Clonidine as an adjunct therapy to opioids for neonatal abstinence syndrome: a randomized, controlled trial.
Clonidine as an adjunct therapy to opioids for neonatal abstinence syndrome: a randomized, controlled trial.
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DOI：
10.1542/peds.2008-0978
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发表时间：
2009-05
期刊：
影响因子：
8
通讯作者：
Gauda EB
中科院分区：
文献类型：
--
作者：
Agthe AG;Kim GR;Mathias KB;Hendrix CW;Chavez-Valdez R;Jansson L;Lewis TR;Yaster M;Gauda EB
确定口服可乐定是否会缩短阿片类药物脱毒治疗新生儿戒断综合征的持续时间。2002-2005年期间，在2家医院招募了宫内暴露于美沙酮或海洛因和新生儿戒断综合征（连续2次改良Finnegan评分≥9）的婴儿，并随访至最终出院。所有入选婴儿（80名）根据标准化算法接受口服稀释的鸦片酊，并随机分配接受口服可乐定（每4小时1 μg/kg）（40名婴儿）或安慰剂（40名婴儿）。主要结局是阿片类药物治疗的持续时间。次要结果包括控制症状所需的鸦片量，治疗失败的次数，以及血压，心率和血氧饱和度的差异。可乐定组的中位治疗时间（11天[95%置信区间：8-15天]）比安慰剂组（15天[95%置信区间：12-17天]）短27%。在可乐定组中，7名婴儿在最初停药后需要重新开始使用阿片类药物，而安慰剂组中没有，可乐定组的治疗/观察总时间显著较短。安慰剂组40%的婴儿需要更高剂量的鸦片，而可乐定组只有20%。安慰剂组有12.5%的婴儿发生治疗失败，而可乐定组没有。两组均未发生高血压、低血压、心动过缓或饱和度下降。可乐定组有3名婴儿死于心肌炎、婴儿猝死综合征和他杀，均在出院后和6个月龄前死亡。在这项随机、双盲试验中，将可乐定添加到标准阿片类药物治疗中，用于宫内暴露于美沙酮或海洛因的脱毒，可减少新生儿戒毒药物治疗的持续时间，而不会引起短期不良心血管结局。需要进行更大规模的试验以确定长期安全性。
To determine if oral clonidine would reduce the duration of opioid detoxification for neonatal abstinence syndrome. Infants with intrauterine exposure to methadone or heroin and neonatal abstinence syndrome (2 consecutive modified Finnegan scores of ≥9) were enrolled at 2 hospitals during 2002–2005 and followed until final hospital discharge. All enrolled infants (80) received oral diluted tincture of opium according to a standardized algorithm and were randomly assigned to receive oral clonidine (1 μg/kg every 4 hours) (40 infants) or placebo (40 infants). Primary outcome was duration of opioid therapy. Secondary outcomes included the amount of opium required to control symptoms, number of treatment failures, and differences in blood pressure, heart rate, and oxygen saturation. The median length of therapy was 27% shorter in the clonidine group (11 [95% confidence interval: 8–15 days]) than in the placebo group (15 days [95% confidence interval: 12–17 days]). In the clonidine group, 7 infants required restarting opium after initial discontinuation versus none in the placebo group, with the total length of treatment/observation remaining significantly less in the clonidine group. Higher dosages of opium were required by 40% of the infants in the placebo group versus 20% in the clonidine group. Treatment failures occurred in 12.5% of the infants in the placebo group versus none in the clonidine group. Hypertension, hypotension, bradycardia, or desaturations did not occur in either group. Three infants in the clonidine group died as a result of myocarditis, sudden infant death syndrome, and homicide, all after hospital discharge and before 6 months of age. In this randomized, double-blind trial, adding clonidine to standard opioid therapy for detoxification from in utero exposure to methadone or heroin reduced the duration of pharmacotherapy for neonatal abstinence without causing short-term adverse cardiovascular outcomes. A larger trial is indicated to determine long-term safety.
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DOI：
10.1016/s0002-9378(16)33250-1
发表时间：
1977-01-01
影响因子：
9.8
作者：
MADDEN, JD;CHAPPEL, JN;DAVIS, R
通讯作者：
DAVIS, R
影响因子：
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作者：
Klein-Schwartz, W
通讯作者：
Klein-Schwartz, W
影响因子：
38.9
作者：
Arenas-López, S;Riphagen, S;Murdoch, IA
通讯作者：
Murdoch, IA
影响因子：
2.5
作者：
KANDALL, SR;ALBIN, S;LOWINSON, J
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LOWINSON, J
影响因子：
3
作者：
Kent, Alison L.;Kecskes, Zsuzsoka;Falk, Michael C.
通讯作者：
Falk, Michael C.