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不同剂量氯胺酮干预对剖宫产术后产妇产后抑郁症状的影响:一项随机、双盲、对照的临床研究。

Effects of different doses of esketamine intervention on postpartum depressive symptoms in cesarean section women: A randomized, double-blind, controlled clinical study.

机构信息

Department of Anesthesiology, Third Xiangya Hospital of Central South University, Changsha, China.

Department of Clinical Pharmacology, Xiangya Hospital, Central South University, Changsha, China; Hunan Key Laboratory of Pharmacogenetics, Institute of Clinical Pharmacology, Central South University, Changsha, China.

出版信息

J Affect Disord. 2023 Oct 15;339:333-341. doi: 10.1016/j.jad.2023.07.007. Epub 2023 Jul 11.

DOI:10.1016/j.jad.2023.07.007
PMID:37442447
Abstract

BACKGROUND

The optimal dosage and method of esketamine for postpartum depressive symptoms (PDS) are unclear. We conducted a randomized controlled trial (RCT) to investigate the effect of different doses of esketamine on PDS in women undergoing cesarean section, with evidence of prenatal depression.

METHODS

The three groups were high- (2 mg kg) and low-dose (1 mg kg) esketamine via patient controlled intravenous analgesia (PCIA), following an initial intravenous infusion of 0.25 mg kg esketamine, compared to placebo (0.9 % saline infusion). All groups also received the sufentanil (2.2 μg kg). The primary outcome was the incidence of PDS at 7 and 42 days postpartum. The secondary outcomes were: the remission from depression and total EPDS scores at 7 days and 42 days postpartum; mean change from baseline in the EPDS score; postoperative analgesia.

RESULTS

i). 0.25 mg kg of esketamine intravenous infusion combined with 1 mg kg (n = 99) or 2 mg kg (n = 99) esketamine PCIA reduces PDS incidence at 7 days postpartum (p < 0.05), with high-dose esketamine PCIA also reduces PDS incidence 42 days postpartum (p < 0.05), compared to placebo (n = 97). ii). Low- and high-dose esketamine PCIA lowers NRS scores at rest within 48 h postoperatively (p < 0.01), with high-dose esketamine also reducing the NRS score during movement at 48 h postoperatively (p = 0.018). iii). Neither high- nor low-dose esketamine PCIA increased postoperative adverse reactions (p > 0.05).

CONCLUSIONS

Esketamine (0.25 mg kg) intravenous infusion combined with 1 mg kg or 2 mg kg esketamine PCIA seems safe and with few adverse effects in the management of PDS and pain in women undergoing cesarean section.

LIMITATIONS

The tolerability and safety of esketamine requires further investigation based on more specific scales; the transient side effects of esketamine could have biased the staff and patients.

TRIAL REGISTRATION

ChiCTR-ROC-2000039069.

摘要

背景

对于产后抑郁症(PDS),氯胺酮的最佳剂量和方法尚不清楚。我们进行了一项随机对照试验(RCT),以研究不同剂量氯胺酮对行剖宫产术且存在产前抑郁的女性的 PDS 的影响。

方法

三组患者分别接受高剂量(2mg/kg)和低剂量(1mg/kg)氯胺酮通过患者自控静脉镇痛(PCIA)治疗,在初始静脉输注 0.25mg/kg 氯胺酮后,与安慰剂(0.9%生理盐水输注)进行比较。所有组均接受舒芬太尼(2.2μg/kg)。主要结局是产后 7 天和 42 天 PDS 的发生率。次要结局是:产后 7 天和 42 天的抑郁缓解率和 EPDS 总分;基线时 EPDS 评分的平均变化;术后镇痛。

结果

i)0.25mg/kg 氯胺酮静脉输注联合 1mg/kg(n=99)或 2mg/kg(n=99)氯胺酮 PCIA 可降低产后 7 天 PDS 的发生率(p<0.05),高剂量氯胺酮 PCIA 也可降低产后 42 天 PDS 的发生率(p<0.05),与安慰剂(n=97)相比。ii)低剂量和高剂量氯胺酮 PCIA 可降低术后 48 小时内静息时的 NRS 评分(p<0.01),高剂量氯胺酮还可降低术后 48 小时运动时的 NRS 评分(p=0.018)。iii)高剂量和低剂量氯胺酮 PCIA 均未增加术后不良反应(p>0.05)。

结论

氯胺酮(0.25mg/kg)静脉输注联合 1mg/kg 或 2mg/kg 氯胺酮 PCIA 似乎安全且不良反应少,可用于治疗剖宫产术后 PDS 和疼痛。

局限性

氯胺酮的耐受性和安全性需要基于更具体的量表进一步研究;氯胺酮的短暂副作用可能会影响工作人员和患者。

试验注册

ChiCTR-ROC-2000039069。

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