医院门诊处方质量控制抽样体系的研究及构建

目的：探究医院门诊处方点评过程中,科学的处方抽样方法。方法：通过引入GB/T 2828.1-2012国家抽样标准,结合随机抽样理论,采用SPSS13.0统计软件包Rv.Normal功能辅助完成抽样过程。结果：结合处方抽样实例,通过科学抽样体系,实践抽样过程,为门诊处方点评工作实现科学抽样提供理论依据。结论：该抽样方法能够提高处方抽样的科学性,使门诊处方点评结果更能体现医院处方总体质量。     

凝胶法和超滤法测定rhGH脂质体包封率的比较△

目的:建立两种测定脂质体包封率的方法,并对测定结果进行比较。方法:分别以葡聚糖凝胶法和超滤法分离rhGH脂质体和游离药物,采用HPSEC法测定外水相药物含量,计算包封率,并用SPSS软件进行t检验。结果:两种方法测定不同药脂比的rhGH脂质体包封率,测定结果无显著性差异。结论:凝胶法的建立需详细考察凝胶的种类对分离度的影响;超滤法分离度良好,分离速度快,为优选的方法。     

处方评价工作中Excel软件抽样方法探讨

目的:为减少处方抽样工作量提供参考。方法:以我院2010年3月16日门诊成人处方1650张为例,根据医院信息系统(HIS)软件提供的门诊处方数据特点,演示利用Excel软件排序、自动筛选、填充等差序列和函数VLOOKUP等功能自动随机等距抽样100张处方的操作步骤。结果与结论:该操作在15分钟内完成了处方抽样,极大简化了处方数据的前期处理和随机抽样的工作量,具有推广和交流意义。     

EMIT法和FPIA法监测全血环孢素A浓度相关性比较

目的 比较酶放大免疫法(EMIT)与荧光偏振免疫法(FPIA)监测全血中环孢素A(CsA)浓度的测定结果,并进行相关性分析.方法 收集126例/次临床使用环孢素A的患者稳态浓度血样,分别用EMIT法及FPIA法测定,并考察两种方法测定结果的相关程度.结果 2种不同方法测定CsA血药浓度平均值(x±s)分别为EMIT法:(205.77±117.65)ng/mL;FPIA法:(186.49±112.16)ng/mL,以SPSS 19.0对经对数转换后的两组浓度数据进行配对样本T佥验,其P=0.00,即两种测定方法有显著性差异.将患者分为肾移植组(63例/次),肝移植组(17例/次),干细胞移植组(31例/次),肾病综合征组(15例/次).以SPSS19.0对四组浓度数据分别进行组内的配对样本T检验,得到肾移植组与肝移植组P＜0.05,差异具统计学意义.干细胞移植组与肾病综合征组P＞0.05,差异无统计学意义.结论 对CsA进行治疗药物监测时应考虑不同分析方法的影响.     

纸片法与培养发酵法检测食具大肠菌群污染结果的比较

食具中大肠菌群的检测，过去采用培养发酵法．时间长步骤繁，影响因素多，现改用大肠菌群快速检验纸片法(下简称快速纸片法)，操作简便，节约用品，报告迅速。为了解两种方法对食具细菌污染检测结果的差异，特用两种方法同时对我市20家饭店的碗具进行抽样检测。现将结果报道如下。     

处方评价中不同抽样方法的应用探讨

摘 要 目的:探讨处方评价工作中不同抽样方法的合理性与可操作性,为处方点评的准确实施提供抽样方法参考。方法：选择我院2014年8月1~31日的所有门急诊处方9 129张（Excel 2007表格方式）,分别采用完全随机抽样、系统等距抽样、分层抽样（按日随机抽样、按科室、按病种分层）方法与全面调查方式对比进行处方点评,以《医院处方点评管理规范（试行）》中不规范、不适宜和超常处方作为评价依据和指标进行比较。结果：完全随机抽样、系统等距抽样、按日随机抽样三种方法与全面调查法在处方点评3项指标差别无统计学意义（P>0.05）,且系统等距抽样方法最为接近总体水平。结论：按系统等距抽样抽取300张左右样本量的抽样方法适用于与我院规模相似的医疗机构的处方点评实际工作应用。     

PCR法与ELISA法检测乙型肝炎病毒的比较分析

目的分析并比较PCR法与ELISA法两种方法检测乙肝病毒的效果。方法本文研究对象为104例乙肝病毒感染者，采集患者血液标本，分别采用PCR法与ELISA法两种方法进行检测，比较两种检测方法的差异性。结果EL1SA检测大三阳组及小三阳组与HBVDNA阳性率比较差异具有统计学意义，P〈0．05。结论对乙肝病毒感染者行PCR法检测HBVDNA更具临床价值。     

刮吸解剖法与电凝法应用的临床研究

目的研究观察外科手术中刮吸解剖法的止血效果,所需时间长短及术后并发症的情况。方法回顾性总结70例食管癌手术患者分别采用电凝法、刮吸解剖法,分别观察应用两种手术方法的出血量、手术时间及是否需要输血来进行比较。结果刮吸解剖法止血效果好,且手术所需时间短,需要输血病人数明显减少,术后并发症发生率低。2组比较差异有统计学意义（P〈0.01）。结论手术中采用刮吸解剖法,患者创口出血量少,术野清晰,解剖分离精确。操作时间明显缩短,需要输血患者数明显减少,减少术中损伤,术后并发症发生率低、增加手术安全性。     

基于ICP-MS法筛选高脂血症患者与健康人血浆中差异金属元素

目的筛选出高脂血症对照组与正常对照组人血浆中差异金属元素。方法分别采用湿法消解与直接稀释法处理血浆样品,通过ICP-MS法对样品血浆进行多元素分析并对测定方法进行方法学考察。结果血浆中均检出Cu、As、Se、Cd、Zn、Mn、Cr、Fe、Pb、Li、V、Co、Ni、Mo、Hg等15种元素。平均回收率为91.81%~108.79%。该方法各元素检出限在1~93 ng·L~(-1)。结论该方法可以准确测量血浆样品中15种微量元素含量,依据含量通过使用SPSS 19.0(美国IBM公司)进行统计学分析,用SPSS 19.0中的独立分析t检验方法进行两组数据差异间的显著性检验,找到目标元素分别为Se、Cr、Zn、Fe、Cu。     

直接法和浸提液法两种不同方法对药包材溶血率影响的研究

目的采用直接法和浸提液法两种检查方法对药品包装材料进行评价,比较两种方法对药包材检测灵敏性的差异。方法选择11种具有代表性的药包材,分别采用直接法和浸提液法进行溶血性能检测,并对两种方法测得的溶血结果进行比对。结果浸提液法溶血率大于直接法,均符合规定但不存在显著性差异(P>0.05)。结论直接法和浸提液法均可用于药包材的溶血性能检测,浸提液法作为药包材溶血性能的一个探索,更符合临床使用特点,建议全面考察药包材溶血性能,增加浸提液评价方法。     

Sample size considerations for historical control studies with survival outcomes

Historical control trials (HCTs) are frequently conducted to compare an experimental treatment with a control treatment from a previous study, when they are applicable and favored over a randomized clinical trial (RCT) due to feasibility, ethics and cost concerns. Makuch and Simon developed a sample size formula for historical control (HC) studies with binary outcomes, assuming that the observed response rate in the HC group is the true response rate. This method was extended by Dixon and Simon to specify sample size for HC studies comparing survival outcomes. For HC studies with binary and continuous outcomes, many researchers have shown that the popular Makuch and Simon method does not preserve the nominal power and type I error, and suggested alternative approaches. For HC studies with survival outcomes, we reveal through simulation that the conditional power and type I error over all the random realizations of the HC data have highly skewed distributions. Therefore, the sampling variability of the HC data needs to be appropriately accounted for in determining sample size. A flexible sample size formula that controls arbitrary percentiles, instead of means, of the conditional power and type I error, is derived. Although an explicit sample size formula with survival outcomes is not available, the computation is straightforward. Simulations demonstrate that the proposed method preserves the operational characteristics in a more realistic scenario where the true hazard rate of the HC group is unknown. A real data application of an advanced non-small cell lung cancer (NSCLC) clinical trial is presented to illustrate sample size considerations for HC studies in comparison of survival outcomes.     

非靶向代谢组学生物样品采集和制备方法探讨

生物样品采集和制备是代谢组学研究的第一步也是最关键的一步,合适的样品采集和制备方法是获得可靠结果的重要保证。样品采集和制备方法与分析通量、分析成本和基质效应等密切相关。样品采集与制备方法如不进行充分验证,实验数据常出现较大偏差,但在实际工作中样品采集和制备过程常被忽视。本文对非靶向代谢组学生物样品常用采集和制备方法作一综述,指明了实际操作中的注意事项,有助于我们根据实验目的和样品性质选择合适的方法。本文重点关注基于高效液相色谱-质谱(HPLC-MS)和气相色谱-质谱(GC-MS)的代谢组学研究中常用样品采集和制备方法。     

Sample Size Computations for PK/PD Population Models

We describe an accurate, yet simple and fast sample size computation method for hypothesis testing in population PK/PD studies. We use a first order approximation to the nonlinear mixed effects model and chi-square distributed Wald statistic to compute the minimum sample size to achieve given degree of power in rejecting a null hypothesis in population PK/PD studies. The method is an extension of Rochon’s sample size computation method for repeated measurement experiments. We compute sample sizes for PK and PK/PD models with different conditions, and use Monte Carlo simulation to show that the computed sample size retrieves the required power. We also show the effect of different sampling strategies, such as minimal, i.e., as many observations per individual as parameters in the model, and intensive on sample size. The proposed sample size computation method can produce estimates of minimum sample size to achieve the desired power in hypothesis testing in a greatly reduced time than currently available simulation-based methods. The method is rapid and efficient for sample size computation in population PK/PD study using nonlinear mixed effect models. The method is general and can accommodate any type of hierarchical models. Simulation results suggest that intensive sampling allows the reduction of the number of patients enrolled in a clinical study.     

处方评价工作中抽样调查方法探讨

目的:建立较为科学、合理的处方抽样调查方法。方法:收集2008年4月～2009年2月本院门诊处方资料,采用分层等比例及非等比例抽样调查法(各取200例),与分层全查法(10725例)的数据进行比较,并以处方评价指标中的针剂使用率计算样本量。结果与结论:分层等比例抽样与全查的调查值比较差别无统计学意义(P>0.05);以总体概率最低值估算最小样本量的调查值接近总体水平,故此法可作为医疗机构开展处方评价工作中抽样调查的基本方法。     

关于药品抽检收样工作中常见问题探讨

目的： 探讨药品抽检收样工作中常见问题,提出解决问题的方法和建议,从而科学有效地规范收样工作。方法： 以多年的药品抽检收样工作实践为基础,分析收样环节容易出现的问题。结果与结论： 收样环节出现的问题主要集中在抽样单信息填写、药品标准使用以及抽样三方面上,因此,提出加强抽样队伍建设、提高收样人员素质以及加强药品标准使用管理方面的措施,可以解决部分常见问题,提高收样工作效率。     

药品抽样中样本数确定的商榷

目的探讨国家《药品抽样指导原则》中,样本数确定可能存在的问题以及解决的办法。方法以概率论和数理统计原理诠释抽样样本数确定的理论基础。结果现行药物固体制剂抽样方法中,样本数的确定可能有悖抽样理论。结论应按照国家标准的相关抽样方案确定样本数。     

Assessing Sample Bias among Venue-Based Respondents at Medical Marijuana Dispensaries

ABSTRACT

Venue-based sampling is the identification of, and outreach to, locations visited by the population of interest for the purpose of collecting data. The method is frequently used to reach specific populations, commonly referred to as “hidden populations.” Medical marijuana users represent a hidden population of persons who use marijuana for medicinal purposes. We examine whether venue-based procedures introduce selection or non-respondent bias into the study. The venue based sampling procedures employed for the UCLA Medical Marijuana Study used a two-stage, venue-based sampling approach. First, analyses were conducted to assess potential bias within dispensaries that agreed to participate in the surveys. Secondly, analyses were conducted to examine differences among patrons who responded to surveys. Overall, selection bias was generally absent among study results. Results also illuminated the minimal respondent bias observed among the survey respondents. Results suggest that the use of dispensaries to access and survey medical marijuana users is a viable option to gather patient information that adequately represents the greater population of medical marijuana users in Los Angeles. Thus, recommendations and conclusions based on findings from venue-based studies of medical marijuana users at dispensary sites serve to impartially inform meaningful research.     

样品确认在国家药品评价抽验工作中的作用

目的 进一步完善我国药品评价抽验模式.方法 阐述现行样品确认工作的背景及程序,分析样品确认在国家药品评价抽验工作中的作用.结果 归纳出当前国家药品评价抽验模式中样品确认的必要性及存在的问题.结论 样品确认工作的开展提高了抽验效能,国家药品评价抽验模式将更加完善.     

Sample size/power calculations for repeated ordinal measurements in population pharmacodynamic experiments

Population pharmacodynamic experiments sometime involve repeated measurements of ordinal random variables at specific time points. Such longitudinal data presents a challenge during modelling due to correlation between measurements within an individual and often mixed-effects modelling approach may be used for the analysis. It is important that these studies are adequately powered by including an adequate number of subjects in order to detect a significant treatment effect. This paper describes a method for calculating sample size for repeated ordinal measurements in population pharmacodynamic experiments based on analysis by a mixed-effects modelling approach. The Wald test is used for testing the significance of treatment effects. This method is fast, simple and efficient. It can also be extended to account for differential allocation of subjects to the groups and unbalanced sampling designs between and within groups. The results obtained from two simulation studies using nonlinear mixed-effects modelling software (NONMEM) showed good agreement between the power obtained from simulation and nominal power used for sample size calculations.     

临床试验Williams设计中样本含量的估算方法

在临床试验中,2组交叉设计应用已相当广泛,其样本含量估算方法也被研究者所熟悉。多组交叉试验由Williams首先提出,因此被称为Wil-liams设计。本文介绍基于Williams设计的样本含量估算方法,并提供示例分析,供研究者参考使用。