Trisenox (arsenic trioxide)注射液-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）。
Generic Name and Formulations:
Arsenic trioxide 1mg/mL; soln for IV inj after dilution; preservative-free.
Company:
Teva Pharmaceuticals
Select therapeutic use: Leukemias, lymphomas, and other hematologic cancers
Indications for TRISENOX:
Induction of remission and consolidation in acute promyelocytic leukemia (APL) refractory to or relapsed from retinoid and anthracycline chemotherapy, and whose APL has the t(15;17) translocation or PML/RAR-alpha gene expression.
Adult:
Give by IV infusion over 1–2 hours; may extend infusion up to 4 hours if acute vasomotor symptoms occur. Induction: 0.15mg/kg per day until bone marrow remission; max 60 doses. Consolidation treatment (begin 3–6 weeks after completion of induction therapy): 0.15mg/kg per day for 25 doses for up to 5 weeks.
Children:
See literature. <5yrs: not recommended. 5–16yrs: doses of 0.15mg/kg per day have been used.
Warnings/Precautions:
Renal or hepatic dysfunction. History of torsades de pointes. Preexisting QT interval prolongation. CHF. Monitor hematology, renal function, and electrolytes at least twice weekly, perform ECG at baseline then weekly (hospitalize if cardiac irregularities develop); unstable patients: monitor more frequently. Correct electrolyte imbalances before starting therapy (maintain K+ above 4mEq/dL and Mg++ above 1.8mg/dL). Pregnancy: (Cat.D), nursing mothers: not recommended.
Interactions:
Caution with drugs that can cause QT prolongation (discontinue these before starting therapy, if possible) or electrolyte imbalances.
Pharmacological Class:
Antineoplastic.
Adverse Reactions:
Leukocytosis, GI upset, fatigue, edema, hyperglycemia, cough, rash, headache, dizziness, paresthesia, arthralgia, renal failure, electrolyte disorders (eg,hypokalemia, hypomagnesemia), abnormal LFTs; APL differentiation syndrome (eg, fever, dyspnea, weight gain, pulmonary infiltrates, pericardial effusion; give high-dose IV steroids at 1st sign), hyperleukocytosis, QT interval prolongation/heart block, atrial dysrhythmias, tachycardia, others (see literature).
How Supplied:
Single-use amps (10mL)—10
