目的 观察参芪扶正注射液联合化疗治疗急性髓系白血病的临床效果及其对机体免疫功能的影响,探讨参芪扶正注射液在辅助化疗中的作用及机制.方法 将112例急性髓系白血病患者随机分为两组:治疗组54例,采用参芪扶正注射液联合DA方案化疗;对照组58例,单独给予DA方案化疗.观察两组患者缓解率、死亡率、骨髓抑制时间、T细胞亚群水平变化及患者化疗不良反应.结果 治疗组患者缓解率及死亡率与对照组比较差异无统计学意义(P > 0.05);治疗组骨髓抑制时间较对照组明显缩短(P < 0.05);治疗组化疗后患者CD3⁺/CD4⁺细胞及CD4⁺/CD8⁺细胞比例较对照组显著增高(P < 0.05);治疗组患者化疗相关不良反应较对照组明显减轻(P < 0.05).结论 参芪扶正注射液能缩短急性髓系白血病患者化疗所致骨髓抑制时间,调节患者T细胞亚群,增强患者机体主动免疫功能,降低化疗相关不良反应.

Objective To observe the clinical efficacy of Shenqi Fuzheng Injection (SFI) combined with chemotherapy in the treatment of acute myeloid leukemia (AML) and the effect on body's immune function, and to explore the function and mechanism of adjuvant chemotherapy with SFI. Methods One hundred and twelve patients were divided into two groups: the treatment group (n = 54) treated with DA protocol plus SFI and the control group (n = 58) treated with DA protocol alone. We observed the remission rate, mortality, the time of myelosuppression, the changes of T lymphocyte subsets; and the side-effects of chemotherapy for the patients in the two groups. Results Comparing the remission rate and mortality rate of the patients between the two groups, there was no statistically significant difference (P > 0.05). The side-effects of the patients in the treatment group were more significantly reduced than those of the patients in the control group (P < 0.05), with the shorter time of myelosuppression (P < 0.05), more CD3⁺/CD4⁺ cells, and higher cell rates of CD4⁺/CD8⁺ (P < 0.05). Conclusion The SFI could shorten the time of myelosuppression induced by the chemotherapy in the treatment of AML, regulate the level of T lymphocyte subsets, enhance the active immune function of body, and reduce the relative side-effects of chemotherapy.