A Pilot First-in-Human Study of Embrace,a Polyethylene Glycol-Based Liquid Embolic Agent,in the Embolization of Malignant and Benign Hypervascular Tumors

PurposeTo investigate the safety and efficacy of an aqueous polyethylene glycol-based liquid embolic agent, Embrace Hydrogel Embolic System (HES), in the treatment of benign and malignant hypervascular tumors.Materials and MethodsA prospective, single-arm, multicenter study included 8 patients, 5 males and 3 females, with a median age of 58.5 years (30–85 years), who underwent embolization in 8 tumors between October 2019 and May 2020. Technical success was defined as successful delivery of HES to the index vessel, with disappearance of >90% of the targeted vascular enhancement or, for portal vein embolization, occlusion of the portal branches to the liver segments for future resection. The volume of HES administered, ease of use (5 point Likert scale), administration time, and adverse events (AEs) were recorded. Evaluation was performed at 7, 30, and 90 days via clinical assessment and blood testing, and follow-up imaging was performed at 30 days.ResultsEight patients were enrolled, and 10 embolizations were performed in 8 lesions. Tumors included hepatocellular carcinoma (n = 4), renal angiomyolipoma (n = 3), and intrahepatic cholangiocarcinoma (n = 1). Technical success was 100%, and the average ease of use was 3.3 ± 1.0 SD. The HES delivery time was 1–28 minutes (median, 16.5 minutes), and the HES volume injected was 0.4–4.0 mL (median, 1.3 mL). All patients reached 30-day follow-up with imaging, and 6 patients reached 90-day follow-up. There were 3 serious AEs in 2 patients that were unrelated to the embolic agent.ConclusionHES resulted in a 100% embolization technical success rate. The product ease of use was acceptable, and no target vessel recanalization was noted on follow-up imaging at 30 days.     

Survivorship Comparisons of Ultracongruent,Cruciate-Retaining and Posterior-Stabilized Tibial Inserts Using a Single Knee System Design: Results From the Australian Orthopedic Association National Joint Replacement Registry

BackgroundUltracongruent (UC) tibial inserts can increase knee replacement stability, but how survivorship compares to cruciate retaining (CR) or posterior stabilized (PS) inserts is unclear.MethodsData from a large joint registry were used to calculate the cumulative percent revision of a single popular knee design used with different inserts. There were 67,523 procedures, of which 12,434 were UC, 21,635 CR, and 33,454 PS. Revision rates and reasons for revision were analyzed.ResultsThe cumulative percent revision at 18 years was 8.3% for UC, 9.2% for CR, and 8.9% for PS. There was no difference when UC was compared to CR, but PS had a higher risk of revision. Revision reasons were similar.ConclusionCompared to the CR, an UC insert did not increase revision rates and was actually lower than a PS insert. An UC insert does not compromise long-term total knee arthroplasty survivorship in the Genesis II prosthesis.     

Computer-aided design of dry powder inhalers using computational fluid dynamics to assess performance

Dry powder inhalers (DPIs) are gaining popularity for the delivery of drugs. A cost effective and efficient delivery device is necessary. Developing new DPIs by modifying an existing device may be the simplest way to improve the performance of the devices. The aim of this research was to produce a new DPIs using computational fluid dynamics (CFD). The new DPIs took advantages of the Cyclohaler® and the Rotahaler®. We chose a combination of the capsule chamber of the Cyclohaler® and the mouthpiece and grid of the Rotahaler®. Computer-aided design models of the devices were created and evaluated using CFD. Prototype models were created and tested with the DPI dispersion experiments. The proposed model 3 device had a high turbulence with a good degree of deagglomeration in the CFD and the experiment data. The %fine particle fraction (FPF) was around 50% at 60?L/min. The mass median aerodynamic diameter was around 2.8–4?μm. The FPF were strongly correlated to the CFD-predicted turbulence and the mechanical impaction parameters. The drug retention in the capsule was only 5–7%. In summary, a simple modification of the Cyclohaler® and Rotahaler® could produce a better performing inhaler using the CFD-assisted design.     

Revisiting the Hydrogen Storage Behavior of the Na-O-H System

Solid-state reactions between sodium hydride and sodium hydroxide are unusual among hydride-hydroxide systems since hydrogen can be stored reversibly. In order to understand the relationship between hydrogen uptake/release properties and phase/structure evolution, the dehydrogenation and hydrogenation behavior of the Na-O-H system has been investigated in detail both ex- and in-situ. Simultaneous thermogravimetric-differential thermal analysis coupled to mass spectrometry (TG-DTA-MS) experiments of NaH-NaOH composites reveal two principal features: Firstly, an H₂ desorption event occurring between 240 and 380 °C and secondly an additional endothermic process at around 170 °C with no associated weight change. In-situ high-resolution synchrotron powder X-ray diffraction showed that NaOH appears to form a solid solution with NaH yielding a new cubic complex hydride phase below 200 °C. The Na-H-OH phase persists up to the maximum temperature of the in-situ diffraction experiment shortly before dehydrogenation occurs. The present work suggests that not only is the inter-phase synergic interaction of protic hydrogen (in NaOH) and hydridic hydrogen (in NaH) important in the dehydrogenation mechanism, but that also an intra-phase H^δ+… H^δ– interaction may be a crucial step in the desorption process.     

Vertical interpositional augmentation genioplasty with porous polyethylene

Recent advances in the field of biomatrix porous implant technology has stirred the interest of the oral and maxillofacial surgical community. One such material (Medpor), is a biocompatible, large-pore, high-density polyethylene implant which has proven both experimentally and clinically to fulfil the criterion for maxillofacial reconstructive and aesthetic surgical grafting.     

Cosolvency of Dimethyl Isosorbide for Steroid Solubility

Dimethyl isosorbide (DMI), which is currently under investigation for its potential use as a pharmaceutical vehicle and drug permeation enhancer, is a water-miscible liquid with relatively low viscosity. The solubilization behavior of DMI as a cosolvent for nonpolar drugs was characterized via dielectric constant measurements of binary solvent systems containing DMI and either water, propylene glycol (PG), or polyethylene glycol (PEG). Evidence from the dielectric constant profiles and NMR studies suggest that DMI undergoes complexation with water and PG, but not with PEG, through hydrogen bonding interactions. The solvent complexation exhibited a major effect on the solubilities of prednisone, dexamethasone, and prednisolone in the mixed solvent systems. Maximum solubility of each drug was found to occur near a DMI/water or DMI/PG concentration ratio of 1:2. In the DMI–PEG mixed system, while there is no apparent interaction between DMI and PEG molecules, the solubility of prednisone was found to increase with decreasing dielectric constant.     

补脾泻肝法治疗腹泻型肠易激综合征临床研究

目的观察补脾泻肝法治疗腹泻型肠易激综合征的临床疗效。方法100例腹泻型肠易激综合征患者随机分为2组,治疗组60例给予白术芍药散加味,对照组40例给予丙咪嗪合替加色罗治疗。2组均4周为1个疗程,观察疗效,并于3-6个月后观察2组病例复发情况。结果治疗组治愈率为65%,总有效率为85%,6个月内复发率为20%,对照组则分别为32.5%、72.5%、55.56%,2组比较差异均有统计学意义(均P<0.05)。结论补脾泻肝法治疗腹泻型肠易激综合征优于丙咪嗪合替加色罗,疗效确切。     

脂肪族聚酯与高氯酸锂络合物的结构与导电性

本文通过酯交换反应合成了一系列脂肪族聚丁二酸酯,对他们的结构和性能作了表征。发现聚酯存在多晶现象,其熔点有奇偶性变化规律。探索了由此系列聚酯与高氯酸锂形成的固体电解质的结构和离子导电性。无机盐的加入提高了电解质的玻璃化温度但降低了聚酯的熔点及结晶度。聚酯电解质的晶体类似于聚酯,其无机盐主要溶解于聚酯的无定形区域。聚酯系列电解质的导电率也有偶奇效应,与熔点变化相反;熔点高的电解质导电率低,熔点低的电解质导电率高。电解质的导电率随温度改变而变化,在室温下电解质的导电率可达10~(-6)s/cm。高分子链上侧基的引入将大大降低电解质的导电性。     

Simultaneous Quantification of an Enantiomer and the Racemic Compound of Ibuprofen by X-ray Powder Diffractometry

Purpose. An X-ray powder diffractometric method was developed for the simultaneous quantification of the relative amounts of the racemic compound (±) of ibuprofen (I) and S(+)-ibuprofen (II), when they occur as a mixture. Methods. The X-ray powder diffraction patterns of I and II show pronounced differences. This formed the basis for the determination of the relative amounts of I and II when they occur as a mixture. X-ray lines with d-spacings of 14.41 and 4.37 Å were unique to I and II, respectively. Mixtures containing different proportions of I and II were prepared which also contained lithium fluoride (III) as an internal standard. Results. A linear relationship was obtained when the intensity ratio (intensity of the 4.37 Å line of II/intensity of the 2.01 Å line of III) was plotted as a function of the weight fraction of II in the mixture. Similar results were obtained in the case of I. Using these standard curves, the weight fractions of I and II in 'unknown' mixtures were determined. The experimentally determined analyte concentration ranged between 98 and 104% of the true value. The relative error in the analyses of individual samples was < 10%. The minimum detectable weight fraction of I in II and II in I were 0.032 (3.2% w/w) and 0.034 (3.4% w/w), respectively. The minimum quantifiable weight fractions were 0.136 for I and 0.112 for II. Since the X-ray diffraction patterns of S(+)-ibuprofen and R(–)-ibuprofen are identical, the conclusions drawn regarding mixtures of I and II will also hold true in the quantitative analyses of mixtures of I and R(–)-ibuprofen.