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目的:评价比较CTF和CAF方案治疗中晚期或转移性乳腺癌的疗效和不良反应。方法:根据GCP指导原则开展多中心临床协作研究。治疗组:THP40mg/m2,静脉注射d1,5-FU500mg/m2,静脉滴注d1、8,CTX500mg/m2,静脉注射d1、8;对照组:ADM40mg/m2,静脉注射d1,5-FU500mg/m2,静脉滴注d1、8,CTX500mg/m2,静脉注射d1、8,21天为1周期,接受2周期化疗后评价。结果:共收治100例,治疗组77例,对照组23例。治疗组CR8例,PR40例,有效率62.3%;对照组CR1例,PR11例,有效率52.2%。THP的有效率高于ADM,但无统计学差异(P>0.05)。两组不良反应中血液不良反应相似,而脱发、皮肤不良反应和心电图指标改变,治疗组明显低于对照组,有统计学差异,其余指标差异无显著性。结论:THP的有效率与ADM相似,但脱发、皮肤不良反应及心电图改变低于ADM,可代替ADM在临床上予以应用,尤其适用于老年患者及年轻女性。
OBJECTIVE: To evaluate the efficacy and adverse effects of CTF and CAF regimens in the treatment of advanced or metastatic breast cancer. Methods: A multi-center clinical collaborative study was conducted in accordance with the GCP guidelines. Treatment group: THP40mg / m2, intravenous d1,5-FU500mg / m2, intravenous drip d1,8, CTX500mg / m2, intravenous d1,8; control group: ADM40mg / m2, intravenous d1,5-FU500mg / m2 , Intravenous drip d1,8, CTX500mg / m2, intravenous d1,8,21 days for the 1 cycle, after 2 cycles of chemotherapy evaluation. Results: A total of 100 cases were treated, 77 cases in the treatment group and 23 cases in the control group. Treatment group CR8 cases, PR40 cases, effective rate 62.3%; control group CR1 cases, PR11 cases, the effective rate was 52.2%. The effective rate of THP was higher than that of ADM, but there was no significant difference (P> 0.05). Adverse reactions in two groups adverse reactions similar to blood, and hair loss, skin adverse reactions and ECG changes in the treatment group was significantly lower than the control group, with statistical differences, the remaining indicators no significant difference. Conclusions: THP is similar in efficacy to ADM. However, alopecia, skin adverse reactions and ECG changes are lower than those of ADM. It can be used clinically instead of ADM and is especially suitable for elderly patients and young women.