Department of Thyroid & Parathyroid Surgery, West China Hospital, Sichuan University, Chengdu, Sichuan, China.
Laboratory of thyroid and parathyroid disease, Frontiers Science Center for Disease-related Molecular Network, West China Hospital, Sichuan University, Chengdu, Sichuan, China.
Endocrine. 2022 Feb;75(2):583-592. doi: 10.1007/s12020-021-02921-9. Epub 2021 Nov 8.
Current guidelines for calcium supplementation for parathyroid function recovery after thyroidectomy are based on low-quality evidence. The present trial compared the effects of oral calcium and vitamin D supplementation on the recovery of parathyroid function when administered routinely or exclusively to symptomatic patients.
This prospective, randomized, open-label clinical trial analyzed 203 patients who underwent total thyroidectomy and developed hypoparathyroidism on postoperative day 1 (POD1) with median age of 41 years and proportion of women of 77.8%. Participants were randomized to group A (calcium and vitamin D supplementation administered only to symptomatic patients) and group B (routine supplementation). The primary outcome was the incidence of protracted hypoparathyroidism in the two groups. Secondary outcomes included risk factors for postoperative protracted hypoparathyroidism and the incidence of symptomatic hypocalcemia.
The incidence of protracted hypoparathyroidism was not significantly different between group A and group B (11 of 99 vs. 17 of 104, P = 0.280). Parathyroid hormone (PTH) in group B exhibited a better recovery tendency. The incidence of postoperative symptomatic hypocalcemia in group B was significantly lower than group A (26.92% vs. 42.42%, P = 0.020). Independent factors predicting protracted hypoparathyroidism included sex, preoperative serum calcium, and POD1 PTH.
Calcium and vitamin D supplementation administered exclusively to symptomatic patients achieved the same effect on protracted hypoparathyroidism as routine supplementation. However, routine supplementation significantly reduced postoperative hypocalcemia. Extra attention is necessary in female patients with high preoperative serum calcium and patients with low POD1 PTH.
Chinese Clinical Trial Registry (ChiCTR), ChiCTR1900022194. Registered March 30, 2019.
目前关于甲状旁腺功能恢复术后补钙的指南主要基于低质量证据。本试验比较了常规或仅用于有症状患者时口服钙和维生素 D 补充对甲状旁腺功能恢复的影响。
这是一项前瞻性、随机、开放标签的临床试验，共纳入 203 例行甲状腺全切除术并于术后第 1 天（POD1）发生甲状旁腺功能减退的患者，其平均年龄为 41 岁，女性比例为 77.8%。患者被随机分为 A 组（仅对有症状的患者给予钙和维生素 D 补充）和 B 组（常规补充）。主要结局是两组患者持续性甲状旁腺功能减退的发生率。次要结局包括术后持续性甲状旁腺功能减退的危险因素和有症状低钙血症的发生率。
A 组和 B 组持续性甲状旁腺功能减退的发生率无显著差异（99 例中有 11 例，104 例中有 17 例，P=0.280）。B 组甲状旁腺激素（PTH）恢复趋势较好。B 组术后有症状低钙血症的发生率明显低于 A 组（26.92%比 42.42%，P=0.020）。预测持续性甲状旁腺功能减退的独立因素包括性别、术前血清钙和 POD1 PTH。
仅对有症状的患者给予钙和维生素 D 补充与常规补充对持续性甲状旁腺功能减退的效果相同。然而，常规补充可显著降低术后低钙血症的发生率。对于术前血清钙水平高和 POD1 PTH 水平低的女性患者，需要格外注意。
中国临床试验注册中心（ChiCTR），ChiCTR1900022194。注册于 2019 年 3 月 30 日。
