Thyroid disorders: Automatic diagnosis in CONSULT I

Automatic diagnosis of thyroid diseases is implemented on CONSULT I^™, a microcomputer system based on the Patrick model for computer-assisted diagnosis in medicine. The thyroid ‘subsystem’ consists of 19 classes (diseases) and 16 features (signs, symptoms, laboratory tests). For 76 test cases obtained from patient records (recognition samples), the ‘true’ class (disease) is decided in the highest ‘probability’ number in 89% of cases and in the differential diagnosis in 100% of cases. Performance is compared to physicians. Estimation of class-conditional probability densities utilizing equivalence regions in the feauture space is discussed.     

C一WISC与WAIS一RC用于16岁正常学生测试结果的比较研究

本研究采用中国修订韦氏儿童智力量表（Ｃ一ＷＩＳＣ）与韦氏成人智力量表中国修订本（ＷＡＩＳ一ＲＣ）对５２名１６岁的高一年级学生进行了测试，结果发现：在ＷＡＩＳ一ＲＣ上的ＩＱ分及分测验量表分普遍高于Ｃ一ＷＩＳＣ，６个言语分测验平均相差１．５个量表分，５个操作分测验平均相差０．９个量表分，言语、操作及全量表智商分别相差６、１、４分，说明两套测验的结果不完全具有等值性，本文对其产生原因作了探讨。     

Is the standard SF-12 Health Survey valid and equivalent for a Chinese population?

Introduction: Chinese is the worlds largest ethnic group but few health-related quality of life (HRQoL) measures have been tested on them. The aim of this study was to determine if the standard SF-12 was valid and equivalent for a Chinese population. Methods: The SF-36 data of 2410 Chinese adults randomly selected from the general population of Hong Kong (HK) were analysed. The Chinese (HK) specific SF-12 items and scoring algorithm were derived from the HK Chinese population data by multiple regressions. The SF-36 PCS and MCS scores were used as criteria to assess the content and criterion validity of the SF-12. The standard and Chinese (HK) specific SF-12 PCS and MCS scores were compared for equivalence. Results: The standard SF-12 explained 82% and 89% of the variance of the SF-36 PCS and MCS scores, respectively, and the effect size differences between the standard SF-36 and SF-12 scores were less than 0.3. Six of the Chinese (HK) specific SF-12 items were different from those of the standard SF-12, but the effect size differences between the Chinese (HK) specific and standard SF-12 scores were mostly less than 0.3. Conclusions: The standard SF-12 was valid and equivalent for the Chinese, which would enable more Chinese to be included in clinical trials that measure HRQoL.     

等效性评价方法研究现状

目的：阐明生物等效性与临床等效性的研究现状及发展方向。方法：介绍新药等效性评价方法的原理，生物等效性分析方法的新进展包括总体或(和)个体生物等效性和多变量生物等效性检验的方法，以及临床等效性中等效界值、目标参数及有待解决的问题，并结合实例进行论述。结论：等效性评价的基本方法已得到推广使用，但在应用上还存在很大的可塑性，不利于新药审评标准的把握，应加强等效性评价方法的正确应用与发展。     

模拟验证等效性检验中β的单、双侧取值

目的 研究临床试验中等效性检验的样本量的计算问题.方法 在概括总结影响等效性检验的样本量与检验效能的几个主要因素（α、β、θ、△、σ）的基础上,重点介绍了等效性检验中α与β的确定与含义,并指出了文献中所存在的分歧;然后利用计算机抽样模拟的方法,依据不同设计类型、不同参数取值下计算的样本量,模拟估算所对应的检验效能.结果 模拟验证了β应该取单侧还是双侧并给出了较为合理的解释.结论 在等效性检验的样本量估算中,当θ为0时,β取双侧;当θ不等于0时,β取单侧.     

龙胆泻肝汤煎剂与丸剂等量性研究

目的:以煎剂和丸剂2种剂型为代表,研究中药制剂等量性,为等效性评价奠定基础。方法:以龙胆苦苷、栀子苷含量和水溶性浸出物为指标,考察龙胆泻肝汤煎剂与丸剂的等量性。结果:以含量为指标,煎剂的日服用量是丸剂的6.39倍;以浸出物为指标,煎剂的日服用量是丸剂的4.02倍。结论:适当增大丸剂目前日服用量方可达到与煎剂相同剂量。增大程度,需结合药理、临床等研究成果定论。     

基于词间关系的叙词表术语翻译

从词间关系角度出发，探讨了叙词表术语翻译的方法。结合实践，分别从等同关系、等级关系及相关关系3种词间关系分析了“英文超级科技词表”中的英文术语翻译为中文的翻译方法，结果显示，利用词间关系进行叙词表术语辅助翻译，能够使术语的翻译更具有专一性和规范性，有利于多语种叙词表的质量控制。     

如何正确运用t检验——两算术均值比较等效性t检验及SAS实现

本文主要介绍临床试验中的等效性检验的概念、原理、作用以及成组设计一元定量资料等效性检验的SAS实现。基于原始的定量数据或者基于给定样本含量、均值、标准差两种数据结构,结合实例展示SAS在等效性检验中的应用,并对结果进行解释、做出结论。     

如何正确运用Z检验——两总体率比较等效性Z检验及SAS实现

本文介绍了两总体率比较等效性Z检验的原理、方法和SAS实现。文中涉及两个方面内容，包括两总体率比较等效性Z检验的原理和方法以及基于SAS软件实现两总体率比较等效性Z检验。文中给出了SAS输出结果并对其进行解释，并分别得出统计学结论和专业结论。     

A randomized,observer-blinded,equivalence trial comparing two variations of Euvichol®, a bivalent killed whole-cell oral cholera vaccine,in healthy adults and children in the Philippines

BackgroundTo contribute to the global demand for oral cholera vaccine (OCV), the production of Euvichol® was scaled up with elimination of thimerosal. To demonstrate the equivalence of the variations, a study was carried out in the Philippines.MethodsHealthy male and female adults and children in Manila were randomized to receive two doses of Euvichol® two weeks apart from either the 100L (Comparator) or the 600L (Test) variation. Primary and secondary immunogenicity endpoints were respectively geometric mean titer (GMT) of vibriocidal antibodies (two weeks post second dose) and seroconversion rate (two weeks after each dose) against O1 Inaba, Ogawa, and O139 serogroups. The GMT of vibriocidal antibodies against O1 Inaba, Ogawa, and O139 two weeks post first dose was also measured. To show the equivalence of two variations of Euvichol®, the ratio of GMT and the difference of seroconversion rate between Test and Comparator vaccines were tested with equivalence margin of [0.5, 2.0] for GMT ratio and of 15% for seroconversion rate, respectively. Safety assessment included solicited reactogenicity within 6 days after each dose and unsolicited and serious adverse events.ResultsA total of 442 participants were enrolled. For the overall population, equivalence between Test and Comparator was demonstrated for vibriocidal antibody response against O1 Inaba and Ogawa serotypes and O139 serogroup in both modified intention-to-treat (mITT) and per protocol analysis, since the 95% confidence intervals (CI) of GMT to any serotypes were within the lower and upper boundary [0.5, 2.0]. Seroconversion rates after two doses also showed equivalence for O1 Inaba, Ogawa, and O139. The vaccine was safe and well tolerated, similarly between the two groups.ConclusionThe study results support the equivalence of the 600L Euvichol® to the 100L formulation in healthy children and adults. The 600L Euvichol® is safe and immunogenic in adults and children.ClinicalTrials.gov registration number: NCT02502331.