部份中文泼尼松处方资料（仅供参考）
英文名：Prednisone MR Tablets
商品名：Lodotra
中文名：泼尼松控释片
生产商：Napp Pharmaceuticals Limited
药品介绍
SkyePharma公司合作伙伴Nitec公司的泼尼松择时释药片（prednisone，Lodotra）获得欧盟的上市批准，用于治疗类风湿关节炎及其引起的早晨僵硬。Lodotra是择时细胞素调节剂，清晨安全释放单一小剂量泼尼松。
本品采用SkyePharma公司的Geoclock专利技术制成的特殊片剂，口服后不立即释放泼尼松，而是约在4小时后。Lodotra设计为口服后6小时血药浓度达峰，这可使患者晚上10时口服片剂后睡觉，直到第二日清晨2时释药，4时血药浓度达峰。此时是解除关节僵硬和醒来疼痛的最佳时间。这种晚上服药清晨释药制剂特别适用于治疗类风湿关节炎引起的关节僵硬。
给药说明：因其需经肝脏转化后方具有生物活性，故用于肝功能不全者效差，余同泼尼松龙。
药理机理
1.肾上腺皮质激素类药，具有抗炎、抗过敏、抗风湿、免疫抑制作用，作用机理为：
2.抗炎作用：本产品可减轻和防止组织对炎症的反应，从而减轻炎症的表现。激素抑制炎症细胞，包括巨噬细胞和白细胞在炎症部位的集聚，并抑制吞噬作用、溶酶体酶的释放以及炎症化学中介物的合成和释放。
3.免疫抑制作用：包括防止或抑制细胞介导的免疫反应，延迟性的过敏反应，减少T淋巴细胞、单核细胞、嗜酸性细胞的数目，降低免疫球蛋白与细胞表面受体的结合能力，并抑制白介素的合成与释放，从而降低T淋巴细胞向淋巴母细胞转化，并减轻原发免疫反应的扩展。可降低免疫复合物通过基底膜，并能减少补体成分及免疫球蛋白的浓度。
用法与用量
1.口服一般1次5～l0mg，每日10～60mg。
2.对于系统性红斑狼疮、胃病综合征、溃疡性结肠炎、自身免疫性溶血性贫血等自身免疫性疾病，一般每日40～60mg，病情稳定后逐渐减量。
3.对药物性皮炎、荨麻疹、支气管哮喘等过敏性疾病，一般每日20～40mg，症状减轻后减量，每隔1～2日减少5mg。
4.防止器官移植排异反应，一般在术前1～2天开始，每日口服100mg，术后1周改为60mg，以后逐渐减量。
5.治疗急性白血病、恶性肿瘤，每日口服60～80mg，症状缓解后减量。
不良反应
本品较大剂量易引起糖尿病、消化道溃疡和类库欣综合征症状，对下丘脑-垂体-肾上腺轴抑制作用较强。并发感染为主要的不良反应。
制剂与规格
片：5mg。
Nitec's prednisone (Lodotra), a partner of SkyePharma, was approved by the European Union for the treatment of rheumatoid arthritis and its morning stiffness. Lodotra is a timing cytokine modulator that safely releases a single small dose of prednisone in the morning.
This product uses a special tablet made by SkyePharma's patented Geoclock technology. It does not release prednisone immediately after oral administration, but it takes about 4 hours. Lodotra was designed to peak blood levels 6 hours after oral administration, which allowed the patient to sleep after taking the tablets at 10 pm until the second day at 2 am, and the blood concentration peaked at 4 o'clock. This is the best time to relieve joint stiffness and wake up. This morning medication release formulation is especially suitable for the treatment of joint stiffness caused by rheumatoid arthritis.
Phase III trials of 288 patients at 26 European treatment centers have demonstrated that Lodotra's pre-sleep dosing significantly reduces symptoms compared with the current recommended morning-release prednisone at 8 o'clock. A 12-week study to observe the duration of morning stiffness as the primary endpoint showed that the Lodotra group was significantly superior to the standard immediate release prednisone group. Half of the patients had a one-third reduction in morning stiffness (greater than one hour) and a one-third reduction in pain. Lodotra is well tolerated and as safe as standard treatment.
The controlled release formulation improves the treatment of rheumatoid arthritis compared to conventional glucocorticoid formulations. Some of the researchers said, "These results support the need to increase the dose of prednisone, the time to choose oral glucocorticoids based on the circadian rhythm of rheumatoid arthritis, can effectively treat the hypothesis of rheumatoid arthritis."
Nitec is also preparing to market Lodotra in the United States, and is conducting a second critical phase III clinical study to submit a new drug application to the US FDA. The company is also studying the use of prednisone tablets to treat severe asthma and rheumatic polymyalgia.
https://www.medicines.org.uk/emc/medicine/23778