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目的 比较注射用紫杉醇脂质体与传统紫杉醇注射液 (紫烷素 )治疗乳腺癌和非小细胞肺癌疗效及不良反应的差别。方法 采用多中心、随机对照的方法进行研究 ,分为试验组和对照组。试验组给紫杉醇脂质体每次剂量 135mg/m2 ;对照组给紫烷素每次剂量 135mg/m2 。两组均联合阿霉素或顺铂治疗 ,每 3周重复 1次 ,为 1周期 ,共 2周期。结果 入组 12 9例患者中 ,有 12 8例可供评价不良反应 ,12 6例可供评价疗效。试验组 6 3例 ,完全缓解率 1.6 % ,部分缓解率 33.3% ,总有效率34.9% ;对照组 6 3例 ,完全缓解率 6 .3% ,部分缓解率 2 2 .2 % ,总有效率 2 8.6 %。两组疗效差异无显著性。在血液学毒性方面 ,两组发生率差异无显著性。在聚氧乙基代蓖麻油与无水乙醇的混合溶媒所产生的相关毒性方面 ,试验组发生率明显低于对照组 ,差异有显著性。结论 紫杉醇脂质体联合阿霉素或顺铂治疗晚期乳腺癌和晚期非小细胞肺癌效果良好 ,与紫烷素疗效相当 ,但过敏反应发生率明显低于紫烷素。
Objective To compare the efficacy and adverse reactions between paclitaxel injection and traditional paclitaxel injection for the treatment of breast cancer and non-small cell lung cancer. Methods A multicenter, randomized controlled study was conducted and divided into experimental and control groups. The experimental group to paclitaxel liposomes each dose of 135mg / m2; control group to the dosage of veratrine 135mg / m2. Two groups were combined with doxorubicin or cisplatin treatment, repeated once every 3 weeks for 1 cycle, a total of 2 cycles. Results Among the 129 patients enrolled, 12 8 patients were evaluated for adverse reactions and 126 patients were evaluated for efficacy. The experimental group 6 3 cases, the complete remission rate was 1.6%, the partial response rate was 33.3%, the total effective rate was 34.9%; control group 6 3 patients, the complete remission rate was 6.3%, the partial response rate was 22.2%, the total effective rate 2 8.6%. No significant difference between the two groups. In hematologic toxicity, there was no significant difference between the two groups. In the relative toxicity of polyoxyethyl castor oil and ethanol mixed solvent, the incidence of the experimental group was significantly lower than the control group, the difference was significant. Conclusion paclitaxel liposomes combined with doxorubicin or cisplatin in the treatment of advanced breast cancer and advanced non-small cell lung cancer with good effect, and the efficacy of the same effect of the alkalin, but the incidence of allergic reactions was significantly lower than that of the purple.