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find Keyword "吡仑帕奈" 16 results
  • Ⅲ期临床试验非盲延期阶段联合使用吡仑帕奈的局灶性癫痫患者的四年药物安全性、耐受性及发作结局:307 号研究

    评估 307 号研究(临床试验验证码:NCT00735397)Ⅲ期非盲延期阶段(OLEx)联合使用吡仑帕奈的局灶性癫痫患者的药物安全性、耐受性及痫性发作结局。患者在完成任一 III 期双盲试验后均可进入非盲延期阶段(Open-labelextension,OLEx)。对所有 OLEx 队列中有同样最小吡伦帕奈暴露剂量的局灶性癫痫和继发全面性癫痫(Secondarily generalized seizures,SGS)的患者进行药物安全性及耐受性和痫性发作结局(每 28 d 中位痫性发作减少率、反应率和无发作率)的分析。另外,针对 OLEx 的早期失访进行了额外的敏感性分析。从 1 480 例双盲试验中随机分组的患者共纳入 1 218 例。大部分患者(65.4%~80.9%)仅用吡仑帕奈 12 mg,每日一次,进行治疗,并在相同剂量下完成长期的检测,或是相对基线联合使用少量抗癫痫药物(AEDs)。长期的药物安全性及耐受性结果与双盲研究一致。导致超过 1% 的患者研究中断治疗的紧急不良反应事件(Treatment-emergent adverse events,TEAEs)包括眩晕、易激、疲劳。有临床意义的 TEAEs 稳定期为 4 年。所有队列中患者的痫性发作结局随时间持续改善。对于接受 3 年(n = 436)、4 年(n = 78)药物治疗的患者 28 d 中位痫性发作减少率分别为 62%、70.6%,相应的 50% 反应率为 59.6%、67.9%。最大 28 d 中位痫性发作减少率发生于基线水平的 SGS 患者,接受 3 年(n = 190)、4 年(n = 28)药物治疗分别为 88.0% 和 100.0%。在这些队列中分别有 40.0% 和 53.6% 的患者达到了无 SGS。排除早期失访后的 28 d 中位痫性发作减少率结果类似。长期吡仑帕奈联合用药(≤4 年)不会导致新的药物安全性及耐受性问题,并且可以很大程度地减少痫性发作,特别是基线水平的 SGS 患者。

    Release date:2020-03-20 08:06 Export PDF Favorites Scan
  • AMPA 受体及其拮抗剂在癫痫持续状态中的作用

    癫痫持续状态(Status epilepticus,SE)通常定义为长时间持续的癫痫发作或反复发作且发作间期未完全恢复。SE 是一种急症,通常与严重的残疾、较高的发病率和死亡率相关。尽管受临床的影响,但从自限性癫痫发作过渡到持续的、难治性的癫痫发作的潜在机制仍尚不完全明确。在 SE 中,约 40%的患者对抗癫痫药物(AEDs)(一线治疗)无效;因此,需要更有效的药物。在这篇综述中,我们着重于目前对于 α-氨基-3-羟基-5-羟基-5-甲基-4-异恶唑丙酸(alpha-amino-3-hydroxy-5-methyl-4-isoxazole propionic acid,AMPA)受体在 SE 中作用的了解,以及其拮抗剂的临床前功效和当前发表的涉及具有这种作用机制的药物的临床研究。我们对关于 AMPA 受体、AMPA 受体拮抗剂和 SE 的实验性和临床研究文章进行了全面的文献检索。近年来,AMPA 受体在 SE 发作期间和发作后的作用变得逐渐清晰,现在已被广泛接受的是其早期变化发生在初始阶段,这可能有导致 SE 的维持及其对治疗的抵抗性。AMPA 受体拮抗剂已在几种 SE 动物模型中被证实可终止发作,这些研究支持着抑制 AMPA 受体的治疗潜力。迄今为止,人体研究的相关数据很有限,但前景广阔,它们支持在 SE 患者中使用 AMPA 受体拮抗剂。当二线药物首次尝试失败后,AMPA 受体拮抗剂可能成为确定的 SE 患者的新治疗选择,特别是在苯二氮卓作为二线治疗失败后,甚至效果可能更好。

    Release date:2020-05-19 01:07 Export PDF Favorites Scan
  • 第三代新型抗癫痫药吡仑帕奈在癫痫治疗中的研究进展

    吡仑帕奈是第三代新型抗癫痫药物(AEDs),也是首个治疗癫痫的高度选择性非竞争性 α-氨基-3-羟基-5-甲基-4-异喃恶唑丙酸(α-Amino-3-hydroxy-5-methyl-4-isoxazolepropionic acid,AMPA)型谷氨酸受体拮抗剂。现已在许多国家广泛用于治疗各种癫痫,并取得较好疗效。文章对吡仑帕奈在癫痫治疗方面的临床用法、药物代谢动力学、临床疗效和不良反应等作一综述,以帮助临床医生更全面地了解吡仑帕奈临床特点,利于癫痫的个体化治疗。

    Release date:2021-02-27 02:57 Export PDF Favorites Scan
  • 拉考沙胺和吡仑帕奈单药治疗癫痫的研究进展

    抗癫痫发作药物(Antiseizure medications,ASMs)在癫痫患者的治疗中起着重要的作用,因为大多数患者需要长期的抗惊厥治疗。由于高达 30% 的患者对药物治疗不耐受,因此需要选择新的治疗。单药治疗是新诊断癫痫治疗的金标准,如果第一次治疗不成功,可以选择第二次单药治疗。拉考沙胺(Lacosamide,LCM)和吡仑帕奈(Perampanel,PER)是第三代新型 ASMs,最新被批准用于局灶性癫痫的单药治疗。PER 对 α-氨基-3-羟基-5-甲基 4-异恶唑丙酸(AMPA)受体具有独特的和选择性的作用模式。LCM 通过选择性地增强电压门控钠通道的慢失活来发挥作用。文章对拉考沙胺和吡仑帕奈的作用机制、药物代谢动力学,以及作为单药治疗在癫痫患者中的有效性及安全性等方面作一综述,以期为临床医师提供用药参考,利于癫痫的个体化治疗。

    Release date:2021-06-24 01:26 Export PDF Favorites Scan
  • Efficacy and safety of adjunctive perampanel in children with refractory epilepsy

    ObjectiveIn order to evaluate the efficacy, safety and tolerability of adjunctive perampanel in children with refractory epilepsy. MethodsThis study collected medical records of 34 children with refractory epilepsy, who were admitted to Children’s Hospital of Soochow University from January 2020 to January 2021. By comparing the baseline status with the status at 4, 8, 12, 24, 36, and 48 weeks of follow-up, the efficacy and adverse reactions of perampanel were evaluated. ResultsThe mean age of the patients treated with perampanel was 8.1±4.1 years. The male-to-female ratio was 1: 1. After the addition of perampanel, the average responder rate at the 4th, 8th, 12th, 24th, 36th, 48th weeks were 37.5%, 46.7%, 50.0%, 47.4%, 53.8%, 42.9%. The adverse events were reported by 32.4%, and the retention rate was 88.2%. ConclusionsPerampanel has good efficacy, safety and tolerability in the treatment of refractory epilepsy. Moreover, personalized treatment and better baseline seizure control may increase the effectiveness and retention rate of perampanel.

    Release date:2021-10-25 01:58 Export PDF Favorites Scan
  • Clinical study of the adjunctive treatment of perampanel in children with refractory epilepsy

    Objective To study the efficacy and adverse events of adjunctive perampanel in children with refractory epilepsy. Methods A prospective study was carried out in 45 children with refractory epilepsy, who were treated in our hospital from January 2020 to February 2021 using perampanel as an add-on treatment, with a criteria for enrollment and the starting dose of perampanel. Follow-up would be taken at once a month. Afte 3 months would check blood routine, liver function, kidney function and humoral immunity. The EEG was reviewed after 6 months. The initial dose of perampanel was 0.04 mg/(kg·d) (the maximum didn't exceed 2 mg/d), increasing by 0.04 mg/(kg·d) every two weeks, and the maximum maintenance dose didn't exceed 6 mg/d. The efficacy and adverse reactions of perampanel were evaluated by comparing the seizure frequency and EEG results before and after a 6-month add-on therapy.ResultsAmong the 45 children,complete seizure control was achieved in 7 cases after the therapy, and the seizure attacks were reduced in 26 cases, showing a total response rate of 73.3%. After the treatment, the epileptiform discharge of 28 children was reduced, and the effective rate was 62.22%. During the observation period, all the blood routine, liver function, kidney function,and humoral immunity of the children were normal.10 cases of adverse reactions occurred after the additional treatment of perampanel, and the adverse reaction rate was 22.22%. Conclusions Perampanel has good efficacy and safety in the add-on treatment of refractory epilepsy.

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  • Research progress of perampanel in the treatment of childhood epilepsy

    Perampanel (PER) is a third-generation novel anti-seizure drug, a postsynaptic neuronal (α-Amino-3-hydroxy-5-methyl-4- isoxazolepropionic acid, AMPA) receptor antagonist, which effectively controls seizures by inhibiting glutamate-induced neurological hypertransmission. PER can not only be used for the addition of focal epilepsy 4 years old and above, but also monotherapy for children (≥ 4 years old) for the treatment of focal epilepsy patients, its efficacy and safety is relatively good, has been used clinically in many countries, the article overviewed the pharmacokinetics, mechanism, and the addition and monotherapy in different epilepsy types of childhood epilepsy and other aspects, in order to provide a reference for clinical medication, and provide individualized treatment for children with epilepsy.

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  • Clinical efficacy of perampanel monotherapy in children with focal epilepsy

    Objective To explore the efficacy and safety of Perampanel (PER) monotherapy in children with focal epilepsy. Methods Forty-six children with focal epilepsy who were newly diagnosed in the Department of Neurology of Wuxi Children's Hospital and had not used anti-seizure medications during January 2021 to June 2022 were selected, including 24 males and 22 females, with an average age of (7.2 ± 2.4) years old. Mono-therapy of PER as the PER group (23 cases), mono-therapy of Levetiracetam (LEV) as the LEV group (23 cases). Compare the clinical efficacy and adverse reactions between the two groups. Result The total effective rate was 87.0% (20/23) in PER group and 73.9% (17/23) in LEV group after 3 months of treatment (P<0.05); the total effective rate in the PER group was 78.3% (18/23), and 60.9% (14/23) in the LEV group after 6 months of treatment (P<0.05). The differences were statistically significant. In the PER group, 2 children had adverse reactions, 1 case was lethargic, and 1 case was dizziness. By temporarily reducing the drug dose and slowing the rate of dosing, the adverse reactions disappeared. In LEV group, 3 children had adverse reactions, all of who were irritable in varying degrees. By slowing down the rate of drug addition, 2 children’s symptoms disappeared and 1 child's symptoms relieved during 3 ~ 6 months. Conclusion The new anti-seizure medication — PER has a better anti-epileptic effect on focal epilepsy, which is better than LEV. The adverse reactions of both drugs are less and mild, and can be selected according to clinical conditions.

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  • Research progress of clinical application of perampanel

    Epilepsy is a common chronic disease of the nervous system, which has certain adverse effects on the cognitive, psychological and social functions of the patients. To date, anti-seizure medications (ASMs) remain the first-line treatment option for epilepsy, but many patients with epilepsy still do not have effective seizure control when multiple ASMs are used in combination. Therefore, there is an urgent need for a new target and mechanism ASMs to bring about new treatment options and hope for patients with intractable epilepsy. Perampanel, a new third-generation ASMs, whereas second-generation ASMs tend to exert anti-seizure effects mainly by regulating ion channels or enhancing related mechanisms such as gamma-aminobutyric acid (GABA) effects, perampanel exerts its effects mainly by targeting the excitatory neurotransmitter glutamate. Perampanel is the first selective α-amino-3-hydroxy-5-methyl-4-isoxazole-propionate (AMPA) receptor antagonist and the first selective inhibitory ASMs for excitatory postsynaptic function. Because of its unique target and mechanism, it has been approved by many countries in the world for adjuvant additive therapy and monotherapy for patients with focal and general epilepsy. In addition, with the discovery of the neuroprotective, antioxidant, neurotransmitter regulation effects of perampanel, it also provides a new potential choice for the treatment of other diseases. This article mainly reviews the mechanism of action, pharmacokinetics, clinical trials and treatment of other diseases other than epilepsy of perampanel.

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  • Clinical study of pirenpanet as add-on therapy for intractable epilepsy

    Objective To observe the efficacy and adverse reactions of pirenpanet in patients with refractory epilepsy treated with add-on therapy. MethodsForty-one patients with medically refractory epilepsy were selected from January 2021 to December 2021 in the Department of Epilepsy of Jiamusi Central Hospital, among which 25 males and 16 females. The self-control study was conducted before and after the treatment with pirenpanet. The observation period was 1 year, and the clinical efficacy, platelet, liver and kidney function and EEG discharge index were observed at 6 months and 12 months respectively. Changes in seizure frequency after treatment were divided into the following 3 groups: effective control: no seizure; effective: seizures reduced by 50% ~ 99%; Ineffective: < 50% reduction in seizures or exacerbation. Results Among the 41 patients with drug-refractory epilepsy, 8 (8/41, 19.51% P < 0.05) were seizure-free, 17 (17/41, 41.46% P < 0.05) were effective, and the total effective rate was (25/41, 60.98%); Sixteen cases (16/41, 39.02%) were ineffective. There were 31 children in 41 cases (31/41, 75.61%), of which 18 cases (18/31, 58.06%) were effective, 16 cases (16/31, 51.61%) had mental and motor retardation, and 8 cases (8/16, 50%) were effective; There were 10 adults (10/41, 24.39%) and 7 effective patients (7/10, 70%). After one year's treatment, the EEG changes of the patients were observed, and the abnormal discharge of 6 patients was reduced according to the discharge index, 2 patients had no abnormal discharge, and the other patients had no obvious EEG changes. Conclusion Pirenpanet is effective and safe as an add-on therapy for medically refractory epilepsy.

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