复方黄黛片联合维甲酸诱导治疗急性早幼粒细胞白血病的临床研究

发布时间：2018-06-16 08:46

本文选题：复方黄黛片 + 急性早幼粒细胞白血病　；参考：《广州中医药大学》2017年硕士论文

【摘要】：目的:本研究旨在通过对比分析复方黄黛片和三氧化二砷在急性早幼粒细胞白血病诱导治疗中的临床疗效,进一步探究复方黄黛片在该疾病诱导缓解治疗中的确切疗效与安全性,为急性早幼粒细胞白血病诱导治疗的优化方案选择提供参考。方法:本试验采用单盲、平行、随机对照的方法,共纳入病例30例,随机分为口服复方黄黛片联合维甲酸为诱导治疗方案的复方黄黛片组(治疗组)14例,和以三氧化二砷联合维甲酸为基础方案的三氧化二砷组(对照组)16例。统计和比较两组病人诱导治疗前后的临床症状、血分析、骨髓形态、基因和染色体,凝血功能、肝肾功能及其它主要不良事件,并运用统计学方法对比和分析两组病人的数据,得出结论。结果:1、复方黄黛片组诱导治疗的完全缓解率(CR,complete remission)为92.8%,三氧化二砷组完全缓解率则为100%,二者完全缓解率无统计学意义。复方黄黛片组达CR时间为43.76±9.51天,而三氧化二砷组为39.96±8.60天,两组达CR时间有统计学差异,说明两组的诱导缓解率相似,但复方黄黛片组达CR所需时间稍长于三氧化二砷组。2、诱导缓解后,两组的PML-RARα基因转阴率,无统计学差异,直至研究结束,两组血液学、分子学均呈持续缓解,未出现复发。3、两组PT、APTT恢复时间无差异,但Fib、D-二聚体恢复时间有统计学差异,复方黄黛片组凝血功能恢复所需时间较三氧化二砷组缩短,说明复方黄黛片组对凝血功能的恢复有裨益,并可减少治疗过程中血液制品的输注量。4、诱导治疗中两组弥散性血管内凝血的发生率无统计学差异,主要表现为皮肤黏膜出血、牙龈出血、尿血。5、诱导治疗过程中,两组在高白细胞峰值、高白细胞的持续时间及相关临床表现,无统计学差异。6、心电图异常、肝功能损害、胃肠道反应等其他不良反应的发生率,两组无明显差异,停药或对症治疗后可恢复正常。说明以复方黄黛片为主的诱导治疗方案与静脉用砷剂有着相似的安全性。结论:1、以复方黄黛片联合维甲酸为基础的诱导治疗方案的完全缓解率等同静脉用三氧化二砷,但达完全缓解的时间稍长。2、以复方黄黛片为基础的诱导方案可缩短凝血功能恢复时间,减少早期出血及相关并发症的出现,并可减少治疗中的血制品输注。3、两组心电图异常、肝功能损害、胃肠道反应等不良反应的发生率无明显差异,说明以复方黄黛片为主的诱导治疗方案与静脉用砷剂有着相似的安全性。因此,以复方黄黛片为基础的诱导治疗方案是可行的临床选项,复方黄黛片联合维甲酸这一完全口服方案可作为常规诱导治疗方案在临床中推广。
[Abstract]:Objective: to compare and analyze the clinical effect of compound Huangdai tablets and arsenic trioxide in the induction of acute promyelocytic leukemia. To further explore the exact efficacy and safety of compound Huangdai tablets in the treatment of the disease induced remission, and to provide a reference for the selection of optimal regimen for the induction treatment of acute promyelocytic leukemia. Methods: a single blind, parallel, randomized control method was used in this study. 30 patients were randomly divided into two groups: compound Huangdai tablet combined with retinoic acid as induction therapy group (treatment group, n = 14). And arsenic trioxide combined with retinoic acid as the basic scheme of arsenic trioxide group (control group, 16 cases). The clinical symptoms, blood analysis, bone marrow morphology, gene and chromosome, coagulation function, liver and kidney function and other major adverse events before and after induction treatment were statistically analyzed and compared between the two groups. come to conclusion Results the complete remission rate of compound Huangdai tablet group was 92.8%, and that of arsenic trioxide group was 100%. There was no significant difference between the two groups. The CR time of compound Huangdai tablet group was 43.76 卤9.51 days, while that of arsenic trioxide group was 39.96 卤8.60 days. However, the time required to reach CR in compound Huangdai tablet group was slightly longer than that in arsenic trioxide group. After induction and remission, there was no significant difference in the conversion rate of PML-RAR 伪 gene between the two groups. Until the end of the study, the hematology and molecular studies of the two groups showed a sustained remission. The recovery time of PTT APTT was not different between the two groups, but the recovery time of FibD- dimer was statistically different. The coagulation function recovery time of compound Huangdai tablet group was shorter than that of arsenic trioxide group. The results showed that compound Huangdai tablet group was beneficial to the recovery of coagulation function, and could reduce the transfusion volume of blood products. There was no significant difference in the incidence of disseminated intravascular coagulation between the two groups in induction therapy, and the main manifestation was skin and mucosal hemorrhage. Gingival bleeding, urine blood. 5. During induction treatment, there was no significant difference between the two groups in peak white blood cell, duration of high white blood cell and related clinical manifestations, abnormal electrocardiogram and liver function damage. There was no significant difference in the incidence of other adverse reactions such as gastrointestinal reactions between the two groups. The results showed that the induction therapy of compound Huangdai tablet was similar to that of arsenic for intravenous use. Conclusion the complete remission rate of the induced therapy based on compound Huangdai tablets combined with retinoic acid is equivalent to that of intravenous arsenic trioxide. However, the time of complete remission was a little longer. The induction regimen based on compound Huangdai tablet could shorten the recovery time of coagulation function, reduce the occurrence of early bleeding and related complications, and reduce the transfusion of blood products. There was no significant difference in the incidence of adverse reactions such as liver function damage and gastrointestinal reaction, which indicated that the induction therapy regimen with compound Huangdai tablet was similar to that of arsenic for intravenous use. Therefore, the induction therapy based on compound Huangdai tablet is a feasible clinical option, and the complete oral regimen of compound Huangdai tablet combined with retinoic acid can be used as a routine induction therapy in clinical practice.
【学位授予单位】：广州中医药大学
【学位级别】：硕士
【学位授予年份】：2017
【分类号】：R733.71

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