案例分析与情景模拟在急诊护理教学的效果

目的探讨分案例分析法结合情景模拟法在急诊护理学生教学中的应用价值。方法以2016年10月-2017年10月本院纳入的46例急诊科实习护士为例展开研究,以教学方式的不同将46例急诊科实习护士分成观察组(n=23,接受案例分析法结合情景模拟法教学)和对照组(n=23,接受传统法教学),教学结束后对比分析两组急诊科实习护士的学习情况以及评判性思维能力。结果教学结束后,经考核发现,观察组实操成绩以及理论成绩均高于对照组(P <0.05);观察组寻求真相、求知欲、系统化能力以及分析能力等评判性思维能力均高于对照组(P <0.05)。结论在急诊护理学生教学中应用案例分析法结合情景模拟法进行教学,有利于急诊科实习护士掌握理论知识以及实操知识,同时还可以提高其评判性思维能力,可实现有效教学。     

2型糖尿病中个性化综合饮食护理的应用效果

目的观察2型糖尿病患者中个性化综合饮食护理的应用效果。方法选择本院2018年1月—2018年12月接收的80例2型糖尿病患者实施此次研究,根据随机数字表法分为观察组(40例)和对照组(40例)。观察组使用个性化综合饮食护理,对照组使用常规护理措施,比较两组患者临床效果。结果观察组依从性为95.00%,对照组为80.00%(P<0.05)。两组护理前餐后2 h后血糖含量、糖化血红蛋白水平及空腹血糖含量比较差异无统计学意义(P>0.05)。观察组护理后餐后2 h后血糖含量、糖化血红蛋白水平及空腹血糖含量均低于对照组(P<0.05)。结论将个性化综合饮食护理用于2型糖尿病患者治疗中。     

Population Pharmacokinetics and Dosing Simulations of Ceftazidime in Chinese Neonates

An accurate dosage determination is required in neonates when antibiotics are used. The adult data cannot be simply extrapolated to the pediatric population due to significant individual differences. We aimed to identify factors impacting ceftazidime exposure in neonates and to provide drug dosing guidance to clinicians. Forty-three neonates aged less than 60 days with proven or suspected infections were enrolled in this study. After intravenous administration, blood samples were collected, and plasma ceftazidime concentration was determined using a HPLC method. Pharmacokinetic data were fitted using a nonlinear mixed-effects model approach. One-compartmental model could nicely characterize the ceftazidime in vivo behavior. The covariate test found that the postmenstrual age (day) was strongly associated with systemic drug clearance (L/h), and the effect of body weight (kg) was identified as the covariate on distribution volume (L). Compared with the base model, the addition of covariates improved the goodness-of-fit of the final model. Model validation (bootstrap, visual predictive check, and prediction-corrected visual predictive check) suggested a robust and reliable pharmacokinetic model was developed. Personalized dosage regimens were provided based on model simulations. The intravenous dose should be adjusted according to postmenstrual age, body weight, and minimum inhibitory concentration.     

Pharmacokinetics and tissue distribution of crotonoside

1.?Crotonoside is a bioactive ingredient from Croton Herba with a strong antitumour activity. This study aimed to develop a highly sensitive and selective high-performance liquid chromatography (HPLC) method to quantify crotonoside in biological samples for pharmacokinetics and distribution studies.

2.?Protein precipitation by perchloric acid was used to separate crotonoside from the biological samples, and the recovery rates for crotonoside and the internal standard (luteoloside) were >80%. All calibration curves examining the crotonoside levels in plasma and tissues were linear (all correlation coefficients >?0.99).

3.?The response to crotonoside appeared to be dose disproportional to the maximum plasma concentration and the area under the time–concentration curve in plasma over the range of 12.5–50.0?mg/kg, and crotonoside was highly distributed in tissues after intravenous administration. The highest crotonoside level was detected in the liver (28.79?±?14.96?μg/g), whereas crotonoside was undetected in the brain.     

苍耳子药材的HPLC特征图谱研究

摘 要 目的：建立苍耳子药材的HPLC特征图谱,为评价不同产地苍耳子的质量提供参考。方法: 采用Alltima C18（250 mm×4.6 mm,5 μm）,流动相乙腈 0.1%磷酸溶液梯度洗脱,流速：0.8 ml·min^-1,检测波长：278 nm,柱温：25 ℃,对来自河南、吉林、安徽等地共47批苍耳子样品运用“中药指纹图谱相似度评价系统”进行分析。 结果:以绿原酸为参照峰,初步构建了由5个特征峰组成的苍耳子HPLC 特征图谱。结论:该方法简便、可靠,为苍耳子药材的质量控制提供了有效的评价方法。     

Delivery of radix ophiopogonis polysaccharide via sucrose acetate isobutyrate-based in situ forming systems alone or combined with its mono-PEGylation

This work aimed to achieve long-lasting delivery of radix ophiopogonis polysaccharide (ROP) by sucrose acetate isobutyrate (SAIB)-based in situ forming systems (ISFSs) alone or combined with mono-PEGylation of ROP. When the ‘90%SAIB/10% solvent’ system was used, the mean residence time (MRT) of ROP was prolonged by 4.3 5?～?7.00 times and the initial release rate was reduced significantly. However, this system was only suitable for days-long sustained release of ROP in short-term therapy. As to the ‘SAIB/additives/solvent’ system containing mono-PEGylated ROP, the results indicated that SAIB/poly(d,l-lactide-co-glycolide) (PLGA)/N-methyl-2-pyrrolidone (NMP) was superior to SAIB/polylactic acid (PLA)/NMP and SAIB/PLA/ethanol in controlled release. Moreover, weeks- to months-long (16–60 d) smooth release of ROP could be achieved by varying the concentration (10–30%) and molecular weight (MW) of PLGA (10–50?kDa) or by employing a moderate MW of PEGylated ROP (～20 or ～30?kDa). With further increasing the conjugate MW to ～40?kDa, the contribution of drug elimination to its plasma retention seemed to surpass that of the SAIB-based system, resulting in that the system no longer had an obvious influence on the in vivo behavior of the conjugate. Besides, the results of host response confirmed that with less solvent being used, the SAIB-based systems showed a higher biocompatibility than the PLGA-based systems, suggesting that they could be freely chosen in the prevention and/or cure of chronic diseases.     

Common Deficiencies of <Emphasis Type="Italic">in vitro</Emphasis> Binding Bioequivalence (BE) Studies Submitted in Abbreviated New Drug Applications (ANDAs)

There are several drug products that bind phosphate or bile acid in the gastrointestinal (GI) tract to exert their therapeutic efficacy. In vitro binding studies are used to assess bioequivalence (BE) of these products. The objective of this study is to identify the common deficiencies in Abbreviated New Drug Applications (ANDAs) for these products. Deficiencies were compiled from ANDAs containing in vitro binding BE studies. The deficiencies were classified into eight categories: Pre-Study Method Validation, During-Study Sample Analysis, Study Design, Study Procedure, Dissolution/Disintegration, Analytical Site Inspection, Data Submission, and Formulations. Within each category, additional subcategories were defined to characterize the deficiencies. A total of 712 deficiencies from 95 ANDAs for 11 drug products were identified and included in the analysis. The four categories with the most deficiencies were During-Study Sample Analysis (27.8%), Pre-Study Method Validation (17.3%), Data Submission (16.7%), and Study Design (15.7%). For the During-Study Sample Analysis category, failure to submit complete raw data or analytical runs ranked as the top deficiency (32.8%). For the Study Design category, using an unacceptable alternate study design (26.8%) was the most common deficiency. Within this category, other commonly occurring deficiencies included incorrect/insufficient number of absorbent concentrations, failure to pre-treat drug product with acid, insufficient number of replicates in study, incorrect calculation of k1 and k2 values, incorrect dosage form or pooled samples used in the study, and incorrect pH of study medium. The review and approval of these products may be accelerated if these common deficiencies are addressed in the original ANDA submissions.     

生长激素和脱氢表雄酮在卵巢低反应患者的临床应用及其研究进展

卵巢低反应（POR）是指在控制性超促排卵（COH）过程中,卵巢对促性腺激素（Gn）刺激反应不佳的病理状态。随着社会发展,女性生育年龄普遍推迟,以及“二孩政策”的放开,目前高龄欲生育的女性逐年增加。而年龄大于40岁的女性,POR发生率较高,如何解决这部分患者的生育问题,不仅是我国今后辅助生殖领域的热点话题,也是国际性的研究趋势。目前临床上常使用一些药物预处理来改善患者治疗结局。本文就近促排卵周期前,临床上最常用的预治疗药物生长激素和脱氢表雄酮的研究进展进行综述。