中成药临床综合评价指标体系及评价路径

目的 构建综合中药特点的中成药临床综合评价指标体系,探索中成药临床综合评价路径,为中成药治疗或干预疾病的临床综合价值判断提供科学、可操作、可量化的评价工具,提高中成药临床合理用药水平和药事服务质量。方法 采用文献研究法,梳理研究中开展药品临床综合评价的流程、维度和方法。构建体现中成药特点的中成药临床综合评价理论框架,初步形成指标池。通过德尔菲法对形成的指标池进行遴选和优化,形成中成药临床综合评价指标体系。采用多准则决策法探索构建中成药临床综合评价路径。结果 通过文献研究法和德尔菲法对指标体系进行确认、遴选和优化,最终形成包含7个一级指标和39个二级指标的中成药临床综合评价指标体系。参考国际药物经济学与结果研究学会(ISPOR)发布的多准则决策分析(MCDA)实践指南,探索构建中成药临床综合评价路径。结论 构建的中成药临床综合评价指标体系层次分明、系统性和可操作性强,在一级指标及二级指标中分别融入了中成药特色指标,可量化评价中成药的临床价值,多维度、多层次、全面综合的反映中成药的临床综合价值。构建的中成药临床综合价值评价路径能够为相关研究开展提供指导,具有一定的合理性和可行性。     

基于层次分析法开展儿童用药循证综合评价

摘 要 目的：建立我国儿童临床用药综合评价方法。方法：采用文献研究法和专家咨询法,梳理综合评价方法建立的理论基础及可行性,采用层次分析法建立儿童用药循证综合评价方法。结果：基于层次分析原理,通过构建指标体系、确定指标权重、构建证据体和证据质量评价、以及综合评分四个过程开展儿童药物循证综合评价,并以六种大环内酯类药物为例进行实证研究,证实其可行性。结论：以层次分析法为基础的儿童用药循证综合评价方法能客观地衡量多个药品之间的优劣关系,为儿童临床合理用药提供依据。     

运用FMEA法的临床药师绩效考核方式的可行性评价

目的 评估临床药师绩效考核方式的可行性。方法 基于失效模式与效果分析法（FMEA）评估临床药师绩效考核的若干因素。结合绩效考核的因素子集进行分析,分别从临床药师服务的效果、服务的效率、量化指标的完成情况、患者的满意度及临床的认知程度等角度综合进行评价,计算绩效考核诸因素的可行性水平。结果 文中列举实例说明了FMEA法应用于临床药师绩效考核的实施步骤及可行性,可结合可行性水平PL值相对较低的项目,督促药师有侧重点地提升工作质量。结论 FMEA法用于评价临床药师的绩效考核方式积极有效,公正客观,利于临床药师的成长。     

基于Delphi法构建临床药师核心能力指标体系的研究

目的 初步构建临床药师核心能力指标体系。方法 通过文献回顾设计问卷,应用Delphi法,选取38名专家进行2轮问卷函询。结果 2轮专家咨询问卷回收率分别为97.4%,97.2%;专家权威系数范围为0.71~0.95。形成了临床药师的核心能力指标体系：包括一级指标5项,二级指标26项。结论 专家的积极性和权威性较高,形成的指标体系为临床药师的培养和临床药学工作的开展提供依据。     

AHP-CRITIC法在门诊药房药师绩效考核中的应用

目的 采用AHP-CRITIC法对门诊药房药师进行绩效考核。方法 通过资料分析和专家咨询,构建门诊药房药师绩效考核体系,运用AHP-CRITIC法确定指标权重,进行绩效综合评分。结果 构建了一套两级门诊药房药师绩效考核体系,包括8个一级指标和22个二级指标。采用AHP-CRITIC法确定的指标权重,对门诊药房药师绩效进行综合评分及排序,结果与实际情况相符。结论 本研究所构建的考核体系科学、全面;AHP-CRITIC法确定的权重系数客观、真实。     

我院儿科门诊阿莫西林/克拉维酸钾干混悬剂应用调查

摘 要 目的：建立一套科学合理的临床药师开展2型糖尿病慢病管理的评价指标,为临床药师实施2型糖尿病慢病管理提供参考。方法: 通过检索文献,初步筛选临床药师进行2型糖尿病慢病管理的评价指标,然后利用德尔菲专家咨询法,对筛选指标的重要性及可操作性进行评价,最终确立合理的临床药师开展2型糖尿病慢病管理的评价指标。结果: 经过2轮德尔菲专家咨询,并对询函结果可靠性进行统计分析,专家的积极系数、意见权威系数及协调程度均较高,表明询函结果可靠。根据2轮德尔菲专家咨询结果,统计各评价指标的重要性以及可操作性,根据Likert5级评分法,筛选出评分4分以上的指标,最终构建了一套包括糖化血红蛋白达标率、用药依从性,治疗药物正确使用率等在内的12个临床药师进行2型糖尿病慢病管理的评价指标。结论: 构建的质量评价指标可以为临床药师在2型糖尿病慢病管理的临床实践中提供有证据支持的参考依据。     

乳腺癌药品评价指标体系的构建

目的 探索构建我国乳腺癌治疗药品的综合评价指标体系,从多维度评估药品的综合价值支持临床合理用药。方法 通过文献综述、专家咨询收集证据,构建评估框架体系,建立具体评估指标,进行指标量化与赋权,并对最终构建的指标体系制定评分细则。结果 15名咨询专家积极系数为1.00,权威系数为0.90,重要性和可行性协调系数分别为0.305和0.336。最终构建的指标体系包括6个维度下的14个二级指标：安全性、经济性、适宜性、可及性各2个,有效性和创新性各3个。其中,有效性、安全性、经济性所占权重较高,分别赋分39分、19分、14分。结论 构建的药品综合评价指标体系符合乳腺癌药品价值评估的需求,临床可通过该体系对药品评分比较,从而为临床探索基于价值的药品评分提供经验参考。     

基层医院药师胜任力评价指标体系的构建

目的构建科学、合理、可行的基层医院药师胜任力评价指标体系。方法运用胜任力理论,通过文献研究、问卷调查及半结构式访谈,初步构建基层医院药师胜任力标准体系框架,运用德尔菲咨询法和层次分析法确定指标及指标权重。运用模糊综合评价法对药师胜任力进行评价,将模糊综合评价结果与年度考核成绩进行相关性分析,以验证评价体系的有效性。结果构建的药师胜任力评价指标体系包括5项一级指标,28项二级指标。胜任力评价指标体系的有效性得到验证,胜任特征具有较强的区分能力,能有效区分和鉴别优秀药师和普通药师。结论药师胜任力评价指标体系不仅为评价药师工作提供了科学依据,也为药师的选拔、培养提供了参考依据。     

内分泌科临床药师对住院医嘱的干预记录分析

摘 要 目的：分析临床药师对内分泌科住院医嘱的不合理用药干预情况。方法: 回顾性分析2016年6月～2017年8月,临床药师对内分泌科住院医嘱的干预情况。按照干预的不合理用药类型、干预条数以及临床医生的采纳进行统计分析。结果:临床药师共提出114次医嘱干预,医生采纳105次(92.11%),并对医嘱进行了相应的调整。结论:临床药师对内分泌科住院医嘱审核干预有利于促进临床合理用药,减少医疗风险。     

军队新药研发项目的风险评估体系研究

目的

风险管理是保证新药研发项目顺利进行的强有力措施。因此,建立适合新药研发项目的风险评估指标体系对提高医药项目成功率至关重要。方法 对近5年来“军队科技重大专项”支持的20多个新药研发项目进行分析,归纳、整理和总结出新药研发项目的风险因素,通过德尔菲法和专家访谈法明确风险评价指标体系,并采用基于层次分析法的模糊综合评价法,对体系的指标进行定量研究。结果 按照不同阶段的新药研发项目,分别建立了药物候选阶段、药物临床前阶段和药物临床阶段的风险评估指标体系和权重。结论 本指标体系较为客观准确,有助于新药研发项目中的风险控制。     

探讨呼吸系统复方制剂审报时应注意的一些问题

本文介绍了国内外呼吸系统复方制剂的组成及其审评要求,以便 申报单位具体了解相关政策及注意事项。     

Eprosartan for the treatment of hypertension

Antihypertensive agents are proven to reduce the cardiovascular risk of stroke, coronary heart disease and cardiac failure. The ideal antihypertensive agent should control all grades of hypertension and have a placebo-like side effect profile. Angiotensin II (AII) receptor antagonists are a relatively new class of antihypertensive agent that block AII Type 1 (AT₁) receptors, and reduce the pressor effects of AII in the vasculature. By this mechanism, they induce similar pharmacological effects compared with angiotensin-converting enzyme (ACE) inhibitors, resulting in a lowering of blood pressure. However, AII receptor blockers differ from ACE inhibitors with respect to side effects, and induce less cough, a side effect which may be related to bradykinin or other mediators such as substance P. Within the class of AII blockers, eprosartan differs from other currently available agents in terms of chemical structure, as it is a non-biphenyl, non-tetrazole, non-peptide antagonist with a dual pharmacological mode of action. Eprosartan acts at vascular AT₁ receptors (postsynaptically) and at presynaptic AT₁ receptors, where it inhibits sympathetically stimulated noradrenaline release. Its lack of metabolism by cytochrome P450 enzymes confers a low potential for metabolic drug interactions and may be of importance when treating elderly patients and those on multiple drugs. In clinical trials, eprosartan has been demonstrated to be at least as effective in reducing blood pressure as the ACE inhibitor enalapril, and has significantly lower side effects. Eprosartan is safe, effective and well-tolerated in long-term treatment, either as a monotherapy or in combination with other antihypertensive drugs such as hydrochlorothiazide.     

Adult neural stem cells for the treatment of neuroinflammation

Background: The application is in the field of stem cells and their therapeutic application for the treatment of inflammation. Objective: It aims at characterizing the potential of adult-derived neural progenitor and stem cells for the treatment of inflammation of the central nervous system (CNS). Methods: Neural progenitor and stem cells were isolated and expanded from the subventricular zone (SVZ) of adult mice (aNSCs). They were administered intravenously in an animal model of multiple sclerosis (MS). Results: Mice transplanted either at the disease onset or at the onset of the first relapse show clinical signs of improvements. Adult NSCs exert their therapeutical activity by reducing neuroinflammation. Conclusion: The application claims the use of aNSCs and multipotent somatic stem cells for the treatment of inflammation, associated with neurological diseases, disorders and injuries particularly, and for inducing tolerance to the immune central and/or peripheral system     

基于可信计算平台的可信动态客体监管系统的设计与实现

大部分安全操作系统在处理客体时,没有区分具体的客体类型,均采用统一的方法进标识,而且多数安全操作系统中采用传统访问控制方法保护的客体均是静态客体,忽略了对动态客体的保护,使得黑客或攻击者可以进行欺骗和中间人攻击,因此,安全操作系统中的动态客体并不可信.首先分析了操作系统中客体的类型,提出了可信动态客体的概念,并分析了其特点.为了防止动态客体泄露信息,提出了基于TPM的可信动态客体监管系统.一方面,该系统要求主体必须在TPM中注册,确保主体身份合法性,才能利用可信动态客体进行信息传递;另一方面,在TPM中必须存储创建该可信动态客体的属主的身份信息,以确保可信动态客体身份的合法性.最后进行了安全和性能分析,分析表明该可信动态客体监管系统可以阻止黑客利用动态客体进行欺骗和中间人攻击,防止信息泄露,为进一步建立可信计算环境提供了基础.     

Antidepressant-like effect of the organoselenium compound ebselen in mice: Evidence for the involvement of the monoaminergic system

Ebselen [2-phenyl-1,2-benzisoselenazol-3(2H)-one] is a seleno-organic compound which possesses a potent antioxidant activity and has been shown to exert neuroprotective effects in vitro and in vivo in a variety of pro-oxidative insults. The present study investigates a possible antidepressant activity of ebselen using two predictive tests for antidepressant activity in rodents: the forced swimming test and tail suspension test. Additionally, the mechanisms involved in the antidepressant-like effect of ebselen in mice were also assessed. Ebselen (10 mg/kg, s.c.) decreased the immobility time in the forced swimming test without accompanying changes in ambulation in the open-field test. In contrast, the administration of ebselen (10-30 mg/kg) did not produce any effect in the tail suspension test. The anti-immobility effect of ebselen (10 mg/kg, s.c.) was not prevented by pre-treatment of mice with p-chlorophenylalanine (PCPA, 100 mg/kg, i.p., an inhibitor of serotonin synthesis, 4 consecutive days), NAN-190 (0.5 mg/kg, i.p., a serotonin 5-HT_1A receptor antagonist) or ketanserin (5 mg/kg, i.p., a serotonin 5-HT_2A/2C receptor antagonist). On the other hand, the pre-treatment of mice with prazosin (1 mg/kg, i.p., an α₁-adrenoceptor antagonist), yohimbine (1 mg/kg, i.p., an α₂-adrenoceptor antagonist), SCH23390 (0.05 mg/kg, s.c., a dopamine D₁ receptor antagonist) or sulpiride (50 mg/kg, i.p., a dopamine D₂ receptor antagonist) completely blocked the antidepressant-like effect of ebselen (10 mg/kg, s.c.) in the forced swimming test. It may be concluded that ebselen produces an antidepressant-like effect in the forced swimming test that seems to be dependent on its interaction with the noradrenergic and dopaminergic systems, but not with the serotonergic system.     

我国医疗保险制度的实施对基本药物制度建设的启示

目的为国家基本药物制度建设提供参考。方法运用社会政策相关理论,对我国医疗保险制度实施过程中的不足之处进行分析,进而提出对我国基本药物制度建设的启示。结果与结论在基本药物制度的建设过程中应慎用模糊措辞,严把政策制定关;准确传达政策宗旨,提高政策认知程度;减少非正式规则的参与;成立专门的组织机构实施基本药物制度;加强政策宣传,完善监控机制及信息反馈机制。     

纽曼保健系统模式在老年高血压患者护理中的应用

目的探讨纽曼保健系统模式在老年高血压患者中的护理效果。方法将66例老年高血压患者随机分为对照组和观察组各33例。观察组采用纽曼保健系统模式，对照组采用常规护理，比较两组患者的血压及生活质量。结果观察组收缩压平均下降26．70mmHg，舒张压平均下降15．10mmHg，与对照组比较，差异有统计学意义（P〈0．05）。观察组患者生活质量总体功能评分平均为16．70分，与对照组比较，差异有统计学意义（P〈0．05）。结论对高血压病患者实施纽曼保健系统护理模式，可有效控制患者的血压，提高生活质量。     

《欧盟医疗器械警戒系统在英国的实施指南》简介及对我国的启示

通过对2008年9月颁布的《欧盟医疗器械警戒系统在英国的实施指南》的研究,简要介绍其主要内容,并提出我国应该加强企业责任主体建设,完善上报内容,制定医疗器械不良事件监测指南等建议。     

Development and identification of a multicompartment model for the distribution of adriamycin in the rat

The distribution kinetics of adriamycin in the rat were analyzed by using a multicompartment mathematical model. The set of a priori unknown model parameters, the drug rate constants, were estimated from 48 hr multicompartment drug distribution data by applying multivanate system identification techniques. Simultaneously, the information in all the measurements is exploited for the calculation of drug concentration time curves of each compartment of the model. No quantitative a priori information is required in the form of blood flow or membrane transport limitations. This approach requires only qualitative a priori biological information in the form of a mathematical model structure and successfully analyzes complex multidimensional pharmacokinetics. It results in a compact and realistic representation of physiologic drug transport processes.This study was supported by the Koningin Wilhelmina Fonds of the Dutch National Cancer League.     

Latest approaches for the treatment of obesity

Introduction: Obesity is a body weight disorder characterized by excess adiposity that increases the risk for developing co-morbidities such as type 2 diabetes. A large medical need exists for new anti-obesity treatments capable of promoting 10% or greater weight loss, with minimal side effects.

Areas covered: The authors describe the application of monogenic forms of rare obesity and genome-wide association studies in selecting critical pathways for drug discovery. Furthermore, they review in detail several pathways and pharmacological targets in the central nervous system (e.g., the leptin-melanocortin axis, the opioid system, GLP-1/GLP-1 system, and FGF21/FGFR1c/β-Klotho axis) that play an important role in the regulation of feeding behavior and energy homeostasis. Special focus is given to new strategies that engage well-known targets via novel mechanisms in order to circumvent issues seen with previous drug candidates that failed in the clinic. Finally, the authors discuss the recent developments around fixed-dose combinations, targeted polypharmacology, and non-traditional combinations of drugs and devices.

Expert opinion: The future for new weight-loss approaches to treat obesity looks promising. Current therapies have shown modest effects on weight loss in the general obese population but will have greater impact in smaller homogeneous sub-populations of obese subjects using personalized medicine. Drug combinations that target multiple, complementary pathways have the potential to promote double-digit weight loss in a broader, heterogeneous patient population. Furthermore, the development of advanced subcutaneous delivery technologies has opened up opportunities to develop breakthrough peptide and biologic agents for the treatment of obesity.