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[目的]观察乳腺癌患者曲妥珠单抗治疗过程中的临床耐受性及心脏安全性。[方法]对Her-2基因过表达82例女性乳腺癌患者在曲妥珠单抗使用过程中进行心电图监测。记录出现的心脏相关症状。采用超声心动图法,分别于曲妥珠单抗使用前1个月及使用后每3个月监测1次左室射血分数(LVEF)。[结果]曲妥珠单抗使用过程中心脏相关症状主要为胸闷、心悸及呼吸困难。心电图异常主要表现为ST-T段改变、窦性心动过速、传导阻滞、窦性心动过缓。以上不良事件的程度绝大多数为Ⅰ～Ⅱ度。监测3、6、9、12、15个月时的LVEF均值分别为69.93%±5.72%、70.64%±5.12%、71.03%±5.31%、70.29%±5.10%、69.08%±5.84%,与基线时比较均有下降,但均未出现低于50%的病例。在监测15个月过程中,LVEF平均下降幅度介于4.35%～2.10%之间。监测3、6、9、12、15个月时LVEF下降幅度≥16%患者的比例分别为4.00%、2.99%、2.17%、2.78%和4.35%。蒽环类药物经治的患者在曲妥珠单抗使用第3、6、9、12、15个月监测到LVEF下降≥10%的比例分别为15.40%、11.90%、14.30%、22.7%和20.00%。并没有发现明显高于未使用过蒽环类的患者。[结论]乳腺癌患者在曲妥珠单抗治疗期间都伴随着LVEF水平的降低,但是随着治疗时间的延长并没有发现LVEF的进行性下降,患者的总体耐受性良好,说明治疗期间的定期监测十分重要。
[Objective] To observe the clinical tolerance and cardiac safety of trastuzumab in patients with breast cancer. [Method] 82 cases of breast cancer patients overexpressing Her-2 gene were monitored during trastuzumab use. Record the occurrence of heart-related symptoms. Echocardiography was used to monitor left ventricular ejection fraction (LVEF) 1 month prior to trastuzumab use and 3 months after use. [Results] The main cardiac-related symptoms during trastuzumab were chest tightness, palpitations and dyspnea. ECG abnormalities mainly for the ST-T segment changes, sinus tachycardia, conduction block, sinus bradycardia. The vast majority of the above adverse events for Ⅰ ~ Ⅱ degrees. The mean LVEF at 3, 6, 9, 12 and 15 months were 69.93% ± 5.72%, 70.64% ± 5.12%, 71.03% ± 5.31%, 70.29% ± 5.10% and 69.08% ± 5.84% When compared to the decline, but did not appear less than 50% of the cases. During the 15 months of monitoring, the average decrease of LVEF ranged from 4.35% to 2.10%. Monitoring 3,6,9,12,15 months when the LVEF decline ≥ 16% of patients were 4.00%, 2.99%, 2.17%, 2.78% and 4.35% respectively. Anthracycline-treated patients were found to have 15.40%, 11.90%, 14.30%, 22.7%, and 14.7% reduction in LVEF ≥10% at trastuzumab 3, 6, 9, 20.00%. No patients were found to be significantly higher than those who had not used anthracyclines. [Conclusion] Patients with breast cancer have a decreased level of LVEF during trastuzumab treatment. However, with the prolongation of treatment time, no progressive decline of LVEF was found, and the overall tolerability of patients was good, indicating that during the treatment Regular monitoring is very important.