Shao Ping, Ou Jianjun, Peng Mei, Zhao Jingping, Chen Jindong, Wu Renrong
Institute of Mental Health of The Second Xiangya Hospital, Central South University, 139# Renmin Middle Road, Changsha 410011, Hunan, P.R. China; Brains Hospital of Hunan Province, 427# Renmin Middle Road (3 Duan), Changsha 410007, Hunan, P.R. China.
Institute of Mental Health of The Second Xiangya Hospital, Central South University, 139# Renmin Middle Road, Changsha 410011, Hunan, P.R. China.
PLoS One. 2015 Apr 24;10(4):e0123373. doi: 10.1371/journal.pone.0123373. eCollection 2015.
To investigate the developmental effects of clozapine and other atypical antipsychotics on infants who were exposed to as fetus.
The developmental progress of 33 infants who were exposed to clozapine as fetus was compared to 30 infants who were exposed to risperidone, olanzapine or quetiapine as fetus by assessing Apgar scoring, birth weight at birth, body weight, height, and the Bayley Scales of Infant and Toddler Development, Third Edition (BSID-III) at months 2, 6 and 12 of age. Five subscale scores of BSID-III including cognitive, language, motor, social-emotional, and adaptive behavior were also compared. Student's t test and Chi-square analysis were used as appropriate. Repeated measurements were evaluated by analysis of covariance.
Of the 63 infants, 58 (92.1%) completed a 12-month study period. At the age of 2 and 6 months, mean adaptive behavior scores of BSID-III were significantly lower in clozapine-exposed infants than infants who exposed to other atypical antipsychotic at 2 and 6 months of age. More clozapine-exposed infants had delayed development (defined as the subscale score of <85) for adaptive behavior at 2 and 6 months of age. There was no difference between the two groups for cognitive, language, motor, social and emotional at 2, 6 and 12 months of age. More infants who were exposed to clozapine as fetus (25 of 33, 75.8%) had disturbed sleep and a labile state than those who were exposed to other atypical antipsychotics (8 of 30, 26.7%) during 2 months of age (P<0.001).
These results suggest that clozapine has more adaptive behavior effects on infants who were exposed to as a fetus than other atypical antipsychotics at 2 and 6 months of age.
ClinicalTrials.gov NCT01479400.
研究氯氮平及其他非典型抗精神病药物对胎儿期暴露于这些药物的婴儿发育的影响。
通过评估阿氏评分、出生时体重、体重、身高以及2个月、6个月和12个月大时的贝利婴幼儿发展量表第三版（BSID-III），比较33名胎儿期暴露于氯氮平的婴儿与30名胎儿期暴露于利培酮、奥氮平或喹硫平的婴儿的发育进程。还比较了BSID-III的五个分量表得分，包括认知、语言、运动、社会情感和适应性行为。适当使用学生t检验和卡方分析。重复测量通过协方差分析进行评估。
63名婴儿中，58名（92.1%）完成了为期12个月的研究期。在2个月和6个月大时，胎儿期暴露于氯氮平的婴儿的BSID-III平均适应性行为得分显著低于暴露于其他非典型抗精神病药物的婴儿。更多胎儿期暴露于氯氮平的婴儿在2个月和6个月大时适应性行为发育延迟（定义为分量表得分<85）。两组在2个月、6个月和12个月大时的认知、语言、运动、社会和情感方面没有差异。与暴露于其他非典型抗精神病药物的婴儿（30名中的8名，26.7%）相比，更多胎儿期暴露于氯氮平的婴儿（33名中的25名，75.8%）在2个月大时睡眠障碍且状态不稳定（P<0.001）。
这些结果表明，在2个月和6个月大时，氯氮平对胎儿期暴露于该药物的婴儿的适应性行为影响比其他非典型抗精神病药物更大。
ClinicalTrials.gov NCT01479400。
