英文药名：DELTYBA（Delamanid Tablets） 中文药名：迪拉马尼片（德拉马尼） 生产厂家：大塚制药 药品介绍 Deltyba是40年以来第一个在日本获得上市许可的抗结核药, 也是唯一获批的用于治疗耐多药结核病的药物。 继今年4月份欧洲药品监管部门批准上市后，又获得日本药品监管部门的批准。 日本的结核病患病人数在逐年下降；然而，据估算仍有2万例结核病现患病人，使得日本在发达国家中成为结核病患病非常高的国家之一。在过去10年间，耐多药结核病患者的治愈率毫无改善，这也使得日本消除结核病的进程复杂化。现有抗结核药物对耐多药结核病患者的有效性降低，导致患者的住院时间延长，治愈率仅为40-70%。因此，强烈渴求抗结核新药的问世，以提高耐多药结核病患者治愈率，并缩短患者住院时间。 在临床实验中，将Deltyba与世界卫生组织推荐的背景治疗方案联合使用，证实了Deltyba的有效性，并改善了患者的长期治疗转归。 全球45万例耐多药结核病患者中，仅20%的患者接受了治疗，而接受治疗患者的治疗成功率不足一半。由于治疗成功率低，每年约17万例耐多药结核病患者死亡。 日本东京（7月4日）–大塚制药株式会社（大塚）今天接到日本卫生、劳动与福利部的正式批准，可以将Deltyba（德拉马尼）作为成人耐多药肺结核病患者适当联合治疗方案的一部分来使用。 Deltyba是一种新型杀菌剂，是通过干扰结核分枝杆菌细胞壁中的分枝菌酸生物合成而发挥作用。在体外实验中，它表现出对各类结核分枝杆菌，包括对异烟肼和利福平等一线抗结核药已耐药的结核分枝杆菌的高度杀灭活性。 Deltyba已被日本卫生、劳动与福利部认定为孤儿药，这意味着该药是一种用于治疗罕见疾病的药物。 完整治疗资料附件：http://www.info.pmda.go.jp/go/pack/6222006F1029_1_04/ デルティバ錠50mg Brand name : DELTYBA Tablets 50mg（デルティバ錠） 　Active ingredient: Delamanid 　Dosage form: brownish-yellow tablet, diameter: 11.7 mm, thickness: 5.3 mm 　Print on wrapping: Front: デルティバ錠50mg, Otsuka; Back: デルティバ錠50mg, DELTYBA tab 50mg, 吸湿注意, Otsuka Effects of this medicine This medicine exerts its antibacterial activity against Mycobacterium tuberculosis by inhibiting the synthesis of mycolic acids in M. tuberculosis. It is usually used to treat pulmonary multidrug-resistant tuberculosis. Before using this medicine, be sure to tell your doctor and pharmacist •If you have previously experienced any allergic reactions (itch, rash, etc.) to any medicines. •If you are pregnant, possibly pregnant or breastfeeding. •If you are taking any other medicinal products. (Some medicines may interact to enhance or diminish medicinal effects. Beware of over-the-counter medicines and dietary supplements as well as other prescription medicines.) Dosing schedule (How to take this medicine) •Your dosing schedule prescribed by your doctor is <<to be written by a healthcare professional>> •In general, for adults, take 2 tablets (100 mg of active ingredient) at a time, twice daily after breakfast and dinner. Strictly follow the instructions. •If you miss a dose, take the missed dose as soon as you remember it. However, if it is close to the time for the next dose, skip the missed dose and follow your regular dosing schedule. You should never take two doses at one time. •If you accidentally take more than your prescribed dose, consult with your doctor or pharmacist. •Do not stop taking this medicine unless your doctor instructs you to do so. Precautions while taking this medicine •As periodic electrocardiographic monitoring and serum albumin concentration measurements are necessary while on this medicine, follow the instructions of your doctor. Possible adverse reactions to this medicine The most commonly reported adverse reactions include insomnia, headache, and somnolence. If any of these symptoms occur, consult with your doctor or pharmacist. The symptoms described below are rarely seen as initial symptoms of the adverse reactions indicated in brackets. If any of these symptoms occur, stop taking this medicine and see your doctor immediately. •palpitations, chest discomfort, chest pain [QT prolongation] The above symptoms do not describe all the adverse reactions to this medicine. Consult with your doctor or pharmacist if you notice any symptoms of concern other than those listed above. Storage conditions and other information •As this medicine is hygroscopic, tablets should be kept in the package sheet and not be removed until immediately before use. •Keep out of the reach of children. Store away from direct sunlight, heat and moisture. •If there is a remainder, this is to be discarded. Do not store it. Ask your pharmacist or medical institution about how to discard it. Otsuka Pharmaceutical Co., Ltd.Internal Published: 9/2014 The information on this sheet is based on approvals granted by the Japanese regulatory authority. Approval details may vary by country. Medicines have adverse reactions (risks) as well as efficacies (benefits). It is important to minimize adverse reactions and maximize efficacy. To obtain a better therapeutic response, patients should understand their medication and cooperate with the treatment. Deriva: New TB treatment for about 40 years On July 4, 2014, the manufacture and sale of tuberculosis chemotherapeutic drug Delamanide (product name DELTIBA tablet 50 mg) was approved. Adaptation is "multidrug-resistant pulmonary tuberculosis", once 100 mg twice daily, after morning and supper. Currently, in standard treatment of tuberculosis, Rifampicin (RFP: trade name Rifagin et al.), Isoniazid (INH: trade name Iscochin, Isoniazid, Hydra et al.), Ethambutol (EB: Esambutol, Ebutol et al.), Pirazinamide (PZA: Pyramid) in combination therapy for 2 months followed by 4 months of maintenance therapy with a combined use of RFP and INH. The cure rate in this treatment program is about 90% for drug-sensitive tuberculosis patients. On the other hand, for patients with multidrug-resistant pulmonary tuberculosis who are resistant to the first-line drugs RFP and INH, according to the WHO guidelines, two drugs for EB and PZA, one for injection and one for tuberculosis for injection such as kanamycin and levofloxacin And a fluoroquinolone antimicrobial agent such as Cravit et al.), Etc., are strongly recommended. However, even if these treatment programs are carried out, it is reported that the cure rate is 50 to 70% and the mortality rate is about 25%. In the case of In Japan, 110 to 120multidrug-resistant patients with pulmonary tuberculosis per year occur. In addition to INH and RFP, the proportion of "supermulti-drug resistant pulmonary tuberculosis" that is resistant to anti-tuberculosis drugs for injection and fluoroquinolone antibiotics is higher than those in other countries, and in 2006, patients with multidrug-resistant pulmonary tuberculosis Of survey results indicate that about 29% of patients were superdrug resistant. Delramanide suppresses the biosynthesis of mycolic acid specific to mycobacteria including Mycobacterium tuberculosis and exerts anti-tuberculosis action. In nonclinical studies and early clinical phase II studies, the minimum inhibitory concentration is lower than INH and RFP, and it has been confirmed to have strong antituberculous activity. In the international joint study for patients with multidrug - resistant pulmonary TB patients including Japanese, delamanide was added to the standard therapy for 2 months, and the sputum idiotization rate was significantly higher than that in the placebo group. In addition, the proportion of effective treatment outcome patients in the final treatment outcome after 2 years was reported to be 74.5% in the group treated with Delamanide more than 2 months in the standard treatment, and 55.0% in the group in which the addition was 2 months or less Has been done. In addition, DELAMANIDE does not show cross-resistance with existing anti-tuberculosis drugs, has anti-tuberculosis activity against tubercle bacilli under aerobic and anaerobic environments, and also has a bactericidal action against intracellular M. tuberculosis Have been approved. Overseas it was approved in Europe in April 2014 and was released in the UK in May. In Japan, on February 8, 2008, we received designation of drugs for rare diseases. Please note that 52.7% of adverse reactions (including clinical laboratory abnormalities) are accepted in the international joint test until approval. Main side effects are insomnia (12.2%), headache (10.4%), QT prolongation (7.1%), somnolence (6.3%) and so on, and the occurrence of QT prolongation as a serious side effect has been reported. In addition, in order to prevent the appearance of resistant bacteria and to promote proper use, at the registered medical institution/pharmacy with the doctor/pharmacist registered in the RAP (Responsible Access Program) conducted by the pharmaceutical company, only for patients registered by the doctor Can be used. -------------------------------------------------------- 产地国家：日本 原产地英文商品名: Deltyba tab（デルティバ錠）50mg/Tablet 60Tablets/bottle  原产地英文药品名: delamanid 中文参考商品译名: Deltyba片（デルティバ錠）50毫克／片 60片/盒 中文参考药品译名: 迪拉马尼 生产厂家中文参考译名:  大塚制药 生产厂家英文名: Otsuka -------------------------------------------------------- 产地国家：德国 原产地英文商品名: Deltyba tab  50mg/Tablet  40Tablets/bottle  原产地英文药品名: delamanid 中文参考商品译名: Deltyba片  50毫克/片 40片/盒 中文参考药品译名: 迪拉马尼 生产厂家中文参考译名:  大塚制药 生产厂家英文名: Otsuka