Hua Ran, Hou Yuanyuan, Yang Li, Gao Hui, Yang Fei, Liu Wei, Jiang Junhong, Wang Baotian, Wu De
Department of Pediatrics, First Affiliated Hospital of Anhui Medical University, Hefei, People's Republic of China.
Department of Pediatrics, Suzhou Hospital of Anhui Medical University, Suzhou, People's Republic of China.
Neuropsychiatr Dis Treat. 2025 Sep 12;21:2067-2082. doi: 10.2147/NDT.S533262. eCollection 2025.
As there are currently limited pharmacologic interventions for provisional intellectual development disorder (PIDD), with treatment mainly relying on rehabilitation training and education, this study aimed to evaluate the efficacy and safety of cerebroprotein hydrolysate I (CH-I) in children with PIDD.
We conducted a prospective study of 102 children under three years of age who were diagnosed with PIDD in a hospital setting. The control group received standardised rehabilitation training comprising physical therapy, occupational therapy, speech therapy and cognitive development training. In addition to this, the treatment group received a 14-day course of continuous intravenous CH-I infusions, followed by 76 days of oral administration of its derivatives. Neurological function was assessed using the Gesell developmental scales, and brain changes were evaluated using magnetic resonance imaging (MRI) scans. Adverse reactions were closely monitored throughout the study. Changes in various indicators were compared between the two groups at baseline and at 14, 30, 60 and 90 days after treatment.
At 90 days of treatment, the treatment group showed greater improvement than the control group in fine motor and adaptive functioning compared to their respective baseline periods, and the difference was statistically significant (<0.05). The rate of improvement in fine motor, adaptive, language, and personal-social skills in the treatment group on day 90 of treatment was statistically significant when compared to the control group (<0.05). Adverse events occurred in 26 subjects in the treatment group (55.3%) and 21 subjects in the control group (47.7%). The difference in the incidence of adverse events in each system between the two groups was not statistically significant. No serious adverse events occurred in either group.
CH-I may help to improve fine motor skills and adaptability in children under three years of age with PIDD, improve rehabilitation efficiency, and have good clinical safety.
由于目前针对暂时性智力发育障碍（PIDD）的药物干预有限，治疗主要依赖康复训练和教育，本研究旨在评估脑蛋白水解物I（CH-I）对PIDD患儿的疗效和安全性。
我们对在医院环境中诊断为PIDD的102名三岁以下儿童进行了一项前瞻性研究。对照组接受包括物理治疗、职业治疗、言语治疗和认知发展训练在内的标准化康复训练。除此之外，治疗组接受为期14天的连续静脉输注CH-I疗程，随后口服其衍生物76天。使用格塞尔发育量表评估神经功能，并使用磁共振成像（MRI）扫描评估脑部变化。在整个研究过程中密切监测不良反应。比较两组在基线以及治疗后14、30、60和90天各项指标的变化。
治疗90天时，与各自的基线期相比，治疗组在精细运动和适应功能方面的改善程度大于对照组，差异具有统计学意义（<0.05）。治疗组在治疗第90天时精细运动、适应、语言和个人社交技能的改善率与对照组相比具有统计学意义（<0.05）。治疗组有26名受试者（55.3%）发生不良事件，对照组有21名受试者（47.7%）发生不良事件。两组各系统不良事件发生率的差异无统计学意义。两组均未发生严重不良事件。
CH-I可能有助于改善三岁以下PIDD患儿的精细运动技能和适应性，提高康复效率，且具有良好的临床安全性。
