Trisenox(arsenic trioxide 中文译名：三氧化二砷注射液)获批用于白血病治疗药物
美国食品药物监督管理局批准了一种新的治疗急性白血病（APL）的药物，该药从研制到被批准的速度之快是很少见的。Trisenox 在美国，从研究到被批准用了3年时间。该药对于使用其他药物无效的白血病患者很有帮助。
在40名应用Trisenox治疗的患者中，28名患者（70％）获治愈。治愈的平均时间为51天。
急性白血病（APL）是一种白血细胞恶性肿瘤。患者骨髓和血液中的白血细胞迅速增加。这个结果导致，贫血，易感染，出血。据估计，每年有1500名新的急性白血病病例发生。有400名患者对于一线疗法不敏感或发生复发。
Trisenox中的活性物质是三氧化二砷。它可以将癌变的白血细胞转变成正常白血细胞。砷制剂疗法早已用于治疗白血病，但已被现代的化疗方法和抗生素治疗所代替。最近，中国科学家发现砷制剂疗法中的关键物质是三氧化二砷。
Trisenox的不良反应中包括一种称为急性白血病（APL）特异综合症，在该综合症中白血细胞数量极高，导致炎症和血液凝集。另一种严重的副作用是心律异常（QT间期延长）。
附：完整治疗资料
https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=DEC51FAB-3784-DEB7-752F-2D4D5692A20F

TRISENOX® (arsenic trioxide) injection
Important Safety Information
WARNING: APL DIFFERENTIATION SYNDROME, CARDIAC CONDUCTION ABNORMALITIES, AND ELECTROLYTE MONITORING
APL Differentiation Syndrome: Patients with APL treated with TRISENOX have experienced symptoms similar to a syndrome called the retinoic-acid-Acute Promyelocytic Leukemia (RA-APL) or APL differentiation syndrome, characterized by fever, dyspnea, weight gain, pulmonary infiltrates and pleural or pericardial effusions, with or without leukocytosis. This syndrome can be fatal. High-dose steroids have been administered at the first suspicion of the APL differentiation syndrome and appear to mitigate signs and symptoms. At the first signs that could suggest the syndrome (unexplained fever, dyspnea and/or weight gain, abnormal chest auscultatory findings or radiographic abnormalities), immediately initiate high-dose steroids (dexamethasone 10 mg intravenously BID), irrespective of the leukocyte count, and continue for at least 3 days or longer until signs and symptoms have abated. The majority of patients do not require termination of TRISENOX therapy during treatment of the APL differentiation syndrome.
Cardiac Conduction Abnormalities: Before initiating therapy, perform a 12-lead ECG, assess serum electrolytes and creatinine, correct preexisting electrolyte abnormalities, and consider discontinuing drugs known to prolong QT interval. Arsenic trioxide can cause QT interval prolongation and complete atrioventricular block. QT prolongation can lead to a torsade de pointes-type ventricular arrhythmia, which can be fatal. The risk of torsade de pointes is related to the extent of QT prolongation, concomitant administration of QT prolonging drugs, a history of torsade de pointes, preexisting QT interval prolongation, congestive heart failure, administration of potassium-wasting diuretics, or other conditions that result in hypokalemia or hypomagnesemia. One patient (also receiving amphotericin B) had torsade de pointes during induction therapy for relapsed APL with arsenic trioxide.
Contraindications: TRISENOX is contraindicated in patients who are hypersensitive to arsenic.
APL Differentiation Syndrome: Nine of 40 patients with APL treated with TRISENOX, at a dose of 0.15 mg/kg, experienced the APL differentiation syndrome.
Cardiac Conduction Abnormalities: Torsade de Pointes, Complete Heart Block, and QT Prolongation: Sixteen of 40 patients (40%) had at least one ECG tracing with a QTc interval greater than 500 msec. Prolongation of the QTc was observed between 1 and 5 weeks after TRISENOX infusion, and then returned towards baseline by the end of 8 weeks after TRISENOX infusion. Monitor ECG weekly and more frequently for clinically unstable patients. For QTc greater than 500 msec, complete corrective measures and reassess the QTc with serial ECGs prior to initiating TRISENOX. During TRISENOX therapy, maintain potassium concentrations above 4 mEq/L and magnesium concentrations above 1.8 mg/dL. Reassess patients who reach an absolute QT interval value > 500 msec and immediately correct concomitant risk factors, if any, while the risk/benefit of continuing versus suspending TRISENOX therapy should be considered. The risk may be increased when TRISENOX is coadministered with medications that can lead to electrolyte abnormalities (such as diuretics or amphotericin B).
Carcinogenesis: The active ingredient of TRISENOX, arsenic trioxide, is a human carcinogen. Monitor patients for the development of second primary malignancies.
Embryo-Fetal Toxicity: TRISENOX can cause fetal harm when administered to a pregnant woman. One patient who became pregnant while receiving arsenic trioxide had a miscarriage. Advise pregnant women of the potential risk to a fetus. Advise females and males of reproductive potential to use effective contraception during and after treatment with TRISENOX.
Lactation: TRISENOX is excreted in human milk. Because of the potential for serious adverse reactions in nursing infants, discontinue breastfeeding during treatment with TRISENOX.
Laboratory Tests: Electrolyte and glucose levels, as well as hepatic, renal, hematologic, and coagulation profiles should be monitored at least twice weekly, and more frequently for clinically unstable patients during the induction phase and at least weekly during the consolidation phase.
Drug Interactions: Avoid the concomitant use of TRISENOX with medications that can prolong the QT/QTc interval or those that can lead to electrolyte abnormalities. Concomitant use of drugs that can prolong the QT/QTc interval with TRISENOX may increase the risk of serious QT/QTc interval prolongation. Electrolyte abnormalities increase the risk of serious QT/QTc interval prolongation. Monitor ECGs and electrolytes more frequently in patients who are unable to avoid concomitant use of these medications and TRISENOX.
Pediatric Use: In a pediatric study, the toxicity profile observed in 13 pediatric patients with APL between the ages of 4 and 20 receiving TRISENOX was similar to that observed in adult patients. Additional drug-related toxicities reported included: gastrointestinal disorders, metabolic and nutrition disorders, respiratory disorders, cardiac failure congestive, neuralgia, and enuresis. One case each of pulmonary edema and caecitis were considered serious reactions. No children less than 4 years of age were enrolled in the trial due to the rarity of APL in this age group.
Patients with Renal Impairment: Exposure of arsenic trioxide may be higher in patients with severe renal impairment. Patients with severe renal impairment (creatinine clearance less than 30 mL/min) should be monitored for toxicity when these patients are treated with TRISENOX, and a dose reduction may be warranted. The use of TRISENOX in patients on dialysis has not been studied.
Patients with Hepatic Impairment: Since limited data are available across all hepatic impairment groups, caution is advised in the use of TRISENOX in patients with hepatic impairment. Monitor patients with severe hepatic impairment (Child-Pugh Class C) who are treated with TRISENOX for toxicity.
Most Common Adverse Reactions: Most patients experienced some drug related toxicity, most commonly leukocytosis, gastrointestinal (nausea, vomiting, diarrhea, and abdominal pain), fatigue, edema, hyperglycemia, dyspnea, cough, rash or itching, headaches, and dizziness. These adverse effects have not been observed to be permanent or irreversible nor do they usually require interruption of therapy.
欧盟扩展批准梯瓦Trisenox用于急性早幼粒细胞白血病
近日，欧洲药品监管机构扩展批准梯瓦制药旗下Trisenox的应用范围，允许其用于治疗新确诊的急性早幼粒细胞白血病，这是一种罕见而侵袭性的白血病，如果不进行治疗，该疾病可在数小时或数天内使患者死亡。
Trisenox（三氧化二砷）最初于2002年在欧洲获批用于复发或难治性急性早幼粒细胞白血病，适用于以类维生素及抗癌药物治疗没有响应的患者，或以这种疗法治疗后疾病又复发的患者。
这一最新决定可以让患者获取到该首个无需化疗的治疗方案，该药物与维甲酸联合应用作为一线药物使用时，其显示有99%的总生存率（APL0406 研究），经过平均4年多的随访后，该疗法几乎没有复发病例出现。
急性早幼粒细胞白血病由一种遗传异位引起，该遗传异位影响白细胞生长的方式，这种白细胞就缺乏了利用维甲酸的能力。Trisenox如何治疗急性早幼粒细胞白血病目前尚不能完全理解，但人们认为它阻止了DNA的产生，据欧洲药品管理局称，DNA产生对于白血病细胞生长是必要的。

--------------------------------------------
注：以下产品不同国家和生产厂家上市，采购以咨询为准
--------------------------------------------
产地国家：美国
原产地英文商品名:
TRISENOX 1MG/ML 10ML AMP 10/PAC
原产地英文药品名:
ARSENIC TRIOXIDE
中文参考商品译名:
萃克森注射液 1毫克/毫升 10毫升/安瓿 10安瓿/盒
中文参考药品译名:
三氧化二砷
生产厂家中文参考译名:
CEPHALON INC
生产厂家英文名:
CEPHALON INC
--------------------------------------------
产地国家：美国
原产地英文商品名:
TRISENOX AMP 1MG/ML 10ML 10=
原产地英文药品名:
ARSENIC TRIOXIDE
中文参考商品译名:
萃克森注射液 1毫克/毫升 10毫升/安瓿 10安瓿/盒
中文参考药品译名:
三氧化二砷
生产厂家中文参考译名:
CEPHALON INC
生产厂家英文名:
CEPHALON INC
--------------------------------------------
产地国家：日本
原产地英文商品名:
Trisenox Injection（トリセノックス注）10mg/VIAL 5Support/BOX
原产地英文药品名:
Arsenic Trioxide
中文参考商品译名:
萃克森注射液（トリセノックス注）10毫克/支 5支/盒 
中文参考药品译名:
三氧化二砷
生产厂家中文参考译名:
日本新薬
生产厂家英文名:
Japanese drug
--------------------------------------------
产地国家：瑞士
原产地英文商品名:
Trisenox Injection 1mg/10mL/ampule 10ampule/box
原产地英文药品名:
ARSENIC TRIOXIDE
中文参考商品译名:
萃克森注射液 10毫克/10毫升/安瓿 10安瓿/盒
中文参考药品译名:
三氧化二砷
生产厂家中文参考译名:
Teva Pharma AG
生产厂家英文名:
Teva Pharma AG
--------------------------------------------
产地国家：意大利
原产地英文商品名:
TRISENOX-10mg/10mL/Ampule
原产地英文药品名:
ARSENIC TRIOXIDE
中文参考商品译名:
萃克森注射液 10毫克/10毫升/安瓿 10安瓿/盒
中文参考药品译名:
三氧化二砷
生产厂家中文参考译名:
Cephalon s.r.l.
生产厂家英文名:
Cephalon s.r.l.