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已发表论文
脑蛋白水解物 I 联合康复训练治疗儿童暂时性智力发育障碍的疗效及安全性
Authors Hua R, Hou Y, Yang L, Gao H, Yang F, Liu W, Jiang J, Wang B, Wu D
Received 9 April 2025
Accepted for publication 1 September 2025
Published 12 September 2025 Volume 2025:21 Pages 2067—2082
DOI https://doi.org/10.2147/NDT.S533262
Checked for plagiarism Yes
Review by Single anonymous peer review
Peer reviewer comments 2
Editor who approved publication: Dr Yu-Ping Ning
Ran Hua,1,* Yuanyuan Hou,1,2,* Li Yang,1 Hui Gao,1 Fei Yang,3 Wei Liu,3 Junhong Jiang,1 Baotian Wang,1 De Wu1
1Department of Pediatrics, First Affiliated Hospital of Anhui Medical University, Hefei, People’s Republic of China; 2Department of Pediatrics, Suzhou Hospital of Anhui Medical University, Suzhou, People’s Republic of China; 3Hebei Zhitong Biopharmaceutical Co., Ltd., Shijiazhuang, People’s Republic of China
*These authors contributed equally to this work
Correspondence: De Wu, Department of Pediatrics, First Affiliated Hospital of Anhui Medical University, No. 218 Jixi Road, Hefei, Anhui, 230022, People’s Republic of China, Email derk_wu@163.com
Purpose: 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.
Patients and Methods: 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.
Results: 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 (P< 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 (P< 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.
Conclusion: 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.
Keywords: cerebroprotein hydrolysate I, provisional intellectual development disorder, Gesell developmental scales, pediatric, efficacy, safety
1Department of Pediatrics, First Affiliated Hospital of Anhui Medical University, Hefei, People’s Republic of China; 2Department of Pediatrics, Suzhou Hospital of Anhui Medical University, Suzhou, People’s Republic of China; 3Hebei Zhitong Biopharmaceutical Co., Ltd., Shijiazhuang, People’s Republic of China
*These authors contributed equally to this work
Correspondence: De Wu, Department of Pediatrics, First Affiliated Hospital of Anhui Medical University, No. 218 Jixi Road, Hefei, Anhui, 230022, People’s Republic of China, Email derk_wu@163.com
Purpose: 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.
Patients and Methods: 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.
Results: 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 (P< 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 (P< 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.
Conclusion: 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.
Keywords: cerebroprotein hydrolysate I, provisional intellectual development disorder, Gesell developmental scales, pediatric, efficacy, safety