Li Dapeng, Tian Mengran, Zhang Yan, Yu Yang, Cheng Wenyuan, Li Yigong, Wang Junyi, Wei Songfeng, Wang Xin, Yang Xiaoyong, Zhao Jingzhu, Yun Xinwei, Zhang Wei, Song Jiayin, Zhang Huan, Zheng Xiangqian, Gao Ming
Department of Thyroid and Neck Oncology, National Clinical Research Center for Cancer, Key Laboratory of Cancer Prevention and Therapy, Tianjin's Clinical Research Center for Cancer, Tianjin Medical University Cancer Institute and Hospital, Tianjin, China.
Department of Clinical Laboratory, National Clinical Research Center for Cancer, Key Laboratory of Cancer Prevention and Therapy, Tianjin's Clinical Research Center for Cancer, Tianjin Medical University Cancer Institute and Hospital, Tianjin, China.
Front Oncol. 2022 Aug 26;12:967451. doi: 10.3389/fonc.2022.967451. eCollection 2022.
Hypocalcemia is the most common complication that challenges surgeons performing total thyroidectomy. Conventional postoperative calcium and calcitriol supplement has been reportedly effective; however, a time lag has been reported before taking effect. Therefore, the role of preoperative strategy is yet to be determined.
In this prospective, randomized, open-label, parallel-controlled phase II clinical study (registration number: ChiCTR2200059815), a short-term preoperative administration of calcitriol and calcium was proposed in 210 patients undergoing total thyroidectomy and bilateral central compartment neck dissection. Patients were recruited and randomized (1:1:1) into three groups: (A) combined (preoperative calcitriol and calcium), (B) calcium only (preoperative calcium only), and (C) control (no preoperative intervention). Finally, a total of 172 patients were qualified for final analysis.
Our data showed that 16 of 63 patients (25.4%) in the combined group had symptomatic hypocalcemia, whereas more patients from the control group (25 of 57 patients, 43.9%, P = 0.033) had symptomatic hypocalcemia. Further, the postoperative calcium level in the combined group is higher than in the control group (2.15 ± 0.15 vs. 2.09 ± 0.15 mmol/L, P = 0.031). Moreover, patients from the combined group showed lower calcium rates of <2.00 mmol/L (12.7% vs. 28.1%, P = 0.036). Remarkably, compared with the control group, patients with transient hypoparathyroidism in the combined group showed fewer rates for both symptomatic and biochemical hypocalcemia (28.6% vs. 61.1% for symptomatic hypocalcemia; 47.6% vs. 75% for biochemical hypocalcemia). Patients without transient hypoparathyroidism in all three groups showed no significant difference in rates for either symptomatic or biochemical hypocalcemia, indicating that this preoperative strategy is only effective for patients with transient hypoparathyroidism. We did not observe such beneficial effects in patients from the calcium group.
Preoperative administration of calcitriol and calcium could reduce symptomatic and biochemical hypocalcemia, especially for those with transient hypoparathyroidism. Moreover, this maneuver could be recommended as a clinical routine in patients undergoing total thyroidectomy and bilateral central compartment neck dissection.
http://www.chictr.org.cn/edit.aspx?pid=164316&htm=4, identifier ChiCTR2200059815.
低钙血症是全甲状腺切除术中外科医生面临的最常见并发症。据报道，传统的术后补钙和补充骨化三醇有效；然而，其起效前存在时间延迟。因此，术前策略的作用尚待确定。
在这项前瞻性、随机、开放标签、平行对照的II期临床研究（注册号：ChiCTR2200059815）中，对210例行全甲状腺切除术和双侧中央区颈部淋巴结清扫术的患者进行了术前短期骨化三醇和钙剂给药。患者被招募并随机（1:1:1）分为三组：（A）联合组（术前骨化三醇和钙剂）、（B）单纯钙剂组（仅术前补钙）和（C）对照组（无术前干预）。最后，共有172例患者符合最终分析条件。
我们的数据显示，联合组63例患者中有16例（25.4%）出现症状性低钙血症，而对照组更多患者（57例中的25例，43.9%，P = 0.033）出现症状性低钙血症。此外，联合组术后血钙水平高于对照组（2.15±0.15 vs. 2.09±0.15 mmol/L，P = 0.031）。而且，联合组血钙<2.00 mmol/L的发生率更低（12.7% vs. 28.1%，P = 0.036）。值得注意的是，与对照组相比，联合组中发生短暂性甲状旁腺功能减退的患者出现症状性和生化性低钙血症的比例均较低（症状性低钙血症：28.6% vs. 61.1%；生化性低钙血症：47.6% vs. 75%）。三组中未发生短暂性甲状旁腺功能减退的患者在症状性或生化性低钙血症发生率上无显著差异，表明该术前策略仅对发生短暂性甲状旁腺功能减退的患者有效。我们在单纯钙剂组患者中未观察到此类有益效果。
术前给予骨化三醇和钙剂可降低症状性和生化性低钙血症，尤其是对发生短暂性甲状旁腺功能减退的患者。此外，对于行全甲状腺切除术和双侧中央区颈部淋巴结清扫术的患者，可将此操作推荐为临床常规。
http://www.chictr.org.cn/edit.aspx?pid=164316&htm=4，标识符ChiCTR2200059815。
