Tan Qingti, Wang Yu, Zhang Guoying, Lu Bin, Wang Tao, Tao Tao, Wang He, Jiang Hua, Chen Wei
Pediatric Intensive Care Unit, Chengdu Women's and Children's Central Hospital, School of Medicine, University of Electronic Science and Technology of China, Chengdu, China.
Institute for Emergency and Disaster Medicine, Sichuan Provincial People's Hospital, University of Electronic Science and Technology of China, Chengdu, China.
Transl Pediatr. 2021 Oct;10(10):2579-2593. doi: 10.21037/tp-21-456.
We investigated the efficacy and metabolic dose-effect of multi-trace element injection I [MTEI-(I)] for severe pediatric patients via a parallel, randomized control study.
The inclusion criteria were as follows: (I) patients who required parenteral nutrition (PN) due to various diseases, and were expected to receive PN for >5 days; (II) patients aged <18 years; (III) patients with no serious cardiac, hepatic, renal, or pulmonary dysfunction; and (IV) patients with an established central venous pathway. Enrolled patients were randomly assigned into two groups using sequentially numbered, sealed, opaque envelopes: Group A (low-dose group) received MTEI-(I) at 1 mL/kg/d, and Group B (high-dose group) received MTEI-(I) at 2 mL/kg/d, up to a maximum dose of 15 mL/d. The concentrations of manganese (Mn), copper (Cu), zinc (Zn), and selenium (Se) were detected. The following indexes were measured after 5 days of treatment (T5): β-oxidation of very-long-chain fatty acids, arginine and proline metabolism, pentose phosphate metabolism, ketone body metabolism, citric acid cycle, purine metabolism, caffeine metabolism, and pyruvate metabolism. The participants, care givers, and data analysis staff were blinded to the group assignment.
Overall, at T5, Mn and Cu levels were decreased, while Zn and Se levels were increased. The increase of Zn levels (A: 0.170±0.479 B: 0.193±0.900) and decrease of Cu levels (A: -0.240±0.382 B: -0.373±0.465) of patients in Group B (n=22) were significantly higher than those in Group A (n=18). At T5, the β-oxidation of very-long-chain fatty acids, arginine and proline metabolism, pentose phosphate metabolism, ketone body metabolism, citric acid cycle, purine metabolism, caffeine metabolism, and pyruvate metabolism were variably decreased (P<0.05) in Group B compared to Group A.
Our results suggested that the high-dose administration of MTEI-(I) is safe for severe pediatric patients, and may alleviate inflammation and antioxidation, relieve hyperactivity caused by stress, and improve tissues-based hypoxia and renal function.
Chinese Clinical Trial Registry ChiCTR2100052198.
我们通过一项平行随机对照研究，调查了多种微量元素注射液I [MTEI-(I)] 对重症儿科患者的疗效和代谢剂量效应。
纳入标准如下：(I) 因各种疾病需要肠外营养 (PN) 且预计接受PN超过5天的患者；(II) 年龄<18岁的患者；(III) 无严重心、肝、肾或肺功能障碍的患者；(IV) 已建立中心静脉通路的患者。使用连续编号、密封、不透明的信封将入选患者随机分为两组：A组（低剂量组）接受1 mL/kg/d的MTEI-(I)，B组（高剂量组）接受2 mL/kg/d的MTEI-(I)（最大剂量为15 mL/d）。检测锰 (Mn)、铜 (Cu)、锌 (Zn) 和硒 (Se) 的浓度。治疗5天（T5）后测量以下指标：极长链脂肪酸β氧化、精氨酸和脯氨酸代谢、磷酸戊糖代谢、酮体代谢、柠檬酸循环、嘌呤代谢、咖啡因代谢和丙酮酸代谢。参与者、护理人员和数据分析人员对分组情况不知情。
总体而言，在T5时，Mn和Cu水平降低，而Zn和Se水平升高。B组（n = 22）患者的Zn水平升高（A组：0.170±0.479，B组：0.193±0.900）和Cu水平降低（A组：-0.240±0.382，B组：-0.373±0.465）显著高于A组（n = 18）。在T5时，与A组相比，B组的极长链脂肪酸β氧化、精氨酸和脯氨酸代谢、磷酸戊糖代谢、酮体代谢、柠檬酸循环、嘌呤代谢、咖啡因代谢和丙酮酸代谢均有不同程度降低（P<0.05）。
我们的结果表明，高剂量给予MTEI-(I) 对重症儿科患者是安全的，可能减轻炎症和抗氧化，缓解应激引起的多动，并改善组织性缺氧和肾功能。
中国临床试验注册中心ChiCTR2100052198。
