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甲状腺乳头状微小癌主动监测的临床试验

Clinical Trials of Active Surveillance of Papillary Microcarcinoma of the Thyroid.

作者信息

Miyauchi Akira

机构信息

Kuma Hospital, Center for Excellence in Thyroid Care, Kobe, Japan.

Department of Surgery, Kuma Hospital, 8-2-35 Shimoyamate-dori, Chuo-ku, Kobe, 650-0011, Japan.

出版信息

World J Surg. 2016 Mar;40(3):516-22. doi: 10.1007/s00268-015-3392-y.

DOI:10.1007/s00268-015-3392-y
PMID:26744340
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC4746213/
Abstract

BACKGROUND

The incidence of thyroid cancer is increasing globally. This is mainly due to the increase in the detection of small papillary carcinomas, including papillary microcarcinomas (PMC) 1 cm or smaller. It was suggested recently that PMCs are overdiagnosed and overtreated.

METHODS

In 1993, the author proposed a clinical trial to compare surgery and observation for low-risk PMC at doctors' meeting in Kuma Hospital, which was approved and the trial started in the same year. Patients choose immediate surgery or observation. This paper shares our 22-year experience with the active surveillance of more than 2000 patients with low-risk PMC and compares the outcomes of immediate surgery with that of active observation.

RESULTS

The oncological outcomes of these management groups were similarly excellent. In our active surveillance trial on 1235 patients, 8% of patients showed tumor enlargement by 3 mm or more at 10 years of observation, and 3.8% of the patients showed novel appearance of lymph node metastasis at 10 years. Patients 40 years or younger tended to show progression of the disease. Patients with these slight progressions of the disease were successfully treated with a rescue surgery. None of the patients in both study groups died of the disease. However, incidences of unfavorable events, such as temporary vocal cord paralysis (VCP) and temporary and permanent hypoparathyroidism, were significantly higher in the immediate surgery group than in the observation group (4.1 vs. 0.6%, p < 0.0001; 16.7 vs. 2.8%, p < 0.0001; and 1.6 vs. 0.08%, p < 0.0001, respectively). Permanent VCP occurred in two of the surgery group.

CONCLUSIONS

As a result, although we still offer two options, immediate surgery or observation, to patients with low-risk PMC at Kuma Hospital, we now strongly recommend observation as the best choice.

摘要

背景

全球甲状腺癌的发病率正在上升。这主要是由于小乳头状癌(包括直径1厘米及以下的微小乳头状癌,即PMC)的检出率增加。最近有人提出,PMC存在过度诊断和过度治疗的情况。

方法

1993年,作者在熊本医院的医生会议上提出了一项临床试验,比较低风险PMC的手术治疗和观察等待,该试验获得批准并于同年开始。患者可选择立即手术或观察等待。本文分享了我们对2000多名低风险PMC患者进行主动监测的22年经验,并比较了立即手术与主动观察的结果。

结果

这些治疗组的肿瘤学结果同样出色。在我们对1235例患者的主动监测试验中,8%的患者在观察10年时肿瘤增大3毫米或更多,3.8%的患者在10年时出现新的淋巴结转移。40岁及以下的患者往往疾病进展。这些疾病有轻微进展的患者通过补救手术成功治愈。两个研究组均无患者死于该疾病。然而,立即手术组的不良事件发生率,如暂时性声带麻痹(VCP)、暂时性和永久性甲状旁腺功能减退,明显高于观察组(分别为4.1%对0.6%,p < 0.0001;16.7%对2.8%,p < 0.0001;1.6%对0.08%,p < 0.0001)。手术组有两名患者发生永久性VCP。

结论

因此,尽管在熊本医院我们仍为低风险PMC患者提供立即手术或观察等待这两种选择,但我们现在强烈推荐观察等待作为最佳选择。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/8889/4746213/874ca0d01069/268_2015_3392_Fig4_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/8889/4746213/5e1ecc46505f/268_2015_3392_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/8889/4746213/2392af4f4af8/268_2015_3392_Fig2_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/8889/4746213/33fff736a789/268_2015_3392_Fig3_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/8889/4746213/874ca0d01069/268_2015_3392_Fig4_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/8889/4746213/5e1ecc46505f/268_2015_3392_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/8889/4746213/2392af4f4af8/268_2015_3392_Fig2_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/8889/4746213/33fff736a789/268_2015_3392_Fig3_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/8889/4746213/874ca0d01069/268_2015_3392_Fig4_HTML.jpg

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