Bai Yun-Xiao, Wu Hui-Liang, Xie Wan-Li, Li Xia, Han Jing-Jing, Liu Jie, Chen Shi-Qiang, Yin Ping, Dong Nian-Guo, Wu Qing-Ping
Department of Anesthesiology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, 430022, China.
Institute of Anesthesia and Critical Care Medicine, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, 430022, China.
Crit Care. 2025 Mar 11;29(1):108. doi: 10.1186/s13054-025-05331-9.
Delirium and postoperative cognitive dysfunction (POCD) are common complications post-cardiac surgery, yet no specific medical intervention is currently recommended for prevention. This study aimed to evaluate the efficacy of gastrodin infusion in preventing delirium and POCD in critically ill patients following cardiac surgery.
A double-blind, randomized, placebo-controlled trial was conducted on patients aged 18-75, scheduled for coronary artery bypass grafting (CABG) surgery, with or without valve replacement. Participants were randomized in a 1:1 ratio to receive gastrodin infusion 600 mg twice daily or placebo from the day of surgery until the postoperative day (POD) 6. The co-primary outcomes were the incidences of delirium and POCD, assessed from ICU admission until POD 7 and at 1 and 3 months postoperatively. This study was registered with the Chinese Clinical Trials Registry (ChiCTR1800020414).
Of 160 randomized participants, 155 were analyzed (77 gastrodin, 78 placebo) according to a modified intention to treat principle. The incidence of postoperative delirium was 19.5% in the gastrodin group and 35.9% in the placebo group, with a significant relative risk of 0.54 (95% CI 0.32-0.93, p = 0.022). The incidence of in-hospital POCD was 2.9% and 4.0% in the placebo and gastrodin groups, respectively. The odds of hospital discharge were significantly greater in the gastrodin group (subhazard ratio, 1.20; 95% CI 1.00-1.84; p = 0.049). Adverse events occurred in 9.1% (7/77) of patients administered gastrodin and 14.1% (11/78) of patients administered the placebo, with none being drug-related.
Gastrodin infusion significantly reduced postoperative delirium and improved discharge outcomes in patients undergoing CABG, but larger studies are needed to confirm its efficacy in preventing delirium.
谵妄和术后认知功能障碍(POCD)是心脏手术后常见的并发症,但目前尚无预防的特异性药物干预措施。本研究旨在评估天麻素输注对预防心脏手术后危重症患者谵妄和POCD的疗效。
对18至75岁、计划行冠状动脉旁路移植术(CABG)、无论是否行瓣膜置换术的患者进行双盲、随机、安慰剂对照试验。参与者按1:1比例随机分组,从手术日至术后第6天,每天两次接受600 mg天麻素输注或安慰剂。共同主要结局是谵妄和POCD的发生率,从入住重症监护病房(ICU)至术后第7天以及术后1个月和3个月进行评估。本研究已在中国临床试验注册中心注册(ChiCTR1800020414)。
根据改良意向性分析原则,对160名随机分组的参与者中的155名进行了分析(天麻素组77名,安慰剂组78名)。天麻素组术后谵妄发生率为19.5%,安慰剂组为35.9%,相对风险显著为0.54(95%可信区间0.32 - 0.93,p = 0.022)。安慰剂组和天麻素组住院期间POCD发生率分别为2.9%和4.0%。天麻素组出院几率显著更高(亚风险比,1.20;95%可信区间1.00 - 1.84;p = 0.049)。接受天麻素治疗的患者中有9.1%(7/77)发生不良事件,接受安慰剂治疗的患者中有14.1%(11/78)发生不良事件,均与药物无关。
天麻素输注显著降低了CABG患者术后谵妄的发生率并改善了出院结局,但需要更大规模的研究来证实其预防谵妄的疗效。