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目的观察病理确诊的晚期非小细胞肺癌(NSCLC)患者在一线化疗控制后行紫杉醇脂质体单药维持治疗的疗效。方法晚期NSCLC患者60例,一线化疗方案治疗后疾病稳定,随机均分为两组。治疗组给予紫杉醇脂质体每天135mg/m~2,21d为1个周期,行4或6个周期治疗,治疗完成后评价疗效、生活质量及不良反应;对照组不用维持治疗。结果治疗组客观缓解率(ORR)和疾病控制率(DCR)均高于对照组(36%vs.13%和83%vs.53%)(P<0.05)。治疗组中位疾病无进展生存期(PFS)高于对照组(4.5个月vs.2.9个月)(P<0.05)。治疗组患者中,既往未接受过紫杉类化疗的ORR、DCR及中位PFS均高于接受过紫杉类化疗者,但差异无统计学意义(P>0.05)。治疗组主要不良反应为骨髓抑制、神经毒性和肌肉毒性等,均可耐受。结论紫杉醇脂质体作为NSCLC患者的维持治疗临床疗效明显,不良反应可耐受。
Objective To observe the curative effect of paclitaxel liposomes maintenance therapy in patients with advanced non-small cell lung cancer (NSCLC) diagnosed by pathology after controlled by first-line chemotherapy. Methods Sixty patients with advanced NSCLC were treated with first-line chemotherapy and the disease was stable and randomly divided into two groups. The treatment group was given paclitaxel liposomes daily 135mg / m ~ 2, 21d for a period of 4 or 6 cycles of treatment, after treatment to evaluate the efficacy, quality of life and adverse reactions; the control group without maintenance treatment. Results The objective response rate (ORR) and disease control rate (DCR) in the treatment group were significantly higher than those in the control group (36% vs.13% and 83% vs.53%, respectively) (P <0.05). Median progression-free survival (PFS) was higher in the treatment group than in the control group (4.5 months versus 2.9 months) (P <0.05). In the treatment group, the ORR, DCR and median PFS were not significantly higher than those who received the taxane chemotherapy, but the difference was not statistically significant (P> 0.05). The main adverse reactions in the treatment group were myelosuppression, neurotoxicity and muscle toxicity, which could be tolerated. Conclusion paclitaxel liposomes as a maintenance treatment of patients with NSCLC clinical curative effect is obvious, side effects can be tolerated.