bph的循证治疗董碧蓉南宁.pptx

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1、一.临床治疗依据的演变19001900s s 个人经验个人经验权威性教学无对照病例报告病例对照研究,临床试验以科学为本的病因学19701970s s 临床终点指标研究+临床经验以证据为本的临床用药19951995 第1页/共74页医药费用直线攀升！卫生服务需求不断增加！卫生资源利用不均！医患关系紧张！第2页/共74页the rate of radical prostatectomy per 100,000 male Medicare beneficiaries,adjusted for age and race手术率范围差异令人难以置信：20/100,000 in Rhode 20/100,0

2、00 in Rhode 429/100,000 in Alaska 429/100,000 in Alaska 21:1 21:1有些州经历太多的手术，许多病人阳萎和失禁相反，有些州手术不足合理的治疗可能存在于两极端之间。第3页/共74页“Keepthebalancebetweenbenefitsandharms”临床决策第4页/共74页临床关于BPH的治疗问题很多干预类型的选择内科药物治疗l -受体阻滞剂l l 5-5-还原酶抑制剂还原酶抑制剂 l l 中药和植物制剂中药和植物制剂外科治疗用药时机？单药/联合？用药疗程？不良事件？药物相互作用?第5页/共74页What is the Evid

3、ence-based Practice（EBP)整合病人价值，临床医生的专业技能和最好证据，将三者完美地结合以制定出患者的治疗措施 Integrating patient values,clinical expertise and best evidence Sackett DL 2001第6页/共74页Model of evidence based clinical decisions clinical circumstancespatient preference research evidence Clinical expertise 临床医生将专业技能，整合证据，同时考虑病人意愿与价值

4、，与病人及家属进行沟通，然后协助做出决策的能力。第7页/共74页1.1.临床经验（clinical expertise）l进行医学实践活动的基本能力：问诊、查体、与病人沟通的能力l对疾病病理生理、解剖知识的了解（专业知识）l临床个人经验的积累 第8页/共74页尿道移行带（增生发 生部分）中央区（癌发生部分）外周带外周带BPHBPH从从移行带发生移行带发生（Benign Prostatic Hyperplasia，BPH）解剖知识第9页/共74页Development of BPH:Early Slide 1 of 3BPH的发生（早期）的发生（早期）膀胱膀胱包绕前列腺包绕前列腺上分的肌肉上分的

5、肌肉前列腺前列腺组织组织外科外科包膜包膜前列腺段尿道前列腺段尿道第10页/共74页Development of BPH:Intermediate Slide 2 of 3BPH的发生（中期）的发生（中期）前列腺前列腺组织组织外科外科包膜包膜狭窄的前列腺狭窄的前列腺段尿道段尿道第11页/共74页Development of BPH:Late Slide 3 of 3严重狭窄的前严重狭窄的前列腺段尿道列腺段尿道BPH的发生（晚期）的发生（晚期）前列腺前列腺组织组织外科外科包膜包膜第12页/共74页40-7940-79岁每年增岁每年增长长0.6ml0.6ml，2020年后年后体积增加体积增加12ml

6、12ml如果原来体积是如果原来体积是20ml20ml,20,20年后体积年后体积会达到会达到32ml32ml 前列腺的体积与年龄有关生理知识第13页/共74页前列腺增生症的发病率随年龄前列腺增生症的发病率随年龄增长而明显增加增长而明显增加流行病学知识第14页/共74页Definition of TermsnLUTSLower-urinary-tract symptomsnBPEBenign prostatic enlargement(macroscopic)nBOOBladder-outlet obstructionnBPHBenign prostatic hyperplasia(micros

7、copic/histologic)nBPOBenign prostatic obstruction(BOO caused by BPE)nClinical BPH LUTS+BPE+BOO Slide I.1病理生理知识第15页/共74页Adapted from Nordling J et al.In Benign Prostatic Hyperplasia.Plymouth,United Kingdom:Health Publication,2001:107-166.Pathophysiology of Clinical BPH:Overlapping but Independent Fea

8、turesSlide I.2LUTSEnlargedprostateBOO病理生理知识第16页/共74页Pathophysiology of Clinical BPH:Predictive Risk FactorsSlide I.4Increasing ageProstatic enlargementElevated prostate-specific antigen(PSA)Lower-urinary-tract symptoms(LUTS)Decreased urinary flow rate 第17页/共74页BPH的临床表现特点的临床表现特点排尿期症状(梗阻性,占25%)l排尿费力,尿

9、不尽感l尿线细慢l尿流中断白天晚上储尿期症状(刺激性,占25%)l尿频(排尿次数增加)l尿急l夜尿增加储尿期+排尿期症状占50%日夜不轻松第18页/共74页膀胱憩室膀胱憩室上尿路积水上尿路积水尿潴留尿潴留前列腺增生的危害性前列腺增生的危害性尿路感染尿路感染膀胱结石膀胱结石血尿血尿腹股沟疝、脱肛、痔疮腹股沟疝、脱肛、痔疮反复起夜，影响休息，反复起夜，影响休息，诱发心脑血管疾病发作诱发心脑血管疾病发作第19页/共74页前列腺容积和前列腺容积和LUTSLUTS前列腺容积对生活质量的影响 30ml 30ml 是 30ml 40ml 40ml 是 40ml 50ml 50ml 是 50ml 50ml 的

10、 3.5 3.5 倍中到重度症状影响QoLQoL是无症状的4-64-6倍第20页/共74页国际前列腺症状评分表国际前列腺症状评分表(IPSS)(IPSS)0-7分分=轻度；轻度；8-19分分=中度；中度；20-35分分=重度重度第21页/共74页2.2.最佳临床研究证据（The best evidence)指与临床密切相关的研究，以人体研究证据l 设计良好的临床研究才是让证据说话的基石l 随机对照试验是防治性研究的金标准l 将来有可能有新的证据出现第22页/共74页证据的级别的证据的级别的“金字塔金字塔”临床研究证据分级临床研究证据分级第23页/共74页寻求 POEMsPOEMs，避免DOEs

11、DOEs q熟悉如何寻找临床问题的答案是重要的技能qPOEM:Patient-Oriented Evidence that Matters 病人为中心的测量指标（终点指标）DOE：Disease-Oriented Evidence”常引起误导，通常不成熟第24页/共74页BPHBPH的治疗目标的治疗目标终点指标终点指标生活质量生活质量 AURAUR发生率发生率前列腺手术率前列腺手术率不良反应发生率不良反应发生率 保护膀胱功能保护膀胱功能 中间中间指标改善指标改善尿流率尿流率残余尿残余尿症状症状前列腺体积前列腺体积1010年前观点年前观点目前观点目前观点第25页/共74页源于对源于对9090种杂

12、志持续种杂志持续6 6个月的个月的调查显示：调查显示：l97%97%的文献是DOEsDOEs或其他。l80478047篇文献中仅213213篇（2.6%)2.6%)是POEMsPOEMs第26页/共74页如何寻找高质量证据如何寻找高质量证据?lTextbook(print or online)lMedline or PubMed search:find and review articleslPre-appraised evidence Best Evidence Clinical Evidence(Therapy only)Cochrane Collaboration(Therapy onl

13、y)UpToDate第27页/共74页循证教科书要求使用超文本（hyepertext,PDA)的电子图书收入的知识须是源于当前最好的研究证据每一项证据都有质量评级随着新证据的出现不断更新通过互联网传送给每一个医生和决策人员.第28页/共74页推荐教科书Clinical Evidence(the BMJ Publishing Group and the American College of Physicians 1999 年第1次出版)Evidence-Based on Call(CD)Harrisons textbooks(CD)Merck Manual第29页/共74页EBCP DATA

14、Resources qSummaries of the primary evidenceACP Journal Club|Clinical Evidence|eMedicine|FPIN Clinical Inquiries|InfoPOEMs|UpToDateqDatabasesMEDLINE|Cochrane LibraryqElectronic textbooks and librariesACP Medicine|Harrisons|MD Consult|Stat!Ref qMeta-Search EnginesSUMSearch|TRIP Plus:Turning Research

15、into Practice第30页/共74页点击点击第31页/共74页双击第32页/共74页第33页/共74页第34页/共74页第35页/共74页第36页/共74页第37页/共74页第38页/共74页第39页/共74页第40页/共74页第41页/共74页双击第42页/共74页点击第43页/共74页第44页/共74页点击第45页/共74页第46页/共74页Clincial Trial 132Other Reviews 3第47页/共74页第48页/共74页第49页/共74页评价证据Evaluating the Validity of The Study对每一个研究必须回答三个基本问题 There

16、 are three basic questions that need to be answered for every type of study:l 研究结果的真实性如何？Are the results of the study valid?l 临床意义和统计学意义What are the results?l 结果有助于我处理病人吗？Will the results help in caring for my patient?第50页/共74页评价方式评价方式自己进行文献评价 Critically appraise articles yourself借助已评价的证据资源Used a so

17、urce that appraises trials for youlBest EvidencelClinical Evidence lCochrane LibrarylUpToDate第51页/共74页Diagnosis of Clinical BPH:International RecommendationsSlide IV.1Assessment ICBPH GuidelinesQuantification of symptomsIPSSRecommendedQuantification of symptomsbother scoreRecommendedDigital rectal e

18、xaminationRecommendedUrinalysis RecommendedPSA measurementRecommendedVoiding diary(frequency-volume charts)RecommendedUrinary flow-rate recordingOptionalPostvoid residual urine volume studiesOptionalPressure-flow studiesOptionalProstate imaging(TRUS)OptionalUpper-urinary-tract imaging(US or IVU)Opti

19、onalLower-urinary-tract endoscopyOptionalSerum creatinine measurementNot recommendedAdapted from Fifth International Consultation 2001 on BPH.In Benign Prostatic Hyperplasia.Plymouth,United Kingdom:Health Publication,2001:519-535.第52页/共74页BPH的治疗目标ICBPHICBPH制定的制定的制定的制定的BPHBPH的治疗目标：的治疗目标：的治疗目标：的治疗目标：l

20、l缩小前列腺体积和缩小前列腺体积和/或减轻梗阻或减轻梗阻ll防止远期并发症防止远期并发症4 4 4 4ll缓解临床症状缓解临床症状4 4 4 44.Evaluationandtreatmentoflowurinarytractsymptomsinolderman.2001 5th international consultation on BPH.Recommendation of theinternationalscientificcommittee第53页/共74页Evidence-Based Medicine:Proven treatment for Clinical BPHEviden

21、ce-based medicine is based on results of clinical research.Drugs in the same therapeutic class may exert different pharmacologic effects.Independent clinical studies must establish each drugs efficacy,safety,and effect on outcomes.Outcome studies with drugs for clinical BPH should evaluate the effec

22、ts of therapy on AUR and BPH-related surgery.Slide V.1第54页/共74页PROSCAR:Durable Efficacy in Long-Term TrialsDurationLong-Term ImprovementStudy(years)SymptomsProstate VolumeUrinary FlowNorth American1 SCARP2 PROSPECT2 PROWESS2 PLESS4 North American Extension*Maintained MaintainedMaintainedScandinavian

23、 Open Extension*MaintainedMaintainedMaintainedSlide V.4=significant improvement from baseline vs.placebo(p0.05);SCARP=Scandinavian Study of Reduction of the Prostate;PROSPECT=Proscar Safety Plus Efficacy Canadian Two-Year Study;PROWESS=Proscar Worldwide Efficacy and Safety Study;PLESS=Proscar Long-t

24、erm Efficacy and Safety Study*Benefits achieved during double-blind therapy were maintained in extensions.第55页/共74页治疗组对照组保列治保列治 治疗对前列腺体积的影响治疗对前列腺体积的影响第56页/共74页EffectsofPROSCARontheNaturalHistoryofClinicalBPH:ReducedRiskofAURSlide V.5PlaceboPROSCAR57%riskreductionp0.00115105041230ProbabilityofAURYear

25、s No.of AURs36252018 No.at risk1503145413981347 No.of AURs1411710 No.at risk1513148714491421PlaceboPROSCARp0.001 at 4 years PROSCAR vs.placeboAdapted from McConnell JD et al N Engl J Med 1998;338(9):557-563.第57页/共74页EffectsofPROSCARontheNaturalHistoryofClinicalBPH:ReducedRiskofSurgerySlide V.655%ris

26、kreductionp0.0011510501230ProbabilityofsurgeryNo.of surgeries37523231No.at risk1503145413741314No.of surgeries1822920No.at risk1513148314381410Years4PlaceboPROSCARPlaceboPROSCARp0.001 at 4 years,PROSCAR vs.placeboAdapted from McConnell JD et al N Engl J Med 1998;338(9):557-563.第58页/共74页Effect of PRO

27、SCAR on the Natural History of BPH:Relative Risk Reductions vs.Interventions in Other DiseasesRiskConditionOutcomeInterventionReduction(%)OsteoporosisVertebral fracture Alendronate4447Hip fracture Alendronate 2151AtherosclerosisPTCA or CABGStatins1737 Fatal/nonfatal MI Statins 2540EpilepsySeizuresAn

28、ticonvulsants3887Superficial bladder cancer RecurrenceBCG+surgery3180Kidney stonesRecurrence Pharmacotherapy6380BPHAURPROSCAR57Surgery PROSCAR 55Slide V.7PTCA=percutaneous transluminal coronary angioplasty;CABG=coronary artery bypass graft;BCG=bacillus Calmette-GurinAdapted from Roehrborn CG et al U

29、rology 2000;56:9-18.McConnell et al N Eng J Med 1998;338(9):557-563.第59页/共74页PSA and PROSCARPredictably reduces PSA by 50%in men with BPH Multiplication of PSA values by 2 in men treated for 6 months preserves predictive value of PSA measurements Slide V.8In PLESS,PROSCAR did not mask prostate cance

30、r detected by PSA第60页/共74页Long-Term Experiencewith PROSCARSustained improvements over 7 years of therapyReductions in symptom scoresSustained reductions in prostate volume 25%reduction at year 7Sustained increases in urinary flow 2.5 ml/sec increase at year 7Consistent safety and tolerability profil

31、e over 8 years of therapySlide VI.1Data on file,MSD.第61页/共74页Rapid and Sustained Reduction in the Risk of Long-Term Outcomes with PROSCARDouble-blind studyOpen-label extensionSlide VI.3n values indicate number of patients completing each trial phaseAdapted from Roehrborn CG et al.Poster 419.Placebo(

32、n=1503)PROSCAR 5 mg(n=1513)Placebo PROSCAR 5 mg(n=858)PROSCAR 5 mg PROSCAR 5 mg(n=979)543210Yearly%ofAURand/orBPH-relatedsurgery123456Studyyear3.71.94.42.13.31.03.02.01.00.71.41.3第62页/共74页Slide VI.4 *p0.05 PROSCAR vs.placebo at every time point after 4 months to 1 year and p0.001 PROSCAR vs.placebo

33、every 4 months,years 1 to 4*Significant improvement vs.baseline with PROSCAR and placebo at 4 years,p7PV36ml4 Yr Tx第65页/共74页From evidencesBPHBPH治疗中治疗中受体阻滞剂的作用机制及疗效受体阻滞剂的作用机制及疗效MTOPS研究尽管前列腺体积增加24，仍有明显疗效尿道阻力下降逼尿肌稳定逼尿肌收缩力改善第66页/共74页From evidences to action面临错综复杂的BPH患者，如何决定一个治疗方案？最好的证据（来自于相关的研究）医生的经验患者的

34、意愿综而合之确定治疗方案Syntegration Make a decision第67页/共74页证据综合决定A way from clinical evidence to action第68页/共74页The Patient-Physician Connection让患者理解治疗的利/弊找出病人的价值与意愿帮助病人做出适合于病人的选择（不是替病人作出选择）第69页/共74页Patient Satisfaction Is Important in the Treatment of Clinical BPHTreatment selection in BPH should take into a

35、ccountPatients perception of the impact of BPH on quality of lifePatients ability to deal with bother caused by symptomsPatients attitudes toward risk of possible complicationsSlide VII.1第70页/共74页The Physicians Rolein Patient EducationPhysicians should involve patients with BPH in the choice of therapyPatient education should include discussions ofThe natural history of BPH(including potential for serious complications)Benefits,risks,and costs of alternative approaches第71页/共74页总结总结第72页/共74页谢谢！Thank you Thank you very much very much!第73页/共74页感谢您的观看！第74页/共74页