去甲长春花碱治疗转移性乳腺癌药物应用方法的比较研究

Comparative study of continuous vinorelbine infusion and conventional use for the treatment of metastatic breast carcinoma

目的 :比较去甲长春花碱 (NVB)持续静脉输入与常规用法治疗转移性乳腺癌的疗效和毒性。方法 :62例患者随机分成两组 ,持续输入组 ( 2 8例 )使用NVB6mg/m2 ,静脉推注 ,d1后 ,NVB 6mg/(m2 ·d)采用微管注射泵通过锁骨下深静脉置管进行 2 4h持续给药 ,持续输入12 0h ;DDP 2 5mg/m2 ,静脉滴入 ,d1～d3 。常规用法组 ( 3 4例 ) ,使用NVB 2 5mg/m2 ,静脉推注 ,d1、d8;DDP用法同持续输入组 ,2～ 3个周期后进行疗效评价。结果 :可评价疗效的 5 9例 ,持续输入组 ( 2 7例 )CR为 1例 ,PR为 14例 ,有效率为5 5 6% ( 15 /2 7) ;常规用法组 ( 3 2例 )无CR ,PR为 14例 ,有效率为 43 7%( 14 /3 2 ) ,两者相比差异无统计学意义 ,P >0 0 5。而毒性反应中 ,持续输入组Ⅲ～Ⅳ度的白细胞下降和中性粒细胞减少分别为 48 1%和 40 7% ,而常规用法组为 65 6%和 68 8% ,并且在中性细胞减少上 ,两者相比差异有统计学意义 ,P <0 0 5。结论 :持续静脉输入NVB治疗转移性乳腺癌可提高疗效。

OBJECTIVE:To compare the efficacy and toxicity of continuous vinorelbine infusion and conventional use for the treatment of metastatic breast carcinoma.METHODS:Sixty-two patients were enrolled into the study.These patients were randomized to receive either NVB continuous infusion (arm A) or NVB conventional use (arm B).Patients in arm A received the therapy with NVB 6 mg/m 2 iv d 1,NVB 6 mg/(m 2·d) iv infusion for 24 hours d 1-d 5 and DDP 30 mg/m 2,iv,d 1- d 3.Vinorelbine was given through a catheter in the venae subclavia by continuous infusion for 24 hours.Patients in arm B received the therapy with NVB 25 mg/m 2 iv d 1,d 8 and DDP 25 mg/m 2 iv for d 1-d 3.Chemotherapy was repeated every 3 weeks.Patients were evaluated for response every two or three cycles of treatment.RESULTS:In arm A,27 patients were assessable for response and toxicity.Major objective responses were observed in 15 patients(55.6%),including one complete response.In arm B,major objective responses were observed in 14 of 32 patients(43.7%),in which there was no complete response.There were no significant differences in response rate between the two arms P>0.05.In arm A,Ⅲ-Ⅳ grade leucopenia and granulocytopenia was 48.1% and 40.7%,in arm B 65.6% and 68.8%.There were significant differences in granulocytopenia between the two arms,P<0.05.CONCLUSIONS:Vinorelbine continuous infusion increases efficacy and decreases toxicity for the treatment of metastatic breast carcinoma.