骨组织工程基因治疗在颅颌面重建中的应用

骨组织工程中直接添加生长因子的方法存在着诸多不足,基因治疗和组织工程技术的结合,为克服这一难题提供了新的方向。本文回顾骨组织工程基因治疗的原理和特点,介绍了脂肪细胞作为骨组织工程靶细胞的研究现状,以及一种大动物模型报告基因的应用;并就颅颌面骨组织工程基因治疗中两种新的组织特异性成骨基因作一综述。     

口腔扁平苔藓65例临床研究

目的 总结扁平苔藓（OIJP）诊断治疗经验。方法 回顾性分析本院65例OLP患者的诊疗资料。结果89．23％的患者经治疗后，症状有所缓解。结论 中西医结合治疗OLP安全有效。     

Prevalence of Apparent Treatment-Resistant Hypertension in the United States According to the 2017 High Blood Pressure Guideline

ObjectiveTo evaluate the prevalence of apparent treatment-resistant hypertension (aTR-hypertension) in US adults with treated hypertension by using the nationally representative National Health and Nutrition Examination Survey (NHANES).Patients and MethodsNonpregnant US adults older than 20 years with a self-reported history of treated hypertension who had blood pressure measured in NHANES cycles 2007 to 2014 were included in this study. Study participants were stratified into 4 groups according to average blood pressure and antihypertensive medication use: well-controlled hypertension, undertreated hypertension, aTR-hypertension by the 2017 guideline, and aTR-hypertension by the Seventh Report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC 7) guideline. National Health and Nutrition Examination Survey sample weights were used to estimate the national prevalence.ResultsFrom 2007 to 2014, 5512 participants with treated hypertension representing 46.7 million people nationally were included. Compared with JNC 7 guideline criteria, application of the 2017 high blood pressure guideline criteria increased the prevalence of aTR-hypertension in US adults with treated hypertension from 12.0% to 15.95%, identifying an additional 1.85 million individuals with aTR-hypertension nationally. Individuals newly reclassified as having aTR-hypertension were younger. However, the prevalence of thiazide diuretic use remained less than 70%, and that of mineralocorticoid antagonist use remained less than 10% regardless of the guideline definition.ConclusionOn the basis of the 2017 high blood pressure guideline, the prevalence of aTR-hypertension is 15.95% in US adults with treated hypertension. This represents an absolute increase of 4% (1.85 million additional individuals nationally) compared with the JNC 7 guideline definition, with a consistent increase across all subpopulations with treated hypertension.     

陕西省药品不良反应报告主体工作现状的实证研究

摘 要 目的:调查研究陕西省药品不良反应报告主体工作开展的现状,探讨目前存在的问题和不足,从组织体系建设、制度政策等方面提供切实可行的建议。方法：以陕西省药品不良反应报告主体（药品生产企业、药品经营企业、医疗机构）为研究对象对其进行整群抽样,使用SPSS 19.0统计软件,运用描述性统计分析等方法对回收问卷进行分析处理,得出相应统计结果。结果：陕西省药品不良反应报告主体工作现状、制度建设、上报情况良好,但工作人员满意度方面有待进一步加强。结论：针对研究结果,提出以下建议：完善药品不良反应监测工作组织建设;优化办公条件;保证药品不良反应监测经费;加强工作交流;加强制度建设。     

医院感染管理中信息化管理的应用和效果分析

目的：探讨信息化管理应用于医院感染管理中的效果,为临床工作者提供参考。方法在医院信息化管理的基础上,将医院感染管理平台、医院信息平台和临床实验室信息系统等相连接。实时监测传染性疾病、抗生素使用情况、消毒灭菌情况、病原菌和药敏信息,网上直报和反馈各项信息。结果信息化管理开展了感染管理相关的前瞻性监测,简化了程序,节省了时间,对医院感染做到了早发现、早报告、早控制。该院采用了医院感染管理信息化管理后,抗菌药物的应用更合理,环境卫生更优,医院感染发生率和感染管理漏报率显著下降(P<0.05),并形成了全面的监测报表。结论信息化管理应用于医院感染管理中,提高了医院感染管理水平,实现了医疗信息共享,有效防控感染流行爆发。     

Predictors of the Onset of Type 1 Diabetes Obtained from Real-World Data Analysis in Cancer Patients Treated with Immune Checkpoint Inhibitors

Medications that target programmed cell death protein-1 (PD-1) have proven effective. However, blockade of PD-1/Programmed death-ligand 1(PD-L1) causes immune-related adverse events (irAEs). Characteristics of this irAE include many symptom, low in frequency, and difficulty in prevention. The key to a successful ICI-related treatment lies in the management of irAEs resulting from immune checkpoint inhibitor (ICI) treatment. Although it is difficult to predict irAE, we tried to extract features of irAE expression from analysis of real-world database. This study used data extracted from the Japan Adverse Drug Event Report (JADER) database to assess risk factors associated with serious side effects of irAE, type 1 diabetes (T1DM). The analysis targets were nivolumab, atezolizumab, durvalumab, and pembrolizumab, and the study period was from July 2014 to June 2019. Analysis of Japanese population data confirmed that being women and having melanoma were risk factors for developing ICI-related T1DM. Analysis using this database in combination with information on ICI-related T1DM provides information and guidelines that will help in the safer treatment of ICI in the future.     

Standardizing data exchange for clinical research protocols and case report forms: An assessment of the suitability of the Clinical Data Interchange Standards Consortium (CDISC) Operational Data Model (ODM)

Efficient communication of a clinical study protocol and case report forms during all stages of a human clinical study is important for many stakeholders. An electronic and structured study representation format that can be used throughout the whole study life-span can improve such communication and potentially lower total study costs. The most relevant standard for representing clinical study data, applicable to unregulated as well as regulated studies, is the Operational Data Model (ODM) in development since 1999 by the Clinical Data Interchange Standards Consortium (CDISC). ODM’s initial objective was exchange of case report forms data but it is increasingly utilized in other contexts. An ODM extension called Study Design Model, introduced in 2011, provides additional protocol representation elements.Using a case study approach, we evaluated ODM’s ability to capture all necessary protocol elements during a complete clinical study lifecycle in the Intramural Research Program of the National Institutes of Health. ODM offers the advantage of a single format for institutions that deal with hundreds or thousands of concurrent clinical studies and maintain a data warehouse for these studies. For each study stage, we present a list of gaps in the ODM standard and identify necessary vendor or institutional extensions that can compensate for such gaps. The current version of ODM (1.3.2) has only partial support for study protocol and study registration data mainly because it is outside the original development goal. ODM provides comprehensive support for representation of case report forms (in both the design stage and with patient level data). Inclusion of requirements of observational, non-regulated or investigator-initiated studies (outside Food and Drug Administration (FDA) regulation) can further improve future revisions of the standard.