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

Low-dose and high-dose 131I therapy for low and intermediate risk differentiated thyroid cancer： a randomized controlled clinical study

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.

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＆#39;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.