不同多焦视网膜电图系统在评估视网膜功能上的比较

目的 评估VERIS mfERG （EDI Inc）和Espion multifocal imager （Diagnosys）两种不同系统测量正常眼多焦视网膜电图（mfERG）的电位波反应的差异及其相关性,并用两个不同系统分别测量黄斑前膜患眼的mfERG并进行分析.方法 这是一项横断面研究,在VERIS系统使用Burian-Allen （BA）电极,Espion系统使用BA和DTL电极分别测量25只正常眼的mfERG,将3次测得的一阶反应的相应数据进行配对t检验及Pearson相关分析.两个系统用BA电极分别测量19只黄斑前膜患眼的mfERG,对一阶反应的相应数据进行Fisher＇s exact test分析.结果 VERIS BA测得正常眼N1波、P1波振幅密度值最大,其次为Espion BA,Espion DTL最小;VERIS BA测得N1波、P1波潜伏期最长,Espion BA与Espion DTL差异无统计学意义.Espion BA与VERIS BA测得的P1波振幅密度、潜伏期皆有明显的相关性.黄斑前膜患眼中,VERIS BA比Espion BA能检测到更多P1波振幅密度和P1波潜伏期的异常.结论 不论VERIS或Espion系统都能成功记录多焦视网膜电图,当两种系统都使用Burian-Allen电极时,两者mfERG一阶反应P1波振幅密度及潜伏期有着良好的相关性.     

6－甲氧基正丁苯酞在大鼠肝微粒体中的代谢研究

报道了用ＧＣ／ＭＳ方法及衍生化技术研究６甲氧基正丁苯酞（ＭＢＰ）在大鼠肝微粒体中的代谢转化结果。６甲氧基正丁苯酞在苯巴比妥（ＰＢ）诱导的大鼠肝微粒体中主要转化为３羟基、γ羟基取代物，６羟基正丁苯酞与一个环氧化代谢产物     

双(2,6-哌嗪二酮)类抗肿瘤药物的研究:2,3-二乙酰氧基-1,4-二(3′,5′-二酮-N4′-取代哌嗪甲基)苯的合成

Seventeen compounds having the structure of 2,3-diacetoxy-1,4-bis(3′,5′- dioxo-N⁴′-substituted piperazinyl methyl)benzene were designed and synthesized based on chelation hypothesis. Their antitumor activities on P388 cells,Hep cells and SGC 7901 cells in vitro were tested. Preliminary results showed that compound 4e has potent antitumor effect against P388 cells and.Hep cells in vitro.     

水溶性药物的疏水性修饰及其重组型脂质体的研究

脂质体载水溶性药物出现的共同问题是药物的包封量低、稳定性差。本文以甲硝唑(Ⅰ)为水溶性药物模型,进行疏水性结构修饰,得其肉豆蔻酸酯(Ⅱ)前体药物,分别进行Ⅰ和Ⅱ的脂质体研究,结果表明Ⅱ在脂质体中的包封率较Ⅰ提高10倍以上,渗漏速率降至十分之一,制成含Ⅱ的脂质干膜,经超声分散,可得合乎要求的重组型脂质体,为解决脂质体载药的稳定性问题提供有效途径。体外抗阿米巴原虫试验,镜检观察到载药脂质体进入阿米巴原虫的细胞内,且100%抑制原虫所需剂量Ⅱ脂质体是Ⅰ游离药的二分之一。因此药物疏水化修饰是解决脂质体载水溶性药物稳定性问题的理想途径。     

Molecular evidence that in situ-transduced fetal liver hematopoietic stem/progenitor cells give rise to medullary hematopoiesis in adult rats

We exploited the ability to transduce fetal liver hematopoietic stem/progenitor cells in situ with recombinant retrovirus, together with the ability to analyze proviral integration patterns into chromosomal DNA, to detect the cellular and organ fate of hematopoietic stem and progenitor-derived progeny in tissues and in the circulation of neonatal and adult rats. Two hundred seventeen fetuses were injected with retrovirus supernatant on day 16 of gestation, before the development of the bone marrow cavity. The progeny of 41 stem and progenitor cells from 97 liveborn rats were clonally identified. Pluripotent and lineage-restricted stem/progenitor clones derived from the fetal liver consistently gave rise to progeny in the marrow of newborn and adult rats. Patterns of differentiation of transduced stem and progenitor cells fell into distinct subsets. Blood cells derived from in situ transduced cells that originated in the fetal liver circulated throughout the life span of the adult animals. These data provide molecular evidence of the origin of medullary cavity hematopoiesis by cells derived from the fetal liver that were transduced in vivo, homed to the developing medullary cavity and proliferated in a normal medullary hematopoietic microenvironment.     

大环内酯类抗生素麦迪霉素的电化学特性

在K₂HPO₄,NH₄Cl+NH₃和NaOH的10%(v/v)乙醇水溶液中,除0.01mol·L^-1以上NaOH液作为支持电解质外,麦迪霉素的伏安波皆为两个峰。峰A相当于它的甲醛基还原波,峰B为催化吸附氢波。溶液pH对两峰有强烈的影响。实验表明伏安波有吸附特性,且不可逆。两峰的ip与麦迪霉素的浓度成正比,线性范围分别为3×10^-6～3×10^-5mol·L^-1和1×10^-7～4×10^-5mol·L^-1,检测限为:1×10-6mol·L^-1和5×10^-8mol·L^-1。可应用于麦迪霉素的定量测定。研究了两峰的特性和电极机理,测定了有关的物理常数。     

In Vitro Dissolution Profile Comparison—Statistics and Analysis of the Similarity Factor,f2

Purpose. To describe the properties of the similarity factor (f₂) as a measure for assessing the similarity of two dissolution profiles. Discuss the statistical properties of the estimate based on sample means. Methods. The f₂ metrics and the decision rule is evaluated using examples of dissolution profiles. The confidence interval is calculated using bootstrapping method. The bias of the estimate using sample mean dissolution is evaluated. Results. 1. f₂ values were found to be sensitive to number of sample points, after the dissolution plateau has been reached. 2. The statistical evaluation of f₂ could be made using 90% confidence interval approach. 3. The statistical distribution of f₂ metrics could be simulated using 'Bootstrap' method. A relatively robust distribution could be obtained after more than 500 'Bootstraps'. 4. A statistical 'bias correction' was found to reduce the bias. Conclusions. The similarity factor f₂ is a simple measure for the comparison of two dissolution profiles. But the commonly used similarity factor estimate ^f₂ is a biased and conservative estimate of f2. The bootstrap approach is a useful tool to simulate the confidence interval.     

中药并B超下行外倒转术50例

0　引言　外倒转术是纠正胎位异常的常用手段 ,但单纯施行外倒转术对一些孕妇难以成功 ,为此 ,我们探讨在经 B超下行胎儿外倒转术和先服中药再行此术纠正胎位异常的临床价值 .1　对象和方法1.1　对象　本组 88例均为我院在 1993- 0 8/ 1995 - 0 8在门诊就诊的正常妊娠孕妇 ,年龄 2 1～ 34岁 ,孕周初孕妇 30～ 36wk5 0例 ,经孕妇 30～ 40 wk38例 ,经确诊为横位或臀位 ,其中臀位 85例 .1.2　方法　将上述孕妇随机分为 2组 ,中药组 5 0例 ,其中 ,初孕妇 2 8例 ,术前 1wk服用中药 .当归芍药散加减法 (方剂组成 :当归 6 g,茯苓 9g,川芎 4g,泽泻 …     

Adjustment for unbalanced sample size for analytical biosimilar equivalence assessment

ABSTRACT

Large sample size imbalance is not uncommon in the biosimilar development. At the beginning of a product development, sample sizes of a biosimilar and a reference product may be limited. Thus, a sample size calculation may not be feasible. During the development stage, more batches of reference products may be added at a later stage to have a more reliable estimate of the reference variability. On the other hand, we also need a sufficient number of biosimilar batches in order to have a better understanding of the product. Those challenges lead to a potential sample size imbalance. In this paper, we show that large sample size imbalance may increase the power of the equivalence test in an unfavorable way, giving higher power for less similar products when the sample size of biosimilar is much smaller than that of the reference product. Thus, it is necessary to make some sample size imbalance adjustments to motivate sufficient sample size for biosimilar as well. This paper discusses two adjustment methods for the equivalence test in analytical biosimilarity studies. Please keep in mind that sufficient sample sizes for both biosimilar and reference products (if feasible) are desired during the planning stage.     

内镜下扩大经鼻蝶入路至斜坡区的解剖学研究

目的探索内镜下经扩大鼻蝶入路显露斜坡区的可行性,为切除斜坡区病变提供解剖学参考。方法在10例成人头部固定标本上,内镜下模拟扩大经鼻蝶手术入路显露斜坡区,观察有关显微解剖标志。结果扩大经鼻蝶内镜入路可磨除从鞍后到斜坡、枕骨大孔前缘的骨性结构;可显露斜坡区腹侧硬膜下的椎基底动脉及其分支、后交通动脉及其与大脑后动脉汇合处、动眼神经、脑干腹侧等结构。此入路的手术标志主要包括:蝶筛隐窝、蝶窦开口、视神经隆突、颈内动脉隆突与颈内动脉视神经隐窝、咽结节、枕骨大孔前缘。结论内镜下扩大经鼻蝶手术入路可充分显露鞍后-斜坡区的腹侧硬膜下结构,适用于此区病变的手术治疗。