Johnson R E, Jones H E, Jasinski D R, Svikis D S, Haug N A, Jansson L M, Kissin W B, Alpan G, Lantz M E, Cone E J, Wilkins D G, Golden A S, Huggins G R, Lester B M
Department of Psychiatry and Behavioral Sciences, Johns Hopkins University School of Medicine, Johns Hopkins Bayview Medical Center, Baltimore, MD 21224-6823, USA.
Drug Alcohol Depend. 2001 Jun 1;63(1):97-103. doi: 10.1016/s0376-8716(00)00194-0.
This open-label prospective study examined maternal and neonatal safety and efficacy outcome measures during and following prenatal buprenorphine exposure. Three opioid-dependent pregnant women received 8 or 12 mg sublingual buprenorphine tablets daily for 15-16 weeks prior to delivery. Results showed that buprenorphine in combination with comprehensive prenatal care was safe and effective in these women. Prenatal exposure to buprenorphine resulted in normal birth outcomes, a mean of 4.33 days (minimum possible=4) hospitalization, and a 'relatively mild' neonatal abstinence syndrome comprised primarily of tremors (disturbed), hyperactive moro and shortened sleep after feeding. The infants required no pharmacological treatment. Onset of neonatal abstinence signs occurred within the first 12 h after birth, peaked by 72 h and returned to below pre-12 h levels by 120 h. It is concluded that buprenorphine has potential utility for the treatment of pregnant opioid-dependent women.
这项开放标签的前瞻性研究，调查了孕期暴露于丁丙诺啡期间及之后的母婴安全性和疗效指标。三名阿片类药物依赖的孕妇在分娩前15至16周，每天服用8或12毫克的丁丙诺啡舌下片。结果显示，丁丙诺啡联合全面的产前护理，对这些女性是安全有效的。孕期暴露于丁丙诺啡导致了正常的分娩结局，平均住院4.33天（最短可能为4天），以及一种“相对轻微”的新生儿戒断综合征，主要表现为震颤（不安）、莫罗反射亢进和喂食后睡眠时间缩短。这些婴儿无需药物治疗。新生儿戒断症状在出生后的头12小时内出现，72小时达到高峰，120小时恢复到出生前12小时以下的水平。研究得出结论，丁丙诺啡在治疗阿片类药物依赖的孕妇方面具有潜在效用。
