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目的:评价吉西他滨联合紫杉醇方案与单药长春瑞滨方案在治疗蒽环类耐药的转移性乳腺癌患者中的疗效及不良反应。方法:2009年10月至2012年12月,我科收治的符合治疗条件的晚期乳腺癌患者共126例,随机分为吉西他滨联合紫杉醇组(GT组)及单药长春瑞滨组(NVB组),观察有效率(RR)、疾病控制率(DCR)、无进展生存期(PFS)、总生存期(OS)及不良反应。采用χ~2检验比较各组治疗有效率、疾病控制率及不良反应,采用Kaplan-Meier法计算生存率,采用Log-rank检验进行生存率的比较。结果:GT组较NVB组在RR及OS方面有优势(P=0.033;P=0.013),在DCR、PFS方面差异无统计学意义(P=0.440;P=0.159),在不良反应方面有较多的中重度白细胞减少(P=0.025)、轻度恶心呕吐(P=0.035)、便秘(P=0.030)、肌肉关节疼痛(P=0.000)及疲乏无力(P=0.003)。结论:对于身体状况较好的患者,使用吉西他滨联合紫杉醇方案较单药长春瑞滨方案有助于提高患者的RR及OS,但需注意不良反应的监测及相应的处理。
Objective: To evaluate the efficacy and side effects of gemcitabine combined with paclitaxel and single-agent vinorelbine in patients with anthracycline-resistant metastatic breast cancer. Methods: From October 2009 to December 2012, 126 patients with advanced breast cancer undergoing treatment in our department were randomly divided into gemcitabine combined with paclitaxel group (GT group) and single-agent vinorelbine group (NVB group) (RR), disease control rate (DCR), progression-free survival (PFS), overall survival (OS) and adverse reactions were observed. Chi-square test was used to compare the treatment efficiency, disease control rate and adverse reactions. The survival rate was calculated by Kaplan-Meier method, and the survival rate was compared by Log-rank test. Results: Compared with NVB group, GT group had advantages in RR and OS (P = 0.033; P = 0.013), but no significant difference in DCR and PFS (P = 0.440; P = 0.159) Moderate to severe leukopenia (P = 0.025), mild nausea and vomiting (P = 0.035), constipation (P = 0.030), muscle and joint pain (P = 0.000) and fatigue and weakness (P = 0.003). CONCLUSIONS: Gemcitabine combined with paclitaxel is more effective than single-agent vinorelbine in improving RR and OS in patients with good physical status. However, attention should be paid to the monitoring of adverse reactions and the corresponding treatment.