Thamcharoenvipas Siwaporn, Kerr Stephen J, Tepmongkol Supatporn
Division of Nuclear Medicine, Department of Radiology.
Biostatistics Excellence Centre.
Medicine (Baltimore). 2019 May;98(19):e15573. doi: 10.1097/MD.0000000000015573.
Rapid I-131 turnover Graves' disease patients have low cure rate. We aimed to compare cure percentage at 12 months among 3 treatment doses of I-131 with or without lithium carbonate (LiCO3) in rapid turnover Graves' disease patients.
Sixty Graves' disease patients referred for radioactive iodine treatment were randomised into three arms of treatment: Group A, 3.7 MBq I-131/g thyroid plus 600 mg/day LiCO3, Group B, 5.55 MBq I-131/g plus 600 mg/day LiCO3, and Group C, 7.4 MBq I-131/g without LiCO3. Data were collected at baseline, 3, 6, 9, and 12 months. The primary endpoint were cure rates (percentage of euthyroid or hypothyroid) at 12 months. Pairwise comparisons were made across 3 groups using an equality of proportions test. The secondary endpoint, the odds of cure over the total follow-up for group B and C versus group A, was analyzed using generalized estimating equation (GEE). Side effects of I-131 and LiCO3 treatment were evaluated at 1 to 2 weeks after treatment.
The cure rate at 12 months was 45% (9/20) for group A, 60% (12/20) for group B and 80% (16/20) for group C. The mean difference in proportion cured at 12 months between group C and group A was 35 (7.0 to 66.8)%; P-value = .02. There was a statistically significant difference between cure rates over all follow-up of group C and A after adjustment for sex (adjusted OR = 3.09; 95%CI = 1.32-7.20; P-value = .009), but no significant difference was found between group B and A or C and B in the primary and/or secondary efficacy endpoints. Side effects from the treatment were found in 12% (7/60); 2 in group A, 4 in group B, and 1 in group C. Four of these were likely due to LiCO3 side effects.
Treatment of rapid turnover Graves' disease patients with high dose I-131 (7.4 MBq/g) provides significantly higher cure rates at 12 months, and 3 times odds of cure than 3.7 MBq/g I-131 plus LiCO3 with lesser side effects. We thus recommend 7.4 MBq I-131/g for treatment in these patients.
I - 131代谢迅速的格雷夫斯病患者治愈率较低。我们旨在比较I - 131三种治疗剂量联合或不联合碳酸锂（LiCO3）治疗I - 131代谢迅速的格雷夫斯病患者12个月时的治愈率。
60例接受放射性碘治疗的格雷夫斯病患者被随机分为三个治疗组：A组，3.7MBq I - 131/g甲状腺 + 600mg/天LiCO3；B组，5.55MBq I - 131/g + 600mg/天LiCO3；C组，7.4MBq I - 131/g且不使用LiCO3。在基线、3个月、6个月、9个月和12个月时收集数据。主要终点是12个月时的治愈率（甲状腺功能正常或减退的百分比）。使用比例相等检验对三组进行两两比较。次要终点，即B组和C组相对于A组在整个随访期间治愈的几率，使用广义估计方程（GEE）进行分析。在治疗后1至2周评估I - 131和LiCO3治疗的副作用。
A组12个月时的治愈率为45%（9/20），B组为60%（12/20），C组为80%（16/20）。C组和A组12个月时治愈比例的平均差异为35（7.0至66.8）%；P值 = 0.02。在对性别进行调整后，C组和A组在整个随访期间的治愈率存在统计学显著差异（调整后的OR = 3.09；95%CI = 1.32 - 7.20；P值 = 0.009），但在主要和/或次要疗效终点方面，B组与A组或C组与B组之间未发现显著差异。治疗的副作用发生率为12%（7/60）；A组2例，B组4例，C组1例。其中4例可能是由于LiCO3的副作用。
用高剂量I - 131（7.4MBq/g）治疗I - 131代谢迅速的格雷夫斯病患者，12个月时治愈率显著更高，治愈几率是3.7MBq/g I - 131加LiCO3的3倍，且副作用较小。因此，我们推荐在这些患者中使用7.4MBq I - 131/g进行治疗。
