综合医院研究型学科建设评价指标体系的构建与实践

以某军医大学附属医院的临床学科为研究对象,建立了研究型学科评价指标体系,并应用于医院研究型建设学科的遴选。该指标体系体现了研究型医院学科建设内涵、医院科技创新和科学管理理念、客观指标与专家评审、学科现状和发展愿景相结合的要求,具有较强的科学性和实用性。     

医院综合绩效考核体系的构建与实施

医院综合绩效考核体系包括成本核算办法、平衡计分卡绩效考核、千分制质控考核、年度绩效考核、单项奖等方面,介绍和分析了各种绩效考核办法及其利弊。构建医院综合绩效考核体系,可以相互扬长避短,兼顾多个方面,促进医院又好又快发展。     

重组干扰素α-2b栓治疗宫颈人乳头瘤病毒亚临床感染的疗效及安全性观察

目的探讨重组干扰素α-2b栓治疗宫颈人乳头瘤病毒（HPV）亚临床感染的疗效及安全性观察。方法选择宫颈HPV亚临床感染患者80例,随机分为观察组与对照组。观察组患者予以重组人干扰素α-2b栓阴道内放置,每晚1枚,隔日1次,10d为1个疗程,连用3个疗程。对照组患者予以双唑泰栓阴道塞入,每晚1枚,隔日1次,10d为1个疗程,连用3个疗程。观察并比较两组患者治疗后的临床疗效及药物不良反应情况。结果治疗3个疗程后,观察组患者临床总有效率为95．0％,明显高于对照组的80．0％（X^2=4．11,P〈0．05）。对照组与观察组治疗期间分别出现不良反应4例和2例,均为阴道瘙痒,症状较轻微,未发生严重的药物不良反应。两组患者治疗期间不良反应发生率比较差异无统计学意义（X^2=0．18,P〉0．05）。结论重组干扰素α-2b栓治疗宫颈HPV亚临床感染的疗效较肯定,具有不良反应轻,安全性较好,使用方便等优点。     

疫苗制备中外源病毒检测方法

疫苗安全性是公众及药品监管机构非常关注的问题。由于疫苗生产原材料如组织、细胞基质、血清、胰蛋白酶等来源于动物,因此疫苗产品存在外源病毒污染的风险。外源病毒对人有潜在危害,实施系统性的检测和采取严格的预防措施可以有效降低外源性因子污染的风险。几十年来,某些经典的检测法已经成为广谱筛查外源病毒污染的标准方法,但其存在一定的局限性。随着大规模基因并行测序、微阵列等分子生物学检测新方法的建立,疫苗外源因子检测方法日趋多样化,增加了检测疫苗外源因子污染种类和概率。     

Energy absorption during impact on the proximal femur is affected by body mass index and flooring surface

Impact mechanics theory suggests that peak loads should decrease with increase in system energy absorption. In light of the reduced hip fracture risk for persons with high body mass index (BMI) and for falls on soft surfaces, the purpose of this study was to characterize the effects of participant BMI, gender, and flooring surface on system energy absorption during lateral falls on the hip with human volunteers. Twenty university-aged participants completed the study with five men and five women in both low BMI (<22.5 kg/m²) and high BMI (>27.5 kg/m²) groups. Participants underwent lateral pelvis release experiments from a height of 5 cm onto two common floors and four safety floors mounted on a force plate. A motion-capture system measured pelvic deflection. The energy absorbed during the initial compressive phase of impact was calculated as the area under the force–deflection curve. System energy absorption was (on average) 3-fold greater for high compared to low BMI participants, but no effects of gender were observed. Even after normalizing for body mass, high BMI participants absorbed 1.8-fold more energy per unit mass. Additionally, three of four safety floors demonstrated significantly increased energy absorption compared to a baseline resilient-rolled-sheeting system (% increases ranging from 20.7 to 28.3). Peak system deflection was larger for high BMI persons and for impacts on several safety floors. This study indicates that energy absorption may be a common mechanism underlying the reduced risk of hip fracture for persons with high BMI and for those who fall on soft surfaces.     

疾病诊断相关组在医院绩效评价中的应用探讨

目前,尽管国内外关于医院绩效评价的研究较多,但普遍存在评价结果缺乏可比性的不足。其主要原因是不同医院收治的疾病类型不同、治疗难度和风险差别较大。基于DRGs的医院绩效评价方式为研究打开了思路。本文在明确当前公立医院绩效评价内容的基础上,指出了基于DRGs开展医院绩效评价的两个条件,即统一优质的数据和完善的信息系统,阐述了评价的三个维度,即医疗服务产出、效率和质量,并就上述三个维度内的相关评价指标的计算方法进行了说明。本文最后给出了基于DRGs开展医院绩效评价的五点现实意义:一是有助于优化医院内部成本结构;二是有助于规范科室临床路径工作;三是创新科室或医生的绩效考核方式;四是形成政府与医院间的长效监管机制;五是有助于探索DRGs付费模式在全国的推广。     

磷酸西格列汀治疗2 型糖尿病疗效观察

目的：观察口服降糖药磷酸西格列汀对2 型糖尿病患者的临床疗效及安全性。方法：对47 例血糖控制欠佳的2 型糖尿病患 者进行为期12 月的磷酸西格列汀治疗并观察,分别在治疗前和治疗3、6、12 个月后检测空腹血糖( FBG) 、餐后2 h血糖、胰高血 糖素、糖化血红蛋白、血常规、血压、肝肾功能、体重。结果：磷酸西格列汀治疗3、6、12 个月后空腹血糖及餐后2 h血糖、胰高血糖 素、糖化血红蛋白水平均较治疗前明显下降(P＜0.05 或0.01),体重、血压、肝肾功能、血常规无明显变化(均P＞0.05)。结论：磷酸 西列汀可显著降低2 型糖尿病患者的空腹血糖、餐后2 h血糖、糖化血红蛋白及抑制α细胞活性,同时无明显副作用,是治疗2 型 糖尿病有效且安全的口服降糖药。     

2013 年重组人干扰素alpha2b 注射剂评价性抽验质量分析

目的:评价国产重组人干扰素α2b注射剂的质量现状及存在问题。方法:采用法定检验方法结合探索性研究进行样品检验,统计分析检验结果,对国产重组人干扰素α2b注射剂的质量现状进行评价。结果:法定检验显示92批成品91批合格,合格率98.9%;24批原液20批合格(部分检验),合格率83.3%;探索性研究表明,按欧洲药典标准在原液中增加相关蛋白含量测定,则有两家企业的产品符合要求。结论:该品种总体质量状况良好,现行检验标准基本可行,建议在原液中增加相关蛋白含量检测。     

拉曼技术在药物逆向工程中的应用

逆向工程以目标产品进行逆向分析及研究,是仿制药开发过程中的一个重要环节,在目前的仿制药一致性评价中发挥显著功效。 尽管物理、化学方法众多,但原研制剂的逆向工程分析仍然极具挑战、极其耗时。逆向工程的最终目的不仅是确定原研制剂中所有可能 的化学成分,还要深入揭示其制剂原则和药物释放机制。而如何高效合理地应用各种分析技术,是深入了解原研药的第一步。文章概述 了一种光谱技术——拉曼光谱在药物逆向分析工程中的实用性,特别介绍在某些情况下,当其他常用固态分析技术如 X 射线粉末衍射、 差示扫描量热法等不适用时,拉曼光谱对原研制剂中药物活性成分(API)晶型的鉴定。文章通过对拉曼光谱在某些特定条件下应用的具 体案例的演示,展示了分子振动相关光谱分析手段在药物逆向分析工程中的应用前景。     

Safety of a novel oxygen-coordinated niacin-bound chromium(III) complex (NBC): I. Two-generation reproduction toxicity study

The objective of this study was to evaluate the effects of a novel oxygen-coordinated niacin-bound chromium(III) complex (NBC) on the reproductive systems of male and female rats, the postnatal maturation and reproductive capacity of their offspring, and possible cumulative effects through multiple generations. Sprague-Dawley rats were maintained on feed containing NBC at dose levels of 0, 4, 15, or 60 ppm for 10 weeks prior to mating, during mating, and, for females through gestation and lactation, across two generations. For the parents (F₀ and F₁) and the offspring (F₁ and F_2a), reproductive parameters such as fertility and mating, gestation, parturition, litters, lactation, sexual maturity and development of offspring were assessed. Results from the current study indicated that dietary exposure of NBC to parental male and female rats of both (F₀ and F₁) the generations during the premating and mating periods, for both sexes, and during gestation and lactation in case of female rats, did not cause any significant incidence of mortality or abnormal clinical signs. Compared to respective controls, NBC exposure did not affect reproductive performance as evaluated by sexual maturity, fertility and mating, gestation, parturition, litter properties, lactation and development of the offspring. Based on the findings of this study, the parental as well as the offspring no-observed-adverse-effect level for NBC was determined to be greater than 60 ppm in diet or equivalent to 7.80 and 8.31 mg/kg body weight/day in male and female rats, respectively.