【摘要】 目的：针对慢性粒细胞白血病建立用于BCR-ABL融合基因检测的新型d PCR体系，探讨其在BCR-ABL^p190/210/230检测中的分析性能和临床适用性。方法：开发检测BCR-ABL^p190/210/230的新型d PCR体系，比较其与q PCR的灵敏度差异，及在慢性粒细胞白血病患者减药或停药期间药物副作用改善的差异。结果：在176份样本中，q PCR和d PCR在检测BCR-ABL的灵敏度方面表现出较高的一致性（82.39%）,d PCR的阳性率约为q PCR的5倍（20.45%vs 3.98%）。随访期间，减药或停药的初始d PCR阴性患者较减药或停药前血常规（25%vs 10%）、肾/肝/胃（25%vs20%）及心脏功能（10%vs 0）均有明显改善。结论：d PCR检测体系可应用于BCR-ABL^p190/210/230检测，较q PCR一致性佳，阳性检出率高，基于d PCR指导的停药或减少剂量在改善药物副作用上有一定效果。更多还原

【Abstract】 Objective:To establish a new digital polymerase chain reaction （d PCR） system for the detection of BCR-ABL fusion gene in patients with chronic myeloid leukemia （CML）,and explore its analytical performance and clinical applicability in the detection of BCR-ABL^p190/210/230.Methods:A new d PCR system for detecting BCR-ABL^p190/210/230 was successfully developed,and its sensitivity difference with q PCR and improvement of drug side effects in patients with CML during drug reduction or withdrawal were compared.Results:Among 176 samples,q PCR and d PCR showed high consistency in the sensitivity of detecting BCR-ABL （82.39%）,and the positive rate of d PCR was about 5 times higher that of q PCR （20.45%vs 3.98%）.During follow-up,blood routine （25%vs 10%）,kidney/liver/stomach （25%vs 20%） and cardiac function （10%vs 0） were significantly improved after drug reduction or withdrawal in patients with initial d PCR negative compared with before drug reduction or withdrawal.Conclusions:This new d PCR detection system can be applied to the detection of BCR-ABL^p190/210/230.It has better consistency and higher positive detection rate than q PCR.Drug withdrawal or dose reduction guided by dPCR has a certain effect on improving drug side effects.更多还原