Objective To observe the clinical efficacy and safety of Fuzheng Quxie Chinese herbal combined with granulocyte colony-stimulating factor (G-CSF) pre-excitation chemotherapy in the treatment of acute myeloid leukemia (AML). Methods 74 AML patients were divided into two groups according to random number table method. 37 cases in control group were treated by pre-excitation chemotherapy containing G-CSF. The treatment group was treated by Fuzheng Quxie Chinese medicine on the basis of the control group. The curative effect was evaluated after 2 months of treatment in two groups. The changes of TCM symptom scores (including fatigue, fever, hemorrhage, dry mouth and bone pain) and physical condition scores of eastern American cancer collaboration group (ECOG) before and after treatment were compared. The duration of peripheral blood neutrophil absolute value (ANC) ＜1.0×109/L, platelet count (PLT) ＜20×109/L, interval of erythrocyte suspension infusion and interval of platelet suspension infusion were compared between the two groups. The incidence of pulmonary infection, diarrhea, nausea and vomiting, fever and other adverse reactions were compared between the two groups. Results The total effective rate was 89.19％ in treatment group and 37.84％ in control group. The curative effect of the treatment group was better than that of the control group (P＜0.05). Compared with the group before treatment, the scores of TCM symptoms after treatment such as fatigue, fever, hemorrhage, dry mouth and bone pain in the two groups were significantly lower (P＜0.05), and the scores of TCM symptoms in the treatment group were lower than those in the control group (P＜0.05). Compared with the group before treatment, the ECOG physical condition score after treatment were significantly improved (P＜0.05), and the improvement of ECOG physical condition score of the treatment group was better than that of the control group (P＜0.05). The duration of ANC＜1.0×109/L and PLT＜20×109/L in the treatment group were shorter than those in the control group (P＜0.05), the interval of erythrocyte suspension infusion and platelet suspension infusion were longer than those in the control group (P＜0.05), and the incidence of pulmonary infection, diarrhea, nausea and vomiting, fever and other adverse reactions in the treatment group were less than those in the control group (P＜0.05). Conclusion Fuzheng Quxie Chinese medicine combined with G-CSF pre-excitation chemotherapy regimen in the treatment of AML can significantly improve the clinical efficacy, effectively improve the symptoms of patients, promote the recovery of ANC and PLT levels, reduce the use of red blood cell suspension and platelet suspension, improve the physical condition of patients, reduce the occurrence of adverse reactions, and have a significant role in reducing toxicity and synergy.%目的 观察扶正祛邪中药联合含粒细胞集落刺激因子 (G-CSF) 预激化疗方案治疗急性髓细胞白血病 (AML) 的临床疗效及安全性.方法 将74例AML患者按照随机数字表法分为2组.对照组37例予含G-CSF的预激化疗方案治疗;治疗组37例在对照组治疗基础上加用扶正祛邪中药治疗.2组均治疗2个月后统计疗效, 比较2组治疗前后中医症状 (包括乏力、发热、出血、口干及骨痛) 评分及美国东部肿瘤协作组 (ECOG) 体能状态评分变化情况, 比较2组治疗期间外周血中性粒细胞绝对值 (ANC) ＜1.0×109/L的持续时间、血小板计数 (PLT) ＜20×109/L的持续时间、红细胞悬液输注间隔时间及血小板悬液输注间隔时间, 比较2组发生肺部感染、腹泻、恶心呕吐、发热及其他不良反应情况.结果 治疗组总有效率89.19％, 对照组总有效率37.84％, 治疗组疗效优于对照组 (P＜0.05);2组治疗后临床症状乏力、发热、出血、口干及骨痛评分与本组治疗前比较均明显降低 (P＜0.05), 且治疗后治疗组各临床症状评分均低于对照组 (P＜0.05);2组治疗后ECOG体能状态评分情况与本组治疗前比较均有明显改善 (P＜0.05), 且治疗组治疗后ECOG体能状态评分改善情况优于对照组 (P＜0.05);治疗组治疗期间ANC＜1.0×109/L持续时间及PLT＜20×109/L持续时间均短于对照组 (P＜0.05), 红细胞悬液输注间隔时间及血小板悬液输注间隔时间均长于对照组 (P＜0.05);治疗组发生肺部感染、腹泻、恶心呕吐、发热及其他不良反应情况少于对照组 (P＜0.05) .结论 扶正祛邪中药联合含G-CSF预激化疗方案治疗AML可明显提高临床疗效, 有效改善患者症状表现, 促进ANC及PLT水平恢复, 减少红细胞悬液及血小板悬液的应用, 改善患者体能状态, 减少不良反应发生, 具有明显的减毒增效作用.
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