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受试者为18例(男10例,女8例)21岁以下(平均11.4岁)的儿科实体瘤患者,除1例患有稳定性慢性肾功能衰竭而接受腹膜透析外,其他肝、肾功能均在正常范围。受试者连续口服鬼臼乙叉甙(etoposide)注射液(以生理盐水3倍稀释),每8h1次,剂量为25、50、60或75mg/m~2/d,共21d,休息7d后继续治疗。 在第1疗程的第1d和21d服药后不同时间取血,高效液相色谱法测定血浆中鬼臼乙叉甙浓度,进行药代动力学研究;试验前及以后每周进行血液常规、生化、电解质等多项检查,第1疗程结束时(第28d)按美国国立癌症中心(NCI)的常见毒性标准评估受试
Subjects were 18 cases (male 10, female 8) pediatric solid tumors below 21 years of age (average 11.4 years), except one patient with stable chronic renal failure receiving peritoneal dialysis, other liver and kidney The functions are in the normal range. The subjects were given oral etoposide (three-fold dilution with normal saline) once every 8 hours at a dose of 25, 50, 60, or 75 mg/m~2/d for 21 days, after a rest of 7 days. Continue treatment. Blood was taken at different times on the 1st and 21st days of the first course of treatment. The concentration of podophyllotoxin in plasma was determined by high performance liquid chromatography and pharmacokinetic studies were conducted; routine and biochemical tests were performed weekly before and after the experiment. Electrolyte and other tests, evaluated at the end of the first course (day 28d) according to the Common Toxicity Criteria of the National Cancer Center (NCI)