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甲氧氯普胺和苯海拉明:对乙酰氨基酚单独无效时治疗妊娠头痛的随机对照试验(MAD 头痛研究)。

Metoclopramide and Diphenhydramine: A Randomized Controlled Trial of a Treatment for Headache in Pregnancy when Acetaminophen Alone Is Ineffective (MAD Headache Study).

机构信息

Division of Maternal-Fetal Medicine, Department of Obstetrics, Gynecology, and Women's Health, Saint Louis University School of Medicine, St. Louis, Missouri.

出版信息

Am J Perinatol. 2018 Nov;35(13):1281-1286. doi: 10.1055/s-0038-1646952. Epub 2018 May 3.

DOI:10.1055/s-0038-1646952
PMID:29723901
Abstract

OBJECTIVE

We investigated whether metoclopramide administered with diphenhydramine (MAD) relieves headache in pregnant women when acetaminophen alone is ineffective, using codeine for comparison.

STUDY DESIGN

Normotensive pregnant women in the second or third trimester were randomized to MAD intravenously (10 mg and 25 mg, respectively) or codeine orally (30 mg) for headache after 650 to 1,000 mg of acetaminophen failed to relieve their headaches. Headache severity (pain score 0-10) was noted at intervals over 24 hours. The primary outcome was reduction in pain score 6 hours after medication administration. A sample size calculation of 35 patients per group was based on estimated reduction in headache pain score by at least two points, with an of 0.05 and a power of 80%.

RESULTS

No difference was seen in the primary outcome. MAD pain scores were lower at 30 minutes (3 ± 2.8 versus 5.8 ± 2.3,  < 0.001), 1 hour (2.2 ± 2.3 vs. 4.1 ± 3;  < 0.01), and 12 hours (1.3 ± 2.5 vs. 2.7 ± 3;  < 0.05), but not at 6 hours. Time to perceived headache relief was shorter for MAD than for codeine (20.2 ± 13.4 vs. 62.4 ± 62.2 minutes;  < 0.001). More patients in the MAD group reported full headache relief within 24 hours (76.5 vs. 37.5%;  < 0.01).

CONCLUSION

MAD effectively relieves headaches in pregnant women when acetaminophen fails.

摘要

目的

我们研究了当对乙酰氨基酚无效时,与可待因相比,用苯海拉明加甲氧氯普胺(MAD)治疗是否能缓解孕妇的头痛。

研究设计

血压正常的孕妇在妊娠中期或晚期,在对乙酰氨基酚 650 至 1000 毫克后头痛未缓解,随机静脉内给予 MAD(分别为 10 毫克和 25 毫克)或口服可待因(30 毫克)。每隔一段时间记录 24 小时内的头痛严重程度(疼痛评分 0-10)。主要结局是用药后 6 小时疼痛评分的降低。根据疼痛评分至少降低 2 分的估计值,计算出每组 35 例患者的样本量, 为 0.05,功效为 80%。

结果

主要结局无差异。MAD 疼痛评分在 30 分钟(3 ± 2.8 与 5.8 ± 2.3,  < 0.001)、1 小时(2.2 ± 2.3 与 4.1 ± 3;  < 0.01)和 12 小时(1.3 ± 2.5 与 2.7 ± 3;  < 0.05)时较低,但在 6 小时时没有差异。MAD 组感知头痛缓解的时间短于可待因组(20.2 ± 13.4 与 62.4 ± 62.2 分钟;  < 0.001)。MAD 组在 24 小时内报告完全缓解头痛的患者更多(76.5%与 37.5%;  < 0.01)。

结论

当对乙酰氨基酚无效时,MAD 能有效缓解孕妇头痛。

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