我国新药审评项目管理影响因素研究

目的： 提取和筛选出我国新药审评项目管理的影响因素,为我国药品监管部门建立新药审评项目管理模式提供参考。方法： 运用项目管理理论、文献研究法,提取我国新药审评项目管理影响因素,并通过问卷调查法和因子分析法建立我国新药审评项目管理影响因素指标体系,并对指标体系重要性进行评估和权重分析。结果： 在二级指标上的权重排序是药品审评项目计划管理 > 审评时限管理 > 药品审评项目团队组织结构 > 项目管理人的能力 > 药品审评项目过程管理 > 项目管理人的职权 > 药品审评质量管理。在三级指标上,细化审评流程、选择合适的项目管理人和建立完善的药品审评质量评价体系是影响最大的因素。结论： 在审评项目启动前,首先,要细化审评流程,制定审评计划,审评计划的制定是明确审评目标和在规定时限完成的前提;其次,选择合适的项目管理人,保证沟通和信息的高效流通;最后,进一步完善药品审评质量管理,保证审评质量和效率。     

Improved sectioned images and surface models of the whole dog body

The objective of this research was to produce high-quality sectioned images of a whole dog which can be used to create sectional anatomy atlases and three-dimensional (3D) models. A year old female beagle was sacrificed by potassium chloride injection and frozen. The frozen dog was then serially ground using a cryomacrotome. Sectioned surfaces were photographed using a digital camera to create 3555 sectioned images of whole dog body (intervals, 0.2 mm; pixel size, 0.1 mm; 48 bit color). In a sectioned image, structures of dimension greater than 0.1 mm could be identified in detail. Photoshop was used to make segmented images of 16 structures. Sectioned and segmented images were stored in browsing software to allow easy access. Segmented images were reconstructed to make surface models of 16 structures using Mimics software and stored in portable document format (PDF) using Adobe 3D Reviewer software. In this research, state-of-art sectioned images and surface models were produced for the dog. The authors hope that the sectioned images produced will become a useful source of software for basic and clinical veterinary medicine, and therefore, are distributing the sectioned images and surface models through browsing software and PDF file available free of charge.     

当代脑计划研究进展

科技的进步让人们对大到宇宙小到微观粒子的世界有深入的认识,但是人类对自身大脑的精细结构和运行机制的了解甚少。为此,多个国家和地区纷纷提出并开展“脑研究计划”,简称“脑计划”,以提高对人类大脑的认知,并寻求治疗神经及精神系统疾病的方法。本文对近年来欧盟、美国、日本及我国开展的“脑计划”进行综述,分别介绍各个国家和地区“脑计划”的研究方向及取得的突破性成果,介绍正在开展的“齐鲁脑计划”。“脑计划”的开展有利于推动人工智能等相关学科进步和经济社会发展,未来“脑计划”的实施需要更深入的国际合作。     

The evolution of craniofacial resection: A new workflow for virtual planning in complex craniofacial procedures

Complex craniofacial surgery has been later to take advantage of computerized planning than traditional maxillofacial procedures. Virtual reality, 3D model navigation, and bioengineering analyses have changed our approach to the surgical planning of craniofacial resection, increasing the benefits of surgery in terms of accuracy while decreasing complication rate.This study introduces a new workflow for 3D reconstruction, virtual model navigation, and alignment analyses, and demonstrates its successful application in a sample of four patients. A case of squamous cell carcinoma of the maxillary and ethmoid sinus in a 62-year-old patient is presented to evaluate the application of the workflow for a combined transfacial and transcranial resection. Results demonstrate that virtual surgical planning was successfully translated into navigational coordinates and reproduced in the operating room.While the literature provides a wide range of applications of virtual planning for traditional maxillofacial procedures, its introduction for complex craniofacial procedures remains difficult. The presented case shows that it is worth investigating the correlation between virtual reality planning and surgical accuracy for craniofacial resection, and related advantages in terms of surgical safety and improved prognosis.     

Combination of ventilator care bundle and regular oral care with chlorhexidine was associated with reduction in ventilator associated pneumonia

BackgroundVentilator associated pneumonia (VAP) is an important source of morbidity and mortality in patients receiving mechanical ventilation. VAP is associated with prolongation of mechanical ventilation, ICU and hospital stay and increases in costs.MethodsQuality improvement project. Mechanically ventilated patients received oral care every 8 h with chlorhexidine 2%. A formal process was developed to evaluate compliance with the following ventilator bundle initiatives: head of the bed elevation to 30–45°, daily sedation vacation and assess the readiness to extubate, providing peptic ulcer disease prophylaxis and providing deep vein thrombosis prophylaxis (unless contraindicated).ResultsThe rate of VAP before starting the project, in the first 6 months of year 1431H, was 16.2 cases/1000 ventilator days. Six month after inception of the quality improvement project, the VAP rates decreased to 5.6 cases/1000 ventilator days at the end of 1431H, and at the end of 1432H, it was 5.5 cases/1000 ventilator days. This leads to significant reduction in mortality (adjusted according to APACHE II) from 23.4% to 19.1% (p value 0.024) and the length of stay in ICU from 9.7 to 6.5 days (p value 0.00002).ConclusionThe combination of regular oral hygiene with chlorhexidine 2% and rigorous implementation of ventilator care bundle was associated with significant reduction in VAP rate in mechanically ventilated patients. This has led to reduction in length of stay in ICU from 9.7 to 6.5 days and reduction in mortality from 23.4% to 19.1%.     

脊柱手术患者Time-out前期病房安全核查的实施

目的有效确认脊柱手术患者术前相关信息,保证手术如期进行。方法将脊柱外科择期手术患者180例,根据入院先后顺序分为对照组(82例)和干预组(98例),对照组按常规完成术前准备,术前1d对手术患者术前相关信息进行核查,干预组在对照组基础上按自制的Time-out前期病房安全核查要素对手术所需准备项目进行核查,比较两组手术如期进行率及手术安排满意度。结果干预组手术如期进行率、手术安排满意度显著高于对照组(P0.05,P0.01)。结论对脊柱手术患者实施Time-out前期病房安全核查,可有效确认患者术前相关核查的要素,充分发挥手术安全监测、预警作用,保证术前准备到位,利于提高科室整体医疗质量。     

湖北省中药饮片GMP认证中存在主要问题及建议

摘 要为全面理解中药饮片的生产质量管理规范（GMP）认证相关标准,提高企业对中药饮片GMP的认识,逐步统一检查员的检查尺度,本文对2017年湖北省中药饮片检查缺陷进行统计分析,对GMP认证过程中缺陷项目进行分类描述,提出相应的改进建议,以期为企业和检查员理解GMP标准提供参考。     

2011—2015年江苏省饮水型氟中毒流行病学特征分析

目的了解江苏省饮水型氟中毒病区防治措施的实施进度,动态监测病情变化趋势,综合评价改水等其他因素对病情的影响。方法于2011-2015年,选择江苏省徐州沛县、连云港东海县、宿迁泗洪县3个氟中毒监测县,每个县抽取3个村共9个村做为监测村,采集水样并检测水氟值,按Dean法对全部8~12岁儿童的氟斑牙进行检查。结果 2011-2015年儿童氟斑牙检出率分别为33.68%(194/576),29.43%(176/598),27.26%(190/697),24.26%(163/672),26.84%(222/827),呈下降趋势(χ^2=88.821,P<0.05)。男童、女童的氟斑牙检出率分别为27.51%(631/2 294)和29.18%(314/1 076),差异无统计学意义(χ^2=6.785,P>0.05)。8~12岁儿童的氟斑牙检出率分别为28.57%(148/518),31.54%(211/669),27.91%(187/670),26.97%(192/712),25.84%(207/801),差异无统计学意义(χ^2=16.423,P>0.05)。未改水监测村、改水水氟超标监测村、改水水氟合格监测村氟斑牙检出率分别为36.58%(117/320),52.46%(192/366),23.70%(636/2 684),其中,改水水氟超标监测村儿童的氟斑牙检出率高于未改水监测村和改水水氟合格监测村,差异均有统计学意义(χ^2=26.694、31.469,均P<0.05);而改水水氟合格监测村与未改水监测村儿童的氟斑牙检出率间比较,差异无统计学意义(χ^2=2.131,P>0.05)。结论江苏省饮水型氟中毒总体病情逐步得到控制,改水后水氟超标对儿童氟斑牙影响较大。