紫杉醇脂质体与紫杉醇联合顺铂治疗晚期非小细胞肺癌的临床研究

Clinical study of comparing paclitaxel liposome and paclitaxel combined with cisplatin in the treatment of advanced nonsmall cell lung cancer

目的对比紫杉醇脂质体(LEP)与紫杉醇(PTX)联合顺铂(DDP)治疗晚期非小细胞肺癌(NSCLC)的临床疗效及安全性。方法晚期NSCLC患者48例,随机分为对照组和试验组,对照组采用紫杉醇175mg/m2,试验组采用紫杉醇脂质体175 mg/m2,均联合顺铂75 mg/m2化疗,21天为1个周期,治疗2个周期后评价疗效,记录近期疗效与治疗期间不良反应。结果近期疗效:对照组有效率37.50%,疾病控制率为79.17%,试验组有效率为41.67%,疾病控制率为83.33%,两组差异均无统计学意义(P>0.05)。不良反应:白细胞减少、贫血及血小板减少的发生率两组差异无统计学意义(P>0.05),脱发和恶心、呕吐的发生率两组差异亦无统计学意义(P>0.05),但试验组皮疹、呼吸困难、肌肉痛及周围神经炎的发生率明显低于对照组,差异有统计学意义(P<0.05)。结论紫杉醇脂质体治疗晚期NSCLC与紫杉醇疗效相当,但周围神经炎及过敏反应较紫杉醇为轻。

Objective To compare the efficacy and safety of paclitaxel liposome combined with cisplatin and paclitaxel combined with cisplatin in the treatment of advanced non-small cell lung cancer（ NSCLC）. Methods 48 patients with advanced NSCLC were randomized into two groups,experimental group were given paclitaxel liposome at 175 mg / m2,and control group were given paclitaxel at 175 mg / m2. Both groups combined with DDP at 75 mg / m2 per cycle every 21 days. The efficacy and safety were evaluated after two cycles. Results The overall response rate was 37. 50% in experimental group and 41. 67%in control group,and the disease control rate was 79. 17% in experimental group and 83. 33% in control group. There was no significant difference between two groups（ P〉0. 05）. Though there was no significant difference in incidence of neutropenia,anemia,thrombocytopenia and alopecia,nausea and vomiting,but the occurred rates of rash、muscle pain and peripheral neuritis were significantly lower in experimental group than those in control group. Conclusion In the treatment of advanced NSCLC,both paclitaxel liposome combined with cisplatin and paclitaxel combined with cisplatin have similar efficacy,but paclitaxel liposome can significantly reduce the incidence of peripheral neuritis and serious hypersensitive reactions.