information provision, and collaborative goal-setting practices), showing there is a need for capacity building in this area. Therefore, we are not yet able to state what interventions are effective in which context, nor fully understand how behaviour change occurs for clinicians providing aphasia management. Implications for speech-language pathologists are discussed. An overarching call to action is the need for clinicians and researchers to work together to drive future implementation efforts that can succeed in closing the aphasia management evidence-practice gaps.     

Impaired self-awareness after traumatic brain injury: a systematic review. Part 1: Assessment,clinical aspects and recovery

BackgroundImpaired self-awareness (ISA) has frequently been found to be both frequent and deleterious in patients with moderate to severe traumatic brain injury (TBI).ObjectivesThe present paper is the first of a two-part systematic review of ISA after traumatic brain injury (TBI), focusing on assessment methods, clinical aspects and recovery.MethodsFollowing the PRISMA guidelines, 95 articles meeting the inclusion criteria were included.ResultsISA occurs in 30% to 50% of patients with moderate to severe TBI, although it tends to improve with time. There is no one single gold-standard measure of ISA. Self-proxy discrepancy scores, with scales such as the Patient Competency Rating Scale or the Awareness Questionnaire, or a structured interview such as the Self Awareness of Deficits Interview, are the most frequently used assessment methods, with adequate psychometric properties. Scores on these different scales correlate only moderately with each other, which suggests that they may address different aspects of self-awareness. ISA mainly concerns cognitive and behavioral problems rather than physical or sensory impairments and may concern different areas of functioning, such as anticipatory, emergent or meta-cognitive awareness.ConclusionISA is a complex and multifaceted issue that should be systematically assessed in rehabilitation settings using a range of relatively well-validated tools. The consequences and predictors of ISA after TBI will be addressed in a companion paper.     

A comparison of efficacy and safety of complementary and alternative therapies for severe mycoplasma pneumonia in children: A protocol for systematic review and meta-analysis

Background:In recent years, the incidence rate of children with severe Mycoplasma pneumoniae pneumonia (SMPP) is increasing, which poses a great threat to children''s life and safety. There are some limitations in the existing drugs for the treatment of SMPP, and the supplementary and alternative therapy of SMPP plays an irreplaceable role in the treatment of this disease. This study will evaluate the efficacy and safety of various complementary and alternative therapies for SMPP by means of mesh meta-analysis. In order to provide the basis for clinical rational use.Methods:Two researchers will independently and comprehensively searched the Cochrane Central controlled trials registry, Cochrane Library, PubMed, web of science, EMBASE, CNKI, and Wanfang database to collect randomized controlled trials (RCT) studies on complementary and alternative therapies for SMPP. And the relevant references included in the systematic review/meta-analysis are screened. The retrieval time limit is from the establishment of the database to November 2020. We will use Revman 5.3 software for meta-analysis and use grade to grade the quality of evidence in the net meta-analysis (NMA).Results:The aim of this study was to compare the efficacy and safety of different complementary and alternative therapies in the treatment of SMPP, with a view to evaluating and ranking different interventions.Conclusion:The supplement and replacement therapy of SMPP can improve the clinical efficacy, relieve the clinical symptoms, improve the quality of life of children, and reduce adverse reactions, which can provide strong support for the rational use of clinicians.INPLASY registration number:INPLASY2020110079.