英文药名：LYRICA OD Tablets（Pregabalin） 中文药名：普瑞巴林口腔崩解片 生产厂家：辉瑞公司 リリカOD錠25mg／リリカOD錠75mg／リリカOD錠150mg 药物分类名称 疼痛治疗剂（神经性疼痛/纤维肌痛） 批准日期：2017年6月 商標名 LYRICA OD Tablets 25mg LYRICA OD Tablets 75mg LYRICA OD Tablets 150mg 一般名 プレガバリン（Pregabalin） 化学名 （3S）-3-（Aminomethyl）-5-methylhexanoic acid 分子式 C8H17NO2 分子量 159.23 構造式 性状 普瑞巴林是一种白色粉末。 它微溶于水，几乎不溶于乙醇（99.5）。 药效药理 1. 鎮痛作用 普瑞巴林不能防止动物实验中对急性有害刺激的逃避行为，并抑制由于周围神经损伤和糖尿病以及慢性肌肉骨骼疼痛引起的神经性疼痛。 它还显示由化学，炎症，组织损伤和痛觉过敏模型引起的自发性疼痛的镇痛作用。 (1) 慢性压迫性损伤（CCI）模型中的抗异常性疼痛注）作用 普瑞巴林通过大鼠CCI模型抑制静态和动态异常性疼痛。 (2) 脊髓神经结扎（SNL）模型中抗异常性疼痛的作用 普瑞巴林通过SNL模型抑制大鼠产生的静态和动态异常性疼痛。 (3) 链球菌素（STZ）糖尿病模型中的抗异常性疼痛 普瑞巴林抑制大鼠STZ糖尿病模型中发生的静态和动态异常性疼痛。 (4) 脊髓损伤疼痛模型中的抗异常性疼痛 普瑞巴林抑制脊髓损伤模型中由于体重下降到小鼠脊髓中的静止异常性疼痛。 (5) 慢性肌肉骨骼疼痛模型中的抗异常性疼痛 普瑞巴林抑制大鼠慢性肌肉骨骼疼痛模型中发生的静态异常性疼痛。 (6) 福尔马林试验中自发性疼痛的镇痛作用 在通过对大鼠足垫施用福尔马林引起的两相疼痛相关行为中，普瑞巴林抑制了第二阶段，这被认为涉及中枢致敏。 注意：无害触觉刺激的疼痛通常被称为接触型异常性疼痛，它被分为静态（由轻轻按压皮肤一点压力引起）和动态（由对皮肤的轻微摩擦引起）异常性疼痛。 2. 作用机序 普瑞巴林抑制细胞表面的钙通道表达，钙通过与α2δ亚基结合而流入，α2δ亚基在中枢神经系统中电压门控钙通道的作用中起辅助作用，而普瑞巴林 已经建议抑制神经递质释放。 此外，已经提出，普瑞巴林的止痛作用也参与下降疼痛调节系统对去甲肾上腺素和5-羟色胺途径的作用。 适应病症 神经性疼痛，与纤维肌痛有关的疼痛。 用法与用量 ・ 神经性疼痛 成人；每天接受150mg的普瑞巴林作为初始剂量，分成两次，然后在一周或更长时间内以每日剂量逐渐增加至300mg。此外，根据年龄和症状，剂量可以酌情增加或减少，但最大日剂量不应超过600毫克，两者每天口服两次。 ・ 与纤维肌痛有关的疼痛 成人每天接受150mg普瑞巴林作为初始剂量，每日两次，每日1次，逐日增加至300mg，然后维持在300〜450mg。此外，根据年龄和症状，适当调整，但最大日剂量不得超过450毫克，每次口服每天口服两次。 包装规格 口腔崩解片 25毫克：100,500片（PTP） 75毫克：100,500片（PTP） 150毫克：100片（PTP） 制造销售 辉瑞公司 Lyrica ® OD tablet release for pain medicine June 8, 2017 Pfizer Inc. Eisai Co., Ltd. Eisai Co., Ltd. (Headquarters: Bunkyo-ku, Tokyo, Representative Executive Officer: Haruo Naito, hereinafter "Eisai") is pleased to announce that Pfizer Inc. (Head Office: Shibuya-ku, Tokyo, President: Ichiro Umeda, On June 8, we added "Lyrica® OD tablets 25 mg, 75 mg and 150 mg" (OD tablets: orally disintegrating tablets) as a supplemental formulation of "Lyrica ® capsule" (generic name: pregabalin) We will release it. Lyrica capsules are co-promoted by Pfizer and Eisai in Japan, and we provide proper use information related to this drug. For Lyrica OD tablets as well, we will jointly promote. Patients with Lyrica's indications, neuropathic pain, and pain associated with fibromyalgia are often older, some of whom have decreased swallowing function. Lyrica OD tablet is a dosage form that makes it easy for such patients to take it, and it is expected that it will lead to improved convenience at the time of taking by quickly disintegrating in the oral cavity. Pfizer and Eisai will continue to contribute to the improvement of QOL of patients suffering from pain associated with neuropathic pain and fibromyalgia through Lyrica. Outline of Lyrica OD tablet for pain medication Product name Lyrica ® OD Tablet (Lyrica® OD Tablet) 25 mg · 75 mg · 150 mg Generic name Pregabalin Manufacturing marketing approval acquisition date February 17, 2017 Drug price listing date May 31, 2017 Release date June 8, 2017 Manufacture and sale Pfizer Inc. Sales alliance Eisai Co., Ltd. Indications and effects Neuropathic pain, Pain associated with fibromyalgia Dosage · Dose Neuropathic pain Normally, adults receive 150 mg of pregabalin as an initial dose twice daily, and then gradually increase to 300 mg as a daily dose over a week or more. Incidentally, depending on age and symptoms, it should be increased or decreased accordingly, but the maximum daily dose shall not exceed 600 mg, and each should be administered orally twice a day. Pain associated with fibromyalgia Usually, adults receive 150 mg of pregabalin as an initial dose twice a day, gradually increased to 300 mg as a daily dose over 1 week and then maintained at 300 to 450 mg. Incidentally, depending on the age and symptoms, the dose may be increased or decreased as appropriate, but the maximum daily dose should not exceed 450 mg. Both are administered orally twice a day. Packaging Lyrica OD tablets 25 mg: 100 tablets (PTP), 500 tablets (PTP) Lyrica OD tablet 75 mg: 100 tablets (PTP), 500 tablets (PTP) Lyrica OD tablet 150 mg: 100 tablets (PTP 完整说明书附件：http://www.info.pmda.go.jp/go/pack/1190017F1029_1_02/