新型片剂Uceris（Budesonide 中文药名：布地奈德缓释片）获FDA批准对活动期的轻-中度溃疡性结肠炎患者提供新的治疗方案 2013年1月14日，Santarus宣布美国食品药品管理局(FDA)已批准Uceris(布地奈德)缓释片用于诱导活动性轻至中度溃疡性结肠炎(UC)患者的缓解。 Uceris片芯含有布地奈德和聚合物，后者可使关键成分缓慢释放。布地奈德是一种合成的皮质类固醇。 为支持这项批准，在共计970例活动性轻至中度UC成人患者中进行了2项类似设计的随机、双盲、安慰剂对照研究。2项研究均对Uceris 9 mg和6 mg与安慰剂进行了比较，并包括活性对照组(研究1为2.4 g美沙拉明；研究2为未获准用于治疗UC的9 mg布地奈德)。主要终点为治疗8周后缓解诱导作用。两项研究均表明，Uceris 9 mg缓释片的诱导缓解作用均优于安慰剂。 与Uceris相关的最常见不良反应包括头痛、恶心、血液皮质醇水平下降、上腹疼痛、乏力、胃肠气胀、腹胀、痤疮、尿路感染、关节痛以及便秘。 Uceris说明书中包含了有关使用Uceris时发生肾上腺皮质功能亢进、肾上腺抑制以及免疫抑制风险的警告和注意事项内容。当患者由较大全身效应的糖皮质激素治疗转为较小全身效应的治疗时(如 Uceris)，可出现肾上腺功能损害风险。若转换用药，在开始服用Uceris之前，应缓慢降低以前服用的糖皮质激素剂量。 这次获准的成人患者给药方案为每日早晨口服1片9 mg片剂，持续8周。Santarus公司预计在2013年3月上市销售Uceris。 Uceris (Budesonide Extended-Release Tablets) Uceris Launched for Ulcerative Colitis UCERIS (budesonide) 9mg extended-release tablets by Santarus Santarus announced the launch of Uceris (budesonide) extended-release tablets for the induction of remission in patients with active, mild to moderate ulcerative colitis. Uceris contains budesonide in a novel oral tablet formulation that utilizes proprietary MMX multi-matrix system technology, which is designed to result in the controlled release and distribution of budesonide throughout the length of the colon. Budesonide is a corticosteroid known to have localized anti-inflammatory effect. Uceris is available in 9mg extended-release tablets in 30-count bottles UCERIS Rx Generic Name and Formulations: Budesonide 9mg; extended-release tablets. Company: Salix Pharmaceuticals, Inc. Indications for UCERIS: Induction of remission in patients with active, mild-to-moderate ulcerative colitis. Adult: Swallow whole. 9mg once daily in the AM for up to 8 weeks. Children: Not established. Pharmacological Class: Glucocorticosteroid. Warnings/Precautions: Active or quiescent tuberculosis, untreated fungal, bacterial, systemic viral or parasitic infections. Supplement with systemic glucocorticosteroid in surgery or other stress situations. Caution when transferring from steroids with high systemic availability (monitor). May unmask allergies previously controlled by systemic corticosteroids. If exposed to chickenpox or measles, consider immune globulin or antiviral prophylactic therapies. Hypertension. Diabetes. Osteoporosis. Peptic ulcer. Glaucoma. Cataracts. Moderate-to-severe liver disease: monitor for hypercorticism; consider discontinuing. Elderly. Pregnancy (Cat. C). Nursing mothers: not recommended. Interactions: May be potentiated by CYP3A4 inhibitors (eg, ketoconazole, itraconazole, ritonavir, indinavir, saquinavir, erythromycin); consider discontinuing. Avoid grapefruit or grapefruit juice. May be affected by gastric acid reducing agents (eg, PPIs, H2-blockers, antacids). Adverse Reactions: Headache, nausea, decreased blood cortisol, upper abdominal pain, fatigue, flatulence, abdominal distension, acne, urinary tract infection, arthralgia, constipation; hypercorticism, adrenal suppression, immunosuppression. Metabolism: Hepatic (CYP3A4). Elimination: Renal, fecal. Generic Availability: NO How Supplied: Tabs—30