摘要
目的:观察TAC方案(多西他赛+表柔比星+环磷酰胺)和AC-T方案(表柔比星+环磷酰胺,序贯多西他赛)在治疗乳腺癌过程中与多西他赛相关的不良反应,以评估2种方案的临床安全性。方法:将2004年7月至2008年6月期间确诊的乳腺癌患者110例纳入研究,并分为2个组:TAC治疗方案组和AC-T治疗方案组。TAC治疗方案组72例,年龄范围28～55岁,平均(45±7.2)岁;AC-T治疗方案组38例,年龄范围35～66岁,平均(48±6.4)岁。TAC治疗方案组患者给予静脉推注表柔比星60 mg/m2,环磷酰胺500 mg/m2及静脉滴注多西他赛75 mg/m2,均第1天给药,21 d为1个周期,共6个周期。AC-T治疗方案组患者给予静脉推注表柔比星75 mg/m2,环磷酰胺500 mg/m2,均第1天给药,21 d为1个周期,共4个周期;之后,静脉滴注多西他赛75 mg/m2,第1天给药,21 d为1个周期,共4个周期。观察2种方案治疗过程中多西他赛相关不良反应。结果:TAC与AC-T治疗方案组出现中性粒细胞减少者分别为72例(100%)[其中64例(88.9%)为III/IV度中性粒细胞减少]和32例(84.2%)[其中16例(42.1%)为III/IV度中性粒细胞减少];粒细胞缺乏性发热分别为62例(86.1%)和6例(15.8%);2种治疗方案比较,III/IV度中性粒细胞减少及粒细胞缺乏性发热差异均有统计学意义(均P<0.01);过敏反应分别为10例(13.9%)和5例(13.2%);水钠潴留分别为3例(4.17%)和1例(2.63%);外周神经毒性分别为33例(45.8%)和12例(31.6%);皮肤指甲改变分别为28例(38.9%)和13例(34.2%);2组比较,过敏反应、水钠潴留、外周神经毒性及皮肤指甲改变的发生率差异均无统计学意义(均P>0.05)。结论:AC-T治疗方案是一种较为安全的化疗方案。
Objective： To observe docetaxel-related adverse reactions to TAC regimen （docetaxel plus epirubicin and cyclophosphamide） and AC-T regimen （epirubicin plus cyclophosphamide followed by docetaxel） in treatment of breast cancer in order to evaluate their clinical safety. Methods： From July 2004 to June 2008, 110 patients with comfirmed breast cancer were enrolled in the study and divided into two groups： the TAC regimen group and the AC-T regimen group. The TAC regimen group comprised 72 patients; patient age ranged from 28 to 55 years [ average age （45 ± 7.2） years ]. The AC-T regimen group comprised 38 patients; patient age ranged from 35 to 66 years [average age （48 ±6.4） years]. The patients in the TAC regimen group received an Ⅳ push of epirubicin 60 mg/m^2, an Ⅳ push of cyclophosphamide 500 mg/m^2, and an Ⅳ infusion of docetaxel 75 mg/m^2 on day 1 of every 21-day eycle for 6 cycles. The patients in the AC-T regimen group received an IV push of epirubicin 75 mg/m^2 and an IV push of cyclophospharnide 500 mg/m^2 on day 1 of every 21-day cycle for 4 cycles, followed by an IV infusion of docetaxel 75mg/m^2 on day 1 of every 21-day cycle for 4 cycles. Doeetaxel-related adverse reactions were observed during treatment with the two regimens. Results： Neutropenia in the TAC regimen and AC-T regimen groups was 72 cases （ 100% ） [64 cases （88.9%） of grade 3/4 neutropenia] and 32 eases （84.2%） [ 16 eases （42.1%） of grade 3/4 neutropenia], respectively; granulocytic fever was 62 cases （86.1%） and 6 cases （ 15.8% ）, respectively. The differences in grade 3/4 neutropenia and granulocytic fever between the TAC regimen and AC-T regimen groups were statistically significant （ all P 〈 0.01 ）. Anaphylaxis was 10 cases （ 13. 9% ） and 5 cases （ 13. 2% ）, respectively; water-sodium retention was 3 cases （4. 17% ） and one case （2.63%）, respectively; peripheral neurotoxicity was 33 cases （45.8%） and 12 cases （31.6%） , respectively; changes in skin and nail were 28 cases （38.9%） and 13 cases （34.2%）, respectively. There were no significant differences in incidence of anaphylaxis, water-sodium retention, peripheral neurotoxicity, and changes in skin and nail between the TAC regimen and AC-T regimen groups （all P 〉 0.05 ）. Conclusion： AC-T regimen is a relatively safe chemotherapy regimen.
出处
《药物不良反应杂志》
2009年第3期165-169,共5页
Adverse Drug Reactions Journal
基金
"上海市卫生局课题"资助项目(2008152)
关键词
多西他赛
乳腺癌
不良反应
安全性
docetaxel
breast cancer
adverse reactions
safety
