3种长效钙通道阻滞药治疗轻、中度原发性高血压的成本-效果分析

目的评价3种常用长效钙通道阻滞药治疗轻、中度原发性高血压的疗效和成本-效果。方法门诊轻、中度原发性高血压患者180例随机分为3组,每组60例,分别口服硝苯地平30 mg、非洛地平5 mg和氨氯地平5 mg,每日1次,疗程8 wk,观察3组疗效并进行成本-效果分析。结果硝苯地平、非洛地平和氨氯地平有效率分别为90%、93%和95%,3组间无显著差异(P>0.05);成本-效果比分别为11.54、10.35和11.28,以非洛地平组为参照,硝苯地平和氨氯地平的增量成本-增量效果比分别为22.06和62.59。结论非洛地平治疗轻、中度原发性高血压成本-效果优于硝苯地平和氨氯地平。     

以医学进展为依托发展药学教育具有不可替代性

1990年以来,分子诊断、生物治疗、组织工程、单克隆抗体、蛋白质组学、功能基因识别、DNA复制与重组,以及DNA损伤与修复取得了明显的进展,这些医学进展对药学施加影响并与药学融合,医学对药学的这种影响自然会延伸到药学教育之中。本文强调这里列举的八个方面的融合仅仅具有例证性质。笔者希望同仁们能够重视这些举证,进而站到更高的层面上去思考我国的药学教育。     

Evaluation of a tiered in vitro testing strategy for assessing the ocular and dermal irritation/corrosion potential of pharmaceutical compounds for worker safety

Introduction: Irritation reactions are a frequently reported occupational illness. The potential adverse effects of pharmaceutical compounds (PCs) on eye and skin can now be assessed using validated in vitro methods.

Objectives: Our overall aim is to reduce animal testing by replacing the historically utilized in vivo test methods with validated in vitro test methods which accurately determine the ocular and dermal irritation/corrosion potential of PCs to inform worker safety within the pharmaceutical space. Bristol–Myers Squibb (BMS) and the Institute for In Vitro Sciences (IIVS) have therefore conceptualized and internally qualified a tiered in vitro testing strategy to inform occupational hazards regarding eye and skin irritation and corrosivity of PCs. For the small scale pre-qualification phase, we paired historical in vivo and newly generated in vitro data for 15 PCs to determine the predictive capacity of in vitro assays already validated for the eye and skin irritation/corrosion endpoints and accepted for certain regulatory submissions. During the post-qualification phase, a group of 24 PCs were subjected exclusively to the developed tiered testing strategy, which is based on three Organisation for Economic Co-operation and Development (OECD) in vitro methods.

Materials and methods: The qualified in vitro testing strategy utilizes the Corrositex^® assay for the corrosivity (OECD TG 435), the Bovine Corneal Opacity and Permeability (BCOP) assay for ocular irritation (OECD TG 437), and the EpiDerm? tissue model-based Skin Irritation Test (SIT) for dermal irritation (OECD TG 439). In the first step, the pH of each PC was determined. For compounds with pH extremes ≥11 or ≤2, the Corrositex^® assay was generally conducted first. For compound(s) that were incompatible with or were negative in the Corrositex^® assay or had pH values between 2 and 11, the BCOP assay and SIT were performed first.

Results: The results of the tiered testing strategy’s qualification phase demonstrated that the BCOP assay is sensitive enough to identify a wide range of eye irritation/corrosion potentials and its over-prediction rate was considered acceptable to inform occupational hazards and ensure the proper handling practices of PCs. The SIT correctly predicted the skin irritation potential of 14 out of the 15 PCs included in the qualification phase, only over-predicting one PC. In the post-qualification phase, four PCs out of four tested were predicted corrosive by the Corrositex^® assay and thus no further testing was needed or conducted. The rest of the PCs were evaluated in the BCOP assay (both neat and as a 20% dilution), with the higher response being used for hazard classification. Four PCs were determined to be severe eye irritants, 1 a moderate irritant, 8 were mild irritants, and 8 were non-irritants. The same set of PCs was evaluated using the SIT and were classified as non-irritants to skin. These results are consistent with the BMS historical in vivo results showing a very low number of PCs as skin irritants.

Conclusions: This tiered in vitro testing strategy, which replaces the use of animal studies, was found to be reasonably accurate in its predictive capacity when compared to historical in vivo results and represents a conservative and reliable platform that can be utilized for the prediction of ocular and dermal irritation/corrosion potential of PCs and for subsequent GHS classification and worker safety hazard communications.     

临床药学服务实践及体会

介绍我院临床药师开展临床药学服务的的工作内容及效果.探讨临床药学服务在促进合理用药和医院药学发展中起的重要作用.     

中、美、英、欧药典制药用水微生物检查法对比研究

目的比较中、美、英、欧药典制药用水微生物检查法,为《中国药典》的修订提供参考,为推动制药用水微生物检查法与国际接轨提供合理化建议。方法通过采用不同的检查方法、培养基、培养条件对20个样本进行实验,并对不同实验条件进行两两配对的 t检验,统计分析比较方法的差异性。结果采用R2A培养基,30～35℃,120 h ,薄膜过滤法,培养效果较好。同时,《中国药典》2010年版的方法可行。结论可以采用 R2A 培养基、30～35℃、120 h、薄膜过滤法对制药用水进行微生物限度检查。     

药学学科研究生培养目标模型构建

利用Nvivo11软件对国内58所和美国30所药学院校的培养目标文本进行质性分析,探索了两国培养目标文本的结构和差异,根据学生发展核心素质理论、核心领域能力、领导技能等设计了适合我国药学院校培养目标构建的结构模型,有助于方便准确的构建出符合学校特色且完善的药学硕士研究生培养目标。本研究还提出国内药学院校在构建培养目标时,应更加尊重学校历史特色,同时注重研究生全球化、领导力意识、创新创业意识、人文素质、责任担当等方面的要求,才能保障研究生全面发展,增强研究生的职业竞争优势。     

生产企业视角下我国药品短缺原因分析

目的：生产企业视角下实证分析我国药品短缺原因,为保障短缺药品供应措施提供实证参考,以期从源头预防药品短缺。方法：2016年4月至2016年8月对全国范围的65家生产企业进行实地调研,基于生产企业的视角对我国药品短缺原因进行实证分析。结果：生产企业视角下导致药品短缺的原因主要有：出厂价太低、生产原辅料短缺、药品销量下降、未通过新版GMP认证。结论：深入分析导致药品短缺的原因,结合我国的国情和当前的政策基础,提出针对性的政策建议以期缓解药品短缺问题。     

我院儿科药房药学服务SWOT分析及改进

目的提升医院儿科药房药学服务的质量。方法采用SWOT分析法从优势、劣势、机遇、威胁4个方面分析医院儿科药房药学服务的开展情况,并提出有针对性的发展策略。结果医院全面落实用药交代,加强合理用药宣传,普及用药知识,开展药物治疗监测及药物基因检测等,实现了个体化精准用药;增加处方前置审核,运用信息化技术,可为患儿安全用药保驾护航。结论建议医院应加强对儿科药学服务的重视,建立更完善的儿科药学服务体系;药师应明确自身定位,发扬优势,弥补劣势,积极探索多元的药学服务模式,以促进儿童安全、合理用药。     

我院临床药师药物咨询分析

目的：对临床用药咨询进行分析,了解临床需求,提高临床药学服务质量。方法：收集整理100例临床药物咨询资料,对用药咨询的内容进行回顾性分析。结果：咨询药物中以抗感染药物最多（33%）,咨询内容分类中药物用法用量最多（17.6％）。结论：药物咨询是临床药学工作的重要内容,有助于临床药师与医护人员、患儿及家属的交流,提供合理安全的用药。