拓扑替康、羟喜树碱治疗脑转移癌的临床安全性观察

Observation on clinical safety of topotecan and hydroxycamptothecine in treating patients with brain metastatic carcinoma

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 hydroxycamptothecine in treating patients with brain metastatic carcinoma. Methods： Eighty-six patients clinically diagnosed as having brain metastatic carcinoma entered the study from April 2004 to December 2007. The primary carcinoma of the patients was small cell lung carcinoma （26 cases） , non-small cell lung carcinoma （32 cases）, and mammary cancer （28 cases）. The 86 patients were randomly divided into two treatment groups： the topotecan group （44 cases） and the hydroxycamptothecine group （42 cases）. The patients in the topotecan group were treated with topotecan 0.8 - 1.0 mg/（ m2·d） in 100 ～ 150 ml of sodium chloride 0.9% or glucose 5% , by intravenous infusion within 30 min on day 1 ～ 5. The patients in the hydroxycamptothecine group were treated with hydroxycamptothecine 4.0 - 6.0 mg/（ m^2·d） in 100 - 150 ml of sodium chloride 0.9% or glucose 5% , by intravenous infusion within 30 min on day 1 -5. The chemotherapy was 2 cycles, and one cycle was 21 days. The curative effects were evaluated in the end of the second cycle. The response rate, clinical benefit rate, and adverse reactions were evaluated and compared between the two groups. Results： Two cycles of chemotherapy and evaluation of efficacy were accomplished in 84 cases of the two groups. The percentage of accomplishment was 97.6%. The response rate and clinical benefit rate of topotecan versus hydroxycamptothecine were 37.21 vs 36.59% and 81.40% vs 73.17% , respectively. There were no statistical differences （ P 〉 0. 05 ）. The manifestation of blood toxicity was leukocytopenia and thrombocytopenia. The leukocytopenia and thrombocytopenia in Ⅲ～Ⅳ degrees were 29.55% and 13.64% in the topotecan group, respectively, and 7.14% and 2.38% in the hydroxycamptothecine group, respectively. There were marked differences between the two groups （ P 〈 0. 05 ）. Condusion： Low-dose topotecan and hydroxycamptothecine have a relatively good therapeutic effect, safety, and tolerance in the treatment of brain metastatic carcinoma.