抗癫痫药物临床治疗指南新看点课件

单击此处编辑母版标题样式,单击此处编辑母版文本样式,第二级,第三级,第四级,第五级,抗癫痫药物临床治疗指南新看点,*,抗癫痫药物临床治疗指南新看点,华山医院,俞丽云,抗癫痫药物临床治疗指南新看点,1,抗癫痫药物临床治疗指南新看点华山医院抗癫痫药物临床治疗指南新,制订临床指南的目的,应用指南是一种系统性阐述，用以帮助职业医师以及患者对于特定临床情况作出适当的医疗决定,抗癫痫药物临床治疗指南新看点,2,制订临床指南的目的 应用指南是一种系统性阐述，用以帮助职,临床指南的存在问题,1.评估标准不统一,2.缺乏证据不存在的证据,3.时间局限性过时、更新,4.受到药厂的影响，有一定的利益因素,5.由少部分专家制定,6.个体差异,7.临床医生执行时困难,Shorvon S.Epilepsia 2006,4).10913,抗癫痫药物临床治疗指南新看点,3,临床指南的存在问题1.评估标准不统一Shorvon S.E,制订指南原则,透明：无利益驱动,公平：所有数据采用同样的评估标准,严格：评价方法严格可行,动态：不断更新,抗癫痫药物临床治疗指南新看点,4,制订指南原则透明：无利益驱动抗癫痫药物临床治疗指南新看点4,抗癫痫治疗指南大事记,发布机构,发布年限,苏格兰临床指导协作组(SIGN),2003,英国临床优化研究所,（NICE）,2004,美国神经学会（AAN）,美国癫痫学会（AES）,2004,ILAE,2006,Payakachat et al.J Manag Care Pharma 2006,抗癫痫药物临床治疗指南新看点,5,抗癫痫治疗指南大事记发布机构 发布年限苏格兰临床指导协作组(,Welcome to the National Institute for Healthand Clinical Excellence website,NICE is the independent organization responsible for providingnational guidance on the promotion of good health andthe prevention and treatment of ill health.,On 1 April 2005 NICE joined with the Health Development Agency to becomethe new National Institute for Health and Clinical Excellence(also to be known as NICE).,Clinical Excellence,Public Health Excellence,NICE was set up as a Special Health Authority for England and Wales on 1 April 1999.Its role is to provide patients,health professionals and the public with authoritative,robust and reliable guidance on current best practice.,(http:/),抗癫痫药物临床治疗指南新看点,6,Welcome to the National Inst,NICE指南,对于抗癫痫药物使用的指证，药物选择，换药，停药等原则性问题均作出了相应推荐,Ref:National Institute for Health and Clinical Excellence.Technology appraisal,guidance 76:newer drugs for epilepsy in adults.Available at:,.Accessed July 5,2005.,抗癫痫药物临床治疗指南新看点,7,NICE指南对于抗癫痫药物使用的指证，药物选择，换药，停药等,NICE在治疗中,尽可能选择单药治疗,不推荐常规监测看癫痫药物的血药浓度,停药原则,NICE指南,Ref:National Institute for Health and Clinical Excellence.Technology appraisal,guidance 76:newer drugs for epilepsy in adults.Available at:,.Accessed July 5,2005.,抗癫痫药物临床治疗指南新看点,8,NICE在治疗中NICE指南Ref:National In,NICE指南,目前仍缺乏高质量的临床试验支持新药单药治疗比传统药物更有效,研究中的药物副作用和耐受性并未提供足够多且一致的结果支持新药优于传统药物,仅9项比较新药和老药单药治疗新诊断癫痫患者生活质量的研究，未提供强有力的证据支持新药提高患者生活质量,传统抗癫痫药物单药治疗费用更便宜,Ref:National Institute for Health and Clinical Excellence.Technology appraisal,guidance 76:newer drugs for epilepsy in adults.Available at:,.Accessed July 5,2005.,抗癫痫药物临床治疗指南新看点,9,NICE指南Ref:National Institute,首选单药治疗药物应为传统抗癫痫药物如丙戊酸钠或卡马西平，除如下原因:,禁忌症,与患者目前服用的药物有潜在的相互作用,患者在既往治疗中对该药耐受性差,患者处于准备生育期,新型抗癫痫药物作为初始治疗的二线选择,Ref:National Institute for Health and Clinical Excellence.Technology appraisal,guidance 76:newer drugs for epilepsy in adults.Available at:,.Accessed July 5,2005.,NICE指南,抗癫痫药物临床治疗指南新看点,10,首选单药治疗药物应为传统抗癫痫药物如丙戊酸钠或卡马西平，除如,NICE缺点,1.评定的证据标准和证据分类没有明确的描述,2.传统抗癫痫药没有进行同样的评估,NICE指南,抗癫痫药物临床治疗指南新看点,11,NICE缺点NICE指南抗癫痫药物临床治疗指南新看点11,Neurology.2004,62(8):1252-1260,Neurology.2004,62(8):1261-1273,抗癫痫药物临床治疗指南新看点,12,Neurology.2004,62(8):1252-126,AAN指南,1.AAN指南有明确证据分类和证据评级,2.以有效性作为主要评估指标,3.缺点：,未评估传统药物,生活质量和成本效益未作为参考指标,抗癫痫药物临床治疗指南新看点,13,AAN指南1.AAN指南有明确证据分类和证据评级抗癫痫药物,抗癫痫临床治疗指南比较总结,评价指标,NICE指南,AAN指南,有效性,安全性,生活质量,成本效益,Payakachat et al.J Manag Care Pharma 2006,抗癫痫药物临床治疗指南新看点,14,抗癫痫临床治疗指南比较总结评价指标NICE指南AAN指南有效,Payakachat et al.J Manag Care Pharma 2006,AEDs as Monotherapy,of Partial/Mix Generalized,Tonic-Clonic Seizure,ANN*,NICE,SIGN,Phenobarital,1st,-,-,Carbamazepine(generic Tegretol),Tegretol XR,1st,1st,1st,Phenytoin(generic Dilantin),1st,1st,-,Valproic acid(generic Depakene),Divalproex(Depakote),Divalproex(Depakote ER),1st,1st,1st,Primidone(generic Mysoline),-,-,-,Gabapentin(generic Neurontin),1st,-,-,Zonisamide)Zonegran),-,-,-,Tiagabine(Gabitril),-,-,-,Oxcarbazepine(Trileptal),1st,2nd,1st,Topiramate(Topamax),1st,2nd,-,Levetiracetam(Keppra),-,-,-,Lamotrigine(Lamictal),1st,2nd,1st,抗癫痫药物临床治疗指南新看点,15,Payakachat et al.J Manag Care,NICE指南和AAN指南对于新药的使用推荐,Lancet Neurol,2004;3:61821,DrugNewly diagnosed epilepsyRefractory epilepsy,PartialAbsencePartialPartialIdiopathicSymptomatie,mixedmonotherapygeneralisedgeneralised,USUKUSUKUSUKUSUKUSUKUSUK,Felbamate*NoNANoNAYes,NAYesNANoNAYes NA,GabapentinYesNoNoNoYesYesNoNoNoNoNoNo,LamotrigineYes,Yes,|Yes,Yes,|YesYes*YesYesNo Yes*YesYes*,LevetiracetamNoNoNoNoYesYesNoNoNoNoNoNo,OxcarbazepineYesYesNoNoYesYesYesYesNoNoNoNo,TiagabineNoNoNoNoYesYes|NoNoNoNoNoNo,TopiramateYesYes NoNoYesYes*YesYesYesYes*YesYes*,VigabatrinNANoNANoNAYesNANoNANoNAYes,ZonisamideNoNANo NAYes|NANoNANoNANoNA,None of the drugs is recommended as first choice in newly diagnosed epilepsy by the UK guidelines(see text).NA=not available.*Patients Unresponsive to standard drugs in Whom the risk/benefit ratio supports use;,only patients 18 years;,only patients 4 years with Lennox-Gastaut ayndrome;indication not approved FDA;only patients 6 years;|only patients 12 years;*only patients 2 years;only patients 16years;only generalized tonic-clonic seizures;in the UK the indications are limited to adjunctive use after failure of all other appropriate drug combinations;only West ayndrome;|only adulte.,抗癫痫药物临床治疗指南新看点,16,NICE指南和AAN指南对于新药的使用推荐Lancet Ne,新药的严重/非严重不良事件,Lancet Neurol 2004;3:61821,AEDSerious adver