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rhTSH 辅助放射性碘治疗毒性甲状腺肿。

Recombinant human thyrotropin (rhTSH)-aided radioiodine treatment for non-toxic multinodular goitre.

机构信息

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

Nuclear Medicine, Affiliated XinHua Hospital of Medical School Shanghai Jiaotong University, Shanghai, China.

出版信息

Cochrane Database Syst Rev. 2021 Dec 28;12(12):CD010622. doi: 10.1002/14651858.CD010622.pub2.

Abstract

BACKGROUND

Multinodular goitre is common in women. Treatments for non-toxic multinodular goitre include surgery, levothyroxine suppressive therapy, and radioiodine. Radioiodine therapy is the only non-surgical alternative for non-toxic multinodular goitre. However, a high amount of radioiodine is needed to enable the thyroid nodules to adequately take up the radioiodine, because the multinodular goitre takes up a low amount of iodine. Recombinant human thyrotropin (rhTSH) has been used to increase radioiodine uptake and reduce thyroid volume of the multinodular goitre. Whether the improved reduction of the goitre resulting from rhTSH-stimulated radioiodine therapy is beneficial to the person remains controversial.

OBJECTIVES

To assess the effects of recombinant human thyrotropin-aided radioiodine treatment for non-toxic multinodular goitre.

SEARCH METHODS

We searched the CENTRAL, MEDLINE, Scopus as well as ICTRP Search Portal and ClinicalTrials.gov. The date of the last search of all databases was 18 December 2020.

SELECTION CRITERIA

We included randomised controlled clinical trials (RCTs) comparing the effects of rhTSH-aided radioiodine treatment compared with radioiodine alone for non-toxic multinodular goitre, with at least 12 months of follow-up.

DATA COLLECTION AND ANALYSIS

Two review authors independently screened titles and abstracts for relevance. Screening for inclusion, data extraction, and risk of bias assessment were carried out by one review author and checked by a second. Our main outcomes were health-related quality of life (QoL), hypothyroidism, adverse events, thyroid volume, all-cause mortality, and costs. We used a random-effects model to perform meta-analyses, and calculated risk ratios (RRs) for dichotomous outcomes, and mean differences (MDs) for continuous outcomes, using 95% confidence intervals (CIs) for effect estimates. We evaluated the certainty of the evidence using the GRADE approach.

MAIN RESULTS

We included six RCTs. A total of 197 participants were allocated to rhTSh-aided radioiodine therapy, and 124 participants were allocated to radioiodine. A single dose of radioiodine was administered 24 hours after the intramuscular injection of a single dose of rhTSH. The duration of follow-up ranged between 12 and 36 months. Low-certainty evidence from one study, with 85 participants, showed uncertain effects for QoL for either intervention. RhTSH-aided radioiodine increased hypothyroidism compared with radioiodine alone (64/197 participants (32.5%) in the rhTSH-aided radioiodine group versus 15/124 participants (12.1%) in the radioiodine alone group; RR 2.53, 95% CI 1.52 to 4.20; 6 studies, 321 participants; moderate-certainty evidence in favour of radioiodine alone). A total of 118/197 participants (59.9%) in the rhTSH-aided radioiodine group compared with 60/124 participants (48.4%) in the radioiodine alone group experienced adverse events (random-effects RR 1.24, 95% CI 0.94 to 1.63; 6 studies, 321 participants; fixed-effect RR 1.23, 95% CI 1.02 to 1.49 in favour of radioiodine only; low-certainty evidence). RhTSH-aided radioiodine reduced thyroid volume with a MD of 11.9% (95% CI 4.4 to 19.4; 6 studies, 268 participants; moderate-certainty evidence). One study with 28 participants reported one death in the radioiodine alone group (very-low certainty evidence). No study reported on costs.

AUTHORS' CONCLUSIONS: RhTSH-aided radioiodine treatment for non-toxic multinodular goitre, compared to radioiodine alone, probably increased the risk of hypothyroidism but probably led to a greater reduction in thyroid volume. Data on QoL and costs were sparse or missing.

摘要

背景

多结节性甲状腺肿在女性中很常见。治疗非毒性多结节性甲状腺肿的方法包括手术、左甲状腺素抑制治疗和放射性碘治疗。放射性碘治疗是非毒性多结节性甲状腺肿的唯一非手术选择。然而,需要大量的放射性碘才能使甲状腺结节充分摄取放射性碘,因为多结节性甲状腺肿摄取的碘量较低。重组人促甲状腺激素(rhTSH)已被用于增加放射性碘的摄取并减少多结节性甲状腺肿的甲状腺体积。rhTSH 刺激放射性碘治疗引起的甲状腺肿减少是否对患者有益仍然存在争议。

目的

评估重组人促甲状腺激素辅助放射性碘治疗非毒性多结节性甲状腺肿的效果。

检索方法

我们检索了 CENTRAL、MEDLINE、Scopus 以及 ICTRP 检索门户和 ClinicalTrials.gov。所有数据库的最后一次检索日期是 2020 年 12 月 18 日。

选择标准

我们纳入了比较 rhTSH 辅助放射性碘治疗与单独放射性碘治疗非毒性多结节性甲状腺肿的随机对照临床试验(RCT),随访时间至少 12 个月。

数据收集和分析

两名综述作者独立筛选标题和摘要以确定相关性。纳入标准筛选、数据提取和偏倚风险评估由一名综述作者进行,由第二名综述作者进行检查。我们的主要结局是健康相关生活质量(QoL)、甲状腺功能减退症、不良事件、甲状腺体积、全因死亡率和成本。我们使用随机效应模型进行荟萃分析,并使用 95%置信区间(CI)计算二分类结局的风险比(RR)和连续结局的均数差(MD)。我们使用 GRADE 方法评估证据的确定性。

主要结果

我们纳入了六项 RCT。共有 197 名参与者被分配接受 rhTSh 辅助放射性碘治疗,124 名参与者被分配接受放射性碘治疗。在肌内注射 rhTSH 后 24 小时给予单次放射性碘剂量。随访时间在 12 至 36 个月之间。来自一项研究的低确定性证据(85 名参与者)显示,两种干预措施对 QoL 的影响不确定。rhTSH 辅助放射性碘治疗与单独放射性碘治疗相比,更可能导致甲状腺功能减退症(rhTSH 辅助放射性碘组 197 名参与者中有 64 名(32.5%),单独放射性碘组 124 名参与者中有 15 名(12.1%);RR 2.53,95%CI 1.52 至 4.20;6 项研究,321 名参与者;支持单独放射性碘的中等确定性证据)。rhTSH 辅助放射性碘组 197 名参与者中有 118 名(59.9%),单独放射性碘组 124 名参与者中有 60 名(48.4%)经历了不良事件(随机效应 RR 1.24,95%CI 0.94 至 1.63;6 项研究,321 名参与者;固定效应 RR 1.23,95%CI 1.02 至 1.49,支持单独放射性碘;低确定性证据)。rhTSH 辅助放射性碘治疗可使甲状腺体积减少 11.9%(95%CI 4.4 至 19.4;6 项研究,268 名参与者;中等确定性证据)。一项有 28 名参与者的研究报告称,单独放射性碘组有 1 例死亡(极低确定性证据)。没有研究报告成本。

作者结论

与单独放射性碘治疗相比,rhTSH 辅助放射性碘治疗非毒性多结节性甲状腺肿可能会增加甲状腺功能减退症的风险,但可能会导致甲状腺体积更大程度的减少。关于 QoL 和成本的数据稀疏或缺失。

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