基于糖脂代谢研究筋疽（糖尿病足非缺血性坏疽）湿热毒盛证

[目的]通过现代检验技术研究筋疽(糖尿病足非缺血性坏疽)湿热毒盛证的糖脂代谢指标。[方法]收集136例筋疽(糖尿病足非缺血性坏疽)患者进行不同证型间指标的比较。[结果]湿热毒盛证患者空腹血糖(FBG)、糖化血红蛋白(HbA1c)、餐后2 h血糖(2 hPBG)、晚期糖基化终末产物(AGEs)、白蛋白(ALB)、总胆固醇(TC)、高密度脂蛋白(HDL-C)与其他证型比较存在统计学差异(P<0.05)。湿热毒盛证患者C-反应蛋白(CRP)、人可溶性血管细胞黏附分子1(sVCAM-1)与其他证型组间比较存在统计学差异(P<0.01)。[结论]筋疽(糖尿病足非缺血性坏疽)湿热毒盛证形成的原因与低营养状态下糖脂代谢紊乱引起的高血糖及持续炎症反应相关。     

Fine particulate matter and incidence of metabolic syndrome in non-CVD patients: A nationwide population-based cohort study

Background

It has been reported that particulate matter (PM) is associated with cardiovascular diseases (CVD) while metabolic syndrome is also an important risk factor for CVD. However, few studies have investigated the epidemiological association between PM and metabolic syndrome.

Differential diagnosis of diarrhoea in patients with neuroendocrine tumours:A systematic review

BACKGROUND Approximately 20% of patients with neuroendocrine tumours(NETs) develop carcinoid syndrome(CS),characterised by flushing and diarrhoea.Somatostatin analogues or telotristat can be used to control symptoms of CS through inhibition of serotonin secretion.Although CS is often the cause of diarrhoea among patients with gastroenteropancreatic NETs(GEP-NETs),other causes to consider include pancreatic enzyme insufficiency(PEI),bile acid malabsorption and small intestinal bacterial overgrowth.If other causes of diarrhoea unrelated to serotonin secretion are mistaken for CS diarrhoea,these treatments may be ineffective against the diarrhoea,risking detrimental effects to patient quality of life.AIM To identify and synthesise qualitative and quantitative evidence relating to the differential diagnosis of diarrhoea in patients with GEP-NETs.METHODS Electronic databases(MEDLINE,Embase and the Cochrane Library) were searched from inception to September 12,2018 using terms for NETs and diarrhoea.Congresses,systematic literature review bibliographies and included articles were also hand-searched.Any study designs and publication types were eligible for inclusion if relevant data on a cause(s) of diarrhoea in patients with GEP-NETs were reported.Studies were screened by two independent reviewers at abstract and full-text stages.Framework synthesis was adapted to synthesise quantitative and qualitative data.The definition of qualitative data was expanded to include all textual data in any section of relevant publications.RESULTS Forty-seven publications(44 studies) were included,comprising a variety of publication types,including observational studies,reviews,guidelines,case reports,interventional studies,and opinion pieces.Most reported on PEI on/after treatment with somatostatin analogs;9.5%-84% of patients with GEP-NETs had experienced steatorrhoea or confirmed PEI.Where reported,14.3%–50.7% of patients received pancreatic enzyme replacement therapy.Other causes of diarrhoea reported in patients with GEP-NETs included bile acid malabsorption(80%),small intestinal bacterial overgrowth(23.6%-62%),colitis(20%) and infection(7.1%).Diagnostic approaches included faecal elastase,breath tests,tauroselcholic(selenium-75) acid(Se HCAT) scan and stool culture,although evidence on the effectiveness or diagnostic accuracy of these approaches was limited.Assessment of patient history or diarrhoea characteristics was also reported as initial approaches for investigation.From the identified evidence,if diarrhoea is assumed to be CS diarrhoea,consequences include uncontrolled diarrhoea,malnutrition,and perceived ineffectiveness of CS treatment.Approaches for facilitating differential diagnosis of diarrhoea include improving patient and clinician awareness of non-CS causes and involvement of a multidisciplinary clinical team,including gastroenterologists.CONCLUSION Diarrhoea in GEP-NETs can be multifactorial with misdiagnosis leading to delayed patient recovery and inefficient resource use.This systematic literature review highlights gaps for further research on prevalence of non-CS diarrhoea and suitability of diagnostic approaches,to determine an effective algorithm for differential diagnosis of GEP-NET diarrhoea.     

注射用盐酸柔红霉素的质量评价

目的 按照国家计划抽验要求，评价国内不同企业生产的注射用盐酸柔红霉素的质量。方法 按国家标准检验与探索性研究相结合，对抽验样品进行检验，对检验结果进行统计分析。结果 共抽取样品17批次，按国家标准检验合格率100.0%。探索性研究对主要杂质的来源与结构进行了研究；建立溶液的澄清度检查方法；对包材相容性及稳定性进行了考察。结论 目前国内注射用盐酸柔红霉素总体质量较好；现行标准有待进一步提高，建议现行标准修订有关物质检查方法，增加特定杂质的控制，增加溶液的澄清度检查；建议企业优化生产工艺，以提高产品质量。     

A Proposal for an Alternative Approach to Particle Size Method Development During Early-Stage Small Molecule Pharmaceutical Development

Particle size analysis in the pharmaceutical industry has long been a source of debate regarding how best to define measurement accuracy; the degree to which the result of a measurement or calculation conforms to the true value. Defining a “true” value for the size of a particle can be challenging as the output of its measurement will differ because of variations in measurement approaches, instrumental differences and calculation methods. Consequently, for “real” particles, a universal “true” value does not exist and accuracy is therefore not a definable characteristic. Accordingly, precision is then a measure of the ability to reproducibly achieve a measurement of unknown relevance.This article proposes, in place of accuracy, a means to define the “appropriateness” of a measurement in line with the critical quality attributes (CQA) of the material being characterized. The decision as to whether the measurement is correct should involve a link to the CQA; that is, correlation should be demonstrated, without which the measured particle size cannot be defined as a critical material attribute.Correspondingly, methods should also be able to provide sufficient precision to demonstrate discrimination relating to variation in the CQA. The benefits and challenges of this approach are discussed.     

中药生产过程质量控制关键技术研究进展

中医药发展已上升到国家战略层面,在医药行业贯彻实施"中国制造2025"战略的新形势下,中药生产过程质量控制是中药工业需要加快突破的关键领域之一。对中药生产过程质量控制领域在工艺设计、分析检测、过程建模、制造装备等方面的关键共性问题进行解析,综述了中药生产过程质量控制体系中工艺过程理解、生产过程实时分析方法开发、过程控制策略建立3个方面的研究进展;并结合企业研究实践,介绍了质量源于设计(quality by design,Qb D)、过程分析技术(process analytical technology,PAT)、实验设计(design of experiment,DOE)、多变量统计分析等关键技术在上述3个研究方向中的应用进展,分析了实际工业应用的难点问题并对其应用前景进行展望,旨在为中药企业应用和提升生产过程质量控制技术提供参考。     

ⅣA期胸腺瘤IMRT疗效及安全性初步分析

目的 初步评估IMRT对无法手术ⅣA期胸腺瘤的疗效及安全性。方法 回顾分析2010-2017年间15例无法手术接受IMRT的ⅣA期胸腺瘤患者,其中男9例、女6例,中位数59岁。PTV、CTV、GTV放疗剂量分别为50、60、70Gy分15~20次,分析近期疗效、总生存率及不良反应。结果 中位随访时间48个月,近期部分缓解率93%(14/15),1、3、5年总生存率分别为100%、75%、75%,仅1例出现3级血液系统反应。4例死亡患者均为肿瘤相关死亡。结论 初步证明ⅣA期胸腺瘤IMRT疗效较好、安全性高,可作为无法手术治疗的胸腺瘤患者安全、有效的治疗手段。     

儿童肥胖症的相关影响因素与控制对策分析及其对糖尿病发病情况的影响

目的 分析儿童肥胖症的相关影响因素与控制对策分析及其对糖尿病发病情况的影响,为制定针对儿童肥胖症的防控措施提供理论依据。方法 将2012年5月-2018年1月期间于沈阳市第五人民医院儿科进行体检的836名儿童作为研究对象,统计本组研究对象中肥胖症发生率,并调查所有研究对象性别、年龄、学校性质、生活习惯等因素与肥胖症发生率的相关性。将出现肥胖症的患儿作为观察组,将正常儿童作为对照组,对比两组对象空腹血糖、餐后2 h血糖(2 hPBG),空腹血糖受损(IFG)、葡萄糖耐量异常(IGT)以及糖尿病发生率的差异。结果 836名儿童中,89名存在肥胖症,231名儿童体重超重,516名儿童BMI正常,肥胖症发生率为10.65%;多因素Logistic回归分析结果显示,男性(OR＝6.415,95%CI:2.714~12.684,P=0.027)、年龄>10岁(OR＝9.328,95%CI:2.413~10.152,P=0.003)、居住地在城市(OR＝6.413,95%CI:2.748~8.503,P=0.015)、早餐地点在家里(OR＝6.349,95%CI:2.692~8.419,P=0.009)、周末活动时间<1 h(OR＝14.928,95%CI:4.210~15.384,P<0.001)均是儿童肥胖症的危险因素;观察组FPG及2 hPBG表达水平均显著高于对照组(P<0.05);观察组IFG、IGT及糖尿病发生率均显著高于对照组(P<0.05)。结论 儿童肥胖症的发生与外界及自身多项因素有密切联系,还可能诱发糖尿病等并发症,临床中应针对诱导儿童肥胖症产生的具体因素制定相应控制对策,改善肥胖患儿生活质量,使其健康成长。