低剂量和高剂量131I治疗中低危分化型甲状腺癌的随机对照研究

摘要

Objective To compare the ablation efficacy and therapy response with low-dose (1.1 GBq)and high-dose (3.7 GBq) 131I in postoperative patients with low and intermediate risk DTC.Methods A total of 140 patients (37 males,103 females,age range:18-75 years) were enrolled from October 2014 to June 2015,and randomly assigned to low-dose group (1.1 GBq 131I) and high-dose group (3.7 GBq 131I).Diagnostic whole body scan was performed (6±3) months after radioiodine (131I,185 MBq) therapy after LT4 withdrawal.TSH,FT3,FT4,Tg,TgAb and neck ultrasonography were also examined.x2 test and Fisher's exact test were used to analyze the data.Results The data of 132 patients (33 males,99 females,age range:18-75 years) could be evaluated,and the half of them received low-dose radioiodine and the other half received high-dose radioiodine.Thyroid ablation was complete in 55 patients (55.6％,55/99).The successful ablation rates in low-dose group and high-dose group were 52.7％ (29/55) and 59.1％ (26/44) respectively, with no significant difference (x2 =0.74,P=0.548).In the low-dose group,80.3％ (53/66)had excellent response,19.7％ (13/66) had indeterminate response,and no patients had biochemical incomplete response.In the high-dose group,the proportions were 84.8％ (56/66),10.6％ (7/66) and 4.5％ (3/66),respectively.There were no significant differences between the two groups (x2=4.88,P=0.087).Conclusion The ablation efficacy and therapy response between low-dose group and high-dose group have no significant differences in postoperative patients with low and intermediate risk DTC.%目的 分别使用低剂量(1.1 GBq)和高剂量(3.7 GBq)131I对经甲状腺全切术后的中低危DTC患者进行治疗,比较不同剂量131I的清除甲状腺残余组织(简称清甲)结果、患者对治疗的反应有无差异.方法 2014年10月至2015年6月,共140例(男37例,女103例,年龄18～75岁)患者入选.采用随机数字表法将经甲状腺全切术后的中低危DTC患者随机分配至低剂量组或高剂量组.(6±3)个月后评估停左甲状腺素钠患者的清甲结果,并评估所有患者对治疗的反应.定性资料的组间比较采用x2检验或Fisher确切概率法.结果 共132例(男33例,女99例,年龄18～75岁)患者完成试验,2组均为66例.清甲总体成功率55.6％ (55/99).低剂量组和高剂量组的清甲成功率分别为52.7％ (29/55)和59.1％(26/44),2组清甲结果差异无统计学意义(x2=0.74,P=0.548).低剂量组的反应良好率为80.3％(53/66),反应不确定发生率为19.7％ (13/66),无生化反应不完全者;高剂量组的反应良好率为84.8％(56/66),反应不确定发生率为10.6％(7/66),生化反应不完全者为4.5％(3/66).2组对治疗的反应结果差异无统计学意义(x2=4.88,P=0.087).结论 就甲状腺癌全切术后分期为T1N0-1M0的中低危DTC患者而言,使用低剂量和高剂量131I治疗的清甲结果和对治疗的反应差异均无统计学意义.