Clinical trial of arsenic trioxide in the treatment of patients with middle and high risk myelodysplastic syndrome
10.13699/j.cnki.1001-6821.2017.23.011
- VernacularTitle:亚砷酸治疗中高危骨髓增生异常综合征患者的临床研究
- Author:
Shu-Ming LI
1
Author Information
1. 大理大学附属医院内科,云南 大理671000
- Keywords:
myelodysplastic syndrome;
arsenite;
apoptosis
- From:
The Chinese Journal of Clinical Pharmacology
2017;33(23):2364-2367
- CountryChina
- Language:Chinese
-
Abstract:
Objective To observe the effects of arsenic trioxide combined with cytrarabine + aclacinomycin A + granulocyte-colony stimulating factor (CAG regimen) in the treatment of middle and high risk myelodysplastic syndrome (MDS).Methods One hundred and two patients with middle and high risk myelodysplastic syndrome were randomly divided in-to control group and treatment group,51 cases in each group.Patients in control group were treated with CAG regimen (cytrarabine 10 mg·m-2 · d-1,subcutaneous injection,ql2 h for 2 weeks;aclacinomycin A 20 mg· d-1,intravenous injection for 1 week;granulocyte-colony stimulating factor 200 μg · m-2 · d-1,subcutaneous injection,q12 h for 2 weeks;rest at third and fourth week).Patients in treatment group were treated with arsenic trioxide 10 mg · d-1,intravenous injection for 1 week,rest at third and fourth week) on the basis of control group.Three months a courses,all patients were treated for two courses.Apoptosis of hematopoietic cells in two groups were analyzed by flow cytometry before and after treatment.B cell lymphoma-2 (Bcl-2) and Bcl-associated X protein (Bax)expression levels in two groups were detected by Western blot before and after treatment.Chnical effect and the incidence of adverse drug reaction in two groups were compared.The long-term efficacy was evaluated in two groups.Results The total efficiency in treatment group and control group were 78.43％ (40 cases/51 cases),60.78％ (31 cases/51 cases),with significant difference (P ＜ 0.05).Compared with those before treatment,bone marrow cells apoptosis rate and Bax expression levels in the two groups were significantly increased,while Bcl-2 expression level of was significantly decreased (P ＜ 0.05).The change in treatment group was more significantly compared with control group(P ＜0.05).Follow-up results showed that 1,2 and 3 years cumulative survival rates in treatment group were 84.31％ (43 cases/51 cases),74.51％ (38 cases/51 cases)and 60.78％ (31 cases/51 cases),which had significant differences with those in control group,which were 80.39％(41 cases/51 cases),64.71％ (33 cases/51 cases) and 47.06％ (24 cases/51 cases).The adverse drug reactions in two groups were mainly exhibits fatigue,somnolence,mild liver and kidney injury,nausea and vomiting.The incidence of adverse reactions in control group and treatment group were 47.06％ (24 cases/51 cases) and 41.18％ (21 cases/51 cases),without signiticant difference (P ＞ 0.05).Conclusion Arsenite combined with CAG regimen can effectively induce the apoptosis of abnormal clones in the treatment of middle and high risk myelodysplastic syndrome,delay the survival time of patients,had significant clinical efficacy with mild adverse drug reactions.
