医院药学与循证药学

北京大学第三医院 药剂科赵荣生 刘芳 张文悦 等,LOGO,FIP 医院药学组汇报,主要内容,开幕式,主会场与分会场,壁报和展台,欢迎招待会,第一部分,循证药学,内容,Evidence-based impact of experiential learning循证式经验学习的效果 United KingdomEvidence based practice and complementary medicines: Teaching and learning by example循证药学与补充药物：教学案例 USA,循证药学与补充药物：教学案例,案例式互动教学,案例：良性前列腺增生,患者提出使用一种植物药代替非那雄胺,参考答案：B，C,身边的案例,您所在的医院神经内科的一位医生询问在脑梗死的治疗中,1,6-二磷酸果糖(FDP)注射液的效果如何?,循证药学实践的4个步骤, Asking answerable questions提出有代表意义的问题 Searching the literature查阅文献 Critical appraisal of studies of therapy严格评估研究内容 Application to patient care应用于病人,1将案例表述成关键词,脑梗死,FDP,安慰剂,脑梗死的症状，脑神经功能,2查阅文献,3评估研究的有效性、重要性和相关性,牛津临床证据评价标准,研究结果的内在有效性1a 是否有随机化，是如何完成的？1b 在开始试验时，各组患者之和是否比参与随机化的少？2a 除外待研究的治疗，各组间其他治疗是否一致？2b 是否所有入组病人均计入结果的分析？3 研究是否客观，是否为双盲？,University of Oxford, 2005,研究方法,1.2试验设计及治疗方案为多中心、随机、双盲、安慰剂对照试验。符合上述纳入标准的患者,按区组随机表被随机分配至治疗组及安慰剂组。治疗组加用FDP注射液100ml(10g),静脉输注,2次/d,在20min内输入。对照组加用安慰剂(0.9%氯化钠注射液)100ml,输注方法、次数与FDP组相同。总疗程10d。试验用药由北京华靳制药有限公司提供。安慰剂包装、颜色及剂型与FDP注射液完全一致。除试验药物外,两组均同时应用治疗急性脑梗死常用的药物,包括抗凝剂、活血化瘀药物、扩容剂等。所用药物必须详细记录。,1a,2a,3,结果,1b,结果,2.1入选患者及治疗前特征自2001年11月至2002年7月入选患者总数200例,FDP组101例,安慰剂组99例,除安慰剂组1例病人于治疗第5天,因脑疝合并肺部感染及电解质失衡死亡外,其余病例均完成治疗全过程。治疗前两组在年龄、性别、既往脑梗死和伴随其他疾病的患者比例以及卒中发生到开始治疗的平均时间和神经功能缺损程度等方面均无显著差异(表1)。FDP组及安慰剂组伴随应用的其他药物分别包括:抗凝剂50.6%和49.4%,钙阻滞剂46.0%和54.0%,活血化瘀药47.6%和52.4%,扩容药56.4%和46.6%,降颅压药45.0%和54.3%,两组间伴随用药差异无显著性(P0.05)。,2b,2a,牛津临床证据评价标准,结果如何？1 治疗效果作用多大？（RR，ARR，NNT）2 疗效的精确度如何？结果是否能帮助我的患者？（外部有效性/适用性）我的患者的情况和研究中的是否一致？此种治疗在我的医院是否可行？对于我的病人，此种治疗的潜在获益是否超过潜在危害？,University of Oxford, 2005,第二部分,应用信息学增强用药安全性,内容,Overview of ICT techniques to support the safe use of medicines如何利用ICT技术增强药物的安全使用 USA The information sources to be used in ICT supported medication surveillanceICT技术中用于药物监控的信息资源 The Netherlands Identifying and reducing medication errors: Findings from a national programme识别和降低用药过失：一个国家项目中的发现 USAAchievements in hospital pharmacy: What works医院药学的成果：是什么在起作用 United KingdomAchievements in community pharmacy: Lessons learnt社会药学的成果和教训 Portugal The role of the patient in using ICT for the safe use of medicines使用ICT技术增强药物安全使用的过程中患者的作用 The Netherlands,Overview of ICT techniques to support the safe use of medicines如何利用ICT技术增强药物的安全使用,USA,应用信息学增强用药安全性,ICT for the 21st Century,Information and communication techniquesResponsive at all times and providing access to care over the Internet, by telephone, and other means in addition to face-to-face visits.For exercising the degree of control patients choose over the decisions that affect them.For providing opportunities to share tailor-made information with pharmacists and physicians in order to verify, modify, monitor, and adjust the treatment plan and confirm evidence of treatment success,条码识别,PDA患者管理系统、实验室结果即时获得,应用ICT后昂丹司琼使用情况改善,网上患者学习系统,Identifying and reducing medication errors: Findings from a national programme识别和降低用药过失：一个国家项目中的发现,USA,应用信息学增强用药安全性,美国国家用药安全上报系统,系统界面,系统产品,Achievements in hospital pharmacy: What works医院药学的成果：是什么在起作用,United Kingdom,应用信息学增强用药安全性,不成功的例子,结合自身经验设计的系统,新系统获得了成功，也引发新的思考,第三部分,药师在约束烟草 危害方面的作用,Curbing the Tobacco Pandemic in China控制中国烟草危害 ChinaThe global smoking pandemic and the developing role of pharmacists in its control 全球吸烟的盛行以及药师在控制方面日益重要的作用 United KingdomChinese physicians: Smoking behavior, attitudes and practices toward smokers 中国医师应针对吸烟者的行为、态度以及医疗实践 ChinaDevelopment of pharmacy-based smoking cessation services in Northern Ireland药学发展北爱尔兰的禁烟行动 Northern IrelandEnhancing pharmacists skills and roles in smoking cessation support药师需提高提倡禁烟的技能和影响 MalaysiaTraining the pharmacy workforce en masse A dissemination example from the United States 药学人士的大规模培训美国实例 USAThe pharmacists role in reducing tobacco related harm in India印度药师在降低烟草危害方面发挥的作用 India,Curbing the Tobacco Pandemic in China控制中国烟草危害,Jiang Yuan，MD， MPHDeputy DirectorOffice of Tobacco ControlChina CDC,中国的吸烟情况,中国医生的吸烟率,普通人群吸烟情况,医生对控烟的认识程度不足,新的机遇,More and more patients went to pharmacy(3.31 billion person time in 2006)Cessation demand is increasingSmoking-free Olympics are comingCessation OTC medications should be available in pharmacy,新的要求,Pharmacists capacity of cessation should be improvedAn incentive mechanism should be developedAccess of cessation OTC medications should be increased,Training the pharmacy workforce en masse A dissemination example from the United States 药学人士的大规模培训美国实例,USA,6-12小时培训,培训规模扩大,培训合格的教师,戒烟教育网站,FCTC ：WHOs Framework Convention on Tobacco Control 。 The guide by David Taylor,第四部分,亚洲临床试验,内容,The role of the pharmacist in clinical trials in Chinese hospital pharmacy中国医院药师在临床试验中的作用 China Clinical trials experience in Japan and other Asian countries日本以及其他亚洲国家的临床试验经验 JapanGCP interpretation in China: A comparison to the FDA interpretation中国GCP实施：与FDA相比较 ChinaOutsourcing Preclinical & Clinical R&D to China中国临床前和临床R&D数据分析 ChinaClinical trials in the USA: A comparison with Asia美国与亚洲国家的临床试验比较 USA,The role of the pharmacist in clinical trials in Chinese hospital pharmacy中国医院药师在临床试验中的作用,Liyan Miao Ph.DThe first affiliated hospital of soochow university,药师在临床药理试验中的职责,One of the organizers for clinical trial unitOne of the Ethics committee members for clinical trialPrinciple investigator for Phase I clinical trialManagement of drug for clinical trialCollecting and submitting ADRCollecting some information about pharmacoeconomics,Outsourcing Clinical Trials in China中国外源的临床试验,QingAn Jiao，MDMSD Pharma Services,机遇,More Global R&D/Clinical Development Centers setup in China“Top 20 Pharma Flock to China, Setup CRUs” - CenterWatch “China on Fast Track to Becoming Developed Market” CenterWatch “From imitation to innovation” more R&D investment from domestic pharma/biotech in China With largest patient pool, and with