Marwali Eva M, Boom Cindy E, Budiwardhana Novik, Fakhri Dicky, Roebiono Poppy S, Santoso Anwar, Sastroasmoro Sudigdo, Slee April, Portman Michael A
Pediatric Cardiac Intensive Care and Anesthesiology Division, National Cardiovascular Center Harapan Kita, Jakarta, Indonesia.
Pediatric Cardiac Intensive Care and Anesthesiology Division, National Cardiovascular Center Harapan Kita, Jakarta, Indonesia.
Ann Thorac Surg. 2017 Aug;104(2):688-695. doi: 10.1016/j.athoracsur.2017.01.001. Epub 2017 Feb 6.
This study evaluated the efficacy and safety of oral triiodothyronine (T3; Tetronine, Dalim BioTech, Korea) for infants and children undergoing cardiopulmonary bypass in an Indonesian population.
We performed a single-center, randomized, double-blind, and placebo-controlled trial in children aged 3 years and younger undergoing congenital heart disease operations with cardiopulmonary bypass. We administered oral T3 (1 μg/kg per body weight/dose) or placebo (saccharum lactis) by nasogastric tube every 6 hours for 60 hours after induction of anesthesia. The primary end point, time to extubation, was compared with Cox regression.
The modified intention-to-treat group included 101 placebo and 104 treated patients. The stratified log-rank test did not show a significant treatment difference (p = 0.061) for time to extubation, but after adjustment for age, the nutritional Z score, and Aristotle surgical complexity, the hazard ratio was 1.33 (95% confidence interval, 1.00 to 1.76; p = 0.049). The effect of T3 was stronger in the strata aged 5 months and younger (hazard ratio, 1.86; 95% confidence interval 1.02 to 3.39; p = 0.043). Median intubation time was 47.3 hours for the placebo and 32.1 hours for the T3 group in aged 5 months and younger. Adverse events rates, including arrhythmia, were similar between groups, although sepsis was more frequent with placebo.
Oral T3 supplementation may shorten time to extubation in children undergoing congenital heart disease operations, particularly infants aged 5 months or younger. Administration is relatively safe, simple and inexpensive.
本研究评估了口服三碘甲状腺原氨酸（T3；Tetronine，韩国达林生物科技公司）对印度尼西亚人群中接受体外循环的婴幼儿和儿童的疗效及安全性。
我们在3岁及以下接受先天性心脏病体外循环手术的儿童中进行了一项单中心、随机、双盲和安慰剂对照试验。在麻醉诱导后每6小时通过鼻胃管给予口服T3（1μg/千克体重/剂量）或安慰剂（乳糖），持续60小时。主要终点指标拔管时间采用Cox回归进行比较。
改良意向性治疗组包括101例接受安慰剂治疗的患者和104例接受治疗的患者。分层对数秩检验显示，拔管时间的治疗差异无统计学意义（p = 0.061），但在对年龄、营养Z评分和亚里士多德手术复杂性进行调整后，风险比为1.33（95%置信区间为1.00至1.76；p = 0.049）。T3在5个月及以下年龄组的作用更强（风险比为1.86；95%置信区间为1.02至3.39；p = 0.043）。在5个月及以下年龄组中，安慰剂组的中位插管时间为47.3小时，T3组为32.1小时。各组间包括心律失常在内的不良事件发生率相似，尽管安慰剂组败血症更为常见。
口服补充T3可能缩短先天性心脏病手术患儿的拔管时间，尤其是5个月及以下的婴儿。给药相对安全、简单且成本低廉。
