Department of Hematology, Ningbo First Hospital, Ningbo, Zhejiang, China.
Medical Genetics Center, School of Medicine, Ningbo University, Ningbo, Zhejiang, China.
J Int Med Res. 2020 Sep;48(9):300060520956894. doi: 10.1177/0300060520956894.
The aim of this prospective randomized controlled clinical trial was to explore the relationship between methylation and Pai-Neng-Da (PND) in the treatment of patients with low-risk myelodysplastic syndrome (MDS).
There were 82 low-risk MDS patients who were randomly divided into the following two groups: androl, thalidomide, and PND capsule (ATP group, n = 41); or androl and thalidomide (AT group, n = 41). Hemoglobin and neutrophil and platelet counts and changes in methylation level were assessed.
The plasma hemoglobin level increased in both groups after treatment. However, the platelet count increased only in the ATP group. Patients in the ATP group had a better platelet response than the AT group, and methylation markedly decreased after treatment with ATP but not after treatment with AT. Moreover, male patients had a significantly lower methylation level than female patients, while platelet counts from male patients increased dramatically after the ATP regimens compared with female patients. methylation changes were negatively correlated with platelet changes in ATP group.
PND can improve hematological parameters and decrease the methylation level. Decreasing methylation is associated with the hematologic response that includes platelet in methylation. http://www.chictr.org.cn/: ChiCTR-IOR-15006635.
本前瞻性随机对照临床试验旨在探讨甲基化与培能达（PND）在低危骨髓增生异常综合征（MDS）患者治疗中的关系。
82 例低危 MDS 患者被随机分为以下两组：安特尔、沙利度胺和 PND 胶囊（ATP 组，n=41）；或安特尔和沙利度胺（AT 组，n=41）。评估血红蛋白、中性粒细胞和血小板计数以及甲基化水平的变化。
两组治疗后血浆血红蛋白水平均升高，但仅 ATP 组血小板计数升高。ATP 组的血小板反应优于 AT 组，且 ATP 治疗后甲基化明显降低，而 AT 治疗后无明显变化。此外，男性患者的甲基化水平明显低于女性患者，而 ATP 方案治疗后男性患者的血小板计数明显高于女性患者。ATP 组中甲基化变化与血小板变化呈负相关。
PND 可改善血液学参数并降低甲基化水平。降低甲基化与包括血小板在内的血液学反应有关。[临床试验注册机构]：中国临床试验注册中心，ChiCTR-IOR-15006635。
