参芪扶正注射液在乳腺癌新辅助化疗中的疗效及不良反应的临床观察

目的:观察参芪扶正注射液在局部进展期乳腺癌新辅助化疗中的疗效与不良反应。方法:收集2000年1月至2005年12月126例局部进展期乳腺癌新辅助化疗患者的临床资料。126例患者随机分为2组:对照组(61例)、试验组(65例)。对照组应用CEF治疗方案(CTX 500mg/m2,d1,8;EPI 50mg/m2,d1,8;5-Fu 500mg/m2,d1,8),试验组采用CEF治疗方案加参芪扶正注射液(250ml,1次/d,静脉滴注)。2组的治疗周期均为28d,共2个周期。观察治疗前后2组新辅助化疗的疗效、T淋巴细胞和NK细胞的变化及不良反应。结果:试验组和对照组的总有效率分别为69.2%(45/65)和49.2%(30/61),2组比较差异有统计学意义(P<0.05)。试验组的T-淋巴细胞亚群和NK细胞均有不同程度的提高,与对照组相比有显著差异(P<0.05)。2组的主要不良反应为骨髓抑制及消化道反应,但试验组的反应程度较对照组轻。结论:参芪扶正注射液能提高乳腺癌新辅助化疗患者的免疫功能,并能增强新辅助化疗的疗效及减轻其不良反应。

Clinical observation of efficacy and adverse reactions on Shenqifuzheng injection used in patients with breast cancer receiving neoadjuvant chemotherapy

Objective: To observe the efficacy and adverse reactions of Shenqifuzheng injection used in patients with breast cancer while receiving neoadjuvant chemotherapy. Methods: Clinical deta of 126 patients with local advanced breast cancer while receiving neoadjuvant chemtherapy was collected from January, 2000 to December, 2005. The 126 patients were divided randomizely into two groups: control group (61 cases) and study group (65 cases). The patients in the control group were administered with CEF regimen (CTX 500 mg/m2, d1, 8; EPI 50 mg/m2, d1, 8; 5-Fu 500 mg/m2, d1, 8). The patients in the study group were treated with CEF regimen plus Shenqifuzheng injection (intravenous infusion of 250 ml, once daily). The cycle of chemotherapy was 28 d, and total two cycles were performed for the two groups. The efficacy, the changes of T lymphocyte and NK cells, and the adverse reactions to neoadjuvant chemotherapy in the two groups were observed before and after the treatment. Results: The overall effective rate of the study group and control group were 69.2% (45/65) and 49.2% (30/61) respectively, and the difference was statistically significant between the two groups (P<0.05). The T lymphocyte subsets and NK cells in the study group were elevated in varying degree in comparison with those in the control group, and the differences were significant (P<0.05). The common adverse reactions of the two groups were myelosuppression and gastrointestinal reactions, but the severity of the reactions of the study group were relative mild than that of the control group. Conclusion: Shenqifuzheng injection can elevate immune function of patients with advanced breast cancer while receiving neoadjuvant chemotherapy. It can also enhance the efficacy and decrease the adverse reactions to neoadjuvant chemotherapy.