Kondrat'eva N A, Kruglova G V, Lorie Iu I, Koshel' I V, Kurmashov V I
Antibiotiki. 1980 Sep;25(9):686-9.
Phase II clinical trials of L-asparaginase of leunase manufactured by "Kyowa" (Japan) was performed in cooperation by 5 institutions of the USSR on 49 patients with various forms of hemoblastosis, including 15 patients aged 1 to 15 and 34 patients aged 16 to 75. The drug was used in a daily dose of 200 IU per 1 kg body weight administered as intravenous drips daily for 2--3 weeks. The daily dose was divided into 2 doses administered at an interval of 12 hours. The efficiency of the treatment did not depend on the patients' sex. Significant efficiency of leunase was observed in children with acute lymphoblastic leukemia (85.7 per cent). The use of the drug in treatment of adults with systemic malignant blood affections was less effective. Some effects recorded in patients with generalized forms of hematosarcoma were transient. The following side effects were noted: nausea, vomiting in 8 children and 13 adults, allergic reactions in the form of pruritus and rashes in 8 adults, impairment of liver and pancreatic functions in 2 children and 1 adult. Acute pancreatonecrosis was recorded in one child. The effect on the peripheral blood was insignificant. Leunase has probably no advantages as compared to other L-asparaginase preparations.
日本“协和”生产的左旋门冬酰胺酶（乐疾宁）的II期临床试验由苏联5家机构合作开展，受试对象为49例患有各种形式成血病的患者，其中包括15例1至15岁的儿童和34例16至75岁的成年人。该药的使用剂量为每公斤体重每日200国际单位，通过静脉滴注给药，持续2至3周。每日剂量分为2次，间隔12小时给药。治疗效果与患者性别无关。在急性淋巴细胞白血病儿童患者中观察到乐疾宁有显著疗效（85.7%）。该药用于治疗患有全身性恶性血液病的成年人效果较差。在患有全身性血肉瘤的患者中记录到的一些疗效是短暂的。观察到以下副作用：8名儿童和13名成年人出现恶心、呕吐，8名成年人出现瘙痒和皮疹形式的过敏反应，2名儿童和1名成年人出现肝功能和胰腺功能损害。1名儿童出现急性胰腺坏死。对周围血液的影响不明显。与其他左旋门冬酰胺酶制剂相比，乐疾宁可能没有优势。
