复方苦参注射液联合紫杉醇脂质体用于乳腺癌新辅助化疗的疗效与安全性评价

Evaluation of the Efficacy and Safety of Compound Sophora flavescens Injection Combined with Paclitaxel Liposome in Neoadjuvant Chemotherapy for Breast Cancer

摘要: 目的：探究苦参注射液联合紫杉醇脂质体方案在乳腺癌新辅助化疗中的疗效与安全性。方法：选取新辅助治疗的60例乳腺癌患者，随机被分成观察组和对照组，每组各30例。对照组进行单纯紫杉类药物化疗，观察组接受同步化疗的基础上加用复方苦参注射液。观察比较两组患者肿瘤消退水平、外周血CEA、CA-153水平、化疗消化道不良反应及生存质量评价。结果：两组患者临床疗效比较：观察组临床治疗有效率及稳定率较对照组水平显著提高，两组比较差异有统计学意义(P < 0.05)。与对照组相比，观察组肿瘤标志物CEA、CA-153水平显著下降，两组相比差异有统计学意义(P < 0.05)。胃肠道不良反应：两组患者消化道不良反应比较，观察组明显低于对照组，提示苦参注射液对紫杉类药物化疗副反应存在潜在的预防及治疗效果，结果具有统计学意义(P < 0.05)。治疗前两组患者生存质量评分比较差异无统计学意义(P > 0.05)；治疗后两组患者生存质量评分均优于治疗前(P < 0.05)，且观察组各项得分均显著高于对照组，两组比较差异有统计学意义(P < 0.05)。结论：复方苦参注射液联合紫杉醇脂质体方案较单纯使用紫杉醇方案，在乳腺癌新辅助化疗中可显著提高临床疗效，并减轻不良反应、有效改善患者的生存质量。

Abstract: Objective: To investigate the efficacy and safety of Sophora flavescens injection combined with paclitaxel liposome regimen in neoadjuvant chemotherapy for breast cancer. Methods: A total of 60 patients with breast cancer treated with neoadjuvant therapy were randomly divided into an observation group and a control group, with 30 cases in each group. The control group was treated with taxane chemotherapy alone, and the observation group was treated with compound Sophora flavescens injection on the basis of concurrent chemotherapy. The tumor regression level, peripheral blood CEA, CA-153 levels, gastrointestinal adverse reactions and quality of life evaluation were observed and compared between the two groups. Results: Comparison of clinical efficacy between the two groups: The effective rate and stable rate of clinical treatment in the observation group were significantly higher than those in the control group, and the difference between the two groups was statistically significant (P < 0.05). Compared with the control group, the levels of tumor markers CEA and CA-153 in the observation group decreased significantly, and the difference between the two groups was statistically significant (P < 0.05). Gastrointestinal adverse reactions: The gastrointestinal adverse reactions in the observation group were significantly lower than those in the control group, suggesting that Kushen injection had potential preventive and therapeutic effects on the side effects of taxane chemotherapy, and the results were statistically significant (P < 0.05). There was no significant difference in the quality of life score between the two groups before treatment (P > 0.05). After treatment, the quality of life scores of the two groups was better than those before treatment (P < 0.05), and the scores of the observation group were significantly higher than those of the control group, and the differences between the two groups were statistically significant (P < 0.05). Conclusion: Compound Sophora flavescens injection combined with paclitaxel liposome regimen can significantly improve the clinical efficacy, reduce adverse reactions, and effectively improve the quality of life of patients with breast cancer.