术前应用骨化三醇预防甲状腺切除术后低钙血症的随机 II 期研究。
Phase II randomized study of preoperative calcitriol to prevent hypocalcemia following thyroidectomy.
机构信息
Department of Otolaryngology-Head and Neck Surgery, University of Virginia Health System, Charlottesville, Virginia, USA.
University of Virginia School of Medicine, University of Virginia Health System, Charlottesville, Virginia, USA.
出版信息
Head Neck. 2021 Oct;43(10):2935-2945. doi: 10.1002/hed.26775. Epub 2021 Jun 2.
BACKGROUND
A prospective, stratified, randomized, double-blind, placebo-controlled study was conducted to observe the impact of preoperative calcitriol supplementation on serum calcium levels following total thyroidectomy.
METHODS
Subjects were randomized 1:1 to receive 1 μg calcitriol or placebo for 1 week preceding thyroidectomy. The primary outcome measure was change in serum calcium from baseline to 18 h post-thyroidectomy. Subjects were also assessed for incidence of symptomatic hypocalcemia, length of stay, readmission for hypocalcemia, and intravenous calcium supplementation.
RESULTS
Forty-seven patients underwent thyroidectomy; 23 received preoperative calcitriol supplementation, and 24 received placebo. Repeated measures regression demonstrated no difference in postoperative serum calcium over time (p = 0.22). There were no occurrences of hypocalcemia, intravenous calcium supplementation, or readmission in either group. No difference was observed in length of stay (p = 0.38). One patient in the calcitriol group developed Grade 3 hypercalcemia.
CONCLUSIONS
Preoperative calcitriol supplementation had no impact on postoperative serum calcium levels compared to placebo.
背景
前瞻性、分层、随机、双盲、安慰剂对照研究旨在观察术前补充骨化三醇对甲状腺全切除术后血清钙水平的影响。
方法
将受试者以 1:1 的比例随机分为骨化三醇组或安慰剂组，在甲状腺切除术前 1 周内接受治疗。主要观察指标为术后 18 小时内血清钙与基线值的变化。还评估了两组的低钙血症症状发生率、住院时间、因低钙血症再入院以及静脉补钙情况。
结果
47 例患者接受甲状腺切除术；23 例接受术前骨化三醇补充治疗，24 例接受安慰剂治疗。重复测量回归分析显示术后血清钙随时间无差异（p=0.22）。两组均未发生低钙血症、静脉补钙或再入院。两组的住院时间无差异（p=0.38）。骨化三醇组有 1 例患者发生 3 级高钙血症。
结论
与安慰剂相比，术前补充骨化三醇对术后血清钙水平无影响。
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