Methadone versus buprenorphine in pregnant addicts: a double-blind, double-dummy comparison study
Methadone versus buprenorphine in pregnant addicts: a double-blind, double-dummy comparison study
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DOI：
10.1111/j.1360-0443.2006.01321.x
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发表时间：
2006-02-01
期刊：
影响因子：
6
通讯作者：
Aschauer, H
中科院分区：
文献类型：
--
作者：
Fischer, G;Ortner, R;Aschauer, H
目的评价美沙酮与丁丙诺啡治疗阿片类药物依赖孕妇的疗效和安全性。设计随机、双假人、双盲、灵活给药比较研究。设置成瘾诊所在维也纳医科大学，奥地利。在怀孕24-29周期间，18名妇女被随机分配接受美沙酮（n = 9）或丁丙诺啡（n = 9）。退出后，14例患者（美沙酮组6例，丁丙诺啡组8例）的数据可用。干预措施：丁丙诺啡舌下片（8-24毫克/天）或口服美沙酮溶液（40-100毫克/天），并配合安慰剂。测量方法：母亲在治疗中保留，尿液毒理学和尼古丁使用。新生儿：常规出生资料，新生儿戒断综合征（NAS）的严重程度和持续时间。发现丁丙诺啡组的保留率较高，但美沙酮组的额外阿片类药物使用明显降低（P = 0.047）。新生儿：美沙酮组新生儿的NAS发病时间（平均60小时）早于丁丙诺啡组（平均在末次给药后72小时）；两组治疗时间均较短（平均5天），43%患者不需要nas治疗。结论初步研究发现差异的能力有限，但观察到的趋势表明这种研究是可行的，值得进一步研究。
Aims To evaluate the efficacy and safety of methadone versus buprenorphine treatment in pregnant opioid-dependent women. Design Randomized, double-dummy, double-blind, flexible-dosing comparison study. Setting Addiction Clinic at the Medical University of Vienna, Austria. Participants Eighteen women were assigned randomly to receive either methadone (n = 9) or buprenorphine (n = 9) during weeks 24-29 of pregnancy. After dropouts, data were available from 14 cases (six in the methadone and eight in the buprenorphine group). Intervention Sublingual buprenorphine tablets (8-24 mg/day) or oral methadone solution (40-100 mg/day), with matched placebos. Measurements Mothers: retention in treatment, urine toxicology and nicotine use. Neonates: Routine birth data, neonatal abstinence syndrome (NAS) in severity and duration. Findings There was somewhat greater retention in the buprenorphine group but significantly lowered use of additional opioids in the methadone group (P = 0.047). Neonates: There was earlier onset of NAS in neonates born to the methadone (mean 60 hours) than to the buprenorphine groups (mean 72 hours after last medication); 43% did not require NAS-treatment with short treatment duration in both groups (mean 5 days). Conclusion This preliminary study had limited power to detect differences but the trends observed suggest this kind of research is practicable and that further studies are warranted.