复方黄黛片治疗急性早幼粒细胞白血病疗效分析

Effect of Compound Huangdai Tablet on Acute Promyelocytic Leukemia

目的：研究复方黄黛片治疗急性早幼粒细胞白血病效果。方法：急性早幼粒细胞白血病62例,参考随机数字表法,按照1∶1比例将纳入患者随机分为观察组和对照组（各31例）。两组患者均参考卫生部关于急性早幼粒细胞白血病临床路径维持期治疗方案（2009年版）进行相应治疗,对照组第1个月予以注射用三氧化二砷、第2个月予以维甲酸胶囊;第3个月第1～7天、第15～21天予以6-羟基嘌呤,第9、12、23、26天予以甲氨蝶呤;观察组第1个月予以复方黄黛片,第2、3个月及治疗周期同对照组。观察两组患者血常规、骨髓涂片、肝肾功能、二便、心电图、各种不良事件。结果：观察组治疗总有效率87.10%、复发率9.68%与对照组的93.55%、6.45%比较,差异无统计学意义（P〉0.05）。第1、第3和第5个疗程结束时,肝肾功能水平与对照组比较,差异无统计学意义（P〉0.05）。恶心呕吐51.61%、腹痛腹泻25.81%、关节痛0.00%、皮疹9.68%、口干6.45%、胸闷0.00%、皮肤干燥3.23%及QT间期延长率3.23%,低于对照组的93.55%、77.42%、6.45%、19.35%、9.68%、6.45%、9.68%和19.35%,差异有统计学意义（P〈0.05）。结论：复方黄黛片治疗急性早幼粒细胞白血病效果显著、确切,与三氧化二砷疗效相当,且安全可靠,值得推广使用。

Objective： To study the effect of Compound Huangdai Tablet on acute promyelocytic leukemia. Methods： A total of 62 patients with acute promyelocytic leukemia were randomly divided into the observation group and the control group（ 31 cases） according to the ratio of 1 ： 1. Two groups were referred to the Ministry of Health on acute promyelocytic leukemia clinical pathways maintenance program（ 2009 edition） for the corresponding treatment. In the first month,the control group was be injected with arsenic trioxide; in the second month,the control group was given retinoic acid capsules. In the third month 1-7 d,15-21 d,the control group was given 6-hydroxy purine; on 9,12,23,26 d,given the methotrexate. In the first month,the observation group was given the Compound Huangdai Tablet. In the second and third month,the treatment was the same as that of the control group. We observed two groups＇ blood,bone marrow smear,liver and kidney function,ECG,and a variety of adverse events. Results： The total effective rate was 87. 10% and the recurrence rate was 9. 68% in the observation group compared with 93. 55% and 6. 45% in the control group. The difference was not statistically significant. At the end of the first,third and fifth courses,the level of liver and kidney function was not statistically significant（ P 〉 0. 05） compared with that of the control group. Nausea and vomiting accounted for51. 61%,abdominal pain 25. 81%,joint pain 0. 00%,rash 9. 68%,dry mouth 6. 45%,chest tightness 0. 00%,skin dry 3. 23% and QT interval prolongation rate 3. 23%,lower than the control group＇s 93. 55%,77. 42 %,6. 45%,9. 65%,9. 68% and 19. 35%,respectively. The difference was statistically significant（ P 〈 0. 05）. Conclusion： Compound Huangdai Tablet is effective and accurate in the treatment of acute promyelocytic leukemia,which is safe and reliable with arsenic trioxide. It is worthy to be popularized and used.