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不同剂量地西他滨治疗高危骨髓增生异常综合征患者的疗效与安全性

[Efficacy and Safety of Different Dosages of Decitabine in the Treatment of High-Risk Patients with Myelodysplastic Syndrome].

作者信息

Tong Chun, Ye Fang, Li Ning-Ning, Wang Huan, Shu Ya-Nan, Wang Ling, Zhang Li-Nan

机构信息

Department of Hematology, Beijing ChuiYangLiu Hospital, Beijing 100022, China.

Department of Hematology, Beijing ChuiYangLiu Hospital, Beijing 100022, China. E-mail:

出版信息

Zhongguo Shi Yan Xue Ye Xue Za Zhi. 2021 Dec;29(6):1845-1850. doi: 10.19746/j.cnki.issn.1009-2137.2021.06.026.

Abstract

OBJECTIVE

To investigate the efficacy of high-risk myelodysplastic syndrome (MDS) patients treated by different doses of decitabine (DAC) and its safety.

METHODS

Thirty patients with high-risk MDS were all treated by demethylation drug DAC. According to the doses of DAC, 30 patients were divided into 10-day regimen [6 mg/(m·d)×10 d, 15 patients] group and 5-day regimen [15 mg/(m·d)×5 d, 15 patients] group. The efficacy and adverse events of the patients in the two groups were observed.

RESULTS

The patients were followed up to May 2020, in the 10-day regimen group, 10 cases achieved complete remission (CR), 3 cases achieved partial remission (PR), and 2 cases were progressive disease (PD). Four cases died, including 1 case for heart failure, 2 cases for respiratory failure and 1 case for serious infection. In the 5-day regimen group, 11 cases achieved CR, 1 case achieved PR, 3 cases were PD. Five cases died, including 2 cases for heart failure and 3 for serious infection. The CR rate and ORR of the patients in the two groups were 66.67% vs 73.33%, 86.67% vs 80.00%, respectively, which showed no significant differences, and the efficacy also showed no significant difference. After treatment, the levels of WBC, NE, Hb and PLT of the patients in 10-day regimen group were higher than those in 5-day regimen. In the 10-day regimen group, there were 11 cases of pneumonia, 2 cases of bacteremia, 1 case of skin infection and 1 case of urinary tract infection. While in the 5-day regimen group, 13 cases of pneumonia, 5 cases bacteremia, 1 case of skin infection and 3 cases of urinary tract infection. There were 2 cases with mild gastrointestinal response in the 10-day regimen group, and 7 cases with obvious nausea and anorexia in the 5-day regimen group. The symptoms were relieved after the treatment of acid suppression, stomach protection and antiemetic. The liver, kidney and heart function were monitored. One case liver function damage and 2 cases cardiac insufficiency were observed in the 10-day regimen group. Seven cases regimen cardiac insufficiency and 4 cases regimen liver function damage were observed in the 5-day regimen group.

CONCLUSION

10-day regimen and 5-day regimen are equally effective, but 10-day regimen is less myelosuppressive and more safer, which can be applied in clinical.

摘要

目的

探讨不同剂量地西他滨(DAC)治疗高危骨髓增生异常综合征(MDS)患者的疗效及其安全性。

方法

30例高危MDS患者均接受去甲基化药物DAC治疗。根据DAC剂量,30例患者分为10天方案组[6mg/(m²·d)×10d,15例]和5天方案组[15mg/(m²·d)×5d,15例]。观察两组患者的疗效及不良事件。

结果

患者随访至2020年5月,10天方案组中,10例达到完全缓解(CR),3例达到部分缓解(PR),2例疾病进展(PD)。4例死亡,其中1例死于心力衰竭,2例死于呼吸衰竭,1例死于严重感染。5天方案组中,11例达到CR,1例达到PR,3例PD。5例死亡,其中2例死于心力衰竭,3例死于严重感染。两组患者的CR率和ORR分别为66.67%对73.33%,86.67%对80.00%,差异无统计学意义,疗效也无显著差异。治疗后,10天方案组患者的白细胞、中性粒细胞、血红蛋白和血小板水平高于5天方案组。10天方案组有11例肺炎、2例菌血症、1例皮肤感染和1例尿路感染。而5天方案组有13例肺炎、5例菌血症、1例皮肤感染和3例尿路感染。10天方案组有2例出现轻度胃肠道反应,5天方案组有7例出现明显恶心、厌食。经抑酸、护胃及止吐治疗后症状缓解。监测肝、肾及心功能。10天方案组观察到1例肝功能损害和2例心功能不全。5天方案组观察到7例心功能不全和4例肝功能损害。

结论

10天方案和5天方案疗效相当,但10天方案骨髓抑制较轻且更安全,可应用于临床。

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