Wang Jian, Huang Jun-Bin, Liu Zu-Lin, Zhang Bi-Hong, Xu Hong-Gui, Xue Hong-Man, Chen Chun
Department of Pediatrics, Sun Yat-sen Memorial Hospital, Sun Yat-sen University, Guangzhou 510120, Guangdong Province, China.
Department of Pediatrics, The Seventh Affiliated Hospital, Sun Yat-sen University, Shenzhen 518017, Guangdong Province, China.
Zhongguo Shi Yan Xue Ye Xue Za Zhi. 2017 Dec;25(6):1605-1610. doi: 10.7534/j.issn.1009-2137.2017.06.004.
To investigate the clinical efficacy of Fu Fan Huang Dai Pian(RIF) and arsenic trioxide (ATO) regimens for treatment of children with acute promyelocytic leukemia (APL) and to explore the risk factors affecting the prognosis of patients.
The clinical data of 45 newly diagnosed APL children admitted in our hospital from January 2004 to May 2017 were analyzed retrospectively. Among 45 APL children, 25 children were treated by chemotherapetic regimen including RIF (RIF group), another 20 children were treated by chemotherapeutic regimen including ATO (ATO group). The follow-up was performed in all APL children. The prognosis and incidence of side reactions from drugs in 2 groups were compared, and the high risk factors affecting the prognosis of patients were analyzed.
The median follow-up time was 49.8% months. In RIF group, no early death occured in 25 APL children; 5 cases did not achieve complete remission (CR) after induction therapy, CR rate was 88%. Out of 25 cases 2 caes relapsed, 3 cases died, 20 cases maintained contined CR (CCR), 2 cases failed to be followed-up. In ATO group, 2 cases suffered from early death, 5 cases did not achieve CR after induction therapy, CR rate was 90%, 2 caese relapsed and died, 15 cases maintained CCR, the follow-up failed in 1 caes. The 5 year- OS and EFS rate in all the patients were predicted as (82.2±6.2)% and (76.4±6.6)% respectively. The OS and EFS rate in RIF group were (86.1±7.4)% and (78.4±8.6)% respectively, which were significantly different from OS and EFS rate (76.4%±10.6%) and (74.0%±10.1%) respectively in ATO group (all P>0.05). As for the side reaction from drug, except for the cardiac damage (P<0.05), incidence of other side reactions was not significantly different between 2 groups (P>0.05). In addition, the 5 year-OS and EFS rates in APL children with CNSL were significantly lower than those in APL children without CNSL (all P<0.05), the 5 year OS and EFS rate in APL children did not reache M1 and with high risk were significantly lower than those in APL children reached M1 after induction therapy and with low and standerd risk (P<0.05 and P<0.05); the 5 year-OS and EFS rates did not correlate with age and sex.
The Fu Fang Huang Dai Pian shows the therapeutic efficacy on APL children same as ATO, moreover, no obvious enhancement in incidence of side reactions is observed, therefore, the Fu Fang Huang Dai Pian is effective and safe for treatment of APL children. The CNSL, poor respond to treatment, high risk in clinical stratification are high risk factors affecting prognosis of patients.
探讨复方黄黛片（RIF）与三氧化二砷（ATO）方案治疗儿童急性早幼粒细胞白血病（APL）的临床疗效，并探索影响患者预后的危险因素。
回顾性分析2004年1月至2017年5月我院收治的45例新诊断APL患儿的临床资料。45例APL患儿中，25例采用含RIF的化疗方案治疗（RIF组），另20例采用含ATO的化疗方案治疗（ATO组）。对所有APL患儿进行随访。比较两组患儿的预后及药物不良反应发生率，并分析影响患者预后的高危因素。
中位随访时间为49.8个月。RIF组25例APL患儿无早期死亡；诱导治疗后5例未达完全缓解（CR），CR率为88%。25例中2例复发，3例死亡，20例持续完全缓解（CCR），2例失访。ATO组2例早期死亡，诱导治疗后5例未达CR，CR率为90%，2例复发死亡，15例CCR，1例失访。所有患者的5年总生存率（OS）和无事件生存率（EFS）分别预计为（82.2±6.2）%和（76.4±6.6）%。RIF组的OS和EFS率分别为（86.1±7.4）%和（78.4±8.6）%，与ATO组的OS和EFS率分别为（76.4%±10.6%）和（74.0%±10.1%）相比，差异均无统计学意义（均P>0.05）。在药物不良反应方面，除心脏损害外（P<0.05），两组其他不良反应发生率差异无统计学意义（P>0.05）。此外，合并中枢神经系统白血病（CNSL）的APL患儿的5年OS和EFS率显著低于无CNSL的APL患儿（均P<0.05），诱导治疗未达M1且高危的APL患儿的5年OS和EFS率显著低于诱导治疗达M1且低危和中危的APL患儿（P<0.05和P<0.05）；5年OS和EFS率与年龄、性别无关。
复方黄黛片对APL患儿的治疗效果与ATO相当，且未观察到不良反应发生率明显增加，因此，复方黄黛片治疗APL患儿有效且安全。CNSL、治疗反应差、临床分层高危是影响患者预后的高危因素。
