青黄散联合地西他滨治疗老年骨髓增生异常综合征的临床疗效观察

Clinical Efficacy of Qinghuang Powder and Decitabine in the Treatment of Myelodysplastic Syndrome in Elderly Patients

目的 评价口服砷剂青黄散与地西他滨治疗老年骨髓增生异常综合征(Myelodysplastic Syndrome, MDS)的临床疗效。方法 选取2016年1月—2020年6月期间中国中医科学院西苑医院收治的MDS患者54例,按随机数字表法分为青黄散组32例和地西他滨组22例。治疗4个疗程后,观察比较两组患者临床疗效、不良反应发生率以及总生存期。结果 疗效方面,青黄散组和地西他滨组的总缓解率与总体改善率分别为12.5%(4/32)、25.0%(8/32),地西他滨组的总缓解率与总体改善率分别为22.7%(5/22)、50.0%(11/22),两组的总缓解率与总体改善率比较,差异无统计学意义(P=0.461;P=0.083);但青黄散组的中位生存期(40个月)较地西他滨组(20个月)明显延长(P=0.037)。不良反应发生率方面,青黄散组未观察到明显的血液系统不良反应及治疗相关感染,地西他滨组≥3级血细胞减少的发生率为86.4%(19/22),≥3级感染的发生率为54.5%(12/22)。结论 与地西他滨比较,口服含砷中药青黄散能使老年MDS患者获得更长的生存期,不良反应发生率明显降低。对于不耐受地西他滨治疗的老年MDS患者,青黄散可作为推荐方案。

Objective To evaluate the clinical efficacy of oral arsenic-containing Qinghuang Powder(QHP)and decitabine in the treatment of myelodysplastic syndrome(MDS)in elderly patients.Methods Fifty-four elderly patients with MDS treated in Xiyuan Hospital,China Academy of Chinese Medical Sciences from January 2016 to June 2020 were enrolled and divided into a QHP group(n=32)and a decitabine group(n=22)according to the random number table method.After four courses of treatment,the clinical efficacy,adverse events,and overall survival of the two groups were an-alyzed,and the differences between the two groups were compared.Results In terms of efficacy,the overall response rate(ORR)and overall improvement rate of the QHP group were 12.5%(4/32)and 25.0%(8/32),respectively,and the ORR and overall improvement rate of the decitabine group were 22.7%(5/22)and 50.0%(11/22),respectively.There was no significant difference in the ORR and overall improvement rate between the two groups(P=0.461;P=0.083).However,the median overall survival(mOS)of the QHP group was significantly longer than that of the decitabine group(40 months vs 20 months,P=0.037).In terms of the incidence of adverse events,no obvious hematologic adverse events and treatment-related infectious complications were observed in the QHP group.The incidence of cytopenias≥grade 3 in the decitabine group was 86.4%(19/22),and the incidence of infectious complications≥grade 3 was 54.5%(12/22).Conclusion Compared with decitabine,oral administration of oral arsenic-containing QHP can help elderly patients with MDS to survive longer and significantly reduce the incidence of adverse events.QHP can be recommended for elderly patients with MDS who are intolerant to decitabine.