兒童癲癇患者中吡侖帕奈使用的專家建議_Journal of Epilepsy

Authors：

 執筆人（排名不分先后）吳曄（北京大學第一醫院），操德智（深圳市兒童醫院），馮建華（浙江大學醫學院附屬第二醫院），梁建民（吉林大學第一醫院），彭鏡（中南大學湘雅醫院），孫丹（武漢兒童醫院），張玉琴（天津市兒童醫院），周水珍（復旦大學附屬兒科醫院）

Corresponding?author：

執筆人（排名不分先后）吳曄（北京大學第一醫院），操德智（深圳市兒童醫院），馮建華（浙江大學醫學院附屬第二醫院），梁建民（吉林大學第一醫院），彭鏡（中南大學湘雅醫院），孫丹（武漢兒童醫院），張玉琴（天津市兒童醫院），周水珍（復旦大學附屬兒科醫院）, Email: dryewu@263.net

Keywords：

DOI：

10.7507/2096-0247.202111007

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Citation： 執筆人（排名不分先后）吳曄（北京大學第一醫院），操德智（深圳市兒童醫院），馮建華（浙江大學醫學院附屬第二醫院），梁建民（吉林大學第一醫院），彭鏡（中南大學湘雅醫院），孫丹（武漢兒童醫院），張玉琴（天津市兒童醫院），周水珍（復旦大學附屬兒科醫院）. 兒童癲癇患者中吡侖帕奈使用的專家建議. Journal of Epilepsy, 2022, 8(2): 95-98. doi: 10.7507/2096-0247.202111007 Copy

1.	Potschka H, Trinka E. Perampanel: Does it have broad-spectrum potential? Epilepsia, 2019, 60: 22-36.
2.	衛材(中國)藥業有限公司. 吡侖帕奈藥品說明書. 2021.
3.	Eisai Co. , Ltd (per FDA). Perampanel label. 2019.
4.	Eisai Co. , Ltd (per EMA). Perampanel label. 2021.
5.	Eisai Co. , Ltd (per PMDA). Perampanel label. 2020.
6.	Schulze-Bonhage A. Perampanel for epilepsy with partial-onset seizures: a pharmacokinetic and pharmacodynamic evaluation. Expert Opinion on Drug Metabolism & Toxicology, 2015, 11(8): 1329-1337.
7.	Italiano D, Perucca E. Clinical pharmacokinetics of new-generation antiepileptic drugs at the extremes of age: an update. Clinical Pharmacokinetics, 2013, 52(8): 627-645.
8.	May TW, Boor R, Rambeck B, et al. Serum concentrations of rufinamide in children and adults with epilepsy: the influence of dose, age, and comedication. Therapeutic Drug Monitoring, 2011, 33(2): 214-221.
9.	May TW, Boor R, Mayer T, et al. Concentrations of stiripentol in children and adults with epilepsy: the in?uence of dose, age, and comedication. Ther Drug Monit, 2012, 34(4): 8.
10.	Wallander K, Ohman I, Dahlin M. Zonisamide: pharmacokinetics, efficacy, and adverse events in children with epilepsy. Neuropediatrics, 2014, 45(6): 362-369.
11.	Majid O, Reyderman L, Ferry J, et al. Population pharmacokinetics and exposure-response analyses of adjunctive perampanel in pediatric patients with epilepsy. the 72nd Annual Meeting of the American Epilepsy Society, 2018.
12.	Renfroe JB, Mintz M, Davis R, et al. Adjunctive perampanel oral suspension in pediatric patients from ≥2 to <12 years of age with epilepsy: pharmacokinetics, safety, tolerability, and efficacy. Journal of Child Neurology, 2019, 34(5): 284-294.
13.	Ikemoto S, Hamano S, Hirata Y, et al. Efficacy and serum concentrations of perampanel for treatment of drug-resistant epilepsy in children, adolescents, and young adults: comparison of patients younger and older than 12 years. Seizure, 2019, 73: 75-78.
14.	Ishikawa N, Tateishi Y, Tani H, et al. Clinical profiles associated with serum perampanel concentrations in children with refractory epilepsy. Epilepsy & Behavior, 2019, 94: 82-86.
15.	Gaudio E, Gienapp AJ, Wheless J. Perampanel pharmacokinetics in children: correlation of dose with serum concentrations. Journal of Child Neurology, 2019, 34(8): 427-431.
16.	Yamamoto Y, Shiratani Y, Asai S, et al. Pharmacokinetics, tolerability, and clinical effectiveness of perampanel in Japanese patients with epilepsy. Seizure, 2020, 83: 181-186.
17.	Takenaka O, Ferry J, Saeki K, et al. Pharmacokinetic/pharmacodynamic analysis of adjunctive perampanel in subjects with partial-onset seizures. Acta Neurologica Scandinavica, 2018, 137(4): 400-408.
18.	Yamamoto Y, Usui N, Nishida T, et al. Therapeutic drug monitoring for perampanel in Japanese epilepsy patients: influence of concomitant antiepileptic drugs. Therapeutic Drug Monitoring, 2017, 39(4): 446-449.
19.	Gidal BE, Ferry J, Majid O, et al. Concentration-effect relationships with perampanel in patients with pharmacoresistant partial-onset seizures. Epilepsia, 2013, 54(8): 1490-1497.
20.	Patsalos PN. The clinical pharmacology profile of the new antiepileptic drug perampanel: a novel noncompetitive AMPA receptor antagonist. Epilepsia, 2015, 56(1): 12-27.
21.	Rohracher A, Kalss G, Leitinger M, et al. Two-year real-world experience with perampanel in patients with refractory focal epilepsy: Austrian data. Therapeutic Advances in Neurological Disorders, 2016, 9(6): 445-453.
22.	Yamamoto T, Lim SC, Ninomiya H, et al. Efficacy and safety of perampanel monotherapy in patients with focal‐onset seizures with newly diagnosed epilepsy or recurrence of epilepsy after a period of remission: The open‐label Study 342 (FREEDOM Study). Epilepsia Open, 2020, 5(2): 274-284.
23.	Fogarasi A, Flamini R, Milh M, et al. Open‐label study to investigate the safety and efficacy of adjunctive perampanel in pediatric patients (4 to <12 years) with inadequately controlled focal seizures or generalized tonic‐clonic seizures. Epilepsia, 2020, 61(1): 125-137.
24.	Lin KL, Lin JJ, Chou ML, et al. Efficacy and tolerability of perampanel in children and adolescents with pharmacoresistant epilepsy: The first real-world evaluation in Asian pediatric neurology clinics. Epilepsy & Behavior, 2018, 85: 188-194.
25.	Ishikawa N, Tateishi Y, Tani H, et al. Successful treatment of intractable life-threatening seizures with perampanel in the first case of early myoclonic encephalopathy with a novel de novo SCN1A mutation. Seizure, 2019, 71: 20-23.
26.	Swiderska N, Tan HJ, Rajai A, et al. Effectiveness and tolerability of Perampanel in children, adolescents and young adults with refractory epilepsy: a UK national multicentre study. Seizure, 2017, 52: 63-70.
27.	Auvin S, Dozieres B, Ilea A, et al. Use of perampanel in children and adolescents with Lennox-Gastaut Syndrome. Epilepsy & Behavior, 2017, 74: 59-63.
28.	Huberfeld G, Vecht CJ. Seizures and gliomas - towards a single therapeutic approach. Nature Reviews Neurology, 2016, 12(4): 204-216.
29.	Biró A, Stephani U, Tarallo T, et al. Effectiveness and tolerability of perampanel in children and adolescents with refractory epilepsies: first experiences. Neuropediatrics, 2015, 46(02): 110-115.
30.	Wheless J, Wechsler RT, Lancman M, et al. Perampanel in real‐world clinical care of patients with epilepsy: Interim analysis of a phase IV study. Epilepsia Open, 2021, 6(1): 79-89.
31.	Villanueva V, Garcés M, López-González FJ, et al. Safety, efficacy and outcome-related factors of perampanel over 12 months in a real-world setting: the FYDATA study. Epilepsy Research, 2016, 126: 201-210.
32.	Kamitaki BK, Minacapelli CD, Zhang P, et al. Drug-induced liver injury associated with antiseizure medications from the FDA Adverse Event Reporting System (FAERS). Epilepsy & Behavior, 2021, 117: 107832.
33.	Laurenza A, Yang H, Williams B, et al. Absence of liver toxicity in perampanel-treated subjects: pooled results from partial seizure phase III perampanel clinical studies. Epilepsy Research, 2015, 113: 76-85.

1. Potschka H, Trinka E. Perampanel: Does it have broad-spectrum potential? Epilepsia, 2019, 60: 22-36.
2. 衛材(中國)藥業有限公司. 吡侖帕奈藥品說明書. 2021.
3. Eisai Co. , Ltd (per FDA). Perampanel label. 2019.
4. Eisai Co. , Ltd (per EMA). Perampanel label. 2021.
5. Eisai Co. , Ltd (per PMDA). Perampanel label. 2020.
6. Schulze-Bonhage A. Perampanel for epilepsy with partial-onset seizures: a pharmacokinetic and pharmacodynamic evaluation. Expert Opinion on Drug Metabolism & Toxicology, 2015, 11(8): 1329-1337.
7. Italiano D, Perucca E. Clinical pharmacokinetics of new-generation antiepileptic drugs at the extremes of age: an update. Clinical Pharmacokinetics, 2013, 52(8): 627-645.
8. May TW, Boor R, Rambeck B, et al. Serum concentrations of rufinamide in children and adults with epilepsy: the influence of dose, age, and comedication. Therapeutic Drug Monitoring, 2011, 33(2): 214-221.
9. May TW, Boor R, Mayer T, et al. Concentrations of stiripentol in children and adults with epilepsy: the in?uence of dose, age, and comedication. Ther Drug Monit, 2012, 34(4): 8.
10. Wallander K, Ohman I, Dahlin M. Zonisamide: pharmacokinetics, efficacy, and adverse events in children with epilepsy. Neuropediatrics, 2014, 45(6): 362-369.
11. Majid O, Reyderman L, Ferry J, et al. Population pharmacokinetics and exposure-response analyses of adjunctive perampanel in pediatric patients with epilepsy. the 72nd Annual Meeting of the American Epilepsy Society, 2018.
12. Renfroe JB, Mintz M, Davis R, et al. Adjunctive perampanel oral suspension in pediatric patients from ≥2 to <12 years of age with epilepsy: pharmacokinetics, safety, tolerability, and efficacy. Journal of Child Neurology, 2019, 34(5): 284-294.
13. Ikemoto S, Hamano S, Hirata Y, et al. Efficacy and serum concentrations of perampanel for treatment of drug-resistant epilepsy in children, adolescents, and young adults: comparison of patients younger and older than 12 years. Seizure, 2019, 73: 75-78.
14. Ishikawa N, Tateishi Y, Tani H, et al. Clinical profiles associated with serum perampanel concentrations in children with refractory epilepsy. Epilepsy & Behavior, 2019, 94: 82-86.
15. Gaudio E, Gienapp AJ, Wheless J. Perampanel pharmacokinetics in children: correlation of dose with serum concentrations. Journal of Child Neurology, 2019, 34(8): 427-431.
16. Yamamoto Y, Shiratani Y, Asai S, et al. Pharmacokinetics, tolerability, and clinical effectiveness of perampanel in Japanese patients with epilepsy. Seizure, 2020, 83: 181-186.
17. Takenaka O, Ferry J, Saeki K, et al. Pharmacokinetic/pharmacodynamic analysis of adjunctive perampanel in subjects with partial-onset seizures. Acta Neurologica Scandinavica, 2018, 137(4): 400-408.
18. Yamamoto Y, Usui N, Nishida T, et al. Therapeutic drug monitoring for perampanel in Japanese epilepsy patients: influence of concomitant antiepileptic drugs. Therapeutic Drug Monitoring, 2017, 39(4): 446-449.
19. Gidal BE, Ferry J, Majid O, et al. Concentration-effect relationships with perampanel in patients with pharmacoresistant partial-onset seizures. Epilepsia, 2013, 54(8): 1490-1497.
20. Patsalos PN. The clinical pharmacology profile of the new antiepileptic drug perampanel: a novel noncompetitive AMPA receptor antagonist. Epilepsia, 2015, 56(1): 12-27.
21. Rohracher A, Kalss G, Leitinger M, et al. Two-year real-world experience with perampanel in patients with refractory focal epilepsy: Austrian data. Therapeutic Advances in Neurological Disorders, 2016, 9(6): 445-453.
22. Yamamoto T, Lim SC, Ninomiya H, et al. Efficacy and safety of perampanel monotherapy in patients with focal‐onset seizures with newly diagnosed epilepsy or recurrence of epilepsy after a period of remission: The open‐label Study 342 (FREEDOM Study). Epilepsia Open, 2020, 5(2): 274-284.
23. Fogarasi A, Flamini R, Milh M, et al. Open‐label study to investigate the safety and efficacy of adjunctive perampanel in pediatric patients (4 to <12 years) with inadequately controlled focal seizures or generalized tonic‐clonic seizures. Epilepsia, 2020, 61(1): 125-137.
24. Lin KL, Lin JJ, Chou ML, et al. Efficacy and tolerability of perampanel in children and adolescents with pharmacoresistant epilepsy: The first real-world evaluation in Asian pediatric neurology clinics. Epilepsy & Behavior, 2018, 85: 188-194.
25. Ishikawa N, Tateishi Y, Tani H, et al. Successful treatment of intractable life-threatening seizures with perampanel in the first case of early myoclonic encephalopathy with a novel de novo SCN1A mutation. Seizure, 2019, 71: 20-23.
26. Swiderska N, Tan HJ, Rajai A, et al. Effectiveness and tolerability of Perampanel in children, adolescents and young adults with refractory epilepsy: a UK national multicentre study. Seizure, 2017, 52: 63-70.
27. Auvin S, Dozieres B, Ilea A, et al. Use of perampanel in children and adolescents with Lennox-Gastaut Syndrome. Epilepsy & Behavior, 2017, 74: 59-63.
28. Huberfeld G, Vecht CJ. Seizures and gliomas - towards a single therapeutic approach. Nature Reviews Neurology, 2016, 12(4): 204-216.
29. Biró A, Stephani U, Tarallo T, et al. Effectiveness and tolerability of perampanel in children and adolescents with refractory epilepsies: first experiences. Neuropediatrics, 2015, 46(02): 110-115.
30. Wheless J, Wechsler RT, Lancman M, et al. Perampanel in real‐world clinical care of patients with epilepsy: Interim analysis of a phase IV study. Epilepsia Open, 2021, 6(1): 79-89.
31. Villanueva V, Garcés M, López-González FJ, et al. Safety, efficacy and outcome-related factors of perampanel over 12 months in a real-world setting: the FYDATA study. Epilepsy Research, 2016, 126: 201-210.
32. Kamitaki BK, Minacapelli CD, Zhang P, et al. Drug-induced liver injury associated with antiseizure medications from the FDA Adverse Event Reporting System (FAERS). Epilepsy & Behavior, 2021, 117: 107832.
33. Laurenza A, Yang H, Williams B, et al. Absence of liver toxicity in perampanel-treated subjects: pooled results from partial seizure phase III perampanel clinical studies. Epilepsy Research, 2015, 113: 76-85.

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