Safety and Diagnostic Image Quality of Ultravist^®in an Unselected Sub-Set of Chinese Patients: Data Analyses from a Previous Post Marketing Surveillance

Background: Iopromide (Ultravist&reg) has been shown to be a very safe CM agent in previous post-marketing surveillance studies on Western and Asian populations. Our study aimed to analyse data pertaining to the safety, tolerability and diagnostic image quality of Iopromide in an unselected sub-set of the Chinese population. Methods: we analysed data for Chinese ambulatory and in-patients who received Iopromide for an imaging procedure (in accordance with the local package insert and routine clinical practice), as part of an international post-marketing surveillance study. Use of premedication was at the discretion of the attending physician. Patient demographics, clinical history, type of examination, contrast quality and tolerability, including pre-specified adverse drug reactions, were recorded. All statistical analyses were descriptive. Results: case report forms for 20,000 Chinese patients (61.3% men) were analysed, of whom 153 patients (0.77%) had risk factors for idiosyncratic contrast media reactions (at-risk group). Use of premedication, most commonly corticosteroids, was recorded for 5658 patients (28.3%) and 86 at-risk patients (56.2% of the at-risk group), respectively. The mean (±standard deviation) dose of iodine administered was 29 ± 5.5 g. During the physician’s evaluation of image parameters, contrast quality was considered to be “good” (64.7%) or “excellent” (29.3%) in the majority of patients. 571 patients (2.9%) experienced at least one adverse drug reaction [most frequently nausea (0.70%) and dysgeusia (0.62%)], which were typically transient and of mild intensity. Two serious adverse drug reactions were reported [edema (n = 1), decreased blood pressure and dyspnea (n = 1)]. The incidence of adverse drug reactions was increased in the at-risk group versus the overall patient population, and tended to reduce with premedication (mainly corticosteroids). Conclusions: Iopromide was well tolerated and proved to be an efficient contrast agent in a large, non-selected sub-set of Chinese patients undergoing different types of diagnostic imaging procedures.

Assessment of Safety and Effectiveness of Glaritus^®(Wockhardt’s Insulin Glargine) in a Prospective, Multi-Centric Post Marketing Observational Study in Nepalese Having Type 2 Diabetes Mellitus

Background: Nepal is one of the fastest urbanizing countries in South Asia and is facing the consequences of urban lifestyle leading to obesity and metabolic syndrome. Type 2 diabetes mellitus (T2DM) is currently a high-burden disease in Nepal with a prevalence of 8.4%. Of these 8% - 18% patients are on insulin and 42% patients were reported to have uncontrolled diabetes in the past year. This suggests a need for better therapy options in terms of efficacy and safety. The current study was designed to investigate the effects of Insulin glargine-based therapy in Nepalese with T2DM who could not achieve adequate glycemic control with oral and non-glargine-insulin therapy. Methods: This is a prospective, multi-centric, single arm and post marketing observational study to assess the safety and effectiveness of Glaritus®(Wockhardt’s Insulin Glargine) in 52 T2DM patients from 3 (three) different study sites in Nepal (Bharatpur, Kathmandu and Pokhra) from September 2015 to December 2016. The primary objective of the study was to evaluate the safety of Glaritus®, mainly in terms of hypoglycemia, renal function tests and liver function tests. The secondary objectives were to evaluate the effectiveness of Glaritus®in terms of percentage of patients achieving HbA1c goal of less than 7%, mean changes in HbA1c & fasting plasma glucose (FPG) levels from baseline till the end of study. Results: 3.85% of subjects experienced hypoglycemia during first 3 months of therapy whereas 1.92% had similar experience in next 3 months of therapy. The mean HbA1c values reduced from 9.16% to 7.15% at the end of study. 21.05% of the enrolled subjects achieved the goal of HbA1c ®was well tolerated by the study patients. Conclusion: In patients with type 2 diabetes mellitus inadequately controlled on oral hypoglycemic agents and/or insulin, initiation with Glaritus®significantly improved glycemic control with good tolerability and acceptability. This analysis in T2DM Nepalese patients shows that by significantly improving glycemic control while not increasing risk of hypoglycemia, Glaritus®provides safer basal insulin and may be suited to aggressive treatment regimens. From a societal perspective, it will help more patients reach the glycemic control target as recommended by the current treatment guidelines.

Safety and Efficacy of Combination Therapy with Insulin Glargine and Oral Hypoglycaemic Agents Including DPP-4 Inhibitors in Japanese T2DM Patients: ALOHA 2 Study, a Post-Marketing Surveillance for Lantus^®

Aims: In the Add-on Lantus®?to Oral Hypoglycaemic Agents 2 (ALOHA 2) Study in Japanese adults with type 2 diabetes mellitus (T2DM), data on the safety and efficacy of combination therapy with insulin glargine (Lantus®) and oral anti-hyperglycaemic drugs (OADs) including dipeptidyl peptidase-4 (DPP-4) inhibitors in a real-life setting were collected and analyzed. Methods: This postmarketing surveillance was a prospective, observational, 24-week study that complied with the pharmaceutical affairs law and the ministerial ordinance of “Good Post-Marketing Study Practice (GPSP)” in Japan. Safety, efficacy and patient-reported outcomes (PROs);patients’ satisfaction with treatment (DTSQs and DTSQc) and patients’ self-reported health (EQ-5D and EQ-VAS) of combination therapy of insulin glargine and OADs were evaluated. Results: A total of 2,630 patients were enrolled. Of the 2,602 patients in the safety analysis population, 161 patients experienced 175 cases of adverse drug reactions, and the major adverse drug reaction was hypoglycaemia (140 patients, 5.38%). Out of those with hypoglycaemia, 11 patients (0.42%) had severe hypoglycaemia and the incidence rate (episodes per patient-year) was 0.019. Basal supported oral therapy (BOT) with insulin glargine substantially reduced the HbA1c, FPG and 2 hour-PPG levels for 24 weeks by -1.61%, -54.4 mg/dL and -74.5 mg/dL respectively. The mean weight was increased, however the change was +0.50 kg. In addition, the treatment satisfaction scores of DTSQs (mean treatment satisfaction score increased 3.6 from baseline to last observation) and DTSQc, EQ-5D index scores and EQ-VAS scores were significantly improved. Conclusion: Insulin glargine and OADs combination therapy was suggested to be effective and well tolerated. Patients’ satisfaction with treatment and their self-reported health improved in spite of the addition of injections to oral agents. The combination therapy of insulin glargine and OADs including DPP-4 inhibitors is likely to be considered an important therapeutic option in the diabetic patients.

Antibiotics/antibacterial drug use, their marketing and promotion during the post-antibiotic golden age and their role in emergence of bacterial resistance

During the post-antibiotic golden age, it has seen a massive antibiotic/antibacterial production and an increase in irrational use of these few existing drugs in the medical and veterinary practice, food industries, tissue cultures, agriculture and commercial ethanol production globally. The irrational drug use has been further exacerbated by the increased marketing and promotion of these drugs by the pharmaceutical companies thus increasing their accessibility in the public and hence their improper use. The lack of production and introduction of the newer and effective antibiotic/antibacterial drugs in clinical practice in the post-antibiotic golden age has seen an increase in the emergence of the resistant pathogenic bacterial infections creating a significant problem in the global health of humankind. The massive productions of the antibiotic/antibacterial drugs have contributed to the poor disposal of these drugs and hence many of them are discharged in various water bodies contributing to the environmental antibiotic/antibacterial drug pollution. In the environment, these drugs exert pressure on the environmental bacteria by destroying useful bacteria that are responsible for the recycling of the organic matter and as well as promoting the selection of the resistant pathogenic bacteria that can spread in human and animal population thus causing an increase in the observed bacterial disease burden and hence a significant global public health problem. The resistant bacterial diseases lead to the high cost, increased occurrence of adverse drug reactions, prolonged hospitalization, the exposure to the second- and third-line drugs like in MDR-TB and XDR-TB that leads to toxicity and deaths as well as the increased poor production in agriculture and animal industry and commercial ethanol production.

“岗课赛证”融通的高职数字营销教学模式研究

随着数字经济的崛起,高职教育在数字营销领域面临着新的挑战和机遇。“岗课赛证”融通的教学模式,为培养具备实际工作能力和创新创业精神的数字营销人才打下坚实基础。但现阶段高职院校“岗课赛证”融通的教学模式存在着课程体系与实际需求脱节、实践教学短缺、师资力量不足、评价机制不够完善等问题,为此,高职院校应以“岗课赛证”融通为核心理念,将实际岗位需求与课程设计、竞赛以及证书评定相融合,构建一种全面、实用的数字营销教学模式,以提升学生在数字营销领域的综合能力。

论反垄断法解释的学派分歧及其交谈前景

反垄断学派的形成,将法律解释导入规范轨道,同时也使反垄断学派形成路径依赖,导致其解释方法日益僵化。从制度维度上看,近年来哈佛学派、芝加哥学派和后芝加哥学派之间就垄断行为规制的分歧趋于深化,渐成难以调和之势。为此,追溯考察反垄断学派的理论模式、决策前提、市场假定和价值观念可知,反垄断学派理论模式不仅应当接受经验证据的检验,还极大地取决于以错误成本分析为核心的决策前提,以及垄断行为发生概率和市场自我纠正能力的假定,并最终根源于其或自由或保守的价值传统。为推动反垄断法解释深入回应市场现实,要形成反垄断学派关于市场机制的基本共识,廓清反垄断法解释的交谈合理性空间,并结合数字市场特性,确立经验世界重构背景下的交谈新起点。

无源医疗器械类医用耗材上市后监测监管研究热点与推进路径探讨

目的:探讨基于无源医疗器械类医用耗材上市后监测监管的研究热点与推进路径。方法:采用数据挖掘方法对我国医疗器械监管相关机构网站和中国知网中国国家知识基础设施(CNKI)进行相关文献、文件采集;梳理医疗器械不良事件报告分项数据,提取期刊文献和文件主题要素词,进行文献计量分析与可视化显示。结果:我国医疗器械不良事件报告数量逐年增加,2022年为694866份;在2019年至2022年4个统计年度数据中,无源医疗器械及体外诊断(IVD)试剂的报告数也呈并行增加趋势,占年度医疗器械不良事件报告总数的65.00%左右。期刊文献的常规文献计量表明该领域研究得到监管机构、高校院所、医疗机构及生产企业不同程度参与,监管机构贡献了46篇,占文献总数的56.79%,其次是高校28篇;词篇共现分析显示,研究热点聚集在质量管理、风险管理、国际经验解析、再评价、真实世界研究5类;我国监管机构高度重视上市后监测监管,2006年以来发布相关文件20余份,围绕安全有效愈渐深入。结论:研究热点从基于不良事件报告的质量管理、风险管理、国际经验讨论逐步向主动监测、真实世界研究等方面深入。进一步加强医疗器械尤其是无源医疗器械类医用耗材上市后监测监管需要在政府监管、医疗机构与消费者用户和生产经营企业3个维度同步推进,高校院所、行业组织协同助力,加强监测技术和方法学研究,建立真实世界研究数据资源库与数据标准,拓展不良事件监测序贯活动,研究制定风险控制和纠正预防措施,服务于我国医疗健康和产业发展。

后疫情时代扬州餐饮企业经营风险及应对策略分析

扬州是一座旅游城市,餐饮业既是城市形象的窗口,也是经济发展的重要支柱,受“新冠疫情”影响,旅游业、餐饮业都面临着营业时间受限、顾客减少、成本增加等困难。在此背景环境下,扬州餐饮企业应努力改善经营思路,制定出适合新形势的餐饮业营销策略。

国内外基于真实世界数据的药品上市后安全性主动监测系统对比分析

目的对比分析国内外基于真实世界数据(RWD)构建的药品上市后安全性主动监测系统,以期为我国建立有效可行的全国性系统提供参考。方法检索与梳理全球药品主动监测系统的文献资料,使用框架整合法确定分析框架,编码与标绘有关组织架构、数据特征、运行机制等方面的内容,归纳异同点并总结主动监测模式。结果纳入基于RWD开展主动监测的系统/组织共12个,9个位于欧美国家,1个位于亚洲地区,我国有2个,分别为中国医院药物警戒系统(CHPS)和临床药物不良事件主动监测与智能评估警示系统(ADE-ASAS-Ⅱ)。经过信息整合,从6个维度总结主动监测模式:①组织模式归纳出3类,分别为政府(与学术界、药品生产企业)主导的合作体模式、政府直接管理模式,以及学术联盟协商模式;②数据整合与共享模式包括通用数据模型、通用研究方案与集中式数据库;③数据获取模式可分为2种形式,从数据库自动采集,以及针对目标人群或专项研究进行人工收集;④数据治理模式涉及匿名化、结构化与标准化处理;⑤数据储存与传输模式可分为分布式数据网络与中央数据库存储;⑥数据分析模式包括分布式计算与集中式分析2类。结论目前欧美国家利用RWD开展药品安全性主动监测模式相对成熟,我国在借鉴先进经验的同时,应探索符合本国实际情况的主动监测系统,为患者用药安全保驾护航。

紫龙金片对中晚期非小细胞肺癌患者生存时间的影响

目的探讨紫龙金片参与治疗对中晚期非小细胞肺癌患者生存时间的影响。方法采用前瞻性、观察性真实世界队列研究方法,收集首都医科大学附属北京中医医院肿瘤科中晚期肺癌的医疗健康数据及基于研究目的采集的数据构成数据库,从中调取临床分期为ⅢB~Ⅳ期患者相关资料。以是否服用紫龙金片为暴露因素,提取患者人口学、肺癌诊断、治疗、紫龙金片服用等相关信息,采用Kaplan-Meier法进行单因素分析,COX模型法进行多因素生存分析。结果最终301例患者纳入研究,其中暴露队列99例、非暴露队列202例。暴露队列经手术治疗比例高于非暴露队列(P<0.05)。暴露队列预估平均生存时间为1085.990 d[95%CI(964.694,1207.286)],高于非暴露队列的840.074 d[95%CI(748.942,931.207)],差异有统计学意义(P=0.002)。单因素分析结果显示,患者性别、年龄、病理类型、TNM临床分期、手术治疗、紫龙金片暴露与生存时间相关(P≤0.1)。COX回归模型多因素分析结果显示,老年、肺鳞状细胞癌、较晚临床分期是死亡终点时间的独立危险因素,而女性、接受手术治疗、化学药物治疗、靶向治疗、紫龙金片治疗为独立保护因素,其中临床分期、手术治疗、紫龙金片暴露差异有统计学意义(P<0.05)。结论基于当前数据及分析方法,紫龙金片参与治疗对于中晚期非小细胞肺癌患者的生存时间表现出较为明显的保护作用。

药品上市后安全性主动监测文献计量学分析

目的对国内外药品上市后安全性主动监测文献进行文献计量学可视化分析,展示领域热点现状与趋势,为未来我国研究开展和主动监测管理体系的完善提供参考。方法系统检索Web of Science和CNKI数据库中药品上市后安全性主动监测的英文与中文文献,导入CiteSpace 6.3.R2软件进行发文量、作者、机构和国家合作网络分析,并进行关键词共现、聚类和突现分析。结果经筛选共纳入中文文献415篇,英文文献676篇,年发文量整体呈增加趋势。中文文献作者合作网络相对于英文文献规模较小,合作关系网络较为稀疏,无强中心性机构。中文文献中,国内药品监管机构发挥了重要作用,而药企对自身产品的监测研究仍较少。研究内容涵盖主动监测体系与技术方法研究和特定药物与疾病的药品安全性主动监测实践研究。结论药品上市后安全性主动监测被世界各国广泛关注,我国研究活动热度呈现明显增长趋势,但与国际前沿相比仍有差距,需要进一步加强合作,促进我国主动监测管理体系完善。

基于医药市场环境与岗位职业能力的“医药市场营销”课程改革研究

随着人口老龄化和大数据技术的发展,医药市场出现新变化,激烈的市场竞争下企业期待高质量医药营销人才。因此“医药市场营销”作为药品经营与管理专业的核心课程,应紧密结合医药市场环境,通过丰富教学内容、对接医药营销岗位优化实训项目、积极实施课程思政等途径来培养学生良好的职业素养,并通过线上线下混合式教学、任务导向教学、行业专家进课堂等多种教学方式实现课程目标,培养更贴合市场需求的药商人才。

构建更加科学高效权威的药品上市后监管体系更好保障公众用药安全

建立科学高效权威的药品上市后监管体系是保障药品质量安全的必然要求,也是推动我国从制药大国向制药强国跨越、更好满足人民群众健康需求的应有之义。本文全面总结了当前我国药品上市后监管工作进展,深刻分析了当前面临的新任务和新形势,阐述了做好药品上市后监管工作的内在逻辑,展望了未来的工作方向和任务,为构建更加科学高效权威的药品上市后监管体系提供了参考。

广东省已上市中药制剂备案变更常见问题分析与建议

目的:为我国已上市中药制剂备案变更提供指导与建议。方法:通过整理2023年广东省已上市中药制剂备案变更的受理审评情况,分析持有人申报变更存在的问题及其主要原因,从变更的事前事中事后提出可行建议。结果与结论:对213个已上市中药制剂备案变更品种进行梳理,发现持有人在备案变更方面主要存在申报程序不合规、备案内容不标准、研究验证不充分的问题。建议持有人变更前合理确立变更事项、变更时科学开展研究验证、变更后持续关注风险管理,提升中药制剂备案变更的能力。

抗肿瘤药说明书安全性信息上市后修订的考虑要点

目的介绍抗肿瘤药说明书安全性信息上市后修订的考虑要点,为药品上市许可持有人提供参考。方法基于国家药品监督管理局药品评价中心(简称“评价中心”)近年的修订实例,阐述修订目的、启动原因、决策证据以及修订原则。结果与结论说明书安全性信息修订是一项系统工程。评价中心将持续致力于完善包括抗肿瘤药在内的各种药品说明书安全性信息。药品上市许可持有人应充分发挥主体责任,及时、主动完善说明书,保障人民群众用药安全。

药品上市后变更风险控制的探讨

目的本文根据药品法规的要求,研究探讨药品在上市后发生变更时如何进行风险控制,为药品生产企业变更风险管理提供参考。方法围绕人、机、料、法、环、以及药政法规多个方面进行风险分析,制定控制措施。结果经过风险分析,制定人员培训、对仪器设备进行确认、修订文件、对生产环境进行确认、按药政法规要求申报变更等措施。结论药品上市许可持有人和生产企业是药品上市后变更管理的责任主体,应当建立变更控制体系,对发生的变更进行分类、风险评估、制定控制风险措施以及研究验证工作,将药品质量风险降至最低。

“岗课赛证”视域下高职营销课程教学改革探索

为顺应市场和岗位需求,高职营销课程教学亟需依据“1+X”证书和职业技能大赛的考核标准,构建以“岗课证赛”为核心的教学体系。文章从阐释“岗课证赛”的基本内涵出发,审视了当前营销课程教学的现状及存在的问题,提出深化产教融合、重构课程体系等改革措施,旨在促进高职市场营销专业在“岗课证赛”框架下的优化升级,有效提升营销人才的培养质量。

基于“岗课赛证”模式下的汽车新媒体营销课程改革创新实践

汽车新媒体营销课程是汽车技术服务与营销专业核心课程,致力于培养学生汽车营销策划与新媒体营销的能力。为适应新时代下市场对汽车新媒体人才的需求,基于“岗课赛证”,重构课程体系,以模块-任务式进行教学,引入企业真实项目,通过学院比亚迪产业学院,实现校内教师与企业导师“双师”教学,深化校企合作,校企协同育人。创新课程设计,探究技能链融思政链的“双链育人”模式,实现知识、技能、素质三位一体的育人目标。

Cultured meat in western media: The disproportionate coverage of vegetarian reactions, demographic realities, and implications for cultured meat marketing

This paper examines the media coverage of the 2013 London cultured meat tasting event, particularly in the United States, Canada, and the United Kingdom. Using major news outlets, prominent magazines covering food and science issues, and advocacy websites concerning meat consumption, the paper characterizes the overall emphases of the coverage, the tenor of the coverage, and compares the media portrayal of the important issues to the demographic and psychological realities of the actual consumer market into which cultured meat will compete. In particular, the paper argues that Western media gives a distorted picture of what obstacles are in the path of cultured meat acceptance, especially by overemphasizing and overrepresenting the importance of the reception of cultured meat among vegetarians. Promoters of cultured meat should recognize the skewed impression that this media coverage provides and pay attention to the demographic data that suggests strict vegetarians are a demographically negligible group. Resources for promoting cultured meat should focus on the empirical demographics of the consumer market and the empirical psychology of mainstream consumers.

后疫情下德国“双元制”职业教育与培训:困境与出路

新冠疫情暴发使全球教育系统遭遇重大挑战。在疫情和后疫情时代,德国“双元制”职业教育与培训严重萎缩,面临一系列困境,主要表现在疫情和后疫情期间“双元制”培训对年轻人的吸引力下降、中小微企业参与培训热情进一步降低、“双元制”职业教育与培训主体地位受到学校职业教育的挑战以及就业市场对于高学历人才需求增加。面对疫情对德国“双元制”职业教育与培训市场带来的冲击,德国政府通过一系列数字化项目和促进政策为“双元制”职业教育的健康发展提供保障,奠定了后疫情时代经济复苏的基础。主要举措包括:加强法律体系建设,增强经费保障;扩大宣传,增强职业教育吸引力;调动中小企业积极性,激发培训市场活力;改革课程体系;实现培训供需匹配;提升数字化水平,拓宽学生出路。