【摘要】 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。更多还原

【Abstract】 Objective:To evaluate the efficacy and safety of docetaxel newly made in China in a- dults with relapsed breast cancer and previously treated with anthrocyelines.Methods :213 patients with relapsed breast cancer and a historical treatment with anthrocyclines were enrolled into a multicenter, randomized and comparator control clinical trial.Patients were randomly administered with docetaxel newly made(60～70mg·m^-2+5% GS 250mL（d1） + cisplatin 25～30mg·m^-2+NS500mL （d3～5）,n=105)every 21～28 days for 2 or 3 cycles（treatment group）or the same drug regimen （n= 108） except the docetaxel produced by a different manufacturer （control group）.The efficacy and safety were evaluated after the 2 cycles of therapy.Results:99 out of 105 and 101 out of 108 patients in two groups completed the clinical trial.The response rate （CR+PR） of the treatment versus control group was 42.42% versus 37.62% （P＞0.05）.The main adverse events （gradeⅢ/Ⅳ） in treatment and con- trol group were leueopenia （20.95% vs.12.15%,P＞0.05）,nausea and vomiting （12.38% vs. 7.48%,P＞0.05）,neutropenia （11.43% vs.5.61%,P＞0.05）,diarrhea （7.62% vs.1.87%, P＞0.05）,alopecie （1.90% vs.0%,P＞0.05）,mucosal ulceration （1.90% vs.0%,P＞0.05） and thrombocytopenia （0.95% vs.0%,P＞0.05）.Conclusion:The new docetaxel is therapeutically equivalent to the existing one in the treatment of relapsed breast cancer.更多还原