参芪扶正注射液防治Her2阳性乳腺癌靶向治疗所致心脏毒性的疗效

Effect of Shenqi Fuzheng Injection on Cardiac Toxicity Induced by Targeted Therapy for Her2-Positive Breast Cancer

【目的】探讨参芪扶正注射液防治人表皮生长因子受体-2(Her2)阳性乳腺癌靶向治疗所致心脏毒性的效果。【方法】选取延安大学附属医院收治的80例Her2阳性、雌激素及孕激素阴性的乳腺癌(ERBB2+型乳腺癌)患者,随机将患者分为观察组及对照组,各40例。对照组患者均接受注射用曲妥珠单抗联合化疗治疗。观察组在对照组基础上联合使用参芪扶正注射液。观察两组患者化疗前后Karnofsky评分(KPS评分)、心肌酶[肌钙蛋白I(cTnI)和肌酸激酶同工酶(CK-MB)]及左室射血分数(LVEF)的变化,比较治疗后两组患者心脏毒副反应程度、心电图改变情况及复发转移情况。【结果】化疗前两组间KPS评分、证候评分、生活质量评分、心肌酶及LVEF相比较差异均无显著性(均P>0.05)。化疗结束时观察组KPS评分、各项生活质量评分、LVEF高于对照组,证候评分.cTnI、CK-MB低于对照组,且差异均具有显著性(P<0.05)。观察组心脏毒副反应0级比例为80.0%(32/40),高于对照组的52.5%(21/40)(P<0.05)。化疗结束后观察组心电图改变率(7.50%)低于对照组(27.50%)(P<0.05)。随访2年,两组复发率(12.50%vs12.50%)、转移率(5.00%vs7.50%)及病死率(10.00%vs7.50%)相比较差异均无显著性(P>0.05)。【结论】参芪扶正注射液可降低Her2阳性乳腺癌靶向治疗所致的心脏毒性,提高患者生活质量。

【Objective】To investigate the effect of Shenqi Fuzheng injection on prevention and treatment of cardiac toxicity induced by human epidermal growth factor receptor-2(Her2)-positive breast cancer.【Meth-ods】A total of 80 cases of Her2-positive,estrogen and progesterone-negative breast cancer(ERBB2+breast cancer)treated in our hospital were selected,and the patients were divided into two groups according to the random number table method.There were 40 cases in the observation group and 40 cases in the control group.Patients in the control group received trastuzumab combined with chemotherapy for injection,while patients in the observation group received Shenqi Fuzheng injection on the basis of the control group treatment.The Karnofsky score(KPS),myocardial enzymes[troponin I(cTnl)and creatine kinase isoenzyme(CK-MB)],left ventricular ejection fraction(LVEF)before and after chemotherapy,and the degree of side effects,ECG changes,and recurrence and metastasis were observed.【Results】There were no significant differences in KPS,syndrome score,quality of life score,myocardial enzymes,and LVEF between the two groups before chemotherapy(all P>0.05).At the end of chemotherapy,KPS,various quality of life scores,and LVEF in the observation group were higher than those of the control group and the syndrome score,cTnI,and CK-MB were lower than those of the control group;the differences were statistically significant(P<0.05).The proportion of grade 0 cardiac toxicity in the observation group(32 cases,80.0%)was higher than that in the control group(21 cases,52.5%,P<0.05).After chemotherapy,the rate of ECG change in the observation group(7.50%)was lower than that in the control group(27.50%)(P<0.05).There were no significant differences in the recurrence rate(12.50%vs.12.50%),metastasis rate(5.00%vs.7.50%),and mortality(10.00%vs.7.50%)between the two groups after 2 years of follow-up(P〉0.05).【Conclusion】Shenqi Fuzheng Injection can reduce cardiac toxicity caused by targeted therapy of Her2-positive breast cancer and improve quality of life.