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目的:评价国产多西他赛治疗蕙环类药治疗后复发乳癌的疗效及安全性。方法:采用多中心随机阳性药物对照方法,213例复发乳癌患者随机分为试验组105例和对照组108例。试验组d1给予注射用多西他赛60～70 mg·m～(-2),加5%葡萄糖溶液250mL静脉滴注;d3～d5给予顺铂25～30 mg·m～(-2),加生理氯化钠溶液500 mL静脉滴注。21～28d为1个周期,共2～3个周期。对照组:以已上市的国产注射用多西他赛作为阳性对照药取代试验用药进入上述方案。治疗2个周期后评价疗效及不良反应。结果:入组213例患者,200例完成试验,13例脱落。试验组99例,对照组101例。有效率(CR+PR)试验组42．42%(42/99),对照组37．62%(38/101),两组差异无显著性(P＞0．05)。主要Ⅲ～Ⅳ度不良反应为白细胞降低(试验组和对照组分别为20．95%和12．15%,P＞0．05)、恶心呕吐(分别为12．38%和7．48%,P＞0．05)、中性粒细胞降低(分别为11．43%和5．61%,P＞0．05)、腹泻(分别为7．62%和1．87%,P＞0．05)、脱发(分别为1．90%和0%,P＞0．05)、口腔溃疡(分别为1．90%和0%, P＞0．05)和血小板下降(分别为0．95%和0%,P＞0．05)。结论:多西他赛联合顺铂治疗复发乳腺癌疗效确切、且与已上市的国产多西他赛联合顺铂方案疗效相近,不良反应可耐受,有临床应用价值。
OBJECTIVE: To evaluate the efficacy and safety of domestic docetaxel in the treatment of recurrent breast cancer after the treatment of prostacyclin. Methods: A multicenter randomized controlled trial was conducted. 213 patients with recurrent breast cancer were randomly divided into experimental group (n = 105) and control group (n = 108). D1 test group administered with docetaxel for injection 60 ~ 70 mg · m ~ (-2), plus 5% dextrose solution intravenously 250mL; d3 ~ d5 cisplatin 25 ~ 30 mg · m ~ (-2), Plus physiological sodium chloride solution 500 mL intravenous infusion. 21 ~ 28d for a period of a total of 2 to 3 cycles. Control group: The domestic injection of docetaxel has been listed as a positive control drug to replace the experimental drug into the program. After 2 cycles of treatment evaluation of efficacy and adverse reactions. RESULTS: Of the 213 patients enrolled, 200 completed the trial and 13 lost their status. The experimental group of 99 cases, the control group of 101 cases. 42.42% (42/99) in the effective rate (CR + PR) test group and 37.62% (38/101) in the control group, there was no significant difference between the two groups (P> 0.05). Ⅲ ~ Ⅳ major adverse reaction of leukopenia (test group and control group was 20.95% and 12.15%, P> 0.05, respectively), nausea and vomiting (12.38%, and 7.48%, respectively, (P> 0.05), neutrophils decreased (11.43% and 5.61%, P> 0.05) and diarrhea (7.62% and 1.87%, P> 05), alopecia (1.90% and 0%, respectively, P> 0.05), oral ulcers (1.90% and 0%, respectively, P> 0.05) and thrombocytopenia % And 0%, P> 0.05). Conclusion: docetaxel plus cisplatin in the treatment of recurrent breast cancer is effective, and is similar to combined with cisplatin efficacy of domestic docetaxel has been listed adverse reactions tolerated, clinical value.