国产奥卡西平分散片的人体生物等效性研究

目的:研究国产奥卡西平分散片的人体生物等效性。方法:20名健康男性志愿者,分别随机交叉单剂量口服奥卡西平分散片(受试制剂)与奥卡西平片(参比制剂)300mg后,用高效液相色谱法测定血浆中奥卡西平的活性代谢物单羟基衍生物(MHD)的浓度,并用3p97软件计算药动学参数,对结果进行生物等效性评价。结果:20名受试者单剂量口服受试制剂与参比制剂后,MHD的Cmax分别为(4.231±0.841)、(4.350±0.861)μg·mL-1,tmax分别为(4.13±0.43)、(4.28±0.44)h,t1/2分别为(14.17±2.66)、(14.44±2.09)h,AUC0～60分别为(113.00±22.25)、(118.11±14.20)mg·h·L-1,AUC0～∞分别为(126.35±20.94)、(130.54±16.17)mg·h·L-1。受试制剂相对于参比制剂的生物利用度(F)为(95.67±12.80)%。结论:2种制剂生物学等效。     

An AC Magnetohydrodynamic Microfluidic Switch for Micro Total Analysis Systems

In this paper, a magnetohydrodynamic (MHD) microfluidic switch, which could form the basis for general microfluidic circuits, is reported. The switch uses an AC MHD pumping mechanism in which the Lorentz force is used to pump electrolytic solutions. By integrating two AC MHD pumps into different arms of a Y-shaped fluidic circuit, flow can be switched between the two arms by activating one of the micropumps and setting the other one at a counteracting pressure to prevent flow. Flow could be switched from one microchannel to another at a velocity of 0.3 mm/sec. This type of switch is easily integrated with other biochips and can be used to produce complex fluidic routing, which may have multiple applications in micro total analysis systems (TAS). Examples of applications include on-chip combinatorial chemistry for drug discovery and drug testing, connectors for routing samples to different detectors, and general reconfigurable assays.     

维持性血液透析治疗慢性肾功能衰竭的体会

目的探讨维持性血液透析(maintenance hemodialysis,MHD)的特点和临床疗效。方法回顾性分析21例MHD患者血液透析前后血液指标、体重、血压、尿量的对比。结果血液透析前后患者体重、肾功能、血红蛋白及每日尿量有显著差异(P<0.001)。结论早期充分透析;加强透析中及透析间期的管理;加强营养物质的摄入;防治并发症,可提高MHD患者的生活质量及生存率。     

群组管理干预对维持性血液透析患者的影响

目的:探讨群组管理干预对维持性血液透析(MHD)患者营养状态、血管钙化及生活质量的影响。方法:将2018年4月1日~2019年6月1日收治的86例MHD患者为研究对象,按照随机数字表法分为干预组和对照组各43例。对照组给予常规护理干预,干预组在对照组基础上给予群组管理干预。比较两组干预前及干预3个月后营养状态[采用营养不良炎症评分表(MIS)、测量三头肌皮褶厚度(TSF)、上臂周径(MAC)]、血管钙化情况[检测人成纤维细胞生长因子(FGF-23)、胎球蛋白-A(Fetuin-A)]、心理状态[采用康奈尔医学指数量表(CMI)]和生活质量[采用血液透析患者生活质量量表(KDQ-SF)]。结果:干预3个月后,两组MIS评分、FGF-23水平、CMI评分均低于干预前(P<0.05),且干预组低于对照组(P<0.05);干预3个月后,两组TSF、MAC、Fetuin-A水平及KDQ-SF评分均优于干预前(P<0.05),且干预组优于对照组(P<0.05)。结论:群组管理干预能够改善MHD患者营养状态和血管钙化情况,提升其生活质量,缓解负性情绪,从而改善患者心理状况。     

股静脉穿刺在维持性血液透析中的应用

目的旨在通过采用股静脉穿刺在维持性血液透析（maintenance hemodialysis,MHD）中建立有效的血管通路。方法有些血透患者常常由于血管条件差、透析中反复低血压、高凝状态等不良因素,直接导致动静脉内瘘的闭塞,此时行股静脉直接穿刺是维持性血液透析患者除內瘘以外血管通路的一种较好选择。结论这种操作简便、快速,痛苦小、成功率高,临床实用性强。     

Parent drug and/or metabolite? Which of them is most appropriate to establish bioequivalence of two oral oxcarbazepine formulations in healthy volunteers?

The bioequivalence of two 600-mg oxcarbazepine oral formulations (Aurene^®, Ivax Argentina, [test]; and Trileptal^®, Novartis Laboratories, [reference]) were assessed through the simultaneous determination of oxcarbazepine and the active metabolite 10,11-dyhydro-10-hydroxy-carbamazepine derivative (MHD). 12 healthy male volunteers received a single oral dose of 600 mg of each formulation, in a balanced, randomized, paired, crossover design, with a 7-day wash out period. Oxcarbazepine and MHD concentrations were established at 0.5,1, 1.5, 2, 3, 4, 6, 8, 24 and 48 h post dose by high performance liquid chromatography (HPLC). The regression coefficient determined for oxcarbazepine calibration curves was 0.9933 ± 0.0236; and for MHD, was 0.9897 ± 0.0017. The working range for both oxcarbazepine and its metabolite was from 0.1 to 10.0 μg/ml. The quantification limit was 0.1 μg/ml. The 90% confidence interval (CI) geometric mean for oxcarbazepine C_max, AUC_{(0 – 48 h)} and AUC_{(0 – ∞)} ratios (test : reference) were 74.1 – 146.2%, 85.6 – 171.5% and 89.6 – 169.8%, respectively, and the 90% CI geometric mean for MHD C_max, AUC_{(0 – 48 h)} and AUC_{(0 – ∞)} ratios (test : reference) were 84.0 – 122.3, 93.2 – 117.9 and 96.5 – 116.7, respectively. These results established the bioequivalence of two oxcarbazepine formulations from MHD kinetic data used in 12 healthy volunteers, while it was not possible to establish bioequivalence with oxcarbazepine. MHD quantification is preferred to that of the oxcarbazepine in order to assess bioequivalence, as the metabolite is responsible for the antiepileptic activity, presents linear kinetics in the therapeutic range, has lower intra-individual variability and higher plasma levels and half life than the parent drug.     

ECG-based gating in ultra high field cardiovascular magnetic resonance using an independent component analysis approach

Background

In Cardiovascular Magnetic Resonance (CMR), the synchronization of image acquisition with heart motion is performed in clinical practice by processing the electrocardiogram (ECG). The ECG-based synchronization is well established for MR scanners with magnetic fields up to 3 T. However, this technique is prone to errors in ultra high field environments, e.g. in 7 T MR scanners as used in research applications. The high magnetic fields cause severe magnetohydrodynamic (MHD) effects which disturb the ECG signal. Image synchronization is thus less reliable and yields artefacts in CMR images.

Methods

A strategy based on Independent Component Analysis (ICA) was pursued in this work to enhance the ECG contribution and attenuate the MHD effect. ICA was applied to 12-lead ECG signals recorded inside a 7 T MR scanner. An automatic source identification procedure was proposed to identify an independent component (IC) dominated by the ECG signal. The identified IC was then used for detecting the R-peaks. The presented ICA-based method was compared to other R-peak detection methods using 1) the raw ECG signal, 2) the raw vectorcardiogram (VCG), 3) the state-of-the-art gating technique based on the VCG, 4) an updated version of the VCG-based approach and 5) the ICA of the VCG.

Results

ECG signals from eight volunteers were recorded inside the MR scanner. Recordings with an overall length of 87 min accounting for 5457 QRS complexes were available for the analysis. The records were divided into a training and a test dataset. In terms of R-peak detection within the test dataset, the proposed ICA-based algorithm achieved a detection performance with an average sensitivity (Se) of 99.2%, a positive predictive value (+P) of 99.1%, with an average trigger delay and jitter of 5.8 ms and 5.0 ms, respectively. Long term stability of the demixing matrix was shown based on two measurements of the same subject, each being separated by one year, whereas an averaged detection performance of Se = 99.4% and +P = 99.7% was achieved.Compared to the state-of-the-art VCG-based gating technique at 7 T, the proposed method increased the sensitivity and positive predictive value within the test dataset by 27.1% and 42.7%, respectively.

Conclusions

The presented ICA-based method allows the estimation and identification of an IC dominated by the ECG signal. R-peak detection based on this IC outperforms the state-of-the-art VCG-based technique in a 7 T MR scanner environment.     

MHD患者体内C反应蛋白、胃促生长素与营养指标的关系

目的：探讨维持血液透析（MHD）患者体内 C 反应蛋白、血浆胃促生长素水平与营养指标的相关性。方法选择本院2012年4月-2013年6月接受透析治疗的维持性血液透析患者82例为观察组,且按照患者入组时血清高敏 C 反应蛋白水平（hs-CRP）分为微炎症组（n ＝39例）和非微炎症组（n ＝43）,另选择健康志愿者50例为对照组。对所有受试者的 hs-CRP、白细胞介素-6（IL-6）和肿瘤坏死因子-α（TNF-α）等炎症因子水平、血浆总多肽胃促生长素水平,以及营养状态指标进行分析。结果 MHD 患者在炎症因子水平、整体营养状态和人体学指标,以及总多肽胃促生长素（ghrelin）水平方面均与对照组存在统计学差异（P ﹤0.05）,微炎症组与非微炎症组在血红蛋白（Hb）、血清白蛋白（ALB）、前白蛋白（PA）、转铁蛋白（TF）、肱三头肌皮褶厚度（TSF）、中臂围（MAC）、铁蛋白（Ferritin）、hs-CRP、IL-6和 TNF-α方面存在统计学差异（P ﹤0.05）;MHD 患者共出现营养不良35例（42.6％）,其中微炎症组22例（62.8％）,非微炎症组13例（37.2％）;相关性分析：hs-CRP 分别与 ALB、PA、TF、Ferritin、TSF 和 MAC 呈负相关（P ﹤0.05）,与 IL-6和 TNF-α呈正相关（P ﹤0.01）,血浆 ghrelin 与 TG、ALB 和 PA 呈负相关（P ﹤0.05或 P ﹤0.01）,hs-CRP 和 ghrelin 均与 SGA 呈正相关（P ﹤0.05或 P ﹤0.01）。结论维持血液透析患者营养状态普遍较差,应注意改善体内微炎症状态。其中 hs-CRP 和血浆 ghrelin 均是反映体内营养状态的有效指标,可用于评估 MHD患者的营养状况和预后。     

参麦注射液对维持性血液透析气阴两虚型患者血管内皮功能的影响

目的:观察参麦注射液对血液透析气阴两虚型患者血管内皮功能的影响。方法:选择透析中心维持性血液透析患者60例,分为治疗组和对照组,治疗组在常规血透用药的基础上给予参麦注射液,对照组仅给予常规血透用药,治疗6个月,观察治疗前后两组患者的中医证候积分、血红蛋白、血白蛋白以及血ET-1水平的变化。结果:1治疗后,参麦组中医证候实证积分降低(p0.05),其总体有效率高于对照组;2治疗后,参麦组的ET-1水平较治疗前明显降低(P0.05)。结论:参麦注射液可以减轻透析患者的血管内皮细胞损伤。