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目的:观察和评价拓扑替康和羟喜树碱治疗脑转移癌的安全性。方法:2004年4月至2007年12月临床诊断为脑转移癌的86例患者纳入研究。患者的原发癌为小细胞肺癌(26例)、非小细胞肺癌(32例)及乳腺癌(28例)。86例患者随机分为2个治疗组:拓扑替康组(44例)和羟喜树碱组(42例)。拓扑替康组患者在第1～5天用拓扑替康0.8～1.0mg/(m2.d)加入0.9%氯化钠注射液或5%葡萄糖注射液100～150ml静脉滴注,30min滴完。羟喜树碱组患者在第1～5天用羟喜树碱4.0～6.0mg/(m2.d)加入0.9%氯化钠注射液或5%葡萄糖注射液100～150ml中静脉滴注,30min滴完。21d为1个周期,化疗为2个周期。在第2周期末评价疗效,比较2组治疗有效率和临床获益率以及不良反应。结果:共84例患者完成2个周期化疗和疗效评价,完成率为97.67%。拓扑替康和羟喜树碱组的临床有效率分别为37.21%和36.59%,临床获益率分别为81.40%和73.17%。组间比较无统计学差异(Р>0.05)。血液毒性反应主要为白细胞和血小板减少。拓扑替康组Ⅲ～Ⅳ度的白细胞减少和血小板减少,分别为29.55%和13.64%,羟喜树碱组分别为7.14%和2.38%。组间比较有统计学差异(Р<0.05)。未见明显的非血液毒性反应。结论:低剂量拓扑替康和羟基喜树碱在脑转移癌治疗中具有较为良好的疗效、安全性和耐受性。
Objective: To observe and evaluate the safety of topotecan and hydroxycamptothecin in the treatment of brain metastases. METHODS: Eighty-six patients with brain metastases who were diagnosed clinically from April 2004 to December 2007 were included in the study. His primary cancer was small cell lung cancer (26 cases), non-small cell lung cancer (32 cases) and breast cancer (28 cases). Eighty-six patients were randomized into two treatment groups: topotecan (n = 44) and hydroxycamptothecin (n = 42). Patients in the topotecan group were treated with Topotecan 0.8-1.0 mg / (m2.d) by intravenous drip of 0.9% sodium chloride injection or 100-150 ml of 5% dextrose injection on days 1 to 5 and dripped over 30 minutes. The patients in the group of hydroxycamptothecin were intravenously administered with hydroxy camptothecin (4.0-6.0 mg / (m2.d)) in 0.9% sodium chloride injection or 100-150 ml of 5% dextrose injection on days 1-5, End drops. 21d for a cycle, chemotherapy for 2 cycles. At the end of the second cycle, the curative effect was evaluated. The treatment efficiency and clinical benefit rate and the adverse reactions in the two groups were compared. Results: A total of 84 patients completed two cycles of chemotherapy and efficacy evaluation, the completion rate was 97.67%. The clinical efficacies of topotecan and hydroxycamptothecine group were 37.21% and 36.59% respectively, and the clinical benefit rates were 81.40% and 73.17% respectively. There was no significant difference between the two groups (Р> 0.05). Hematologic toxic reactions are mainly white blood cells and thrombocytopenia. Topotecan group Ⅲ ~ Ⅳ degree of leukopenia and thrombocytopenia were 29.55% and 13.64%, respectively, and the hydroxy camptothecin group was 7.14% and 2.38%, respectively. There was significant difference between groups (P <0.05). No obvious non-hematological toxicity was observed. CONCLUSIONS: Low-dose topotecan and hydroxycamptothecin have good efficacy, safety and tolerability in the treatment of brain metastases.