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剖宫产术后术中氯胺酮减轻产后抑郁症状的效果:一项双盲、随机临床试验。

Intraoperative ketamine for reduction in postpartum depressive symptoms after cesarean delivery: A double-blind, randomized clinical trial.

机构信息

The Second Department of Anesthesia, Shengjing Hospital of China Medical University, Shenyang, China.

出版信息

Brain Behav. 2020 Sep;10(9):e01715. doi: 10.1002/brb3.1715. Epub 2020 Aug 18.

Abstract

BACKGROUND

Postpartum depression (PPD) is a common mental disease happens in perinatal period. Ketamine as an anesthesia and analgesia drug has been used for a long time. In recent years, ketamine is proved to have an antidepression effect with a single administration. We hypothesized that intraoperative ketamine can reduce postpartum depressive symptoms after cesarean delivery.

METHODS

In a randomized, double-blind, placebo-controlled study trail, healthy women scheduled for cesarean delivery were randomly assigned to receive intravenous ketamine (0.25 mg/kg diluted to 5 ml with 0.9% saline) or placebo (5 ml of 0.9% saline) within 5 min following clamping of the neonatal umbilical cord. The primary outcome was the degree of postpartum depressive symptoms, which was evaluated by Edinburgh Postnatal Depression Scale (EPDS, a threshold of 9/10 was used) at 1 week, 2 weeks, and 1 month after delivery. The secondary outcome was the numerical rating scale (NRS) score of pain at 2 days postpartum. This trail is registered in the Chinese Clinical Trial Registry, number ChiCTR1900022464.

RESULTS

Between 26 January 2019 and 15 July 2019, 502 subjects were screened and 330 were randomly allocated: 165 (50%) to the ketamine group and 165 (50%) to the placebo group. There were significant differences in the degree of postpartum depressive symptoms between subjects in the ketamine group and the placebo group at 1 week postpartum (13.1% vs. 22.6%, respectively; p = .029). However, no difference was found between subjects in the two groups at 2 weeks (11.8% vs. 16.8%, respectively; p = .209) and 1 month postpartum (10.5% vs. 14.2%, respectively; p = .319). The NRS score of wound pain (3.0 ± 0.9 vs. 4.0 ± 1.0, respectively; p < .001) and uterine contraction pain (3.0 ± 0.9 vs. 4.1 ± 0.9, respectively; p < .001) was lower in the ketamine group at 2 days postpartum compared with placebo group. The prevalence of headache, hallucination, and dizziness was higher in the ketamine group than the placebo group during the operation.

CONCLUSIONS

Operative intravenous ketamine (0.25 mg/kg) can reduce the postpartum depressive symptoms for 1 week. The long-time effect is remained to be seen.

摘要

背景

产后抑郁症(PPD)是一种常见的围产期精神疾病。氯胺酮作为一种麻醉和镇痛药物,已经使用了很长时间。近年来,研究证明单次使用氯胺酮具有抗抑郁作用。我们假设剖宫产术中给予氯胺酮可以减轻产后抑郁症状。

方法

在一项随机、双盲、安慰剂对照的研究中,计划行剖宫产的健康女性被随机分配在新生儿脐带夹闭后 5 分钟内接受静脉注射氯胺酮(0.25mg/kg 用 0.9%生理盐水稀释至 5ml)或安慰剂(5ml 0.9%生理盐水)。主要结局是产后抑郁症状的严重程度,采用爱丁堡产后抑郁量表(EPDS,采用 9/10 的阈值)在产后 1 周、2 周和 1 个月进行评估。次要结局是产后 2 天的数字评分量表(NRS)疼痛评分。本试验在中国临床试验注册中心注册,注册号 ChiCTR1900022464。

结果

2019 年 1 月 26 日至 7 月 15 日,共筛选出 502 名受试者,其中 330 名被随机分配:165 名(50%)接受氯胺酮组,165 名(50%)接受安慰剂组。在产后 1 周时,氯胺酮组和安慰剂组受试者的产后抑郁症状严重程度存在显著差异(分别为 13.1%和 22.6%,p=0.029)。然而,在产后 2 周(分别为 11.8%和 16.8%,p=0.209)和 1 个月(分别为 10.5%和 14.2%,p=0.319)时,两组受试者之间没有差异。术后 2 天,氯胺酮组的切口疼痛 NRS 评分(3.0±0.9 与 4.0±1.0,p<0.001)和子宫收缩疼痛 NRS 评分(3.0±0.9 与 4.1±0.9,p<0.001)均低于安慰剂组。与安慰剂组相比,术中氯胺酮组头痛、幻觉和头晕的发生率更高。

结论

术中静脉注射氯胺酮(0.25mg/kg)可减轻产后 1 周的抑郁症状。其长期效果仍有待观察。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/87b1/7507540/f36a1ba4fdb7/BRB3-10-e01715-g001.jpg

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