National Institute of Dental and Craniofacial Research, National Institutes of Health, Bethesda, MD, USA.
Rehabilitation Medicine Department, Clinical Center, National Institutes of Health, Bethesda, MD, USA.
J Bone Miner Res. 2022 Jan;37(1):68-77. doi: 10.1002/jbmr.4452. Epub 2021 Oct 18.
In addition to hypocalcemia, patients with hypoparathyroidism report poor quality of life (QOL), complaining of fatigue and "brain fog." Parathyroid hormone (PTH) therapy can effectively manage hypocalcemia; however, the effects of PTH treatment on QOL are unclear. Thirty-one patients with hypoparathyroidism were treated in an open-label study with full replacement subcutaneous PTH 1-34 twice daily for up to 5.3 years, with individualized fine-dosing titration. Prior to initiation of PTH 1-34, conventional therapy was optimized. The 36-Item Short Form (SF-36) Health Survey, Fatigue Symptom Inventory (FSI), and 6-minute walk test (6MWT) were assessed at PTH start (baseline), every 6 months on PTH, and after PTH discontinuation. The SF-36 assesses physical function (PF), physical role limitations (RP), bodily pain (BP), general health (GH), vitality (VT), emotional role limitations (RE), social function (SF), and mental health (MH). Compared to population norms, patients at baseline had lower scores in RP, GH, VT, and MH (p < 0.05), consistent with impaired QOL. With PTH therapy, only GH at 6 months and VT at 12 months improved (p < 0.05). At the last treatment time point, RP, VT, and SF improved compared to baseline (p < 0.05). However, follow-up scores were unchanged from baseline or last PTH treatment, except for SF, which had decreased at follow-up compared to on-PTH (p < 0.05). On the FSI, there were no changes in fatigue frequency; perceived interference was improved at 12 and 18 months and composite severity was improved only at 60 months (p < 0.05). The 6MWT measures did not change. In conclusion, hypoparathyroidism is associated with decreased QOL. Despite the bias in open-label studies to predict improvements in QOL, PTH therapy had limited and non-sustained effects on QOL, inconclusive changes in fatigue experience, and no change in the 6MWT. Although PTH 1-34 can adequately manage the hypocalcemia in hypoparathyroidism, its effects on QOL appear to be minimal. © 2021 American Society for Bone and Mineral Research (ASBMR). This article has been contributed to by US Government employees and their work is in the public domain in the USA.
除了低钙血症外,甲状旁腺功能减退症患者还报告生活质量(QOL)较差,抱怨疲劳和“脑雾”。甲状旁腺激素(PTH)治疗可有效管理低钙血症;然而,PTH 治疗对 QOL 的影响尚不清楚。31 例甲状旁腺功能减退症患者在一项开放标签研究中接受了每日两次皮下全替代 PTH 1-34 的治疗,最长达 5.3 年,并进行个体化精细剂量滴定。在开始 PTH 1-34 治疗之前,优化了常规治疗。在开始 PTH 治疗时(基线)、每 6 个月进行一次 PTH 治疗以及 PTH 停药后,使用 36 项简短健康调查问卷(SF-36)、疲劳症状量表(FSI)和 6 分钟步行试验(6MWT)进行评估。SF-36 评估身体功能(PF)、身体角色限制(RP)、身体疼痛(BP)、一般健康(GH)、活力(VT)、情感角色限制(RE)、社会功能(SF)和心理健康(MH)。与人群正常值相比,患者基线时 RP、GH、VT 和 MH 评分较低(p<0.05),与 QOL 受损一致。随着 PTH 治疗,只有 6 个月时的 GH 和 12 个月时的 VT 有所改善(p<0.05)。在最后一次治疗时间点,与基线相比,RP、VT 和 SF 有所改善(p<0.05)。然而,除了 SF 之外,随访评分与基线或最后一次 PTH 治疗时的评分没有变化,SF 在随访时的评分低于 PTH 时的评分(p<0.05)。FSI 中,疲劳频率没有变化;在 12 个月和 18 个月时,感知干扰有所改善,仅在 60 个月时复合严重程度有所改善(p<0.05)。6MWT 测量值没有变化。总之,甲状旁腺功能减退症与生活质量下降有关。尽管开放标签研究存在预测 QOL 改善的偏差,但 PTH 治疗对 QOL 的影响有限且不持久,疲劳体验的变化不确定,6MWT 无变化。虽然 PTH 1-34 可以充分管理甲状旁腺功能减退症的低钙血症,但它对 QOL 的影响似乎很小。©2021 年美国骨骼与矿物质研究协会(ASBMR)。本文由美国政府雇员撰写,其工作属于公共领域。