Clinical Study On Shengmabiejia Decoction Combined With Metronome Chemotherapy Maintenance Treatment Of Elderly AML With "Deficiency And Toxin Stasis Type"

The purpose of the study is as follows:1.To observe the clinical effect of Shengmaebiejia decoction combined with metronome chemotherapy in the treatment of acute myeloid leukemia(AML)in the elderly with”Deficiency and Toxin Stasis Type ".2.To evaluate the safety of Shengmabiejia decoction combined with metronome chemotherapy in the treatment of AML in the elderly in this type.3.To record the quality of life and physical status of elderly patients with AML(ECOG),improve the scores of TCM syndromes and Comprehensive geriatric assessment(CGA)in the elderly.Method:The elderly patients with AML who met the inclusion criteria were divided into treatment group(n＝15)and control group(n＝15)according to the intention of the patients.The treatment group was treated with Shengmabiejia decoction combined with metronome chemotherapy.According to the Chinese guidelines for diagnosis and treatment of adult acute myeloid leukemia(non-acute promyelocytic leukemia)(2017 edition),the control group received a standard dose of cytarabine(Ara-C)based maintenance chemotherapy regimen.The dosage of cytarabine was 75-100 mg/m2/d,which could be combined with anthracycline drugs(mitoxantrone,daunorubicin,demethoxydaunorubicin).A total of 4-6 courses of treatment were administered.Before and after 4 courses of treatment,according to blood routine,MRD,Schilling classification,peripheral blood flow Cytology and "Zubrod-ECOG-WHO score","TCM syndrome score table" and Comprehensive geriatric assessment(CGA),the clinical curative effect difference of each group was compared.Results:1.After treatment,there was no recurrence in the two groups.One patient in the treatment group changed from CRi to CR.There was no significant difference in the clinical efficacy between the two groups,and there was no significant difference in the level of MRD between the two groups after treatment.2.There were significant differences in "Zubrod-ECOG-WHO score","TCM syndrome score table" and CGA between the two groups after treatment,and the difference was statistically significant(P<0.05).After treatment,the treatment group was superior to the control group in"TCM syndrome score table" and the CGA,which were significantly better than those in the control group(P<0.05).Conclusion:Shengmabiejia decoction combined with metronome chemotherapy is not inferior to routine chemotherapy in the maintenance of elderly patients with AML,and has better safety.Compared with conventional chemotherapy,it can improve the physical fitness and survival status of the elderly,improve the CGA score,and thus improve the prognosis of some elderly AML patients.