Clinical trial of astragalus injection combined with decitabine injection in the treatment of myelodysplastic syndromes
10.13699/j.cnki.1001-6821.2017.21.011
- VernacularTitle:黄芪注射液联合地西他滨注射液治疗骨髓增生异常综合征的临床研究
- Author:
Ke-Feng GU
1
;
Jing-Zhong LU
;
Chao-Ying SONG
Author Information
1. 上海交通大学附属新华医院崇明分院内科
- Keywords:
astragalus;
decitabine;
myelodysplastic syndrome;
cluster of differentiation 34;
cluster of differentiation 117
- From:
The Chinese Journal of Clinical Pharmacology
2017;33(21):2127-2130
- CountryChina
- Language:Chinese
-
Abstract:
Objective To investigate the clinical efficacy and safety profile of astragalus injection combined with decitabine injection in the treatment of myelodysplastic syndromes (MDS).Methods According to admission,67 patients with MDS were divided into treatment group (n =38) and control group (n =29).The control group was given the decitabine injection 25 mg · m-2,daily intravenous drip for 1 h from the first day to the fifth day at each course (4 weeks a course).Treatment group was treated with astragalus injection 30 mL on the basis of control group.Both groups were treated for 4 courses.The clinical efficacy,white blood cell (WBC) count,platelet count,cluster of differentiation 34(CD34) and CD117 levels,and the adverse drug reactions were compared between the two groups.Results After treatment,the total effective rate of the treatment group and the control group were 65.79％ (25 cases/38 cases) and 41.38％ (12 cases/29 cases),the differences were statistically significant (P ＜ 0.05).After treatment,the WBC counts of the treatment group and the control group were (2.82 ±0.42) × 109/L,(2.31 ± 0.26) × 109/L;while the platelet counts were (92.51 ± 17.09) × 109/L and (82.01 ± 10.07) × 109/L;the CD34 expression rates were (7.91 ± 1.88) ％ and (9.13 ± 2.54) ％,respectively,the expression rate of CD117 (9.02 ± 1.63)％ and (10.01 ± 1.53)％,and the differences between the two groups were statistically significant (P ＜ 0.05).The median survival time of treatment group and control group were (32.29 ±9.00),(27.17 ± 10.53) months,the median progression free survival were (22.91 ± 6.61),(21.26 ± 10.02) months,and the differences were statistically significant (P ＜0.05).The adverse drug reactions in the treatment group were nausea and vomiting (5 cases) and fever (3 cases),while those in the control group were nausea and vomiting (6 cases) and fever (5 cases),infection (1 case),liver and kidney injury (1 case).The incidences of adverse drug reactions of the treatment group and the control group were 21.05％ (8 cases/38 cases) and 44.83％ (13 cases/29 cases),with statistically significant difference (P ＜0.05).Conclusion Astragalus injection combined with decitabine injection was effective and safe,it could promote the maturation and differentiation of myeloid cells.
