Section of Specialized Endocrinology, Oslo University Hospital, Oslo, Norway.
Faculty of Medicine, University of Oslo, Oslo, Norway.
J Bone Miner Res. 2021 Jan;36(1):3-11. doi: 10.1002/jbmr.4199. Epub 2020 Nov 22.
Primary hyperparathyroidism (PHPT) was previously considered a disease presenting with multiorgan involvement and a wide range of symptoms. Today, the disease presents with no symptoms or mild symptomatology in most patients. Data regarding nonspecific symptoms such as pain, fatigue, memory loss, depression, and other neuropsychiatric signs have been ambiguous, and results from prospective long-term randomized control trials are lacking. The Scandinavian Investigation on Primary Hyperparathyroidism (SIPH) is a prospective randomized controlled trial (RCT) with 10-year follow up, comparing parathyroidectomy (PTX) to observation without any treatment (OBS). From 1998 to 2005, 191 patients with mild PHPT were included from Sweden, Norway, and Denmark. A total of 95 patients were randomized to PTX and 96 to OBS. The generic Short Form-36 survey (SF-36) and the Comprehensive Psychopathological Rating Scale (CPRS) were studied at baseline, 2, 5, and 10 years after randomization. After 10 years, the PTX group scored significantly better on vitality (PTX 65.1 ± 20.2 versus OBS 57.4 ± 22.7; p = .017) compared to the OBS group in SF-36. We found no differences between the groups in the physical subscales. The OBS group had no significant change in any of the SF-36 scores throughout the study. The CPRS showed an improvement of symptoms in both groups for single items and sum scores after 10 years compared to baseline. There were, however, no significant differences between the two groups in the CPRS data. The results of this large and long-term RCT indicate improvement in some of the mental domains of SF-36 following PTX. However, the treatment effects between the groups were subtle with uncertain clinical significance. The observation group had stable SF-36 values and improvement in CPRS symptom-scores. Thus, in considering only quality of life (QoL) and in the absence of declines in renal and skeletal parameters, it may be safe to observe patients with mild PHPT for a decade. © 2020 American Society for Bone and Mineral Research (ASBMR).
原发性甲状旁腺功能亢进症（PHPT）以前被认为是一种多器官受累且症状广泛的疾病。如今，大多数患者的疾病没有症状或仅有轻微的症状表现。关于疼痛、疲劳、记忆力减退、抑郁和其他神经精神症状等非特异性症状的数据一直存在争议，而且缺乏前瞻性长期随机对照试验的结果。斯堪的纳维亚原发性甲状旁腺功能亢进症研究（SIPH）是一项具有 10 年随访的前瞻性随机对照试验（RCT），比较了甲状旁腺切除术（PTX）与无任何治疗的观察（OBS）。1998 年至 2005 年，从瑞典、挪威和丹麦纳入了 191 例轻度 PHPT 患者。共有 95 例患者被随机分配至 PTX 组，96 例患者被分配至 OBS 组。在随机分组后 2、5 和 10 年时，使用通用 36 项简短健康调查量表（SF-36）和全面精神病理评定量表（CPRS）进行了研究。10 年后，PTX 组在 SF-36 的活力方面的评分明显高于 OBS 组（PTX 组 65.1 ± 20.2 分，OBS 组 57.4 ± 22.7 分；p =.017）。我们发现两组在身体亚量表方面没有差异。整个研究过程中，OBS 组的 SF-36 评分均无显著变化。CPRS 显示，与基线相比，两组的单个项目和总分在 10 年后的症状均有所改善。然而，CPRS 数据两组之间没有差异。这项大型长期 RCT 的结果表明，PTX 后一些 SF-36 的心理领域有所改善。然而，两组之间的治疗效果很细微，临床意义不确定。观察组的 SF-36 值稳定，CPRS 症状评分有所改善。因此，仅考虑生活质量（QoL），并且在肾和骨骼参数没有下降的情况下，对轻度 PHPT 患者进行 10 年观察可能是安全的。 © 2020 美国骨矿研究学会（ASBMR）。
