基于塔巴模式的医院感染预防与控制课程设计研究——来自10所院校师生的数据分析

 目的 调查医院感染预防与控制课程设计中医学生的教育需求及教师的课程设计建议。方法 采用问卷调查全国5个地区10所医学院校师生的医院感染预防与控制教育需求和课程设计意见,参考塔巴目标模式课程设计步骤,论证课程设计方案。结果 584名学生中,仅11.8%(69名)的学生认为当前医院感染预防与控制教育能完全满足其需求,需求得分居前四位的为手卫生、消毒灭菌隔离、医院感染概论和职业防护。352名教师中,72.7%(256名)建议设必修课;86.4%(304名)选择总学时8~24学时,12.5%(44名)选择24学时以上,被调查教师建议10个章节学时平均总和为19.5;需重点掌握13项、熟悉9项知识和技能;86.4%(304名)教师建议理论与见习学时比为1 ∶0.5及以上;53.4%(188名)教师建议采取理论大课+小组见习(含技能操作)+线上学习的形式;63.7%(224名)教师建议师资团队由医院感染管理科+感染病科+护理部教师共同组成。结论 当前医学生的医院感染预防与控制教育远未完全满足需求,单独开课很有必要,建议设置16~24学时必修课,理论联系实践,多学科师资实施多元化教学,按照必修课考核。     

生存研究样本量设计表及其使用方法

目的 :本文就两样本生存研究所需样本量用广义渐近正态法设计出 15 30个方案 ,制成设计表供临床使用。方法 :利用C语言编制程序 ,按通用格式打印设计表。结果 :常用方案查表可得。这些与两样本生存率检验相匹配 ,具有还原性 ,摆脱了比例危险的假设 ,在常见临床条件下观测功效符合预定功效。结论 :这些设计表适用于两样本癌症临床研究的设计 ,尤其便于临床医师或有关研究人员使用     

微乳液反应法制备磺胺嘧啶银均匀微晶及其最佳处方评价

目的：应用微乳液反应法制备磺胺嘧啶银均匀微晶,均匀制得的微晶的粒径大小约为2～4um,均匀微晶的结晶性好,纯度高。用均匀设计方法优化条件,制备的均匀的微晶平均粒径大小为2.09um,实验结果达到预测结果要求。结论：用微乳液反应法能获得磺胺嘧啶银均匀微晶。     

甲硝唑口颊片的工艺研究

采用正交试验设计,考察处方工艺中羧甲基纤维素钠的用量、筛网的大小和片剂的硬度对甲硝唑口颊片的质量影响,从而优选甲硝唑口颊片的最佳处方和制备工艺。制备的甲硝唑口颊片各项指标均符合质量标准,20、50和90min的释放度分别为33．4％、54．3％和74．1％。     

正交试验法筛选口服阿苯达唑毫微球制备工艺

目的为提高阿苯达唑生物利用度,采用α-氰基丙烯酸正丁酯为聚合材料,乳化聚合法制备口服阿苯达唑毫微球,并优化处方工艺.方法紫外分光光度法测定阿苯达唑含量,以包封率为主要指标,乳化聚合二步法制备阿苯达唑毫微球,L9(34)正交试验设计处方工艺.结果首先制备pH为5.0的聚氰基丙烯酸正丁酯空白毫微球,再以0.5 ml/min速率缓慢将空白毫微球注入同体积的阿苯达唑醋酸溶液中,充分搅拌16 h.结论经过优化筛选的组方工艺制备的阿苯达唑毫微球包封率为(61.01士4.06)%,载药量为(48.00士5.20)%.     

白屈菜红碱2种脂质体的制备和口服生物利用度比较

目的 制备白屈菜红碱脂质体（chelerythrine liposomes,Che-Lip）和聚乙二醇修饰白屈菜红碱脂质体（PEGylated chelerythrine liposomes,PEG-Che-Lip）,考察其体外释药和体内口服药动学行为。方法 薄膜超声法制备Che-Lip和PEG-Che-Lip。单因素考察结合Box-Behnken响应面法优化Che-Lip处方,引入二硬脂酰磷脂酰乙醇胺-聚乙二醇2000（DSPE-mPEG2000）制备PEG-Che-Lip。比较Che-Lip和PEG-Che-Lip在模拟胃肠液中溶解度、稳定性和体外释药情况。按20 mg/kg ig给药（以白屈菜红碱计）,测定血药浓度,计算Che-Lip和PEG-Che-Lip主要药动学参数及其相对口服吸收生物利用度。结果 最优处方下制备的Che-Lip和PEG-Che-Lip外观为球形及类球形。Che-Li和PEG-Che-Lip包封率分别为（82.54±0.62）%和（91.13±1.04）%,载药量为（7.64±0.11）%和（7.55±0.18）%,平均粒径分别为（148.15±7.63）nm和（159.37±8.14）nm,ζ电位分别为（-34.2±1.1）mV和（-4.2±0.3）mV。PEG-Che-Lip在模拟胃肠液稳定性高于Che-Lip,Che-Lip和PEG-Che-Lip释药过程均符合Weibull模型。药动学结果显示,Che-Lip的达峰浓度（C_max）和相对口服吸收生物利用度分别增加至1.55倍和2.45倍,PEG-Che-Lip的C_max和相对口服吸收生物利用度分别增加至2.08倍和5.04倍。结论 Che-Li和PEG-Che-Lip可有效促进口服吸收,PEG-Che-Lip优势更明显。     

Measuring physician practice site characteristics: A comparison of data from SK&A and a practice site survey

ObjectiveTo evaluate the comparability of commercially available practice site data from SK&A with survey data to understand the implications of using SK&A data for health services research.Data sourcesResponses to the Comprehensive Primary Care Plus (CPC+) Practice Survey and SK&A data.Study designComparison of CPC + Practice Survey responses to SK&A information for 2698 primary care practice sites.Data collectionCPC + Practice Survey data collected through a web‐only survey from April through September 2017, and SK&A data purchased in November 2016.Principal findingsInformation was similar across data sources, although some discrepancies were common. For example, 56% of practice sites had differences in the reported number of practitioners, and larger sites tended to have larger differences. Among practice sites with 1 practitioner in the survey, only 1.3% had a difference of 3 or more practitioners between the data sources, whereas 63% of practice sites with 11 or more practitioners had a difference of 3 or more practitioners.ConclusionsDiscrepancies between data sources could reflect differences of interpretation when defining practice site characteristics, changes over time in those characteristics, or data errors in either SK&A or the survey. Researchers using SK&A data should consider possible ramifications for their studies.     

Does holding elections during a Covid-19 pandemic put the lives of politicians at risk?

We estimate the impact of French town hall elections held in mid-March 2020 on the mortality of 163,000 male candidates aged above 60. Their excess mortality during March and April was similar to the general population. We compare candidates in cities with two candidate lists to those in cities with only one list, as elections are more intense in contacts in the former group. We also use a regression discontinuity design and investigate mortality in 2020 depending on how candidates fared in the 2014 election. We cannot detect any causal effect of active participation in the 2020 elections on mortality.     

A framework for considering the risk‐benefit trade‐off in designing noninferiority trials using composite outcome approaches

When a new treatment regimen is expected to have comparable or slightly worse efficacy to that of the control regimen but has benefits in other domains such as safety and tolerability, a noninferiority (NI) trial may be appropriate but is fraught with difficulty in justifying an acceptable NI margin that is based on both clinical and statistical input. To overcome this, we propose to utilize composite risk‐benefit outcomes that combine elements from domains of importance (eg, efficacy, safety, and tolerability). The composite outcome itself may be analyzed using a superiority framework, or it can be used as a tool at the design stage of a NI trial for selecting an NI margin for efficacy that balances changes in risks and benefits. In the latter case, the choice of NI margin may be based on a novel quantity called the maximum allowable decrease in efficacy (MADE), defined as the marginal difference in efficacy between arms that would yield a null treatment effect for the composite outcome given an assumed distribution for the composite outcome. We observe that MADE: (1) is larger when the safety improvement for the experimental arm is larger, (2) depends on the association between the efficacy and safety outcomes, and (3) depends on the control arm efficacy rate. We use a numerical example for power comparisons between a superiority test for the composite outcome vs a noninferiority test for efficacy using the MADE as the NI margin, and apply the methods to a TB treatment trial.