Mouse nerve growth factor combined with rehabilitation in the treatment of global developmental delay: a prospective multicenter clinical randomized controlled trial
10.3760/cma.j.cn101070-20230530-00425
- VernacularTitle:鼠神经生长因子联合康复治疗全面性发育迟缓前瞻性多中心临床随机对照研究
- Author:
Jiulai TANG
1
;
Xiaojie LI
;
De WU
;
Wei PANG
;
Hujie SONG
;
Yan HUANG
;
Jin GUO
;
Ling LI
;
Li YANG
;
Ran HUA
;
Fuxiang SONG
;
Yutang LIU
;
Mingda ZHANG
;
Yang LYU
Author Information
1. 安徽医科大学第一附属医院小儿神经康复中心，合肥 230022
- Keywords:
Global developmental delay;
Mouse nerve growth factor;
Multicenter;
Randomized controlled
- From:
Chinese Journal of Applied Clinical Pediatrics
2023;38(11):857-862
- CountryChina
- Language:Chinese
-
Abstract:
Objective:To observe the clinical efficacy of mouse nerve growth factor (mNGF) combined with rehabilitation on children with global developmental delay(GDD).Methods:It was a prospective multicenter clinical randomized controlled trial (RCT) involving 120 children with GDD admitted to 5 hospitals in China from May 2020 to January 2022.They were randomly divided into mNGF group and conventional rehabilitation group using block randomization method.All children were managed by standardized rehabilitation after recruitment, and those in the mNGF group were additionally given mNGF injections.All subjects were surveyed using the Gesell Development Diagnosis Schedules(GDDS) at baseline, 90 days and 120 days after treatment, and their developmental quotient (DQ) was recorded.Clinical efficacy was analyzed by the paired t-test, rank sum test and Chi- squared test. Results:After 90 days of treatment and the continuous follow-up to 120 days, the increases in the DQ of gross motor (7.520±13.900 vs.0.450±11.459), fine motor (7.800±15.346 vs.1.250±11.581), adaptive behavior (7.730±13.428 vs.2.100±12.022) and personal-social behavior (6.780±11.651 vs.1.780±10.120) than baseline were significantly higher in mNGF group than those of conventional rehabilitation group (all P<0.05). Serious adverse events and important drug-related medical events were not reported. Conclusions:mNGF combined with rehabilitation effectively enhances the development levels of gross motor, fine motor, adaptive behavior and personal-social behavior, and continuously improves the condition of GDD in children with a high safety.
