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11.
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。 相似文献
12.
《Journal of pharmaceutical sciences》2019,108(11):3515-3520
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. 相似文献
13.
中药生产过程质量控制关键技术研究进展 总被引:10,自引:8,他引:2
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。 相似文献
14.
Elizabeth D. Krebs Robert B. Hawkins J. Hunter Mehaffey Clifford E. Fonner Alan M. Speir Mohammed A. Quader Jeffrey B. Rich Leora T. Yarboro Nicholas R. Teman Gorav Ailawadi 《The Journal of thoracic and cardiovascular surgery》2019,157(4):1533-1542.e2
Objectives
Expedient extubation after cardiac surgery has been associated with improved outcomes, leading to postoperative extubation frequently during overnight hours. However, recent evidence in a mixed medical-surgical intensive care unit population demonstrated worse outcomes with overnight extubation. This study investigated the impact of overnight extubation in a statewide, multicenter Society of Thoracic Surgeons database.Methods
Records from 39,812 patients undergoing coronary artery bypass grafting or valve operations (2008-2016) and extubated within 24 hours were stratified according to extubation time between 06:00 and 18:00 (day) or between 18:00 and 6:00 (overnight). Outcomes including reintubation, mortality, and composite morbidity-mortality were evaluated using hierarchical regression models adjusted for Society of Thoracic Surgeons predictive risk scores. To further analyze extubation during the night, a subanalysis stratified patients into 3 groups: 06:00 to 18:00, 18:00 to 24:00, and 24:00 to 06:00.Results
A total of 20,758 patients were extubated overnight (52.1%) and were slightly older (median age 66 vs 65 years, P < .001) with a longer duration of ventilation (4 vs 7 hours, P < .001). Day and overnight extubation were associated with equivalent operative mortality (1.7% vs 1.7%, P = .880), reintubation (3.7% vs 3.4%, P = .141), and composite morbidity-mortality (8.2% vs 8.0%, P = .314). After risk adjustment, overnight extubation was not associated with any difference in reintubation, mortality, or composite morbidity-mortality. On subanalysis, those extubated between 24:00 and 06:00 exhibited increased composite morbidity-mortality (odds ratio, 1.18; P = .001) but no difference in reintubation or mortality.Conclusions
Extubation overnight was not associated with increased mortality or reintubation. These results suggest that in the appropriate clinical setting, it is safe to routinely extubate cardiac surgery patients overnight. 相似文献15.
目的探讨分诊安全管理结合风险管理提高急诊科护理质量评分的作用。方法该院于2018年6月起加强对急诊科的分诊安全管理结合风险管理,以于2017年6月—2019年6月在该院急诊科就诊的患者为研究对象,评价管理策略实施前后护理风险发生率、护理质量评分以及患者满意度等评价指标变化情况。结果实施后基础护理、实践操作、消毒隔离、急救药品、护理文件方面的护理质量评分均较实施前显著提高(P<0.05);实施后护理差错、护理缺陷、护理投诉的发生率分别为0.26%、0.58%、0.19%,均较实施前显著降低(P<0.05);实施后护理总满意率为94.92%,较实施前显著提高(P<0.05)。结论分诊安全管理结合风险管理有效提高了急诊科护理质量,提升了患者满意度,减少了护理风险事件的发生。 相似文献
16.
《Gait & posture》2022
BackgroundPreschool age is a critical stage of postural balance development. Posturography normative data during this age are crucial for surveillance of postural balance and for the timely diagnosis of any dysfunction. The aim of this study was to provide normative data, specific to Tunisian preschoolers, according to age and gender, and to examine gender- and age-related differences in postural balance.Research questionAre there postural balance gender- and age-related differences in Tunisian preschoolers?MethodsThe study included 410 (205 boys and 205 girls) preschool children aged between 4- and 5-year-old selected within a large geographic area of Tunisia. Postural balance was assessed using a stabilometric platform under 4 sensory conditions. The mean center of pressure velocity (CoP-V) parameter was selected for analysis. Differences between gender and age groups were analysed using the Mann–Whitney U. Normative data were expressed in percentiles.ResultsSignificant gender effect was found in conditions where sensory inputs are most challenged with a significantly smaller mean CoP-V in girls compared to boys (p < 0.05). Moreover, 5-year-old children had significantly better postural balance than 4-year-old ones in almost all conditions (p < 0.05).SignificanceThe normative data established for Tunisian preschoolers provide useful comparative data for pediatricians, teachers and coaches for the early evaluation and monitoring of postural balance during this age. Gender and age-related differences should be considered in this population. 相似文献
17.
Yinlei
Wen Huaguang Zhang Hanguang Su He Ren 《Optimal control applications & methods.》2020,41(4):1233-1250
In this article, a model-free off-policy reinforcement learning algorithm is applied to address the optimal tracking problem based on multiplayer non-zero-sum games for discrete-time linear systems. In contrast to the traditional method and the policy iteration method for solving the optimal tracking problems, the proposed algorithm operates with the system data rather than the knowledge of the system dynamics. For performing the proposed algorithm, an auxiliary augmented system is constructed via assembling the original system and the reference trajectory while a discount factor is introduced into the performance indexes. It is analyzed that the solutions of the proposed algorithm converge to the Nash equilibrium and the result is not influenced by the probing noise. Two simulations are presented to verify the feasibility and effectiveness of the proposed algorithm. 相似文献
18.
Osric A. Forrest Daniel M. Chopyk Yael Gernez Milton R. Brown Carol K. Conrad Richard B. Moss Vin Tangpricha Limin Peng Rabindra Tirouvanziam 《Journal of cystic fibrosis》2019,18(1):64-70
Background
Resistin is an immunometabolic mediator that is elevated in several inflammatory disorders. A ligand for Toll-like receptor 4, resistin modulates the recruitment and activation of myeloid cells, notably neutrophils. Neutrophils are major drivers of cystic fibrosis (CF) lung disease, in part due to the release of human neutrophil elastase- and myeloperoxidase-rich primary granules, leading to tissue damage. Here we assessed the relationship of resistin to CF lung disease.Methods
Resistin levels were measured in plasma and sputum from three retrospective CF cohorts spanning a wide range of disease. We also assessed the ability of neutrophils to secrete resistin upon activation in vitro. Finally, we constructed a multivariate model assessing the relationship between resistin levels and lung function.Results
Plasma resistin levels were only marginally higher in CF than in healthy control subjects. By contrast, sputum resistin levels were very high in CF, reaching 50–100 fold higher levels than in plasma. Among CF patients, higher plasma resistin levels were associated with allergic bronchopulmonary aspergillosis, and higher sputum resistin levels were associated with CF-related diabetes. Mechanistically, in vitro release of neutrophil primary granules was concomitant with resistin secretion. Overall, sputum resistin levels were negatively correlated with CF lung function, independently of other variables (age, sex, and genotype).Conclusions
Our data establish relationships between resistin levels in the plasma and sputum of CF patients that correlate with disease status, and identify resistin as a novel mechanistic link between neutrophilic inflammation and lung disease in CF. 相似文献19.
《The ocular surface》2020,18(1):108-113
PurposeAromatase inhibitors (AIs) limit the synthesis of oestrogen in peripheral tissues thus lowering levels of oestrogen. The primary aim was to evaluate whether women treated with AIs have altered dry eye symptoms and signs. A sub-aim was to investigate whether symptoms of dry eye in postmenopausal women were associated with symptoms of non-eye pain, ocular pain and self-rated pain perception.MethodsThis cross-sectional, observational, single visit study recruited 56 postmenopausal women (mean age 64.1 + 7.9 years) and 52 undergoing AI treatment (mean age 66.6 + 9.0). Ocular symptoms (OSDI, MGD14) and pain questionnaires (PSQ, OPAS) were administered and signs of dry eye and meibomian gland dysfunction were evaluated.ResultsAlmost half of each group reported dry eye symptoms, defined as OSDI>12 (48% control, 46% AI). The PSQ score was significantly higher in the AI group (p = 0.04). Neither frequency or severity of dry eye (or MGD) symptoms scores were significantly different between groups. In the AI group, meibomian gland expressibility score was worse (p = 0.003); there were no differences in any other signs. Higher OSDI scores were associated with higher OPAS eye-pain scores (r = 0.49, p < 0.001), but not OPAS non-eye pain (r = 0.09, p = 0.35). Pain perception (PSQ) showed a moderate positive association with OPAS eye-pain (r = 0.30, p = 0.003).ConclusionsIn this study elevated ocular symptoms were observed in both the AI treated and the untreated groups, with no difference between the groups. Women undergoing AI treatment for early stage breast cancer had worse meibum expressibility score and increased pain perception compared to an untreated group of women. 相似文献
20.
James Milligan Joseph Lee Matt Smith Lindsay Donaldson Peter Athanasopoulos Kent Bassett-Spiers 《The journal of spinal cord medicine》2020,43(2):223-233
Context: Persons with spinal cord injury (SCI) experience significant challenges when they access primary care and community services.Design: A provincial summit was held to direct research, education, and innovation for primary and community care for SCI.Setting: Toronto, Ontario, Canada.Participants: Key stakeholders (N?=?95) including persons with SCI and caregivers, clinicians from primary care, rehabilitation, and specialized care, researchers, advocacy groups, and policy makers.Methods: A one-day facilitated meeting that included guest speakers, panel discussions and small group discussions was held to generate potential solutions to current issues related to SCI care and to foster collaborative relationships to advance care for SCI. Perspectives on SCI management were shared by primary care, neurosurgery, rehabilitation, and members of the SCI communityOutcome Measures: Discussions were focused on five domains: knowledge translation and dissemination, application of best practices, communication, research, and patient service accessibility.Results: Summit participants identified issues and prioritized solutions to improve primary and community care including the creation of a network of key stakeholders to enable knowledge creation and dissemination; an online repository of SCI resources, integrated health records, and a clinical network for SCI care; development and implementation of strategies to improve care transitions across sectors; implementation of effective care models and improved access to services; and utilization of empowerment frameworks to support self-management.Conclusions: This summit identified priorities for further collaborative efforts to advance SCI primary and community care and will inform the development of a provincial SCI strategy aimed at improving the system of care for SCI. 相似文献