目的比较静脉化学疗法(IVC)联合眼动脉灌注化学疗法(IAC)与单纯IAC治疗儿童视网膜母细胞瘤(RB)的临床疗效、预后及并发症情况。
方法采用队列研究方法，对2015年6月至2019年6月在郑州大学附属儿童医院治疗的眼内期RB患儿300例352眼进行随访。按照治疗方法将患儿分为2个组，其中IAC组140例160眼，接受IAC联合局部激光光凝或冷冻治疗，IVC+IAC组160例192眼，接受IVC联合IAC治疗。对2个组患儿的临床疗效(保眼率)、生存情况及并发症发生情况进行比较。采用Kaplan-Meier法进行生存分析。
结果患者随访2~60个月，随访期内IAC组和IVC+IAC组保眼率分别为85.62%(137/160)和81.21%(154/192)，组间比较差异无统计学意义( P>0.05)。IAC组患儿RB复发率为18.75%(30/160)，转移率为8.57%(12/140)，分别高于IVC+IAC组的10.94%(21/192)和3.13%(5/160)，差异均有统计学意义( χ 2＝4.299， P＝0.038； χ 2＝4.143， P＝0.042)。2个组患儿1年生存率比较差异无统计学意义( χ 2＝1.766， P＝0.184)；随访截止时，IVC+IAC组患儿总生存率为95.00%(152/160)，高于IAC组的88.57%(124/140)，差异有统计学意义( χ 2＝4.193， P＝0.041)。Kaplan-Meier分析显示，IVC+IAC组患儿总体无复发、无转移及总生存率均优于IAC组(均 P<0.05)。IAC组患儿眼睑水肿和/或下垂、眼底出血、眼球内陷及白内障发生率与IVC+IAC组比较差异均无统计学意义(均 P>0.05)，IAC组骨髓抑制发生率为32.14%(45/140)，低于IVC+IAC组的43.75%(70/160)，差异有统计学意义( χ 2＝4.255， P＝0.039)。
结论与单纯IAC治疗比较，IVC联合IAC疗法能够降低RB患儿的转移率和复发率，提高患儿生存率，但全身并发症的发生率较高。
ObjectiveTo compare the clinical efficacy, prognosis and complications between intravenous chemotherapy (IVC) combined with intra-arterial chemotherapy (IAC) and single IAC in the treatment of children retinoblastoma (RB).
MethodsA cohort study was performed.A 4-year follow-up of 300 children (352 eyes) with intraocular RB enrolled in the Children's Hospital Affiliated of Zhengzhou University from June 2015 to June 2019 was conducted.According to the different treatment methods, the children were divided into IAC group (140 cases, 160 eyes) treated with IAC combined with local laser photocoagulation/cryotherapy and IVC+ IAC group (160 cases, 192 eyes) receiving IVC combined with IAC treatment.The clinical efficacy (eye salvage rate), survival and complication incidence of the two groups were compared.The survival analysis was performed by Kaplan-Meier method.This study adhered to the Declaration of Helsinki.The study protocol was approved by the Ethics Committee of Children's Hospital Affiliated of Zhengzhou University (No.20150503). Written informed consent was obtained from custodians of each child prior to their entering into the cohort.
ResultsAll of the children were followed up for 2-60 months.Within the follow-up, the eye retention rate of the IAC group and IVC+ IAC group was 85.62%(137/160) and 81.21%(154/192) respectively, without statistically significant difference ( P>0.05). The recurrence rate and metastasis rate of IAC group were 18.75%(30/160) and 8.57%(12/140), which were significantly higher than 10.94%(21/192) and 3.13%(5/160) of IVC+ IAC group ( χ 2=4.299, P=0.038; χ 2=4.143, P=0.042). There was no significant difference in one-year survival rate between the two groups ( χ 2=1.766, P=0.184), but the overall survival rate of IVC+ IAC group was 95.00%(152/160), significantly higher than 88.57%(124/140) of IAC group ( χ 2=4.193, P=0.041). Kaplan-Meier analysis showed that the overall recurrence-free, metastasis-free and survival rate of IVC+ IAC group were better than those of IAC group, and the differences were statistically significant (all at P<0.05). There was no significant difference in the incidence of eyelid edema and/or ptosis, fundus hemorrhage, enophthalmos and cataract between the two groups (all at P>0.05). The incidence of myelosuppression was 32.14%(45/140) in IAC group, significantly lower than 43.75%(70/160) of IVC+ IAC group ( χ 2=4.255, P=0.039).
ConclusionsCompared with single IAC treatment, IVC combined with IAC can reduce the metastasis rate, recurrence rate in RB child patient and improve the survival rate, but it is with relatively high incidence of systemic complications.
狄奇,申刚,时胜利,等. 眼动脉介入化学疗法与全身静脉－眼动脉联合化学疗法对儿童视网膜母细胞瘤的疗效比较[J]. 中华实验眼科杂志,2022,40(11)：1071-1077.
DOI:10.3760/cma.j.cn115989-20200917-00652版权归中华医学会所有。
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狄奇：参与研究设计、文章起草、文章审核及修改；申刚、张婧：参与研究设计、治疗方案的制定、文章修改；时胜利、卢跃兵：病例收集；刘景、胡靖：研究数据的统计分析及解释；陈志平：参与研究选题及设计、审核文章内容的准确性、可靠性及完整性，并对研究中的所有环节进行把关
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