Trappin-2对HaCaT细胞及银屑病跨膜模型增殖的抑制作用

目的 构建Trappin-2的真核表达体系,初步探讨Trappin-2对HaCaT细胞及银屑病跨膜模型增殖的影响.方法 采用DNA重组技术构建Trappin-2的表达载体pIRES2-EGFP-Trappin-2,通过脂质体法转染入宫颈癌HeLa细胞.将Trappin-2高表达上清加入HaCaT细胞及银屑病跨膜模型中,通过3H-TdR掺入法、MTT法、流式细胞术及组化染色Ki67检测对增殖的影响.结果 Trappin-2作用后MTY和cpm值变化率显示Trappin-2可抑制HaCaT细胞的代谢与DNA合成,同时可使HaCaT细胞G2 S期细胞比例下降,而G1期细胞比例增加.Trappin-2可下调银屑病皮损Ki67表达水平.结论 成功将Trappin-2基因转染HeLa细胞,并进行有效表达,初步证实Trappin-2具有抑制HaCaT细胞及银屑病跨膜模型增殖的特性.     

冠心病合并2型糖尿病患者血浆脂蛋白a水平与冠脉病变的关系

目的:探讨冠心病(CAD)合并2型糖尿病(DM)患者血浆脂蛋白(a)[Lp(a)]水平与冠状动脉(冠脉)狭窄程度及范围之间的关系。方法:163例经冠状动脉造影(CAG)证实为CAD的2型DM患者按冠脉狭窄程度分中度(n=19)和重度(n=144)狭窄组,按病变范围分为单支(31例)、双支(48例)和多支(84例)病变组,54例无冠心病患者作为对照组,分别测量和比较各组Lp(a)、总胆固醇(TC)、三酰甘油(TG)、高密度脂蛋白胆固醇(HDL-C)、低密度脂蛋白胆固醇(LDL-C)、载脂蛋白A-(IApoA-I)及载脂蛋白B(ApoB)水平。结果:中、重度狭窄组的Lp(a)水平高于对照组,中度狭窄组与重度狭窄组之间的Lp(a)水平差异无统计学意义。单支、双支、多支病变组Lp(a)水平高于对照组,多支病变组的Lp(a)水平高于单支、双支病变组,各组间TC、TG、HDL-C、LDL-C、ApoA-I、ApoB水平差异均无统计学意义。多元回归分析显示Lp(a)水平为冠脉狭窄程度和范围的危险因素。结论:Lp(a)水平可作为2型DM合并CAD患者冠脉病变严重性的评价指标之一。     

Tolerability,pharmacokinetics and pharmacodynamics of CMAB001, an anti-CD11a antibody,in Chinese healthy volunteers and psoriatic patients

Aim:

To evaluate the pharmacokinetics (PK), pharmacodynamics (PD) and primary tolerability of an anti-CD11a monoclonal antibody (CMAB001) in Chinese healthy volunteers and psoriatic patients.

Methods:

Two open-label studies were conducted. One was a parallel-group, single-center, dose-escalation test, including 24 healthy adult volunteers from 18 to 45 years in age. All subjects randomly received a single subcutaneous injection dose of 0.5, 1.0 or 2.0 mg/kg. The other was a multiple-dose study: 10 adult psoriatic patients were administered weekly subcutaneous injections of 1.0 mg/kg for 7 weeks.

Results:

CMAB001 was well tolerated in the single- and multiple-dose studies. Slow absorption was observed in both studies. In the single-dose study, the concentration of CMAB001 reached its highest level 2 d later after the injection, and the C_max increased in an approximate dose-proportionate manner, while the area under curve (AUC) showed much greater than dose-proportionate increase. In the multiple-dose study, the steady-state serum concentration level was attained following the 4th injection.

Conclusion:

CMAB001 exhibited a nonlinear pharmacokinetic profile over the dose range from 0.5 to 2.0 mg/kg, and was well tolerated in healthy volunteers and psoriatic patients.     

抗生素缓控释给药系统——载药微球的研究与开发

利用具良好生物相容性和生物可降解性的聚合物制得的微球作为一种新型药物载体,具有良好的缓控释作用,并具有一定的靶向性,可用于口服和注射,在药学领域和临床上有着广阔的应用前景。综述近年来各种抗生素缓控释微球制剂的研究与开发。     

Statistical and regulatory issues in nonrandomized medical device clinical studies

While randomized, well-controlled, clinical trials have been viewed as the gold standard in the evaluation of medical products, it is not uncommon for medical device clinical studies to depart from the paradigm of randomized trials, due to ethical or practical reasons. In nonrandomized studies, the advantages of well-designed and conducted randomized clinical trials are no longer available, and consequently the statistical inference obtained from such studies may carry a lower level of scientific assurance, compared to randomized trials. This paper provides a brief overview of nonrandomized medical device clinical studies in terms of design and statistical analysis as well as regulatory issues, including some challenges that frequently arise in those endeavors.     

骨化三醇对腹透患者钙磷代谢及T淋巴细胞亚群的影响

目的 :了解骨化三醇 (1 ,2 5 (OH) 2 D3 ,罗钙全 )对腹膜透析患者钙磷代谢及免疫功能的影晌。方法 :观察 3 7例腹膜透析 (PD)患者服用骨化三醇前后血清T细胞亚群、IL 8以及血免疫反应甲状旁腺激素 (iPTH)、钙、磷水平变化。结果 :用药前PD组血清T淋巴亚群的CD4/CD8低于正常对照组 (P<0 .0 5 ) ,服用骨化三醇 4wk后 ,CD4/CD8从 0 .5 6±0 .1 0升至 0 .79± 0 .1 2 ;而iPTH显著降低 ,血钙显著升高 ,血磷明显下降。结论 :骨化三醇能改善PD患者钙磷代谢 ,进而改善其免疫功能     

中药知识产权保护现状研究

目的加强中药领域专利保护研究。方法分析了我国中药专利保护现状,探讨存在的问题,并提出相关策略和建议。结果与结论中药及其复方制剂是中医药理论和实践的结晶,我国加入世贸组织以后,保护中药自主知识产权已成为刻不容缓的重大问题。     

构建与医学教育国际标准相衔接的医学本科专业教学计划的几点做法

为适应医学教育的发展形势,积极与＂全球医学教育最低标准＂相接轨,安徽医科大学对临床医学专业课程设置进行了新的设计与整合,以培养具有多方面潜质、多方面能力和良好职业道德与人际沟通素质的人才为价值取向,按照＂一个标准、一个原则、两个整合、两个环节、九个模块＂的思路制定了新培养方案,为深化教学改革,培养创新医学专门人才明确了方向。     

镫骨骨质缺损对听力传导影响的有限元分析

目的建立完善的鼓膜-听骨链模型,利用有限元初步探讨镫骨前、后脚骨质缺损对听力传导的影响。方法实验数据源于对一名无中耳病史的成年男性左侧颞骨进行Micro-CT扫描,在医学影像处理软件Mimics上进行三维重建,利用Geomagic形成需要的曲面,最后在SolidWorks上将成型的鼓膜-听骨链模型进行切割组装,建立正常听骨链模型以及镫骨前、后脚骨质缺损模型,利用模型分析骨质缺损对听力传导的影响。结果建立的鼓膜-听骨链模型镫骨足板频振曲线符合相关文献报道,在镫骨前、后脚骨质缺损病理模型下,曲线与正常中耳模型曲线接近。结论利用多软件综合处理,可建立可信度较高的中耳听骨链模型;有限元模拟分析结果显示,镫骨前、后脚缺损部分骨质,未对听力传导产生明显影响。