口服维A酸联合复方黄黛片治疗非高危急性早幼粒细胞白血病的临床研究

Clinical Study on the Clinical Efficacy and Economy of Retinoic Acid Combined with Realgar-Indigo Naturalis Formula Tablets in the Treatment of Non-high Risk Acute Promyelocytic Leukemia

目的探讨非高危急性早幼粒细胞白血病(acute promyelocytic leukemia ,APL)的口服治疗方案:维A酸(all-trans retinoic acid ,ATRA)联合中药复方黄黛片(realgar-Indigo naturalis formula, RIF)的临床疗效及经济性。方法选取38例初发低中危APL患者为研究对象,随机分为口服组20例及静脉组18例进行诱导及巩固治疗。口服组采用ATRA联合 RIF治疗;静脉组采用ATRA联合三氧化二砷(arsenic trioxide ,ATO)静脉输注,比较两组患者完全缓解率(complete remission rate,CR)、PML-RARa融合基因转阴时间、 5年无病生存率及总治疗费用。结果口服组与静脉组CR比较,差异无统计学意义( χ^2 =-0.054, P =0.074);两组获得CR时间比较,差异无统计学意义( t =1.342 , P =0.061)。监测两组患者治疗中主要不良反应、不同随访时间点PML-RARa融合基因水平、生存率情况比较,差异均无统计学意义( P>0.05 )。诱导治疗阶段口服组( n =17)和静脉组( n =15)平均总费用分别为(51 127.3± 51.6)元、(52 332.5± 32.9)元,差异无统计学意义( P >0.05)。在7次巩固疗程后总费用分别为(76 331.1± 21.1)元、(114 153.2±45.5)元,差异有统计学意义( P <0.05)。口服组在巩固治疗阶段费用明显少于静脉组。结论两组患者在经过不同治疗方案后,在CR、PML-RARa融合基因转阴时间、主要不良反应、 5年无病生存率方面取得相似疗效。但口服组治疗费用明显少于静脉组,且口服方案减少静脉穿刺次数、缩短住院时间,明显节约医疗资源,提高患者生存质量,值得临床推广。

Objective To explore the clinical efficacy and economy of the oral therapeutic regimen with all-trans retinoic acid (ATAR) and traditional Chinese medicine compound realgar-Indigo naturalis formula (RIF) tablets in treatment of non-high risk acute promyelocytic leukemia (APL). Methods A total of 38 patients with early-onset low-and medium-risk APL were selected as the research objects and randomly divided into the oral group ( n =20) and the intravenous group ( n =18) for the induction and consolidation therapy. The oral group was treated orally with ATRA combined with RIF tablets, while the intravenous group was treated intravenously with ATRA combined with arsenic trioxide (ATO). The complete remission (CR) rate, PML-RARa fusion gene negative-conversion time, 5-year disease-free survival rate and total treatment cost were compared between the two groups. Results There was no significant differences in the CR rate ( χ^2 =-0.054, P =0.0736) and CR time ( t =1.342, P = 0.061) between the oral group and intravenous group. The two groups were not statistically different in the main adverse reactions and the PML-RARa fusion gene levels and survival rates at different follow-up time points. In the induction treatment stage, the average total treatment cost of 17 patients in the oral group was (51,127.3 ±51.6) Yuan and that of 15 patients in the intravenous group was (52,332.5 ±32.9) Yuan, and the difference was not statistically significant between the two groups ( P >0.05). In the consolidation treatment stage, the average total treatment cost after 7 courses of consolidation treatment was (76,331.1 ±21.1) Yuan for the 17 patients in the oral group and (114,153.2 ±45.5) Yuan for the 15 patients in the intravenous group, and the difference was statistically significant between the two groups ( P <0.05). The total treatment cost in the consolidation treatment stage was markedly less in the oral group than in the intravenous group. Conclusion The CR rate, PML-RARa fusion gene negative-conversion time, main reverse reactions and 5-year disease-free survival rate were similar for the non-high risk APL patients treated with the two different therapeutic regimens. However, the treatment cost of the oral group was significantly less than that that of the intravenous group and the oral therapeutic regimen reduced the number of venipuncture, shortened the length of hospital stay, markedly saved medical resources and improved patients′ quality of life, so it is worthy of clinical promotion.