Wang Junke, Chen Yuezhi, Zhao Zhiwen, Lian Guodong, Peng Lipan, Zhou Xinxiu, Sha Shengxu, Qiao Wenhao, Tian Hui, Li Leping, Tian Feng, Jing Changqing
Department of Gastrointestinal Surgery, Shandong Provincial Hospital Affiliated to Shandong First Medical University, Jinan, Shandong, China.
Department of General Surgery, Binzhou People 's Hospital Affiliated to Shandong First Medical University, Binzhou, Shandong, China.
Int J Surg. 2024 Dec 1;110(12):7806-7815. doi: 10.1097/JS9.0000000000001818.
There is a scarcity of large randomized clinical trials on the efficacy and safety of high-dose amino acid supplementation (AAS) in patients with gastrointestinal tumors undergoing surgical treatment.
This pragmatic, randomized, controlled, single-center, open-label, parallel-group AMIGITS trial was performed in a tertiary care teaching hospital. Patients with gastrointestinal tumors were randomly assigned to receive either AAS or standard care (SC). Amino acid targets were 2.0 g/kg per day in the AAS group and 1.2 g/kg per day in the SC group. The AAS group received additional amino acids intravenously, while the SC group received an iso-energetic 5% glucose intravenously.
Overall, 407 patients (AAS group, 204; SC group, 203) were included in this study. During the intervention, the actual mean daily energy intake did not differ significantly between the AAS and SC groups (25.53 vs. 25.16 kcal/kg per day, P =0.493). However, the actual mean daily amino acid intake was significantly higher in the AAS group than that in the SC group (1.81 vs. 0.94 g/kg per day, P <0.001). The infection incidence during hospitalization and within 30 days of surgery was significantly lower in the AAS group than that in the SC group ( P =0.031 and P= 0.024, respectively). The 30-day postoperative incidence of amino acid treatment-related adverse events and other complications did not significantly differ between the two groups. The postoperative hospital stay was significantly different between the two groups ( P< 0.001).
AAS was associated with a reduced infection incidence within 30 days of major surgery in patients with gastrointestinal tumors and can be a promising strategy.
关于高剂量氨基酸补充剂（AAS）对接受手术治疗的胃肠道肿瘤患者疗效和安全性的大型随机临床试验较少。
这项务实、随机、对照、单中心、开放标签、平行组的AMIGITS试验在一家三级护理教学医院进行。胃肠道肿瘤患者被随机分配接受AAS或标准护理（SC）。AAS组的氨基酸目标量为每天2.0克/千克，SC组为每天1.2克/千克。AAS组静脉补充额外的氨基酸，而SC组静脉输注等能量的5%葡萄糖。
总体而言，本研究纳入了407例患者（AAS组204例，SC组203例）。在干预期间，AAS组和SC组的实际每日平均能量摄入量无显著差异（分别为每天25.53千卡/千克和25.16千卡/千克，P = 0.493）。然而，AAS组的实际每日平均氨基酸摄入量显著高于SC组（分别为每天1.81克/千克和0.94克/千克，P < 0.001）。AAS组住院期间和术后30天内的感染发生率显著低于SC组（分别为P = 0.031和P = 0.024）。两组之间氨基酸治疗相关不良事件和其他并发症的术后30天发生率无显著差异。两组术后住院时间有显著差异（P < 0.001）。
AAS与胃肠道肿瘤患者大手术后30天内感染发生率降低相关，可能是一种有前景的策略。
