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。     

Opioid maintenance treatment: trajectories in and out of treatment

Problem: Although efficacy studies of opioid maintenance treatment (OMT) have shown evidence of treatment benefits, there is still need for studies on its effectiveness in natural clinical processes. This study investigates the development in health, substance use and social conditions of those who applied for OMT, including those denied access or discharged.

Method: First, persons assessed for admittance in 2005–2011 (n?=?127) were categorized into four trajectory groups based on whether they were admitted or denied (n?=?19), discharged (n?=?31), readmitted (n?=?21) or had been undergoing OMT without interruption (n?=?56). Second, 99 of these, the analytical sample, were interviewed at follow-up using (a) the Addiction Severity Index (ASI) for seven problem-areas and housing, and (b) self-rated change in 11 problem areas. The ASI was compared to baseline interviews after 55 months (mean). Third, outcomes within groups was studied in relation to alternative interventions.

Results: Within the analytical sample, those denied OMT showed no improvements at group level, those discharged had some improvements, more if readmitted than if not and those with uninterrupted OMT showed the most comprehensive improvements. Those outside OMT, denied and discharged, had considerable mortality risks related to ongoing drug use, especially in lack of well-planned alternative interventions.

Conclusion: Improvements strongly relate to access to OMT. This study underscores that access to OMT improves the situation in all areas investigated and decreases the risk for drug-related death. It underscores the importance of two major risk situations, i.e. being denied OMT and being discharged.     

A process evaluation of implementing a vocational enablement protocol for employees with hearing difficulties in clinical practice

Objective: A multidisciplinary vocational rehabilitation programme, the Vocational Enablement Protocol (VEP) was developed to address the specific needs of employees with hearing difficulties. In the current study we evaluated the process of implementing the VEP in audiologic care among employees with hearing impairment. Design: In conjunction with a randomized controlled trial, we collected and analysed data on seven process parameters: recruitment, reach, fidelity, dose delivered, dose received and implemented, satisfaction, and perceived benefit. Study sample: Sixty-six employees with hearing impairment participated in the VEP. The multidisciplinary team providing the VEP comprised six professionals. Results: The professionals performed the VEP according to the protocol. Of the recommendations delivered by the professionals, 31% were perceived as implemented by the employees. Compliance rate was highest for hearing-aid uptake (51%). Both employees and professionals were highly satisfied with the VEP. Participants rated good perceived benefit from it. Conclusions: Our results indicate that the VEP could be a useful treatment for employees with hearing difficulties from a process evaluation perspective. Implementation research in the audiological setting should be encouraged in order to further provide insight into parameters facilitating or hindering successful implementation of an intervention and to improve its quality and efficacy.     

Making clinical decisions for dental care: concepts to consider

Clinical decisions are often made with incomplete information, yet patient care decisions are made every day. Patients vary clinically, uncertainty exists in diagnostic and prognostic information, and many preventive and treatment alternatives have not been formally assessed for their effectiveness. Because scientific information will never answer all clinical questions, clinical decisions are partially based on probabilistic information.
This paper describes how to apply clinical decision making to diagnosing and managing dental caries and periodontal diseases. By using explicit information to quantify probabilities and outcomes, clinical decision making analyzes decisions made under uncertain conditions and the uncertain impact of clinical information.
Clinical decision making incorporates concepts for preventing, diagnosing and treating dental caries and periodontal diseases: risk assessment, evidence-based dentistry, and multiple oral health outcomes. This information can serve as a tool for clinicians to augment clinical judgment and expertise.     

Selective coating of cylindrical matrices with a central hole. I. An interpretation of the swelling process

Cylindrical matrices were prepared by compression either of polyvinyl alcohol 100000 or mixtures of the excipient and a drug (sodium salicylate or theophylline). To modify the cylindrical shape, a hole was bored in the centre of the flat surface through both sides of the matrices. Different swellable systems were obtained applying an impermeable coating to one, two or three surfaces of the perforated matrices. The swelling of the perforated matrices was modified according to the number and the position of the coated surfaces (selective coating) and the loaded drug. Pseudo-zero order kinetics were obtained when the interior hole was the only uncoated surface.     

贫血患者血清红细胞生成素浓度的测定及临床意义

用小鼠胎肝细胞体外血浆凝块培养红系集落(Erythroid colong formig unit inculturc,E-CFUc)方法,以红细胞生成素(Erythropoietin,EPO)850323为标准试剂,测定正常人、贫血病人血清EPO浓度。实验用妊娠13～15d小鼠胎肝细胞。血清均经透析处理,培养液中加量最大不超过10％。EPO(850323)在培养液中浓度为2.5～100mU/ml。血清EPO(mU/ml)测定结果:28例正常人为48.O±17.7,12例再生障碍性贫血病人为946～>10000,1例巨幼细胞性贫血病人为500,1例缺铁性贫血病人为400和18例慢性肾功能衰竭病人则为94.2±87.6。结果表明:贫血病因对血清EPO浓度有影响。     

Kindergarten and first grade: A time for developing and nurturing gifted behaviors in young children

This article concludes that there is a tremendous need for gifted programs at the kindergarten and first grade levels. A review of the literature suggests that it is difficult to identify young gifted children through traditional screening techniques. The author concludes that Renzulli's Enrichment Triad Model may prove useful for identifying young gifted children.     

The Use of Performance Improvement Methods to Enhance Emergency Department Patient Satisfaction in the United States: A Critical Review of the Literature and Suggestions for Future Research

Objectives: The authors reviewed the evidence on performance improvement methods for increasing emergency department (ED) patient satisfaction to provide evidence-based suggestions for clinical practice.
Methods: Data sources consisted of searches through MEDLINE, CINAHL, PSYCHINFO, Cochrane Library, and Emergency Medicine Abstracts and a manual search of references. Articles were included if they reported a performance improvement intervention targeting patient satisfaction in the ED setting. Articles on studies not conducted in the United States or that failed to provide enough details to allow critical evaluation of the study were excluded. Two authors used structured evaluation criteria to independently review each retained study.
Results: Nineteen articles met all selection criteria. Three studies found varying levels of support for multicomponent interventions, predominantly focused on implementation of clinical practice guidelines for specific presenting complaints and process redesign. Sixteen studies evaluated single-component interventions, with the following having at least one supportive study: using alternating patient assignment to provider teams rather than "zone"-based assignment, enhancing provider communication and customer service skills, incorporating information delivery interventions (e.g., pamphlets, video) that target patient expectations, using preformatted charts, and establishing ED-based observation units for specific conditions such as asthma and chest pain.
Conclusions: There is modest evidence supporting a range of performance improvement interventions for improving ED patient satisfaction. Further work is needed before specific, evidence-based recommendations can be made regarding which process changes are most effective. Recommendations are made for improving the quality of performance improvement efforts in the ED setting.     

护理程序在临床教学中的应用

把护理程序运用于临床教学中 ,提高护生的综合素质 ,培养实用型高素质护理人才。通过对护生社会心理状态及学习情况的评估 ,确定知识目标、技能目标、素质目标 ,然后分别组织实施 ,最后作出综合评价。结果显示 ,运用护理程序进行带教后 ,护生的专科知识、技能、服务意识都有了全面的提高 ,同时也培养了护理人员运用护理程序实施带教的能力。揭示 :护理程序在临床教学中的应用具有科学性和实用性 ,值得进一步推广。