科研绩效评价指标体系的初步探讨

目的:探讨科研绩效评价指标体系.方法:结合研究所科研特点,分析传统科研绩效评价方法存在的局限性,提出评价指标选择的原则,初步探讨了科研绩效评价指标体系.结果:建立了研究所科研绩效评价三级指标体系.结论:建立的评价指标体系为进一步进行科研绩效评价奠定了基础.     

浅谈健康教育工作中的心理卫生服务

本文根据大连市健康教育专业机构开展心理卫生服务的实践经验,提出健康教育专业机构必须高度重视日渐增多的心理问题;实施心理卫生服务应采取多种手段,依靠专业人才做好心理健康教育工作等观点,对于健康教育专业机构开展并做好心理健康教育工作有一定的借鉴意义。     

英国的中医药

本文对中医药在英国的发展历史与现状作了简要回顾,同时详细地介绍了目前英国的中医药学会和中医院校及所设课程,为全面了解英国的中医药协会、教育以及科研机构情况提供参考.     

我国全民医疗保障制度建立的依据与目标

在研究分析社会保障制度和医疗保障的发展与变迁及其特征的基础上，提出我国全民医疗保障制度不同的发展阶段目标，第一阶段为保障基本卫生保健的公平可及性；第二阶段为逐步向筹资公平性目标迈进；第三阶段为促进健康公平性目标的实现。对全民医疗保障制度的内涵与外延、全民医疗保障制度设计基本依据与原则进行了阐述。     

关于中医特色GCP的思考

我国《药品临床试验管理规范》（ＧＣＰ）的颁布施行,将对于中药临床试验循着科学化、规范化方向发展起到巨大的推动作用。同时也是新形势对中医药发展提出的新要求。努力探索一套既体现中医药特色,又与国际标准接轨的ＧＣＰ规范操作系统,构筑规范的中医证候诊断标准和临床结局评估标准,不仅是中医药现代化发展的需要,也是对现行ＧＣＰ的一种有益的补充。     

Immunogenicity and safety of a liquid Pentavalent (DTwP-Hb-Hib) combination vaccine manufactured by Human Biologicals Institute in 6–8 weeks old healthy infants: A phase III,randomized, single blind,non-inferiority study

BackgroundA liquid Pentavalent (DTwP-Hb-Hib) combination vaccine, developed by Human Biologicals Institute, underwent a Phase III clinical study in India. In this randomized, single blind, non-inferiority study, the immunogenicity and safety of this Investigational vaccine was compared with Pentavac SD® vaccine in 6–8 weeks old healthy infants.MethodsA total of 405 healthy infants aged 6–8 weeks old were randomized in 2:1 ratio to receive three doses of either the Investigational liquid Pentavalent (DTwP-Hb-Hib) combination vaccine or Pentavac SD® vaccine at four to six weeks interval. Immunogenicity was compared by estimation of antibody titers before the first dose and 4–6 weeks after the third dose of vaccination. Safety of each vaccine was assessed and compared by collection of data on solicited and unsolicited adverse events throughout the study period.ResultsOut of a total of 405 enrolled subjects, 387 subjects completed the study. The seroconversion rates, seroprotection rates and geometric mean titres of the Investigational liquid Pentavalent (DTwP-Hb-Hib) combination vaccine group were found to be comparable and non-inferior to the Pentavac SD® vaccine group at 4–6 weeks after the third dose of vaccination. Pain, erythema and swelling at the site of injection were found to be the most common local adverse events whereas fever, irritability and unusual crying were found to be the most common systemic adverse events in both the vaccine groups. No vaccine related serious adverse event was reported. In this study, both the Investigational vaccine as well as the Comparator vaccine were found to be immunogenic and well tolerated.ConclusionAfter assessment of the results of the study it was concluded that the Investigational liquid Pentavalent (DTwP-Hb-Hib) combination vaccine developed by Human Biologicals Institute was immunogenic and safe when administered to infants aged 6–8 weeks and was non-inferior in immunogenicity and safety to Pentavac SD® vaccine.Clinical Trial Registry of India Identifier: CTRI/2016/01/006541.     

上海综合性医院附设健康体检机构业务发展的SWOT分析

运用SWOT分析工具,总结分析上海综合性医院附设健康体检机构自身的优势、劣势,所面临的机遇和威胁,提出加强品牌宣传,让利于民;加强硬件建设,打通＂检—医绿色通道＂;建章立制,规范管理;社区联动,开拓市场;找准定位,实施差异化竞争;实行院内轮转,培养全科医学人才;完善服务,实现医检分离;开展研究,加强学科建设等促进其健康发展的措施。     

浅谈GCP培训在本科护士科研能力培养中的作用

科研能力的培养是国家教育部对本科护士的教育目标之一.在临床实践中,如何培养及充分发挥本科护士的科研能力一直是临床带教中的重要问题.文章浅谈本科护士经过药物临床试验质量管理规范（good clinical practice,GCP）培训后,对其科研能力的培养.     

社会医疗保险支付社区卫生服务机构开展健康管理的必要性和可行性

论述了社会医疗保险支付社区卫生服务机构开展健康管理的必要性,主要包括能促进社会医疗保险的发展,提高社会保险基金的使用效率及降低医疗费用,促进社区卫生服务的健康发展,提高我国公共卫生服务支出占卫生总费用的比例;探讨了社会医疗保险支付社区卫生服务机构开展健康管理的可行性,并简单分析了现实中存在的障碍。     

Multi-center analytical evaluation of a novel automated tacrolimus immunoassay

Background

Tacrolimus (TAC) is a post-transplantation immunosuppressant drug used in patients for whom careful monitoring of TAC concentration is essential. A new semi-automated immunoassay for TAC measurement, the Elecsys Tacrolimus assay, is available and has been assessed in a multi-center evaluation.

Methods

Residual whole blood samples from patients undergoing TAC therapy after organ transplant were used in assay evaluation at five clinical laboratories in Europe. Experiments included imprecision according to CLSI EP5-A2 (within-run and intermediate), functional sensitivity, linearity according to CLSI EP6-A, and recovery from external quality assessment scheme (EQAS) samples. The assay was compared to LC–MS/MS used routinely at each investigational site, and to the Abbott Architect immunoassay.

Results

Linearity from 0.5 to 40 μg/L was observed and functional sensitivity of 0.3 μg/L (CV ≤ 20%) was determined. Within-run imprecision was ≤ 5.1% on cobas e 602 (5.1% at 1.5 μg/L) and ≤ 8.9% (8.9% at 0.8 μg/L) on cobas e 411. The intermediate imprecision for TAC concentrations ≥ 6.8 μg/L was ≤ 6.5%. At lower therapeutic concentrations (to 1.5 μg/L) it was consistently ≤ 10%. Deming regression analysis of method comparison to LC–MS/MS yielded slopes of 1.07 (95%CI: 1.05/1.10) for heart transplant samples, 1.13 (95%CI: 1.09/1.16) for kidney, and 1.05 (95%CI: 1.02/1.08) for lung transplant samples.

Conclusions

The Elecsys Tacrolimus assay has good linearity, functional sensitivity and intermediate imprecision and is comparable to LC–MS/MS methods. The over-all performance of ECLIA demonstrates a modern generation TAC assay that meets the demands of monitoring drug concentrations in current immunosuppressive regimens.