Crawford Mitchell B, DeLisi Lynn E
aResident, Harvard South Shore Residency Training Program, Harvard Medical School, VA Boston Healthcare System bAttending Psychiatrist, VA Boston Healthcare System, Professor of Psychiatry, Harvard Medical School, Brockton, Massachusetts, USA.
Curr Opin Psychiatry. 2016 May;29(3):211-7. doi: 10.1097/YCO.0000000000000243.
The effectiveness, side-effect profiles, and numerous other characteristics of antipsychotic medications have been extensively studied. However, the majority of publications do not address the many potential sex differences in efficacy and doses of medications, as well as other sex-specific considerations.
Of studies that exist, some suggest that female patients respond to lower doses of antipsychotic medications than males and that side-effect profiles vary between the sexes. However, the majority of preclinical trials use only male laboratory animals, and human clinical trials consist of too few women to analyze their response as a separate group.
Although changes in hormone production occurring at multiple stages throughout a women's life (such as during pregnancy, breast feeding, menopause, and postmenopausal) are presented as too complex to deal with in clinical trials, they could instead be embraced as clinical dilemmas that require additional study and consideration. We suggest that a focus should be made to reanalyze data from existing major treatment trials of antipsychotics to determine what medications specifically provide the most efficacy for female patients and at what dose range. In addition, new prospective studies are needed to specifically address appropriate adjustments in psychopharmacologic treatment for female patients during pregnancy, and when postmenopausal. More studies of the effects of antipsychotics on male and female fetuses in utero and during breast feeding are also needed to better manage women with schizophrenia and their offspring on a long-term basis in the community. There is currently too little known about sex differences in neuropharmacology. With the new USA National Institutes of Health policy to include sex in all new proposals, the time has come to close this gap in knowledge.
抗精神病药物的有效性、副作用特征及许多其他特性已得到广泛研究。然而，大多数出版物并未涉及药物疗效和剂量方面许多潜在的性别差异以及其他特定于性别的考量因素。
在已有的研究中，一些研究表明女性患者对抗精神病药物的反应剂量低于男性，且副作用特征存在性别差异。然而，大多数临床前试验仅使用雄性实验动物，而人体临床试验中女性数量过少，无法将她们的反应作为一个单独的群体进行分析。
尽管女性一生中多个阶段（如孕期、哺乳期、绝经和绝经后）激素分泌的变化被认为过于复杂，难以在临床试验中处理，但它们反而可被视为需要进一步研究和考虑的临床难题。我们建议应着重重新分析现有抗精神病药物主要治疗试验的数据，以确定哪些药物对女性患者疗效最佳以及在何种剂量范围内。此外，需要开展新的前瞻性研究，专门针对孕期及绝经后女性患者心理药物治疗的适当调整进行研究。还需要更多关于抗精神病药物对子宫内及哺乳期雄性和雌性胎儿影响的研究，以便在社区中更好地长期管理患有精神分裂症的女性及其后代。目前对神经药理学中的性别差异了解甚少。随着美国国立卫生研究院新政策要求在所有新提案中纳入性别因素，填补这一知识空白的时机已经到来。
