2018年广东省药品批发企业及零售连锁企业总部GSP飞行检查缺陷分析

该研究对55家药品批发企业及零售连锁企业总部在GSP飞行检查过程中发现的缺陷项目进行统计,分析存在问题。结果显示企业执行GSP工作较好,但质量管理体系、机构和质量管理职责、人员与培训、设施与设备、校准与验证等环节存在问题依然较为集中,可以采用风险管理的思维加强质量管理工作。     

Incidencia,pronóstico y factores asociados al infarto estriatocapsular aislado tras trombectomía mecánica

ObjectivesTo describe baseline and procedural characteristics and clinical outcomes of isolated striatocapsular infarct (iSCI) after mechanical thrombectomy in patients with large-vessel occlusion of the anterior cerebral circulation andits clinical outcome.MethodsWe performed a longitudinal study including all patients treated with mechanical thrombectomy at our centre between 2015 and 2017; patients were divided into 2 groups (iSCI and non-iSCI) according to whether they presented iSCI in a control CT scan at 24 h.ResultsOf the 83 patients identified, 22.9% developed an iSCI. There were no statically significant differences in baseline characteristics or in reperfusion times. Patients presenting iSCI showed better collateral circulation and better reperfusion rates in the bivariate analysis. No significant difference was observed for mortality at discharge or at 3 months, or for functional prognosis at 3 months.ConclusionsEven if successful reperfusion is achieved, iSCI is a common sequela, independently of reperfusion time, especially in patients with good collateral circulation.     

Assessment of collateral hand circulation by modified Allen’s test in normal Indian subjects

BackgroundAllen’s test (AT) and Modified Allen’s Test (MAT) are used as screening methods for assessment of the hand circulation. Few people lack the dual blood supply of hand and are at risk of hand ischemia after any intervention on radial artery. The Purpose of the study was to assess the collateral circulation of hand using MAT in normal Indian subjects and in elderly population to know the prevalence of positivity of Allen’s test.Methods900 participants (1800 hands) were divided in two groups. Group I had participants with age <50 years and group II had participants with age ≥50 years. MAT was performed in all participants and results were compared between the two groups.ResultsIn group I (n = 450, 900 hands), 313 were males and 137 were females, with mean age of 35.04 years. The relative percentages of a normal, equivocal, borderline and abnormal MAT were 77.8%, 16.6%, 3.7% and 1.6%, respectively. In group II (n = 450, 900 hands), 248 were males and 202 were females, with mean age of 60.4 years. The relative percentages of a normal, equivocal, borderline and abnormal MAT were 69.0%, 18.6%, 6.60% and 5.66%, respectively. A positive/abnormal test was significantly more common (5.66% Vs 1.66%, P < 0.00001) in older group.ConclusionMAT is simple, time tested and non invasive test to assess collateral circulation of the hand. A negative MAT safely selects patients for radial artery harvest; however, if the test is positive and in older patients then a second objective test may be needed.     

Congenital anomalies of the optic nerve

Congenital optic nerve head anomalies are a group of structural malformations of the optic nerve head and surrounding tissues, which may cause congenital visual impairment and blindness. Each entity in this group of optic nerve anomalies has individually become more prevalent as our ability to differentiate between them has improved due to better characterization of cases. Access to better medical technology (e.g., neuroimaging and genetic analysis advances in recent years) has helped to expand our knowledge of these abnormalities. However, visual impairment may not be the only problem in these patients, some of these entities will be related to ophthalmologic, neurologic and systemic features that will help the physician to identify and predict possible outcomes in these patients, which sometimes may be life-threatening. Herein we present helpful hints, associations and management (when plausible) for them.     

王国华主任医师治疗凌晨早醒型失眠

在中西医结合理论的指导下,论证运用病证结合方法防治肺心脑共病的独特优势。肺心脑共病是老年患病人群的常见特点。这一疾病有着共同的致病机制,严重影响老年人的生活质量,而临床常见的导致老年人肺心脑共病的原因有很多,症状也不相类似。通过分析肺朝百脉、心主血脉与脑供血的关系,论述了肺、心、脑同治以治疗失眠的可行性,并结合临床多年经验,总结其治疗的经验方法,经过肺心脑同治的中药治疗之后,患者临床症状得到改善。     

Baicalin-loaded PEGylated lipid nanoparticles: characterization,pharmacokinetics, and protective effects on acute myocardial ischemia in rats

Context: Baicalin has many pharmacological activities, including protective function against myocardial ischemia by antioxidant effects and free radical scavenging activity. However, its rapid elimination half-life in plasma and poor water solubility limits its clinical efficacy.

Objective: Novel baicalin-loaded PEGylated nanostructured lipid carriers (BN-PEG-NLC) were developed to improve bioavailability of BN, to prolong retention time in vivo and to enhance its protective effect.

Methods: In this study, BN-PEG-NLC were prepared by the emulsion-evaporation and low temperature-solidification method using a mixture of glycerol monostearate and polyethylene glycol monostearate as solid lipids, and oleic acid as the liquid lipid. The physicochemical properties of NLC were characterized. The pharmacokinetic and pharmacodynamic behaviors of BN-PEG-NLC or BN-NLC were evaluated in acute MI rats.

Results and discussion: The particle size, zeta potential, and entrapment efficiency for BN-PEG-NLC were observed as 83.9?nm, ?32.1?mV, and 83.5%, respectively. The release profiles of BN from both BN-PEG-NLC and BN-NLC were fitted to the Ritger–Peppas modal, which presented burst release initially and prolonged release afterwards. Pharmacokinetics results indicated that BN-PEG-NLC exhibited a 7.2-fold increase in AUC in comparison to BN solution, while a 3-fold increase in comparison to BN-NLC. Biodistribution results revealed that BN-PEG-NLC exhibited higher heart drug concentration compared with BN-NLC as well as BN solution. In the present study, BN-PEG-NLC significantly ameliorated infarct size.

Conclusion: The results of the present study imply that PEG-NLC could be the biocompatible carriers for heart-targeted drug delivery to improve myocardial ischemia.     

Symptomatic nonstenotic carotid disease: Evaluation of a proposed classification scheme in a prospective cohort

IntroductionUnraveling symptomatic nonstenotic carotid disease (SyNC) as a stroke etiology from other cryptogenic stroke may have important implications for defining natural history and for tailoring secondary prevention strategies. We aim to describe the characteristics of the plaques in a prospectively-collected cohort of patients with non-invasive imaging suggesting symptomatic carotid stenosis but whose DSA demonstrated nonstenotic atheromatous disease, and to evaluate the recurrence rate depending on the type of SyNC.MethodsWe reviewed prospectively-collected data for patients presenting with new neurologic events and non-invasive imaging suggestive of moderate or severe (≥50%) carotid stenosis between July 2016 and October 2018. Patients were included in the present study if the degree of stenosis on DSA was < 50%. We assigned these patients into groups based on a previously-proposed working definition of SyNC, and analyzed the rate of recurrent stroke in the following 6 months.Results28 patients had DSA-confirmed < 50% stenosis and constituted the study cohort. The median age was 73 years and 64% were male; median presenting NIHSS was 1 (IQR 0–3). The great majority (86%) of carotid plaques had high-risk features including ulcerated plaque (n = 21, 75%) and plaque > 3 mm thick (n = 18, 64%). 17 of 28 patients (61%) met classification criteria for “definite” or “probable” SyNC. Three of five patients in the “definite SyNC” group experienced recurrent neurologic events.ConclusionThe majority of patients with non-invasive imaging suggesting carotid stenosis harbor symptomatic carotid disease per current classifications despite DSA stenosis < 50%. Current classification schema may allow for risk stratification of SyNC patients and these findings warrant further study.     

“白汤”实物考辨与方剂学意义探析＊

本文简要概述两宋煎点茶汤、以茶入药之俗，并以四君子汤为例对《太平惠民和剂局方》所载“白汤”实物及其方剂学意义进行探讨。《太平惠民和剂局方》所记载“白汤”在方剂的运用中具有一定的规律性，笔者粗考两宋药事、茶事民俗，认为《太平惠民和剂局方》所载“白汤”或为两宋时期冲点团茶。四君子汤中虽无“大行气”之品，然得“白汤”之助却获“大行气”之用。诸家或循此“以茶入药”之实践，终成四君子汤后世“行补兼施，补而不滞”之衍化。