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目的:比较紫杉醇脂质体与紫杉醇治疗非小细胞肺癌和乳腺癌的临床疗效和安全性。方法:本研究为多中心、开放、随机、对照研究。试验组和对照组分别静脉注射紫杉醇脂质体或紫杉醇135 mg·m~(-2),d 1给予,每3 wk重复一次,共2个疗程。非小细胞肺癌2组均联合顺铂75 mg·m~(-2),d 1给予,乳腺癌2组均联合表柔比星60 mg·m~(-2),d 1给予。结果:入组126例病人中,120例病人完成疗程,可评价疗效,非小细胞肺癌试验组有效率27％,对照组有效率17％。乳腺癌试验组有效率43％,对照组有效率37％,2组间疗效比较均无显著差异(P>0．05)。2组不良反应发生率无显著差异(P>0．05)。对照组3例(5％)系因Ⅲ度过敏反应而退出,试验组无过敏反应。结论:紫杉醇脂质体是治疗非小细胞肺癌和乳腺癌安全、有效的药物。
Objective: To compare the clinical efficacy and safety of paclitaxel liposomes and paclitaxel in the treatment of non-small cell lung cancer and breast cancer. Methods: This study was a multicenter, open, randomized, controlled study. The experimental group and the control group were given intravenous injection of paclitaxel liposome or paclitaxel 135 mg · m -2, d 1, repeated every 3 wk, a total of 2 courses. Non-small cell lung cancer (NSCLC) was treated with cisplatin 75 mg · m -2, d 1, and breast cancer were treated with epirubicin 60 mg · m -2 and d 1 respectively. Results: Among the 126 patients enrolled, 120 patients completed the course of treatment, which could evaluate the curative effect. The effective rate was 27% in the non-small cell lung cancer test group and 17% in the control group. The effective rate of breast cancer was 43% in the experimental group and 37% in the control group, with no significant difference between the two groups (P> 0.05). There was no significant difference in the incidence of adverse reactions between the two groups (P> 0.05). The control group of 3 patients (5%) due to Ⅲ degree allergic reaction and exit, the experimental group no allergic reaction. Conclusions: Paclitaxel liposomes are safe and effective in the treatment of non-small cell lung cancer and breast cancer.