^(90)Sr-^(90)Y小剂量敷贴与噻吗洛尔局部外用及其联合应用治疗浅表型婴幼儿血管瘤的前瞻性队列研究  

Efficacy of ^(90)Sr-^(90)Y low dose applicator,topical timolol maleate,and the combination in the treatment of superficial infantile hemangioma:a prospective cohort study

作　　者：余丰文[1] 刘德军[1] 冯彦林[1] 黄克敏[1] 苏少弟[1] 肖菊梅[1] Yu Fengwen;Liu Dejun;Feng Yanlin;Huang Kemin;Su Shaodi;Xiao Jumei(Department of Nuclear Medicine,the First People′s Hospital of Foshan,Foshan 528000,China)

机构地区：[1]广东省佛山市第一人民医院核医学科,528000

出　　处：《中华核医学与分子影像杂志》2021年第5期280-285,共6页Chinese Journal of Nuclear Medicine and Molecular Imaging

基　　金：佛山市科技创新专项资金(2015AG10009)。

摘　　要：目的探讨^(90)Sr-^(90)Yβ射线小剂量敷贴治疗与噻吗洛尔局部外用及其联合应用治疗浅表型婴幼儿血管瘤的疗效及安全性。方法前瞻性纳入2013年5月14日至2017年4月11日广东省佛山市第一人民医院核医学科的400例浅表型血管瘤患儿[男126例,女274例,5.3(3.9,7.1)月龄]。按1∶1∶1∶1比例采用随机数字表法分为4组,分别采用噻吗洛尔局部外用(A组,对照组)、^(90)Sr-^(90)Yβ射线小剂量敷贴(B组)、单程敷贴联合噻吗洛尔(C组)、多程敷贴联合噻吗洛尔(D组)治疗。随访至第104周(W104),以W104前病灶治愈率为主要结局指标,比较不同治疗方案的疗效和安全性,采用Kruskal-Wallis秩和检验、Mann-Whitney U检验、logistic回归等分析数据。结果400例患儿共438处病灶,4组患儿及其病灶基线特征差异均无统计学意义(χ^(2)值:1.709~11.616,H值:3.681~7.653,均P>0.05)。截止至W104,失访病灶11处(2.51%,11/438)、早期退出32处(7.31%,32/438)、治愈357处(81.51%,357/438)、残留15处(3.42%,15/438)、反弹式增长23处(5.25%,23/438),4组患儿均未出现严重不良事件。多因素分析示,病灶厚度[<3 mm组比≥3 mm组比值比(OR)及其95%CI为16.689(7.908~35.223);χ^(2)=54.555,P<0.001]和治疗方案[以A为对照组,B、C、D组OR值(95%CI)分别为16.842(6.179~45.901)、4.801(2.167~10.638)、39.127(10.468~146.243);χ^(2)=47.663,P<0.001]是W104前治愈率的独立影响因子,^(90)Sr-^(90)Y小剂量敷贴治疗明显优于噻吗洛尔局部外用(OR=16.842,95%CI:6.179~45.901)。联合噻吗洛尔可明显减少敷贴治疗累积吸收剂量[D比B:16(8,16)与16(16,24)Gy;z=-4.947,P<0.001]。结论对于浅表型婴幼儿血管瘤,^(90)Sr-^(90)Y小剂量敷贴治疗明显优于噻吗洛尔局部外用,二者联合应用能明显减少敷贴治疗累积吸收剂量。Objective To investigate the clinical efficacy and safety of ^(90)Sr-^(90)Yβ-ray low dose applicator,topical timolol maleate,and their combination in the treatment of superficial infantile hemangioma(IH).Methods From May 14,2013 to April 11,2017,400 children(126 males,274 females,age 5.3(3.9,7.1)months)with superficial IH in Department of Nuclear Medicine,the First People′s Hospital of Foshan were prospectively enrolled.All patients were randomly divided into 4 treatment groups according to the proportion of 1∶1∶1∶1 by the method of random number table:topical timolol maleate(group A,control group),^(90)Sr-^(90)Yβ-ray low dose applicator(group B),single course applicator combined with timolol(group C),and multi-course applicator combined with timolol(group D).Lesions were followed up to the 104th week(W104).Cure rate of W104 was considered as primary end point.Efficacy and safety of different treatment were compared.Kruskal-Wallis rank sum test,Mann-Whitney U test,and logistic regression analysis were used for statistical analysis.Results Totally,438 lesions in 400 cases were included in this prospective study.There was no significant difference in baseline characteristics among 4 groups(χ^(2) values:1.709-11.616,H values:3.681-7.653,all P>0.05).As of W104,11 lesions(2.51%,11/438)were lost follow-up,32 lesions(7.31%,32/438)were with early withdrawal,357 lesions(81.51%,357/438)were cured,15 lesions(3.42%,15/438)were with residual,23 lesions(5.25%,23/438)were with rebound growth,and no serious adverse events occurred in the 4 groups.Multivariate analysis showed that lesions thickness(<3 mm vs≥3 mm,odd ratio(OR)=16.689,95%CI:7.908-35.223;χ^(2)=54.555,P<0.001)and treatment(considering group A as reference category,OR(95%CI)of group B,C and D were 16.842(6.179-45.901),4.801(2.167-10.638)and 39.127(10.468-146.243),respectively;χ^(2)=47.663,P<0.001)were independent factors affecting the cure rate of W104.^(90)Sr-^(90)Y low-dose fractionation radiotherapy was significantly better than topical timolol malea

关 键 词：血管瘤 婴儿 噻吗洛尔 近距离放射疗法 锶放射性同位素 钇放射性同位素 

分 类 号：R732.2[医药卫生—肿瘤]