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/(m2·d)×10 d, 15 patients] group and 5-day regimen [15 mg/(m2·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.
题目: 不同剂量地西他滨治疗高危骨髓增生异常综合征患者疗效及安全性的回顾性分析.
目的: 探讨不同剂量地西他滨治疗高危骨髓增生异常综合征（MDS）患者的临床疗效及安全性。.
方法: 选取高危MDS患者30例，均使用去甲基化药物地西他滨治疗。根据患者使用地西他滨剂量不同，分为10 d [6 mg/（m2·d）×10 d，15例]和5 d方案组[15 mg/（m2·d）×5 d，15例]，比较两组患者地西他滨的疗效及不良反应。.
结果: 随访至2020年5月，10 d方案组获完全缓解10例，部分缓解3例，疾病进展2例；完全缓解率为66.67%，总反应率为86.67%，死亡4例，其中1例死于心衰，2例死于呼吸衰竭，1例死于重症感染。5 d方案组获完全缓解11例，部分缓解1例，疾病进展3例，完全缓解率为73.33%，总反应率为80.00%，死亡5例，2例死于心衰，3例死于重症感染。两组疗效和生存率比较差异均无统计学意义（P>0.05）。治疗后10 d方案组白细胞数、中性粒细胞数、血红蛋白及血小板数均值均高于5 d方案组。10 d方案组发生肺炎11例，菌血症2例，皮肤感染1例，泌尿系感染1例。5 d方案组肺炎13例，菌血症5例，皮肤感染1例，泌尿系感染3例。10 d方案组有2例患者出现轻微消化道反应， 5 d方案组有7例出现明显恶心、食欲减退，经抑酸护胃、止吐等对症处理后，症状缓解。监测肝肾功能及心功能，10 d方案组1例出现肝功能损伤，2例出现心功能不全；5 d方案组4例出现肝功能损伤，7例发生心功能不全。.
结论: 10 d方案组和5 d方案组疗效相当，但10 d方案组骨髓抑制程度及不良反应发生率均较5 d方案组少，安全性更高，具有广泛的临床应用价值。.