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。     

药学干预对喹诺酮类药物应用影响

目的 探索药学干预对喹诺酮类药物应用的影响.方法 选取2016年3月—2017年3月到医院接受喹诺酮类药物治疗的患者进行研究,分为药物干预前、干预后两组,喹诺酮类药物使用过程中采用药学干预的方法 进行护理,对比干预前后喹诺酮类药物的耐药率、不合理用药率和不合理使用情况.结果 药学干预后,喹诺酮类药物对肺炎克雷伯菌、大肠埃希菌和铜绿假单胞菌的耐药率降低,且不合理联合用药、不合理用法用量和用药禁忌等不合理用药率也显著降低,不合理使用情况也在逐渐减少(P<0.05).结论 药学干预对喹诺酮类药物的应用效果显著.     

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。     

Evaluating the transparency of pharmaceutical company disclosure of payments to patient organisations in the UK

Patient organisations contribute to many areas of pharmaceutical policy. In developing their organisational capacity, many turn to financial support from pharmaceutical companies, which may create conflicts of interests. However, the transparency of the industry’s self-regulatory approach to the disclosure of payments to patient organisations has evaded scrutiny. Using company reports disclosing payments to UK patient organisations in 2012–2016, we evaluate the transparency of reporting using indicators derived from industry’s European patient organisation Code. We found a large proportion of companies did not have any disclosure reports available despite many having made payments, confirmed by comparing with annual financial accounts of patient organisations registered as charities. Where disclosure reports were available, many payments were not adequately described, resulting in large portions of money being disclosed without clarity as to the payment type and purpose. We found companies were clearer regarding whether payments were financial or benefits-in-kind, but transparency was particularly inadequate as to whether it could be determined if payments were indirect or direct and restricted or unrestricted, and almost no companies mentioned the VAT status of payments. Our findings suggest that the industry’s self-regulatory approach to transparency has not been working efficiently. We suggest ways for standardising and increasing the precision of information by pharmaceutical companies and advocate for the introduction of a centralised, and easily accessible national-level payment database.     

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。     

从产业组织学角度看中国医疗广告

随着医疗卫生体制改革的全面推行,医疗行业竞争日趋激烈,众多医院采取不同的策略组合以提高其核心竞争力,而广告正是其主要的营销策略之一.本文在对医疗广告特性、类别、作用进行分析的基础上,从产业组织学角度阐述了医疗广告与医疗市场结构、市场效益的关系,提出了中国医疗广告的发展趋势.     

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.     

化工行业职业性机械伤害危险因素的病例-交叉方法研究

目的 研究化工行业机械伤害的有关诱发因素，估计其作用强度。方法 采用病例-交叉设计的方法。以操作和检修时受伤的化工工人为研究对象，每个对象在受伤后2d内完成调查，收集他们受伤前10min、上一工作日同一段时间和受伤前1周内有关诱发因素暴露的信息，用配对时间段方法和一般频数法进行分析，评估各种诱发因素的危险度。结果 一般频数法分析的结构表明，操作方法异常、设备工具缺陷、工作紧迫、注意力不集中、不使用防护用品、精神状况较差、与同事配合不协调、工作环境发生变化等瞬时危害因素的RR值及95%可信限的下限均大于1。配对时间段方法分析的结果与其相拟，但95%可信限较宽。结论 化工行业职业性机械伤害的发生存在着诸多诱发因素。病例-交叉研究中的一般频数法与配对时间段方法相比，前者所得结果较为可靠，研究的相对效率较高。建议进一步使用多个时间段方法进行研究，以减小混杂因素的影响。