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低剂量与高剂量放射性碘用于甲状腺残余消融的长期疗效。

Long-Term Outcome of Low- and High-Dose Radioiodine for Thyroid Remnant Ablation.

机构信息

Department of Nuclear Medicine, Xin Hua Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China.

Department of Nuclear Medicine, Shanghai Tenth People's Hospital, Tongji University School of Medicine, Shanghai, China.

出版信息

Clin Endocrinol (Oxf). 2024 Dec;101(6):682-689. doi: 10.1111/cen.15134. Epub 2024 Sep 4.

Abstract

OBJECTIVE

We conducted a prospective randomized clinical trial to compare the efficacy of low- and high-dose radioiodine for remnant ablation in patients with low-risk differentiated thyroid cancer (DTC) in China. The first-stage results showed equivalence was observed between the two groups. Here, we report recurrence and survival at 3-5 and 6-10 years and biochemical parameters.

DESIGN, PATIENTS AND METHODS: Between January 2013 and December 2014, adult patients with DTC were enroled. Patients had undergone total or near-total thyroidectomy, with or without cervical lymph node dissection, with tumour stages T1-T3 with or without lymph node metastasis, but without distant metastasis. Patients were randomly assigned to the low-dose (1850 MBq) or high-dose (3700 MBq) radioiodine group. They were then followed up for 3-5 and 6-10 years. Data on biochemical abnormalities, recurrence and survival were analysed using Kolmogorov-Smirnov and χ tests.

RESULTS

The data of 228 patients (mean age = 42 years; 70.6% women) were analysed, with 117 patients in the low-dose group and 111 in the high-dose group. There were no significant differences in biochemical abnormalities, recurrence, or survival rates at the 6-10-year follow-up (all p > .05). Nine patients experienced recurrence in the low-dose group (8.7%), while eight patients experienced recurrence in the high-dose group (8.2%). The survival rates were 100% and 98.2% in the low- and high-dose groups, respectively.

CONCLUSIONS

The long-term effectiveness and safety of low-dose (1850 MBq) radioiodine are the same as those of high-dose (3700 MBq) radioiodine for thyroid remnant ablation in Chinese patients with low-risk DTC.

摘要

目的

我们进行了一项前瞻性随机临床试验,以比较中国低危分化型甲状腺癌(DTC)患者中低剂量和高剂量放射性碘用于残留消融的疗效。第一阶段结果表明两组之间存在等效性。在此,我们报告了 3-5 年和 6-10 年的复发和生存情况以及生化参数。

设计、患者和方法:2013 年 1 月至 2014 年 12 月期间,纳入了 DTC 成年患者。患者接受了全甲状腺切除术或近全甲状腺切除术,伴或不伴颈部淋巴结清扫术,肿瘤分期为 T1-T3,伴或不伴淋巴结转移,但无远处转移。患者被随机分配到低剂量(1850 MBq)或高剂量(3700 MBq)放射性碘组。然后对他们进行了 3-5 年和 6-10 年的随访。使用 Kolmogorov-Smirnov 和 χ 检验分析生化异常、复发和生存率的数据。

结果

分析了 228 例患者(平均年龄 42 岁;70.6%为女性)的数据,其中低剂量组 117 例,高剂量组 111 例。在 6-10 年随访时,生化异常、复发或生存率均无显著差异(均 P>.05)。低剂量组有 9 例(8.7%)患者发生复发,高剂量组有 8 例(8.2%)患者发生复发。低剂量组和高剂量组的生存率分别为 100%和 98.2%。

结论

低剂量(1850 MBq)放射性碘用于中国低危 DTC 患者甲状腺残留消融的长期疗效和安全性与高剂量(3700 MBq)放射性碘相同。

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