Dodecafluoropentane Emulsion in Acute Ischemic Stroke: A Phase Ib/II Randomized and Controlled Dose-Escalation Trial

PurposeThis randomized, placebo-controlled, double-blind, dose-escalation acute ischemic stroke trial was designed to demonstrate maximum tolerated dose, characterize adverse events (AEs), and explore clinical outcomes when intravenous dodecafluoropentane emulsion (DDFPe) was used as neuroprotection.MethodsAcute ischemic stroke patients (n = 24) with National Institutes of Health Stroke Scale (NIHSS) score of 2–20 were randomized to either 3 doses of intravenous DDFPe or placebo, 1 every 90 minutes, starting within 12 hours of symptom onset. Doses were given without affecting standard stroke care. Each of the 3 dose cohorts included 8 patients, with 2 receiving placebo and 6 receiving DDFPe. Primary outcomes were serious adverse events (SAEs), AEs, NIHSS score, and modified Rankin Score (mRS).ResultsNo dose-limiting toxicities were encountered, and no maximum tolerated dose was defined. One unrelated delayed death occurred in a DDFPe patient, and another occurred in the placebo group. Group SAEs and AEs were similar in incidence and severity. Early initiation of DDFPe treatment resulted in better NIHSS score response than late initiation (P = .03). Thirty- and 90-day mRS after high-dose therapy suggested clinical improvement (P = .01 and P = .03, respectively). However, the significance of differences in clinical outcomes was limited by small patient numbers and differences in stroke severity between cohorts.ConclusionsIntravenous DDFPe appears to be safe at all doses tested. Clinical improvements in NIHSS score and mRS were significant but compromised by small sample size.     

Systemic toxic effects of local anaesthetics

Local anaesthetics are widely used in the provision of local/regional anaesthesia and the management of acute and chronic pain. Their mechanism of action temporarily inhibits voltage gated sodium channels in neuronal plasma membranes. Local anaesthetic systemic toxicity (LAST) is a serious yet largely preventable complication that can occur by any of the multiple routes of administration. LAST predominantly affects the central nervous and cardiovascular systems. Awareness of LAST and vigilance during administration of local anaesthetics may help in early recognition and successful management of the toxicity. Intralipid emulsion (ILE) infusions have been successfully used in reversing local anaesthetic-induced cardiotoxicity. Since 2007 in the UK, ILE infusion has been incorporated into the safety guidelines for management of LAST.     

ω-3鱼油脂肪乳在慢性阻塞性肺疾病合并自发性气胸患者术后的临床应用

目的 观察ω-3鱼油脂肪乳在慢性阻塞性肺疾病(COPD)合并自发性气胸患者围手术期的临床疗效.方法 COPD合并自发性气胸微创手术患者98例,将98例患者随机分为ω-3鱼油脂肪乳治疗组和对照组,每组患者术后均观察2周,比较两组患者术后体质指数(BMI),血气分析,血清白蛋白,总蛋白及血红蛋白量的变化,观察肺漏气的发生率及持续时间.结果 行ω-3鱼油脂肪乳治疗组BMI,血气分析,血清白蛋白,总蛋白及血红蛋白量均明显增加,且高于对照组,对照组上述观察值虽较2周前有所增加,但差异无统计学意义.治疗组患者术后漏气时间及术后住院时间均较对照组显著缩短.结论 COPD合并自发性气胸患者术后应用ω-3鱼油脂肪乳有助于快速康复.     

鸦胆子油乳协同周剂量TX方案治疗晚期胃癌的疗效研究

摘 要 目的：评价鸦胆子油乳注射液协同周剂量TX方案治疗晚期胃癌的临床疗效。方法：42例晚期胃癌患者随机分为观察组（给予鸦胆子油乳注射液联合周剂量用剂量TX方案）19例和对照组（给予单纯周剂量TX方案化疗）23例。入组患者均至少接受2个周期以上的化疗。观察比较两组近期疗效、生活质量和生存期。结果：观察组近期有效率为63.2%,显著高于对照组的8.7%(P<0.05);观察组疾病控制率为94.7%,对照组为87.0%,差异无统计学意义( P>0.05)。观察组中位生存时间为741 d,显著高于对照组的359 d( P<0.05)。 结论：鸦胆子油乳注射液联合周剂量TX方案治疗晚期胃癌可明显提高患者化疗的近期疗效,延长患者的生存期。     

两种脂肪乳剂不同肠外营养时间对早产儿临床结局影响的比较:一项随机对照多中心研究北大核心CSCD

目的比较两种脂肪乳剂不同肠外营养时间对早产儿临床结局的影响。方法将符合纳入标准的早产儿随机分为两组:中/长链脂肪乳(medium/long-chain triglyceride fat emulsion,简称MCT/LCT)组和多种油脂肪乳[含大豆油、中链甘油三酯、橄榄油、鱼油(soybean oil,medium-chain triglycerides,olive oil,and fish oil),简称SMOF]组。根据肠外营养持续时间(15~21 d、22~28 d、≥29 d)分层分析,比较两组早产儿的临床特征、营养状况、生化指标和临床结局。结果与MCT/LCT组相比,SMOF组肠外营养持续时间分别为15~21 d、22~28 d、≥29 d的早产儿住院期间甘油三酯的峰值水平均较低(P<0.05)。logistic回归趋势性分析显示,随着肠外营养时间延长,MCT/LCT组早产儿肠外营养相关性胆汁淤积症(parenteral nutrition-associated cholestasis,PNAC)及支气管肺发育不良(bronchopulmonary dysplasia,BPD)的发生风险均明显增高(P<0.05),脑损伤的发生风险无明显变化(P>0.05);SMOF组早产儿随着肠外营养时间延长,PNAC及BPD的发生风险均无明显变化(P>0.05),而脑损伤的发生风险明显降低(P=0.006)。结论与MCT/LCT相比,SMOF具有较好的脂质耐受性;随着肠外营养持续时间延长,SMOF不增加PNAC、BPD的发生风险,且对脑损伤具有保护作用,表明在需要长期肠外营养的早产儿中使用SMOF优于MCT/LCT。     

HPLC-ELSD法测定鸦胆子油中四种甘油三酯的含量

目的：建立鸦胆子油中1,2--二亚油酸-3-油酸甘油酯、1,3--二油酸-2-亚油酸甘油酯、三油酸甘油酯、1,3---油酸-2-棕榈甘油酯的含量测定方法.方法：运用岛津2010C高效液相色谱仪和奥泰2000蒸发光检测器,采用Waters C18色谱柱（250 mm×4.6mm,5μm）;流动相为乙腈-二氯甲烷（65∶35）,流速1.0 ml·min-1;检测温度：70℃.结果：四种甘油三酯分别在0.184～2.763 μg、0.382～5.724μg、0.406 ～6.084 μg和0.204～3.066 μg之间线性关系良好,r值分别为0.999 0、0.999 2、0.999 1和0.999 0,回收率分别为99.01％、98.70％、98.92％和98.46％,RSD分别为0.7％、0.5％、0.8％和0.9％.结论：该方法操作简单,分离效果好,灵敏度高,可更好的控制鸦胆子油的质量.     

中/长链脂肪乳不合理用药案例分析

目的：分析某院住院患者应用20％中/长链脂肪乳注射液的情况,对不合理用药典型案例进行分析,为该药的科学管理和临床合理用药提供参考.方法：对某院2012年使用20％中/长链脂肪乳注射液的出院病历进行用药合理性回顾分析.结果：2012年住院患者20％中/长链脂肪乳注射液的应用仍然存在不合理的现象,表现在适应证、用法用量、用药监测等方面.结论：20％中/长链脂肪乳注射液的临床应用需进一步加强管理,药学干预也需不断持续和改进.     

Construction of Oxygen-Rich Carbon Foams for Rapid Carbon Dioxide Capture

As carbon dioxide (CO₂) adsorbents, porous materials with high specific surface areas and abundant CO₂-philic groups always exhibit high CO₂ capacities. Based on this consensus, a category of oxygen-rich macroporous carbon foams was fabricated from macroporous resorcinol-formaldehyde resins (PRFs), which were obtained via an oil-in-water concentrated emulsion. By the active effect of potassium hydroxide (KOH) at high temperatures, the resultant carbon foams (ACRFs) possessed abundant micropores with rich oxygen content simultaneously. At the same time, most of the ACRFs could retain the marcoporous structure of their precursor. It is found that porosity of ACRFs was mainly determined by carbonization temperature, and the highest specific surface areas and total pore volume of ACRFs could reach 2046 m²/g and 0.900 cm³/g, respectively. At 273 K, ACRFs showed highest CO₂ capacity as 271 mg/g at 1 bar and 91.5 mg at 15 kPa. Furthermore, it is shown that the ultra-micropore volume was mainly responsible for the CO₂ capacities of ACRFs at 1 bar, and CO₂ capacities at 15 kPa were mainly affected by the oxygen content. It is also found that the presence of macropores would accelerate ACRFs adsorbing CO₂. This study provides ideas for designing a porous CO₂ adsorbent.     

5%联苯菊酯水乳剂的气相色谱分析

目的建立5%联苯菊酯水乳剂的气相色谱分析方法。方法采用Elite-1701石英毛细管柱与FID检测器,以邻苯二甲酸二正戊酯为内标物,对联苯菊酯水乳剂进行气相定量分析。结果平均回收率为99.95%,标准偏差0.06,变异系数1.19%,线性相关系数为0.998 9。结论气相色谱分析具有快速、简便、精确度和准确度高、线性关系好的优点,是较理想的分析方法。     

A Simple and Noninvasive DOSY NMR Method for Droplet Size Measurement of Intact Oil-In-Water Emulsion Drug Products

In a typical oil-in-water emulsion drug product, oil droplets with varied sizes are dispersed in a water phase and stabilized by surfactant molecules. The size and polydispersity of oil droplets are critical quality attributes of the emulsion drug product that can potentially affect drug bioavailability. More critically, to ensure accuracy in characterization of the finished drug product, analytical methods should introduce minimal physical perturbation (e.g., temperature variation or dilution) before the analysis. The classical methods of dynamic light scattering or electron microscopy can be used but they generally require sample dilution or harsh preparation conditions, respectively. By contrast, the size distribution of emulsion formulations can be assessed with a simple and noninvasive solution nuclear magnetic resonance method, namely, two-dimensional Diffusion Ordered SpectroscopY. The two-dimensional Diffusion Ordered SpectroscopY method probed signal decay of methyl resonances from oil and sorbate molecules and was applied to 3 types of U.S.-marketed emulsion drug products, that is, difluprednate, cyclosporine, and propofol, yielding measured droplet sizes of 40-280 nm in diameter. The high precision of ±6 nm of the new nuclear magnetic resonance method allows analytical differentiation of lot-to-lot and brand-to-brand droplet size differences in emulsion drug products, critical for drug-quality development, control, and surveillance.