ilead制药公司的产品Cayston（氨曲南吸入溶液）已通过FDA的批准，用于治疗由绿脓杆菌感染导致囊肿性纤维化（CF）的患者，以缓解其呼吸症状。 Cayston每次使用剂量75毫克，每天用药3次，疗程28天，通过Altera Nebulizer系统给药——属便携式给药装置，采用了Pari 制药公司研发的eFlow技术。 为了使Cayston符合Altera Nebulizer给药系统的使用特点，Pari也参与了药物的配方研发工作。该药将于下周末开始进入美国市场销售。 Gilead研发部相关负责人诺博特表示，参与Cayston开发工作的研究人员及参加临床实验的CF患者功不可没，该药会很快进入流通领域，造福这类患者。 Cayston已获准在欧盟、加拿大和澳大利亚销售，它在瑞士和土耳其的销售申请也在审批过程中 Manufacturer: Gilead Sciences, Inc. Pharmacological Class: Antibiotic (monobactam). Active Ingredient(s): Aztreonam 75mg/vial; pwd for inhalation via nebulization after reconstitution; preservative-free. Indication(s): To improve respiratory symptoms in cystic fibrosis (CF) patients with Pseudomonas aeruginosa. Pharmacology: Aztreonam is a monobactam antibiotic that is bactericidal against gram (–) aerobes including Pseudomonas aeruginosa. Cross-resistance with other antibiotics such as aminoglycosides, quinolones, and beta-lactams has not been seen in studies with this product. The monobactam antibiotics are structurally different from the beta-lactams, and, although cross-sensitivity is possible, aztreonam may be used with caution in patients with a penicillin allergy. Clinical Trials: A randomized, double-blind, placebo-controlled, multicenter trial was conducted in patients 7 years of age (mean age 30 years) and older and with FEV1 of 25% to 75% predicted. This trial, which was designed to evaluate improvement in respiratory symptoms following a 28-day course of treatment, enrolled 164 patients with CF and P. aeruginosa. All patients were required to use a bronchodilator first, and they were treated on an outpatient basis. Patients were randomized to either Cayston or placebo by inhalation three times daily for 28 days. Also, patients were required to have been off antibiotics for at least 28 days before treatment with study drug. The primary efficacy endpoint was the improvement in respiratory symptoms (by self-assessment) on the last day of treatment with either Cayston or placebo. Respiratory symptoms were also checked two weeks after the treatment period finished. Patients randomized to the study drug had statistically significant improvements in respiratory function. Pulmonary function, as assessed by FEV1, increased from baseline in patients using the study drug compared to the FEV1 in those given placebo. The treatment difference at day-28 between Cayston-treated and placebo-treated patients for percent change in FEV1 was statistically significant at 10% (95% CI: 6%, 14%). Two weeks after the completion of therapy, the difference in improvement in pulmonary function between Cayston and placebo groups had decreased to 6% (95% CI: 2%, 9%). The safety and efficacy of this product have not been established in patients colonized with Burkholderia cepacia, in patients under the age of 7 years, or in those with FEV1<25% or >75% predicted. Legal Classification: Rx Adults & Children: <7yrs: not established. Use a short-acting bronchodilator 15 minutes to 4 hours before each dose; or a long-acting bronchodilator 30 minutes to 12 hours before starting therapy. >7yrs: 75mg (1 vial) by nebulization three times daily (at least 4 hours apart) for 28 days. Use Altera Nebulizer only. Precaution(s): Monobactam or beta-lactam allergy. FEV<25% or >75% predicted: insufficient data. Pregnancy (Cat.B). Interaction(s): Do not mix with other drugs in nebulizer. Adverse Reaction(s): Cough, nasal congestion, wheezing, pharyngolaryngeal pain, pyrexia, chest discomfort, abdominal pain, vomiting, rash; chest tightness, bronchospasm, allergic reactions (discontinue if occurs). Notes: To support and assist patients with cystic fibrosis contact the Cayston Access Program at (877) 7CAYSTON. Cayston should be administered immediately after reconstitution. Do not reconstitute Cayston until ready to administer a dose. How Supplied: Vials—84 (w. diluent) Last Updated: 3/26/2010 制造商： 基列科学公司 类药物： 抗生素（monobactam）。 活性成分（补）： 氨曲南75mg/vial;密码为雾化吸入通过重组后，不含防腐剂。 适应症（补）： 为了改善呼吸道症状囊性纤维化（CF）的患者与绿脓杆菌。 药理： 氨曲南是一个monobactam抗生素，对革兰氏杀菌是（ - ），包括绿脓杆菌需氧菌。交叉耐药，如氨基糖苷类，喹诺酮类等抗生素和β-内酰胺还没有看到这种产品的研究。 抗生素在结构上的monobactam从β-内酰胺不同，而且，虽然交叉敏感是可能的，氨曲南可的患者使用青霉素过敏与谨慎。 临床试验： 随机，双盲，安慰剂对照，多中心试验是在7岁患者进行（平均年龄30岁）和老年人，并与25％至75％预计值FEV1。这次审判，其目的是评估在呼吸道症状的改善治疗后28天的课程，参加164 CF和绿脓杆菌的病人。所有患者都必须使用支气管扩张剂的第一次，他们在门诊治疗。患者被随机分配到Cayston或安慰剂吸入，每日3次为28天。此外，病人要求已经关闭了至少28天前抗生素药物治疗与研究。主要疗效终点是由上呼吸道感染症状的改善自我评估（在治疗的最后一天）的任何Cayston或安慰剂。呼吸系统症状还检查治疗后两个星期内完成。患者随机分配到药物的研究已在呼吸功能显着改善。肺的功能，如评估值FEV1，增加了患者使用药物的研究相比，在服用安慰剂的FEV1从基线。对于值FEV1变化的百分之天之间Cayston治疗和使用安慰剂治疗的患者28待遇上的差别在10％（95％CI为：6％，14％的统计显着）。两个星期后的治疗完成后，在改善肺功能之间Cayston组和安慰剂组下降到6％（95％CI为：2％，9％）的差异。 的安全性和有效性这一产品还没有建立与洋葱伯克霍尔德菌的患者实行殖民统治的病人，未满7岁，或在与FEV1 <25％或> 75％的预测。 法律分类： 接收 成人和儿童： <7yrs：不成立。使用短效支气管扩张剂，以4小时15分钟前，每个剂量;或长效支气管扩张30分钟至12小时之前开始治疗。 > 7yrs：75毫克（1瓶）由每日3次，喷雾（至少4小时除外）为28天。使用Altera雾化器只。 注意事项（补）： Monobactam或β-内酰胺过敏。 FEV1的<25％或> 75％预测：数据不足。妊娠（Cat.B）。 互动（补）： 不要与其他药物混合喷雾器。 不良反应（补）： 咳嗽，鼻塞，气喘，咽喉疼痛，发烧，胸部不适，腹部疼痛，呕吐，皮疹，胸闷，支气管痉挛，（如果发生过敏反应停止）。 注释： 为了支持和协助囊性纤维化联系Cayston访问计划的病人（877）7CAYSTON。 Cayston应立即加以管理后重建。不要重组Cayston直到准备管理的剂量。 如何提供： 小瓶- 84（瓦特稀释剂） 最后更新： 2010年3月26日