英文药名: Coartem(Artemether/Lumefantrine Tablets) 中文药名: 复方蒿甲醚-苯芴醇片 生产厂家: Novartis 药品简介 复方蒿甲醚Coartem (蒿甲醚, Artemether和本芴醇, lumefantrine)片 批准日期：美国FDA：2009年4月7日； 公司：Novartis 一般描述： Coartem (蒿甲醚和本芴醇)是首个世界范围批准青蒿素治疗疟疾的复方。含两种抗疟药固定组分：青蒿素和本芴醇均为杀血裂殖体剂。复方蒿甲醚片其中本芴醇是中国军事医学科学院微生物流行病研究所发明，复方为我国首先联合研制，先与瑞士山德士公司联合开发，后山德士与汽巴-嘉基合并成诺华(Novartis)。 适应症： 适用于治疗体重5公斤以上患者疟原虫Plasmodium falciparum所致急性，无合并症感染。已证实Coartem®片对氯喹耐药地理区域有疗效。本品不用于治疗严重疟疾或预防疟疾。 用法用量： 与食物服用，服前压碎与1～2茶匙水混合。3天期间6次，初始剂量，8小时后，后2天早晨和傍晚各1次。 禁忌：青蒿素和本芴醇或其赋形剂过敏患者。 不良反应： 成人最常见不良反应(30%)是头痛、食欲不振、眩晕、虚弱、关节和肌肉痛。儿童(12%)为发热、咳嗽、呕吐、食欲减退和头痛。   包装规格 · 20mg/120mg *24 片 ·80mg/480mg *25 片 Coartem (Artemether/Lumefantrine) Coartem (artemether/lumefantrine) is an efficient combination of lumefantrine and artemether, indicated in the treatment of malaria. Malaria is an infectious disease caused by parasites. It is normally spread in the tropical and subtropical regions. Over 7,500 sufferers die every day. The disease is often caused by the Plasmodium parasites, which are transmitted by the anopheles mosquito females. The parasites affect the red cells in the blood, causing symptoms like anemia, fever, coma and even death. Unfortunately, there aren’t any vaccines against this unpleasant disease. Luckily, there are a few treatments. Once diagnosed, Coartem (artemether/lumefantrine) destroys the multiplication properties of the parasites. In time, the medicine destroys their organisms. However, the medicine can be used for mild and moderate forms of malaria. It cannot treat the severe cases, which require more powerful and aggressive drugs. Besides, it shouldn’t be used for prevention, as it doesn’t have such protective effects. Administration Coartem (artemether/lumefantrine) is administered with a prescription, orally and by tablets. The treatment is general and isn’t influenced by the severity of the disease. The patient must get 6 doses within 3 days, which means two doses a day. They should be taken in the morning and in the evening, at the same times everyday, before breakfast and dinner. A dose usually implies two tablets. The tablets may be chewed or crushed, up to the patient’s preferences and possibilities. Those who cannot swallow them whole will obviously choose to crush them. Don’t use water to ease the process, but milk instead. It is a good method to fight parasites. You must start eating as soon as you are done with the administration. The chemicals in food will help the organism assimilate the medicine faster. There is, however, the risk to not be able to eat. At the same time, some patients may vomit as soon as they get the tablets. If this happens within the first two hours, a new dose should be administered. If the patient throws out again, the doctor should be called and asked for an advice. The Coartem (artemether/lumefantrine) tablets may be entirely crushed and mixed with food for the young babies. The dose may be adjusted in the patients with various severe problems. For instance, the malnutrition kids shouldn’t get more than 6 tablets during the entire treatment. Such cases are popular, since malaria usually strikes in Africa. Contraindications Coartem (artemether/lumefantrine) is contraindicated in the patients who are allergic to its components. Those with special diseases or dysfunctions require caution. 美国药品管理局( FDA)批准复方蒿甲醚+苯芴醇 （artemether+lumefantrine，Coartem）用于治疗成人及儿童急性非重症疟疾感染。疟疾感染表现为发热、寒战及与感冒类似的症状。如果不进行治疗，可导致严重的并发症，甚至死亡。约90%的死亡病例发生在撒哈拉以南的非洲地区，该病症也流行于亚洲和拉丁美洲的部分地区。 据估计，每年有3.5~5亿的新感染人群，约100万患者死亡，其中大多数为儿童。本品在临床研究中最常见的成人不良反应为头痛、食欲不振、头晕、虚弱、关节痛及肌肉疼痛。儿童常见的不良反应包括发烧（发热）、咳嗽、呕吐、食欲不振和头痛。作为Coartem的有效成分之一的蒿甲醚是在美国批准上市的第一个青蒿素类药物，从青蒿植物中分离获取。 FDA批准抗疟疾药Coartem片上市 美国食品和药物管理局(FDA)已批准Coartem片(成分为蒿甲醚和苯芴醇)用于治疗急性无并发症疟疾感染的成年人和体重超过5公斤的儿童患者。 “疟疾是一个全球性、危及生命的疾病。” FDA国际和特别项目处副主任Murray M.Lumpkin博士说，“令人鼓舞的是有了新的治疗方法，尤其是对儿童有了有效治疗药物。” 但FDA没有批准Coartem片用于治疗重症疟疾，而且该药也不能用于预防目的。重症疟疾不同于急性、无并发症疟疾，重症疟疾的患者会出现意识混乱和其他代谢及终末器官的并发症。这些患者都没有高效的口服药物可以选择，只能给予静脉注射进行治疗。 疟疾已成为世界上许多地区一种严重的公共健康问题。居住在或旅行于这些高发病率地区的美国人面临感染疟疾的风险。受感染蚊子可通过叮咬在人群中传播疟疾。Coartem在对疟疾防治药物氯喹已产生耐药的地理区域已显示出其有效性。 “由于担忧对现有治疗药物产生耐药，此时选择其他的疟疾防治药物将有利于患者的治疗。” 美国FDA药物评价和研究中心抗菌药物办公室主任、公共卫生硕士和医学博士Edward Cox说。 疟疾的临床表现包括发烧、寒战和流感样症状。如果不加以治疗，该疾病可引起严重的并发症，包括死亡。约90%的疟疾死亡病例发生在撒哈拉以南非洲，但在亚洲部分地区和拉丁美洲也很普遍。据估计，每年在全世界范围内新发病例约3.5亿至5亿，有100万例死于该病，其中主要是儿童。 此药应与食物特别是含有脂肪的食品同时服用，以利于机体更好地吸收药物。 Coartem的临床试验中，成年人最常见的不良反应有头痛、食欲不振、头晕、身体虚弱、关节痛和肌肉疼痛。儿童最常见的不良反应有发烧、咳嗽、呕吐、食欲不振和头痛。 Coartem片活性成分之一的蒿甲醚是在美获批的首个青蒿素类药物。青蒿素可用于治疗疟疾，提取自植物黄花蒿的叶子。 根据FDA在2007年的修正法案的规定，将作为有未来应用前景的新药采取一次性优先审查证书授予诺华，这种方式也是为了鼓励治疗热带疾病药物的开发，该授权证书可由接受人转让给其他的制造商。 Coartem是由位于瑞士巴塞尔的诺华制药公司研制生产。