EMA对药用辅料右旋糖酐新的安全性评价

欧洲药品局（EMA）于2018年11月发布了"人用药品辅料右旋糖酐的包装说明书资料"，该文件引用大量文献全面评价了右旋糖酐的安全性，特别指出含有右旋糖酐辅料的注射和吸入制剂的疫苗与药品，应在说明书中描述有关其过敏反应信息的新要求。介绍该文件的主要内容，期望对我国这类药品说明书的撰写和监管有所帮助。     

Conserving resources in the diagnosis of intraoral fibroepithelial polyps

Fibroepithelial polyps (FEPs) are common, benign intraoral lesions that tend to develop slowly at predictable sites, often in response to local irritation or trauma. Historical precedent often results in referral to oral and maxillofacial surgery (OMFS) departments for biopsy, often irrespective of symptoms, and histological assessment. OMFS and pathology services are struggling to cope with an increasing workload that will potentially lead to widespread delays to diagnosis and treatment. Over the past 20 years, clinical pathways and guidance have been developed to ensure that healthcare interventions, such as the removal of third molars, tonsils, skin tags, and benign moles, are evidence-based, have a net patient benefit, and ensure the best use of finite NHS resources. However, no such guidance exists for intraoral lesions and we regard this as an oversight. We analysed the removal of 682 FEPs over a seven-year period and report sensitivities of 92.4% for a “confirmed clinical suspicion of an FEP” and 99.7% for a “confirmed clinical suspicion of a benign diagnosis”. The incidence of non-benign disease was 0.3%. Primary care dentists should be able to diagnose and monitor FEPs and refer only if symptoms are serious or in high-risk patients or sites. Adopting this practice across the UK could free up to 1825 four-hour OMFS clinics, 405 hours of consultant histopathologists’ time, and recurring savings to the NHS estimated to be in the region of £620 000/annum. We believe that the removal of FEPs should be reclassified as an “intervention not normally funded”, and the time and resources put to better use treating patients with lesions of questionable pathology.     

The feasibility of the draw-and-write technique in exploring the resilience of children orphaned by AIDS

Worldwide, researchers routinely study children indirectly through adults who act as proxies for such children. The call for researchers to rather study children directly and adopt less intrusive child-friendly methodologies has become louder. The draw-and-write technique is regarded as a less intrusive child-friendly method of collecting data that can be used for this purpose. This paper reports the findings of a qualitative study that sought to establish the feasibility of the draw-and-write technique in exploring the resilience of children orphaned by AIDS. This study involved a convenience sample of 23 IsiXhosa-speaking orphaned children aged from 13 to 17. The participants were in grades 6 to 10 and they resided in two child and youth care centres in the Eastern Cape province of South Africa. As part of the draw-and-write technique the participants were asked to make drawings of what enabled them to cope with their lives and to write short narratives in which they explained their drawings. Inductive content analysis was used to analyse the data and this process yielded two main themes, namely: personal protective resources and socio-ecological protective resources. The findings show that complex combinations of personal and socio-ecological resilience resources enabled the resilience of the orphaned children. The findings challenge researchers not to be oblivious to alternative child-friendly methods of research such as the draw-and-write technique when young people are the unit of analysis. The findings of this study have implications for research as well as practice in the field of education and psychology.     

Pharmacy in transition: A work sampling study of community pharmacists using smartphone technology

Introduction

The nature of community pharmacy is changing, shifting from the preparation and distribution of medicines to the provision of cognitive pharmaceutical services (CPS); however, often the provision of traditional services leaves little time for innovative services. This study investigated the time community pharmacists spend on the tasks and activities of daily practice and to what extent they are able to implement CPS-related services in daily practice.

我院药物代谢酶和药物作用靶点基因检测与精准药学服务实践与总结

目的回顾我院药物代谢酶和药物作用靶点相关基因检测与精准药学服务实践过程,总结经验,与同行分享。方法从准备工作、相关检测项目的确定,学术推广、项目优化和开展情况等方面详细阐述我院基因检测开展过程与精准药学服务情况。结果根据临床需求,我院已开展了以心脑血管药和抗精神病药为主的27种药物,26项检测,2018年全年位1587名患者提供个体化用药建议,受到临床医生和患者欢迎。结论基于代谢酶和药物作用靶点相关基因检测的个体化用药建议是临床药师参与精准治疗的重要途径,有助于医生和药师之间的沟通,有利于提高药学服务水平。     

重度苯妥英钠中毒的药学监护

目的首先确定中毒药物,然后通过测定血药浓度以了解中毒程度,为重度苯妥英钠中毒患者临床抢救治疗提供依据。方法间隔一定时间采集患者静脉血,萃取血中药物,在211 nm处以反相高效液相色谱法定性,明确中毒药物并测定血药浓度。结果在苯妥英中毒患者中最高血药浓度为68.94 mg.L-1,接近治疗浓度上限的3.5倍。结论患者为重度中毒,危及生命,需临床药师与临床医师积极配合,施行全程药学监护。     

重视医学信用伦理的研究与开发

医疗行业市场化是必然趋势。在医疗行业市场化进程中，医学伦理道德除了道德价值之外，还含有积极的经济内涵。医学伦理道德也是重要的医疗资源，通过参与医疗市场资源的配制和运作，也可以产生经济效益，转化为医疗资本。医疗行业要重视医学伦理道德资源的开发。信用伦理是在市场经济条件下形成的，这是医学伦理学所面临的新课题。笔者认为，不说谎、不期诈，兑现承诺，保证医疗质量，发扬医学人道主义，是医学信用伦理的四项基本标准。     

Fluorimetric assay of rufloxacin in serum and in pharmaceutical formulations

A simple and rapid fluorimetric method for the determination of 9-fluoro-10-[N-(4′-methyl)piperazinyl]-7-oxo-2,3-dihydro-7H-pyrido[1,2,3-d,e][1–4]benzothyazin-6-carboxylic acid hydrochloride (MF 934), in serum and in pharmaceutical formulations, has been developed based on its strong fluorescence, in 0.1 N H₂SO₄, at 526 nm (excitation wavelength at 340 nm). The procedure which involves the direct dilution of the sample requires only a few minutes and the sample volume is only 20–100 μl of serum, depending on the drug concentration. Tedious sample preparation procedures such as extraction, deproteinization, or centrifugation are not necessary. The minimum concentration that can be detected is 0.3 ng ml⁻¹, the standard curve in 0.1 N H₂SO₄ was found to be linear from 0.005 to 1.5 μg ml⁻¹ and from 0.01 to 0.07 g in plasma after dilution with 0.1 N H₂SO₄.     

整合出版资源 迎接国际性竞争

笔者指出需从整合出版权资源、整合出版人才资源、整合作者资源、整合读者资源、整合版权资源、整合发行资源6个方面来加强我国出版业在整体上的实力，来迎接即将到来的国际性竞争。