Proposal for the revision of the guidelines for Non-clinical studies of vaccines for the prevention of infectious diseases in Japan

The efficacy and safety of vaccines for the prevention of infectious diseases are mostly evaluated based on the induction of an immune response against antigens, and do not necessarily depend on the dose administered. Therefore, there are some specific aspects that need to be considered in the development of vaccines and have been described in “The Guidelines for the non-clinical studies of vaccines for the prevention of infectious disease” in Japan. Recent changes in the vaccine development field, such as the introduction of vaccines developed overseas in Japan and vaccine development on a global scale have increased the need for revision of these guidelines.In this study, we identified the current challenges in the development of vaccines through comparison of Japanese and international guidelines. We conducted a questionnaire-based survey of pharmaceutical industries in Japan, and found issues related to non-clinical studies, such as the necessity of safety pharmacology studies and repeated-dose toxicity studies for each route of administration. We examined international guidelines on these issues as well as review reports by regulatory authorities, and determined that the results of repeated-dose toxicity studies can be used to decide whether safety pharmacology studies are required, and that studies to evaluate toxicity due to systemic effects may not be necessary for both intramuscular and subcutaneous administration. We propose revision of the guidelines for the non-clinical studies of vaccines in Japan taking international harmonizaion into account. We expected that the revised guidelines will promote smooth and rational vaccine development.     

Validity evidence for the measurement of the strength of motivation for medical school

The Strength of Motivation for Medical School (SMMS) questionnaire is designed to determine the strength of motivation of students particularly for medical study. This research was performed to establish the validity evidence for measuring strength of motivation for medical school. Internal structure and relations to other variables were used as the sources of validity evidence. The SMMS questionnaire was filled out by 1,494 medical students in different years of medical curriculum. The validity evidence for the internal structure was analyzed by principal components analysis with promax rotation. Validity evidence for relations to other variables was tested by comparing the SMMS scores with scores on the Academic Motivation Scale (AMS) and the exhaustion scale of Maslach Burnout Inventory-Student Survey (MBI-SS) for measuring study stress. Evidence for internal consistency was determined through the Cronbach’s alpha for reliability. The analysis showed that the SMMS had a 3-factor structure. The validity in relations to other variables was established as both, the subscales and full scale scores significantly correlated positively with the intrinsic motivation scores and with the more autonomous forms of extrinsic motivation, the correlation decreasing and finally becoming negative towards the extrinsic motivation end of the spectrum. They also had significant negative correlations with amotivation scale of the AMS and exhaustion scale of MBI-SS. The Cronbach’s alpha for reliability of the three subscales and full SMMS scores was 0.70, 0.67, 0.55 and 0.79. The strength of motivation for medical school has a three factor structure and acceptable validity evidence was found in our study.     

广东省乡镇卫生院医生培训现状分析

目的：了解广东省乡镇卫生院医生培训的现状，为广东省农村卫生人员素质的整体提高提供决策依据。方法；采用现场问卷调查的方法，对全省随机抽样的18家乡镇卫生院的486名医生培训情况进行调查。结果：广东省乡镇卫生院医生有10．2％未参加过任何形式的培训，有67．6％的人认为目前急需的是专业新知识、新技术的培训．有40．6％的乡镇卫生院医生认为经费有限影响其参加培训。结论：广东省乡镇卫生院医生对培训的需求较高．经费有限是影响培训的最主要原因。建议加强政策配套，落实乡镇卫生院医生的在职培训。     

基因快速检测仪检测池的恒温控制装置的研制

介绍一种基因快速检测仪检测池的恒温控制装置,对该装置的有关设计原理、结构、方法及特点做了介绍。经临床试验表明,该恒温装置能实现基因快速检测仪的检测池恒温功能,能使温度稳定在50℃±0.5℃水平。     

An actinometric method for comparing the parameters of equipment for the ultraviolet irradiation of the blood

Actinometry of devices for ultraviolet irradiation of blood for the first time. Water solutions of diazonium salts as sensitive materials are used. Outlooks for optimization of above devices are discussed.     

社区肢残人辅助器具使用全科医学照顾干预效果分析

目的了解社区肢残人辅助器具需求及使用状况,并对全科医学照顾干预作效果分析。方法全科医生采用入户面访对调查对象进行前后二次问卷调查,问卷调查内容包括：一般的人口学资料、残疾程度及生活自理能力、辅助用品使用情况等相关内容并对全科医学照顾干预前后二次数据进行卡方检验及相关资料分析。结果全科医学照顾干预后比干预前肢体残疾人士使用辅助器具上升了9．68个百分点,使用辅助器具局部症状改善或治愈以及跌倒人数干预前后有统计意义（P〈0．01）,肢体残疾人生活自理能力干预前后对照有统计意义（P〈0．05）。结论适合个性化的肢残人士器具使用服务提升了残疾人“人人享有康复服务”社区卫生服务平台,提高肢残人士器具使用率和干预评估是提高肢残人士生活自理能力的有效措施。