艾迪注射液在蒽环类耐药的转移性乳腺癌患者化疗过程中的作用

Randomized Controlled Trial of the Supportive Function of the Aidi Injection in the Process of Chemotherapy in Treating Anthracycline-resistant Metastatic Breast Cancer Patients

目的:观察艾迪注射液在蒽环类耐药的转移性乳腺癌患者化疗过程中的作用。方法:将73例符合标准的晚期乳腺癌患者随机分为治疗组(化疗期间使用艾迪注射液)和对照组(化疗期间不使用艾迪注射液及其他抗肿瘤中成药),观察总有效率(ORR)、疾病控制率(DCR)、肿瘤进展时间(TTP)及各组间不良反应的轻重程度。结果:两组ORR、DCR比较,差异均无统计学意义(P>0.05);治疗组TTP较对照组延长(P<0.05);治疗组出现Ⅲ、Ⅳ度白细胞降低及Ⅰ、Ⅱ度疲乏不适患者较对照组少(P<0.05),Ⅰ、Ⅱ度过敏反应患者较对照组多(P<0.05)。结论:艾迪注射液对于蒽环类耐药的晚期乳腺癌患者的化疗,在ORR及DCR上并无确切的优势,但可起到延长TTP的作用,还能明显减轻患者化疗后的白细胞降低的严重程度及疲乏无力等不适,但需注意过敏反应的预防及处理。

Objective： To observe the effect-enhancing and toxicity-reducing function of Aidi Injection in the process of chemotherapy in treating anthracycline-resistant metastatic breast cancer patients. Methods： In total of 73 cases of patients who met the standards were enrolled and randomized divided into treatment group （Aidi Injection in the process of chemotherapy） and control group （without Aidi Injection or other antitumor Chinese patent medicine preparation in the process of chemotherapy）. The main endpoints were overall response rate （ORR）, disease control rate （DCR）, time to progression （TTP） and the serious levels of adverse events of each group. Results： There were no statistic significance between the treatment group and the eontrol group in ORR or DCR （P〉0.05）. The treatment group showed longer TTP than the control group （P〈0.05）. The treatment group showed less grade Ⅲ and Ⅳ of leucopenia and less grade Ⅰ and Ⅱ of fatigue in spite than control group （P〈0.05）, and more grade Ⅰ and Ⅱ of allergic patients （P〈0.05）. Conclusion： There was no definite advantage in ORR and DCR of using the Aidi Injection in the process of chemotherapy in treating Anthracycline-resistant metastatic breast cancer patients. However, the TFP was elongated in the treatment group. The Aidi injection was observed to have the effect to reduce the severity of leukopenia and the incidence rate of fatigue, but more attention had to pay to the risk of the allergic reactions.