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轻度无症状原发性甲状旁腺功能亢进症的手术治疗或监测:一项前瞻性随机临床试验。

Surgery or surveillance for mild asymptomatic primary hyperparathyroidism: a prospective, randomized clinical trial.

作者信息

Ambrogini Elena, Cetani Filomena, Cianferotti Luisella, Vignali Edda, Banti Chiara, Viccica Giuseppe, Oppo Annalisa, Miccoli Paolo, Berti Piero, Bilezikian John P, Pinchera Aldo, Marcocci Claudio

机构信息

Department of Endocrinology, University of Pisa, Via Paradisa 2, 56124 Pisa, Italy.

出版信息

J Clin Endocrinol Metab. 2007 Aug;92(8):3114-21. doi: 10.1210/jc.2007-0219. Epub 2007 May 29.

Abstract

CONTEXT

It is unclear whether patients with asymptomatic primary hyperparathyroidism (PHPT) do better with parathyroidectomy (PTx) as compared with conservative medical management.

OBJECTIVE

The aim of the study was to evaluate the beneficial effect of PTx vs. conservative management in patients with mild asymptomatic PHPT.

DESIGN

We conducted a prospective, randomized study.

SETTING

The study took place at a referral center.

PATIENTS

We studied 50 patients who did not meet any guidelines for parathyroid surgery as recommended by the National Institutes of Health Consensus Development Conference on Asymptomatic PHPT.

INTERVENTION

Patients were randomly assigned to PTx or no PTx and were evaluated at 6 months and at 1 yr.

MAIN OUTCOME MEASURES

We compared changes (percentage of basal) of lumbar spine bone mineral density (BMD) between the two groups at 1 yr.

RESULTS

The change in BMD at lumbar spine was greater after PTx (+4.16 +/- 1.13 for PTx vs. -1.12 +/- 0.71 for no PTx; P = 0.0002). The change in BMD at the total hip was also significantly greater in the PTx group (+2.61 +/- 0.71 for PTx vs. -1.88 +/- 0.60 for no PTx; P = 0.0001). There was no difference in BMD after 1 yr between both groups at the one-third radius site. In comparison with those who did not undergo surgery, the PTx subjects, after 1 yr, showed significant differences in four quality of life measures as determined by the 36-item short form health survey scale: bodily pain (P = 0.001), general health (P = 0.008), vitality (P = 0.003), and mental health (P = 0.017).

CONCLUSIONS

In patients with mild asymptomatic PHPT, successful PTx is followed by an improvement in BMD and quality of life. Most patients followed without surgery did not show evidence of progression.

摘要

背景

与保守药物治疗相比,无症状原发性甲状旁腺功能亢进症(PHPT)患者接受甲状旁腺切除术(PTx)是否效果更好尚不清楚。

目的

本研究旨在评估PTx与保守治疗对轻度无症状PHPT患者的有益效果。

设计

我们进行了一项前瞻性随机研究。

地点

研究在一家转诊中心进行。

患者

我们研究了50例不符合美国国立卫生研究院无症状PHPT共识发展会议推荐的任何甲状旁腺手术指南的患者。

干预措施

患者被随机分配接受PTx或不接受PTx,并在6个月和1年时进行评估。

主要观察指标

我们比较了两组在1年时腰椎骨密度(BMD)的变化(基础值的百分比)。

结果

PTx后腰椎BMD的变化更大(PTx组为+4.16±1.13,未接受PTx组为-1.12±0.71;P = 0.0002)。PTx组全髋BMD的变化也显著更大(PTx组为+2.61±0.71,未接受PTx组为-1.88±0.60;P = 0.0001)。两组在1年后桡骨三分之一处的BMD没有差异。与未接受手术的患者相比,接受PTx的患者在1年后,在由36项简短健康调查问卷量表确定的四项生活质量指标上显示出显著差异:身体疼痛(P = 0.001)、总体健康(P = 0.008)、活力(P = 0.003)和心理健康(P = 0.017)。

结论

在轻度无症状PHPT患者中,成功的PTx后骨密度和生活质量得到改善。大多数未接受手术的患者没有病情进展的证据。

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