Khoo Kah Seng, Yeo Audrey, Mirzan Asfian Muhammad Ridwan Bin, Ng Khoon Leong
Department of Surgery, Faculty of Medicine, University of Malaya, Kuala Lumpur, Malaysia.
Gland Surg. 2024 Aug 31;13(8):1378-1386. doi: 10.21037/gs-24-190. Epub 2024 Aug 28.
Hypocalcaemia as a common complication after total thyroidectomy [23-40% in University Malaya Medical Centre (UMMC)] and could result in prolonged hospital stay. We compared the early hypocalcaemia rate between prophylactic infusion of calcium and placebo among post total thyroidectomy patients and to establish whether prophylactic intravenous infusion of calcium reduces the rate of hypocalcaemia in the first 48 hours after surgery.
Patients undergoing elective total thyroidectomy in UMMC between June 2020-May 2022, were recruited and randomized to receive placebo or prophylactic calcium infusion. Both groups of patients received same dosages of post-operative prophylactic vitamin D and oral calcium. Early hypocalcaemia (within 48 hours) rate after surgery was the primary outcome and duration of hospital stay was the secondary outcome. The data collected was analysed using per-protocol analysis.
Thirty-four patients were randomized equally (1:1) into both arms. No differences in the early hypocalcaemia rate between the intervention and placebo arms (0% 5.8%, P>0.05). The median serum calcium levels were comparable between the intervention and placebo arms at 6 hours (2.33 2.37 mmol/L, P=0.59) and 48 hours (2.26 2.23 mmol/L, P=0.19) post-surgery. However, the median serum calcium level at 24 hours was statistically significantly higher in the intervention arm than the placebo arm (2.31 2.22 mmol/L, P=0.02). Similar duration of hospital stay between the both groups (2 2 days, P=0.81).
Routine prophylactic calcium infusion with oral calcium and vitamin D does not diminish the rate of early symptomatic hypocalcaemia post total thyroidectomy in a low-risk group. However, its usefulness needs to be further assessed in a large scale randomized controlled trial (RCT) incorporating more bigger population.
Registered on ClinicalTrials.gov (NCT04491357).
低钙血症是全甲状腺切除术后的常见并发症[在马来亚大学医学中心（UMMC）发生率为23%-40%]，可能导致住院时间延长。我们比较了全甲状腺切除术后患者预防性输注钙剂与安慰剂的早期低钙血症发生率，以确定预防性静脉输注钙剂是否能降低术后48小时内的低钙血症发生率。
招募2020年6月至2022年5月在UMMC接受择期全甲状腺切除术的患者，并随机分为接受安慰剂或预防性钙剂输注两组。两组患者术后均接受相同剂量的预防性维生素D和口服钙剂。术后早期（48小时内）低钙血症发生率为主要观察指标，住院时间为次要观察指标。收集的数据采用符合方案分析。
34例患者被等比例（1:1）随机分为两组。干预组和安慰剂组的早期低钙血症发生率无差异（0%对5.8%，P>0.05）。术后6小时（2.33对2.37 mmol/L，P=0.59）和48小时（2.26对2.23 mmol/L，P=0.19）时，干预组和安慰剂组的血清钙中位数水平相当。然而，干预组术后24小时的血清钙中位数水平在统计学上显著高于安慰剂组（2.31对2.22 mmol/L，P=0.02）。两组的住院时间相似（2对2天，P=0.81）。
在低风险组中，常规预防性输注钙剂联合口服钙剂和维生素D并不能降低全甲状腺切除术后早期症状性低钙血症的发生率。然而，其有效性需要在纳入更多人群的大规模随机对照试验（RCT）中进一步评估。
在ClinicalTrials.gov上注册（NCT04491357）。
