环磷酰胺与顺铂联合治疗肿瘤患者剂量优化试验研究

目的 探讨环磷酰胺与顺铂联合化疗最佳给药剂量.方法 对120例卵巢癌和恶性淋巴瘤患者按完全随机分组法分为6组,分别按照环磷酰胺（CTX）500 mg/m2＋顺铂（DDP） 40 mg/m2、CTX 500 mg/m2＋ DDP 50 mg/ m2、CTX 500 mg/m2＋ DDP 60 mg/m2、CTX 600 mg/m2＋ DDP 40 mg/m2、CTX 600 mg/ m2＋ DDP 50 mg/m2、CTX 600 mg/m2＋ DDP 60 mg/m2静脉给药,每周1次,连用2周,比较各组疗效、不良反应.结果 各组间疗效差异无统计学意义（P＞0.05）.高剂量化疗组（CTX 500 mg/m2＋DDP 60 mg/m2、CTX 600 mg/m2＋ DDP 60 mg/m2）白细胞抑制率较高,分别为72.6％、79.3％,淋巴细胞损伤最大,血肌酐、血尿素氮、丙氨酸氨基转移酶、天冬氨酸氨基转移酶水平显著下降,而最低剂量化疗组（CTX 500 mg/m2＋DDP 40 mg/ m2）血象在正常范围,肾功能、肝功能损伤发生率低.结论 CTX与DDP联合化疗最佳给药剂量分别为500、40 mg/m2.

Dose optimization of cyclophosphamide combined with cisplatin in treatment of tumor

Objective To investigate the optimum doses of combined chemotherapy with cyclophosphamide （CTX） and cisplatin （DDP）.Methods 120 cases of ovarian cancer and malignant lymphoma were divided randomly into 6 groups.Drugs were administered to each group：CTX 500 mg/m2 ＋ DDP 40 mg/m2,CTX 500 mg/m2 ＋ DDP 50 mg/m2,CTX 500 mg/m2 ＋ DDP 60 mg/m2,CTX 600 mg/m2 ＋ DDP 40 mg/m2,CTX 600 mg/m2 ＋ DDP 50 mg/m2,CTX 600 mg/m2 ＋ DDP 60 mg/m2.Drugs were administered intravenously once a week for 2 consecutive weeks.Changes in the efficacy and adverse reaction were compared among the groups.Results There was no significant efficacy difference among the groups （P 〉 0.05）.Leukocyte inhibition rate （72.6 % and 79.3 %,respectively） and damage to lymphocyte were maximal in the high-dose chemotherapy groups （CTX 500 mg/m2 ＋ DDP 60 mg/m2,CTX 600 mg/m2 ＋ DDP 60 mg/m2）,and the levels of creatinine,blood urea nitrogen,alanine aminotransferase （ALT） in serum and aspartate aminotransferase （AST） were reduced significantly,whereas the hemogram was within normal range in the lowdose chemotherapy group （CTX500 mg/m2 ＋ DDP 40 mg/m2）,and the frequencies of damage to renal function and hepatic function were low.Conclusion The optimum dose of combined chemotherapy with cyclophosphamide and cisplatin was CTX 500 mg/m2 and DDP 40 mg/m2.