从研究者发起的临床研究“资助合同”审查引发的思考和建议

近年来,研究者发起的临床研究(investigator initiated trial, IIT)快速增长, IIT项目管理的各类问题也日益显现。本文从IIT项目的合同审查角度,通过对我院2018年1月—2019年12月期间受理的150份IIT项目"资助合同",对合同的一般特征及审查常见问题进行回顾统计分析。结果显示:150份IIT资助合同以中文文本为主、与医药公司直接签署为主、内企资助合同为主、Ⅱ/Ⅲ期临床研究为主、干预性临床研究为主、资助方与研究用药品存在关联为主。常见问题表现为:54.4%的IIT论文发表权利受限,28.16%的IIT知识产权归属存争议,66.67%的项目未提供保险, 54.67%的IIT项目不提供免费研究用药品,受试者损害赔偿和研究药品产品质量问题承担主体不清、利益冲突声明制度有待加强等。根据上述分析结果,本文分别从对IIT的资助、结果发表的无偏倚原则、利益冲突声明、知识产权保护意识、受试者权益和医院赔付压力、医保资源隐患、合同审查规范化、医疗机构是否应该设立IIT专管部门等提出了思考和建议。

环氧虫啶多晶型的制备和表征

[目的]制备环氧虫啶的多晶型,并对其进行表征。[方法]采用旋蒸法成功制备环氧虫啶晶型B,通过粉末X射线衍射、差示扫描量热、热重分析、红外光谱、单晶X射线衍射和扫描电镜等对其进行表征,并对其溶解度、粉末粒度和堆密度进行了测试。[结果]晶型B为环氧虫啶与硝基甲烷以1∶1摩尔比的硝基甲烷溶剂化物,在25℃水中溶解度为1616.19 mg/L,平均粒度D_(0.5)为10.650μm,堆积密度为0.289 g/cm^(3),均比原药晶型A有所提高。[结论]通过制备晶型B,可以提高环氧虫啶的溶解度、粉末粒度和堆积密度,方便其制剂加工。

Distinct serumal proteomic patterns between ascending and descending types of loco-regionally advanced nasopharyngeal carcinoma assessed by surface enhanced laser desorption ionization and artificial neural network analyses

Nasopharyngeal carcinoma （NPC） is rare in most countries, especially in Europe and NorthAmerica （incidence rate below 1/100 000 people per year）. However, it has a high incidence in several southern areas in China, especially in the Cantonese region, including Guangzhou city, where the incidence rate is approximately 30-80/100 000 people per year. In the high incidence areas, more than 95% NPCs are poorly differentiated （WHO types 2 and 3）, which are sensitive to radiotherapy and chemotherapy. Besides its special epidemiological and pathological characteristics,