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一项多中心、前瞻性研究,旨在观察中国分化型甲状腺癌患者的初始治疗(DTCC 研究)。

A multicenter, prospective study to observe the initial management of patients with differentiated thyroid cancer in China (DTCC study).

机构信息

Department of Breast & Thyroid Surgery, Wuhan Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.

Department of Thyroid Surgery, West China Hospital, Sichuan University, Chengdu, China.

出版信息

BMC Endocr Disord. 2021 Oct 21;21(1):208. doi: 10.1186/s12902-021-00871-x.

Abstract

BACKGROUND

To assess the gaps between the initial management of patients with differentiated thyroid cancer (DTC) in real clinical practice and the recommendations of the 2012 Chinese DTC guidelines.

METHODS

This multicenter, prospective study was conducted at nine tertiary hospitals across China. Eligible patients were those having intermediate or high-risk DTC after first-time thyroidectomy. During 1 year of follow-up, comprehensive medical records were collected and summarized using descriptive statistics.

RESULTS

Of 2013 patients, 1874 (93.1%) underwent standard surgery according to the guidelines (including total lobectomy plus isthmusectomy and total/near total thyroidectomy), and 1993 (99.0%) underwent lymph node dissection; only 56 (2.8%) had postoperative complications. Overall, 982/2013 patients (48.8%) received radioactive iodine (RAI) therapy after thyroidectomy. Of all enrolled patients, 61.4% achieved the target serum thyroid-stimulating hormone level, with a median time to target of 234.0 days (95% CI: 222.0-252.0). At 1 year of follow-up, proportions of patients with excellent response, incomplete structural response, biochemical incomplete response, and indeterminate response were 34.6, 11.2, 6.6, and 47.5%, respectively; recurrence or metastasis occurred in 27 patients (1.3%). During the overall study period, 209 patients (10.4%) had at least one adverse event: 65.1% of cases were mild, 24.9% moderate, and 10.1% severe.

CONCLUSIONS

This was the first large-scale prospective study of how patients with DTC in China are treated in actual practice. Initial DTC management is generally safe and adheres to the 2012 Chinese guidelines but could be improved, and the level of guideline adherence did not produce the anticipated treatment response at 1 year of follow-up.

摘要

背景

评估中国分化型甲状腺癌(DTC)患者在真实临床实践中的初始管理与 2012 年中国 DTC 指南推荐之间的差距。

方法

这是一项在中国 9 家三级医院进行的多中心前瞻性研究。入选患者为初次甲状腺切除术后为中危或高危 DTC 的患者。在 1 年的随访期间,使用描述性统计方法收集并总结了全面的病历资料。

结果

在 2013 例患者中,1874 例(93.1%)根据指南行标准手术(包括甲状腺全切除术加峡部切除术和甲状腺全/近全切除术),1993 例(99.0%)行淋巴结清扫术;仅有 56 例(2.8%)发生术后并发症。总体而言,2013 例患者中有 982 例(48.8%)在甲状腺切除术后接受放射性碘(RAI)治疗。所有入组患者中,61.4%达到目标血清促甲状腺激素水平,达到目标的中位时间为 234.0 天(95%CI:222.0-252.0)。在 1 年随访时,完全缓解、不完全结构性缓解、生化不完全缓解和不确定反应的患者比例分别为 34.6%、11.2%、6.6%和 47.5%;27 例(1.3%)患者发生复发或转移。在整个研究期间,209 例(10.4%)患者至少发生 1 次不良事件:65.1%为轻度,24.9%为中度,10.1%为重度。

结论

这是中国首例关于 DTC 患者在实际实践中治疗方法的大型前瞻性研究。初始 DTC 管理通常是安全的,且符合 2012 年中国指南,但仍有改进空间,并且指南的遵循程度并未在 1 年随访时产生预期的治疗效果。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/035b/8529744/b203afd77082/12902_2021_871_Fig1_HTML.jpg

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