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。     

VAC结合游离植皮治疗儿童大面积皮肤缺损疗效观察及对患儿生活质量的影响

目的:探讨负压创面治疗技术(Vacuum assisted closure,VAC)结合游离植皮治疗儿童大面积皮肤缺损疗效及对患儿生活质量的影响。方法:选取2015年2月-2019年2月笔者医院收治的60例大面积皮肤缺损患儿作为研究对象,按照随机数表法分为干预组和对照组,每组30例。对照组采用游离植皮术治疗,干预组在对照组的基础上结合VAC治疗,以皮片成活时间、皮片成活率、换药次数及住院天数评估疗效,以长海痛尺分级法评估患儿疼痛等级,以抑郁自评量表(Self-rating depression scale,SDS)、焦虑自评量表(Self-rating anxiety scale,SAS)评估患儿心理状态,以术后不良反应发生率评估患儿预后情况,以自制生活质量表评估患儿生活质量水平。结果:干预组患儿皮片成活时间、换药次数与住院天数均小于对照组,差异有统计学意义(P<0.05)。干预组患儿皮片成活率为93.33%高于对照组的76.67%,差异有统计学意义(P<0.05)。干预组治疗后疼痛感、SDS与SAS评分低于治疗前,且低于对照组,差异有统计学意义(P<0.05)。干预组患儿术后不良反应发生率为6.67%显著低于对照组23.33%,差异有统计学意义(P<0.05)。两组治疗前活动能力、心理健康及社交能力均低于治疗后,干预组治疗后活动能力、心理健康及社交能力均高于对照组(P<0.05)。结论:VAC结合游离植皮治疗儿童大面积皮肤缺损疗效显著,能有效降低患儿生理疼痛与心理焦虑,减少伤口感染等不良反应的发生,提高患儿生活质量,具有推广价值。     

探讨中西医护理改善老年高血压患者生活质量的效果

目的探讨中西医结合护理改善老年高血压患者心理状态及生活质量的效果。方法在医院2018年1月—2018年6月就诊的老年高血压患者中选出60例,按照随机数字法的原则,分成研究组(n=30)和参考组(n=30)。参考组采用单一西医护理,研究组在此之外联合中医护理,比较两组患者的临床疗效。结果入院时研究组与参考组SAS、SDS、SF-6评分差异不显著(P>0.05),护理后1月、3月与参考组相比,研究组SAS、SDS评分显著降低(P<0.05),SF-6评分显著升高(P<0.05);研究组患者对中西结合护理满意度为96.67%,参考组患者对西医护理满意度为73.33%,研究组满意度较参考组高,差异显著(P<0.05)。结论中西医结合护理能够有效改善老年高血压患者的心理状态,提高生活质量。     

医养结合型养老机构卫生服务质量指标体系构建研究

目的:构建基于SERVQUAL模型的医养结合型养老机构卫生服务质量评价指标体系。方法:围绕医养结合型养老机构卫生服务的概念、特性、内涵、内容等,采用文献研究法、半结构式访谈法、Delphi—AHP法等定性与定量相结合的研究方法,构建指标体系并确定指标权重。结果:构建了具有7个一级指标,27个二级指标和77个三级指标的养老机构卫生服务质量评价指标体系。指标体系三轮咨询专家权威系数Cr均高于0.84,专家综合权威性系数均高于0.83;总体专家协调系数Kendall W第一、二轮为0.309,第三轮为0.706,且均通过显著性检验;内容效度指数I-CVI介于0.90~1.00之间,S-CVI为0.94,kappa值均高于0.74;信度系数Cronbachα总体为0.972,各维度Cronbachα系数在0.792~0.921之间。评价指标体系具有较好的稳定性、可靠性和一致性。结论:本研究建立的评价指标体系有利于医养结合型养老机构全面建立贴近老年人卫生服务需求的内设医疗机构,改善机构内卫生服务质量。在对指标体系进行应用时,可转化为机构中老年人对各指标项目的感受(P)与期望(E),以两者的差值(P-E)代表机构的卫生服务质量。根据专家赋权结果,应重点加强医养结合养老机构对可靠性、有效性、经济性等指标项目的建设。     

Assessing perceived quality of primary care under hospital-township health centre integration: A cross-sectional study in China

Since the new round of health care reform in 2009, the vertical integration of hospitals and primary health institutions has become widely implemented in China as an efficient method for improving quality of primary care. This study aimed to answer the following questions: (a) What is the perceived quality of township health centres (THCs) under integration? (B) What differences could be observed among the three typical integration models, namely, private hospital-THC integration, public hospital-THC integration, and loose collaboration? Two rounds of cross-sectional surveys were conducted from November 2016 to June 2018. The Chinese version of the Primary Care Assessment Tool was used to evaluate perceived quality of sample THCs, and 1118 adult patients were interviewed in total. Multiple linear regressions were employed to compare the quality scores between two survey rounds and among different integration models after controlling for potential confounders. The results revealed that the quality of care significantly improved under private hospital-THC integration as observed by comparing two survey rounds, while no change or slight changes were observed in the other two models. The difference observed among the three models was that the perceived quality of THCs integrated with private hospitals was worse than that of THCs integrated with public hospitals and THCs under loose collaboration, while no significant difference was observed between public hospital-THC integration and loose collaboration. Increased attention should be given to highlighting the tight integration between hospitals and THCs and the different roles played by private and public hospitals in the current reform.     

烟雾病临床分型研究进展

烟雾病（moyamoya disease，MMD）是一种颈内动脉末端及其分支起始处进行性狭窄伴颅底异常血管网形成的脑血管疾病，临床上常将其分为缺血型、出血型和无症状型。随着诊疗技术的进步，对MMD临床分型的流行病学特征认识也在不断发展。在成年患者中，缺血型MMD占有重要地位，无症状型亦呈逐渐增多的趋势。不同临床分型MMD的发病年龄、遗传背景、病理生理机制、侧支血管代偿、受累血管分布及其预后存在显著差异。本文总结了对MMD临床分型流行病学特征认识的历史演变，不同临床分型可能的遗传背景、病理生理机制和影像学表现上的差异，为基于不同临床分型的MMD治疗决策提供新的思路。