RATIONALE & OBJECTIVE Although multiple lines of evidence suggest a negative impact of secondary hyperparathyroidism on patients with kidney failure treated by hemodialysis, it is uncertain whether patients can detect associated symptoms. The objective was to determine whether changes in parathyroid hormone (PTH) levels are associated with changes in symptoms within this patient population. STUDY DESIGN Prospective cohort. SETTING & PARTICIPANTS 165 adults with hyperparathyroidism secondary to kidney failure diagnosed, a range of dialysis vintages, and receiving regular hemodialysis from a US single-provider organization. EXPOSURE Change in PTH levels over 24 weeks. OUTCOMES 19 putative symptoms of secondary hyperparathyroidism measured up to 4 times using a self-administered questionnaire that assessed severity on a 5-level ordinal scale. ANALYTICAL APPROACH Longitudinal associations between changes in PTH levels and symptom severity were assessed using generalized additive models. RESULTS The 165 participants studied represented 81% of enrollees (N=204) who had sufficiently complete data for analysis. Mean age was 56 years and 54% were women. Increases in PTH levels over time were associated (P<0.1) with worsening of bone aches and stiffness, joint aches, muscle soreness, overall pain, itchy skin, and tiredness, and the effects were more pronounced with larger changes in PTH levels. LIMITATIONS Findings may have been influenced by confounding by unmeasured comorbid conditions, concomitant medications, and multiple testing coupled with a P value threshold of 0.10. CONCLUSIONS In this exploratory study, we observed that among patients with secondary hyperparathyroidism, increases in PTH levels over time were associated with worsening of 1 or more cluster of symptoms. Replication of these findings in other populations is needed before concluding about the magnitude and shape of these associations. If replicated, these findings could inform clinically useful approaches for measuring patient-reported outcomes related to secondary hyperparathyroidism.

中文翻译：

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维持性血液透析患者继发性甲状旁腺功能亢进的症状：一项前瞻性队列研究。

理由和目的尽管有许多证据表明，继发性甲状旁腺功能亢进症对血液透析治疗的肾衰竭患者具有负面影响，但尚不确定患者是否可以检测到相关症状。目的是确定该患者人群中甲状旁腺激素（PTH）水平的变化是否与症状的变化有关。研究设计前瞻性队列。地点和参与者165名患有继发于肾衰竭的甲状旁腺功能亢进症的成人被诊断出，接受了一系列透析，并接受了美国一家单一医疗机构的定期血液透析。暴露PTH水平在24周内发生变化。结果使用自我管理的问卷对多达5次序贯量表的严重程度进行评估，得出19次推定的继发性甲状旁腺功能亢进症状的评估，其结果高达4倍。分析方法使用广义加性模型评估PTH水平变化与症状严重程度之间的纵向联系。结果研究的165名参与者代表了81％的参与者（N = 204），他们有足够完整的数据进行分析。平均年龄为56岁，女性占54％。随着时间的推移，PTH水平的升高与骨痛和僵硬，关节痛，肌肉酸痛，整体疼痛，皮肤发痒和疲倦的恶化相关（P <0.1），并且随着PTH水平的较大变化，这种影响更加明显。局限性研究结果可能受到无法衡量的合并症混杂影响，并用药物，并进行多次测试，P值阈值为0.10。结论在这项探索性研究中，我们观察到继发性甲状旁腺功能亢进症患者中PTH水平随时间的升高与1种或多种症状的恶化相关。在总结这些关联的大小和形式之前，需要在其他人群中复制这些发现。如果被复制，这些发现可能会为临床上有用的方法，以测量与继发性甲状旁腺功能亢进有关的患者报告的结局。在总结这些关联的大小和形式之前，需要在其他人群中复制这些发现。如果被复制，这些发现可能会为临床上有用的方法，以测量与继发性甲状旁腺功能亢进有关的患者报告的结局。在总结这些关联的大小和形式之前，需要在其他人群中复制这些发现。如果被复制，这些发现可能会为临床上有用的方法，以测量与继发性甲状旁腺功能亢进有关的患者报告的结局。