2019内科 神经内科 癫痫治疗指南新看点教育

NICE指南
? 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
Neurology. 2004,62(8):1252-1260 Neurology. 2004,62(8):1261-1273
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：
Vigabatrin Zonisamide
Serious adverse vevnts Aplastic anaemia, hepatotoxicity Aggresion* Rash, including Stevens Johnson and toxic epidermal necrolysis (high risk for children, also more common with concomitant vaiproic-acid use and low with slow titration); hypereensitivity reactions, including hepatic and renal failure, DIC, and arthritis None Hyponatraemia (more common in elderly people), rash Nonconvulsive status epilepticus Nephrolithiasis, open angle glaucoma, hypohidrosis,? depression, psychosis Visual field defects, psychosis, depression Rash, renal calculi, hypohidrosis ?
AED=antieptic drug; DIC=disseminated intravascular coagulation. * Mosthy in cognitively impaired patients; ? predominantly ch
ildren.
1
On 1 April 2005 NICE joined with the Health Development Agency to become
the new National Institute for Health and Clinical Excellence (also to be known as NICE).
? only West ayndrome; |||| only adulte.
Lancet Neurol 2004; 3: 618 –21
新药的严重/非严重不良事件
AED Felbamate Gabapentin Lamotrigine
Levetiracetam Oxcarbazepine Tiagabine Topiramate
NICE 指南
? 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: /TA076guidance. Accessed July 5, 2005.
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
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
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
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
Partial
Absence
mixed
US UK
US UK
Felbamate*
No NA
No NA
Gabapentin
Yes§ No
No No
Lamotrigine Yes§ Yes|| Yes§ Yes||
Levetiracetam No No
No No
Oxcarbazepine Yes Yes? No No
NICE指南
? NICE 在治疗中 ①尽可能选择单药治疗 ②不推荐常规监测看癫痫药物的血药浓度 ③停药原则
Ref: National Institute for Health and Clinical Excellence. Technology appraisal guidance 76: newer drugs for epilepsy in adults. Available at: /TA076guidance. Accessed July 5, 2005.
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; ?
Ref: National Institute for Health and Clinical Excellence. Technology appraisal guidance 76: newer drugs for epilepsy in adults. Available at: /TA076guidance. Accessed July 5, 2005.
Nonserious adverse Gastrointestinal disturbancse, anorexia, insomnia Weight gain, peripheral cedema, behavioural changes ? Tics? and insomnia
Irritability/behaviour change None Dizziness, asthenia Metabolic acidosis, weight loss, language dysfunxtion, paraesthesia Weight gain Irritability, photosensitivity, weight loss
Shorvon S. Epilepsia 2006,4).1091~3
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
抗癫痫治疗指南大事记
Payakachat et al. J Manag Care Pharma 2006
Welcome to the National Institute for Health and Clinical Excellence website
US
UK
No NA
Yes ? NA
No No
No
No
No Yes** Yes
Yes**
No No
No
No
No No
No
No
No No
No
No
Yes?? Yes??** Yes
Yes**
NA No
NA
Yes? ?
No NA
No
NA
None of the drugs is recommended as first choice in newly diagnosed epilepsy by the UK guidelines (see text). NA=not available.
未评估传统药物 生活质量和成本效益未作为参考指标
抗癫痫临床治疗指南比较总结
Payakachat et al. J Manag Care Pharma 2006
Payakachat et al. J Manag Care Pharma 2006
NICE指南和AAN指南对于新药的使用推荐
Drug
Newly diagnosed epilepsy
Tiagabine
No No
No No
Topiramate
Yes§ Yes? No No
Vigabatrin §§ NA No
NA No
Zonisamide
No
NA
No NA
Refractory epilepsy
Partial
Partial
monotherapy
US UK US
UK
Yes? NA Yes
NA
Yes Yes? No
No
Yes Yes** Yes
Yes
Yes Yes?? No
No
Yes Yes? Yes
Yes?
Yes Yes|| No
No
Yes Yes** Yes§ Yes?
NA Yes NA
No
Yes|||| NA No
NA
Idiopathic generalised
US UK
Symptomatie generalised
临床医生在应用指南时特别注意
上述各抗癫痫药治疗指南的差异在于 单药治疗的推荐上（新药与传统药） 原因：1.证据的评估标准
2. 制定指南的目的差异
临床医生在应用指南时特别注意
? 要特别注意癫痫药物加重癫痫发作
可能加重某些癫痫综合征的抗痫药物
*Patients Unresponsive to standard drugs in Whom the risk/benefit ratio supports use; ? only patients >18 years; ? only pati
ents >4 years
with Lennox-Gastaut ayndrome; § indication not approved FDA; ? only patients ≥6 years; || only patients ≥12 years; ** only patients >2
NICE is the independent organization responsible for providing national guidance on the promotion of good health and the prevention and treatment of ill health.
public with authoritative, robust and reliable guidance on current ‘best
practice' .
(/)
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: /TA076guidance. Accessed July 5, 2005.