紫杉醇脂质体与紫杉醇治疗非小细胞肺癌64例疗效对比

Comparative efficacy of liposomal paclitaxel and paclitaxel in treatment of non-small-cell lung cancer in 64 cases

目的 比较紫杉醇脂质体与普通紫杉醇治疗非小细胞肺癌的临床疗效和安全性.方法 本试验为多中心,开放式,随机,对照研究.分试验组和对照组两组.试验组和对照组分别静脉注射紫杉醇脂质体（力朴素）和普通紫杉醇注射液150 mg/m2,第1、8天,联合顺铂75 mg/m^2,第1～3天,每3周重复1次,共6个周期.结果 64例病人可评价疗效和不良反应.非小细胞肺癌试验组有效率为28.13%,对照组有效率为21.88%,两组疗效比较差异无统计学意义（P＞0.05）.在血液学毒性方面主要不良反应为白细胞、血红蛋白、血小板均减少,以白细胞的减少最明显,但差异均无统计学意义（P＞0.05） 在非血液学毒性方面主要为恶心、呕吐、脱发、肌肉关节痛、呼吸困难和皮疹,除脱发外两组比较差异有统计学意义（P＜0.05）.结论 紫杉醇脂质体是一种安全、有效的药物.紫杉醇脂质体联合顺铂治疗非小细胞肺癌效果良好,与传统紫杉醇疗效相当,但过敏反应发生率及非血液学不良反应均低于传统紫杉醇.

Objective To analyze the efficacy and safety of liposomal paclitaxel in comparison with paclitaxel for patients with non-small-cell lung cancer. Methods Sixty-four patients with non-small-cell lung cancer were randomized to be treated with liposomal paclitaxel or paclitaxel 150 mg/m2 on days 1 and 8 plus cisplatin 75 mg/m2 on days 1 to 3 of a 3-week cycle, all patients received six cycles of this regimen. Results Among 64 patients evaluable for response, the response in the primary tumor and the toxicity were observed, response rates of patients with non-small-cell lung cancer was 28.13% for liposomal paclitaxel plus cisplatin group and 21.88% for paclitaxel plus cisplatin group. There was no statistical significant difference in efficacy between the two groups（ P 〉0.05 ）. The major hematologic toxicity was neutropenia but no statistical significant difference（ P 〉0.05 ）. The major nonhematologic toxicity were nausea, vomiting, losing hair, muscle pain, joint pain, dyspnea and skin rash. The nausea, vomiting, muscle pain, joint pain, dyspnea and skin rash were statistical significant difference between the two groups in safety （ P 〈 0.05 ）. Conclusions Liposomal paclitaxel is effective and safe for the treatment of non-small-cell lung cancer. The chemotherapy regimen of liposomal paclitaxel and cisplatin is effective for the treatment of non-small-cell lung cancer, with considerable effect of traditional paclitaxel, but the incidence of allergic and non-hematologic toxic reaction are lower than conventional paclitaxel.