NTP CERHR MON. 2005 Aug(15):v, vii-I-2, II-xi-147.
The National Toxicology Program (NTP) Center for the Evaluation of Risks to Human Reproduction (CERHR) conducted an evaluation of the potential for methylphenidate to cause adverse effects on reproduction and development in humans. Methylphenidate was selected for evaluation because of 1) widespread usage in children, 2) availability of developmental studies in children and experimental animals, and 3) public concern about the effect of this stimulant on child development. Methylphenidate is a central nervous system stimulant approved by the U.S. Food and Drug Administration for the treatment of attention deficit hyperactivity disorder (ADHD) in persons 6 years of age and older and for narcolepsy. The results of this evaluation on methylphenidate are published in an NTP-CERHR monograph which includes: 1) the NTP Brief, 2) the Expert Panel Report on the Reproductive and Developmental Toxicity of Methylphenidate, and 3) public comments received on the Expert Panel Report. As stated in the NTP Brief, the NTP reached the following conclusions regarding the possible effects of exposure to methylphenidate on human development and reproduction. First, there is negligible concern for methylphenidate-induced tics and movement disorders. This conclusion is based on studies showing that children treated with therapeutic doses of methylphenidate have no evidence of movement disorders or tics due to the medication. Second, there is minimal concern for methylphenidate-induced growth restriction. This conclusion is based on growth restriction being observed in animal studies only at high doses of methylphenidate using a non-therapeutic route of exposure. The effect on growth was reversible. Finally, there are insufficient data to draw conclusions on 1) an association between methylphenidate therapy in pregnant women and pregnancy loss and 2) possible reproductive effects of methylphenidate in humans. NTP-CERHR monographs are transmitted to federal and state agencies, interested parties, and the public and are available in electronic PDF format on the CERHR web site http://cerhr.niehs.nih.gov/ and in printed text or CD-ROM from the CERHR.
美国国家毒理学计划（NTP）人类生殖风险评估中心（CERHR）对哌甲酯对人类生殖和发育产生不良影响的可能性进行了评估。选择哌甲酯进行评估的原因如下：1）在儿童中广泛使用；2）有关于儿童和实验动物的发育研究；3）公众对这种兴奋剂对儿童发育的影响表示关注。哌甲酯是一种中枢神经系统兴奋剂，已获美国食品药品监督管理局批准，用于治疗6岁及以上人群的注意力缺陷多动障碍（ADHD）和发作性睡病。关于哌甲酯的评估结果发表在一份NTP-CERHR专著中，该专著包括：1）NTP简报；2）哌甲酯生殖和发育毒性专家小组报告；3）收到的关于专家小组报告的公众意见。如NTP简报中所述，NTP就接触哌甲酯对人类发育和生殖的可能影响得出了以下结论。首先，对于哌甲酯引起的抽搐和运动障碍几乎无需担忧。这一结论基于多项研究，这些研究表明，接受治疗剂量哌甲酯治疗的儿童没有因药物导致运动障碍或抽搐的证据。其次，对于哌甲酯引起的生长受限几乎无需担忧。这一结论基于仅在动物研究中观察到高剂量哌甲酯通过非治疗性暴露途径导致生长受限，且这种对生长的影响是可逆的。最后，没有足够的数据就以下两点得出结论：1）孕妇使用哌甲酯治疗与流产之间的关联；2）哌甲酯对人类可能的生殖影响。NTP-CERHR专著会发送给联邦和州机构、相关方及公众，可在CERHR网站http://cerhr.niehs.nih.gov/上以电子PDF格式获取，也可从CERHR获取印刷文本或CD-ROM。
