Hérida Regina Nunes SALGADO,et al:Microbiological assay for the determination of azithromycin in ophthalmic solutionsMicrobiological assay for the determination of azithromycin in ophthalmic solutions

IntroductionAzithromyciniscommercializedbypharmaciesinBrazilinophthalmicsolutionform. Despitetheproveneffectivenessandsafetyinitstreatment, thisdrug,untilthen, doesnotpossessamethodologyofstandar dizedanalysisforophthalmicsolutionsinofficialcom pendiumsan…     

临床试验数据采集与报告文件设计制作的技术规程

临床试验数据采集与报告文件的设计和制作对保证试验数据的质量与完整性至关重要。参照临床试验数据管理规范 (GCP)并结合具体实践经验制订本规程。设计规程包括与方案设计同步、文件格式、问题和提示、冗余数据、数据记录指南、标准化、版本管理与培训 ;印制规程包括审批、印制说明书以及厂商选择。     

临床试验知情同意书的设计规程及范例

临床试验知情同意书分“知情告知”与“同意签字”两部分，其设计应符合完全告知、充分理解、自主选择的原则，必要时还应设计帮助受试者理解研究目的、程序、风险与受益的视听资料。临床试验前需作筛选检查，收集生物标本，必须得到两种知情同意，一种用于生物标本的收集和分析，另一种用于得出满意实验室结果并符合纳入标准后参加试验。本文介绍了知情同意书的设计规程，包括设计依据、设计原则、格式、内容与印刷的规定，以及知情同意书的范例。     

热量限制对成年弱视小鼠初级视皮质突触可塑性的调控作用

目的：探讨热量限制（CR）对成年单眼形觉剥夺（MD）弱视小鼠视皮质突触可塑性的调控作用及可能的分子机制。方法：实验研究。将54只新生健康昆明小鼠按随机数字表法分为正常组、MD+自由进食（AL）组、MD+CR组,每组18 只。小鼠21 日龄时构建MD模型,35 日龄时去除剥夺因素,63 日龄时通过行为学检测视敏度及电生理检测视功能;免疫组织化学及Western Blot法检测视皮质组织中可塑性相关蛋白突触后致密蛋白95（PSD95）、突触素（SYP）、生长相关蛋白43（GAP-43）等的表达;RT-PCR检测胰岛素样生长因子1（IGF-1）的表达。采用重复测量双因素方差分析比较各组数据差异。结果：最终正常组、MD+AL组、MD+CR组分别有14、18、18 只小鼠完成研究。从第1 周开始,MD+CR组小鼠体质量百分比的增加明显低于MD+AL组（P<0.05）。MD+AL组小鼠视敏度明显低于正常组和MD+CR组小鼠的视敏度（P<0.05）。MD+AL组小鼠PSD95、GAP-43、SYP的表达均明显低于正常组和MD+CR组小鼠（P<0.05）。MD+AL组小鼠视皮质中IGF-1 mRNA水平较正常组和MD+CR组显著降低（P<0.05）。结论：CR能改善成年MD弱视小鼠视觉功能,增加视皮质中可塑性相关蛋白的表达,重新激活视皮质可塑性,其机制可能与其调节IGF-1的表达有关。     

Suicidal poisonings with methadone in France: Results of a two year national survey by the Toxicovigilance Network

Context. Methadone is used in France since March 1995, only for opioid maintenance treatment, in a syrup form. For the launching of a capsule form in April 2008, French health authorities requested a prospective survey of all cases involving exposure to methadone in either of the two available pharmaceutical forms. Objective. The aim was to document, in different circumstances and compare the safety of the new capsule form to the syrup. This report presents the findings of one arm of the study, devoted to methadone-related suicide attempts. Materials and method. From April 15, 2008 to April 15, 2010, all self-injurious methadone poisonings notified to or managed by the French Toxicovigilance Centers network were included. Analysis mainly focused on patients’ age and gender, estimated quantity ingested, eventual concomitantly taken substances, distribution of symptoms, and site of treatment. Results. 135 methadone-related suicide attempts were recorded. Analysis showed identical epidemiologic and clinical patient characteristics for the two pharmaceutical forms. Ten deaths occurred. The only discrepancy was a higher incidence of suicide attempts in the capsule group. However, as the number of capsule-treated patients increased during the second year, this difference remained significant but tended to decrease. Discussion. Combining these results with Pharmacovigilance and Addictovigilance arms, health authorities estimated that the benefit/risk balance of this new pharmaceutical form remains positive. They revised their position on requirements for prescribing and dispensing of the capsule form, and made them slightly easier. Following this, this “suicide” arm of Toxicovigilance survey was suspended, whereas the second one, concerning accidental pediatric methadone-related poisonings, has been extended until April 2014. Conclusion. In France, suicide attempts were more likely to occur with the capsule formulation. The clinical severity of intoxication was similar between the capsule and liquid forms.     

Assessing compressibility and compactibility of powder formulations with Near-Infrared Spectroscopy

Context: The compressibility and compatibility of a powder formulation is usually determined by compaction and following destructive tensile strength and relative density measurement of the final compact.

Objective: In this study, a non-destructive method with Near-Infrared Spectroscopy (NIRS) was designed and evaluated for the measurement of powder compressibility and compactibility.

Materials and Methods: 12 different formulations with a wide range of difference in properties were investigated by compaction and analysis of the resulting tablets. Two similar tablet batches were produced with every formulation. Relative density and tensile strength were measured with the traditional, destructive method on one tablet batch while a newly developed non-destructive chemometric NIRS method was applied for the second batch. The outcomes of the two approaches were compared to validate the developed method. All data sets were applied to three established mathematical equations to calculate equation factors, which are claimed to represent the formulation compressibility and compactibility. The study focus was set on the equation factor value comparison between the traditional and the newly designed method.

Results & Discussion: The results showed a high similarity between the outcomes of the two methods. An essential difference was noticed for the outcomes of the equation factors after application to the Leuenberger equation.

Conclusion: The approach with the NIRS is suggested as a promising tool for a reliable inline quality monitoring in the tablet manufacturing process.     

Identification of biomarkers for essential hypertension based on metabolomics

AimEssential hypertension (EH) is one of the most important public health problems worldwide. However, the pathogenesis of EH is unclear and early diagnostic methods are lacking. Metabolomics demonstrates great potential for biomarker discovery and the mechanistic exploration of metabolic diseases.Data synthesisThis review included human and animal metabolomics studies related to EH in the PubMed and Web of Science databases between February 1996 and May 2020. The study designs, EH standards, and reported metabolic biomarkers were systematically examined and compared. The pathway analysis was conducted through the online software MetaboAnalyst 4.0.Twenty-two human studies and fifteen animal studies were included in this systematic review. There were many frequently reported biomarkers with consistent trends (e.g., pyruvate, lactic acid, valine, and tryptophan) in human and animal studies, and thus had potential as biomarkers of EH. In addition, several shared metabolic pathways, including alanine, aspartate, and glutamate metabolism, aminoacyl-tRNA biosynthesis, and arginine biosynthesis, were identified in human and animal metabolomics studies. These biomarkers and pathways, closely related to insulin resistance, the inflammatory state, and impaired nitric oxide production, were demonstrated to contribute to EH development.ConclusionsThis study summarized valuable metabolic biomarkers and pathways that could offer opportunities for the early diagnosis or prediction of EH and the discovery of the metabolic mechanisms of EH.     

学前听障儿童开展聋健融合教育形态的思考

在学前聋健融合教育实践与研究在国内部分聋校及幼儿园已逐渐开展.笔者结合多年的教育实践,将学前聋健融合教育分为初期融合、半日融合、全日融合3种形态,从安置参考依据、安置形式、集体教学内容和个别化教育内容、融合教育指导策略等方面进行了阐述,旨在为学前聋健融合教育研究提供借鉴.