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[BMJ最新论文]:静脉注射与肌肉注射催产素预防阴道分娩后出血的随机对照试验
2018年09月30日 时讯速递, 进展交流 暂无评论

Intramuscular versus intravenous oxytocin to prevent postpartum haemorrhage at vaginal delivery: randomised controlled trial

Nita Adnan, Rebecca Conlan-Trant, Ciara McCormick, et al

BMJ 2018; 362 doi: https://doi.org/10.1136/bmj.k3546 (Published 04 September 2018)

Cite this as: BMJ 2018;362:k3546

Abstract

Objective 目的

To determine whether intravenous oxytocin is more effective than intramuscular oxytocin at preventing postpartum haemorrhage at vaginal delivery.

确定静脉注射催产素预防阴道分娩后产后出血较肌肉注射催产素更有效。

Design 设计

Double blind placebo controlled randomised trial.

双盲安慰剂对照随机临床试验

Setting 场景

University affiliated maternity unit in the Republic of Ireland.

以色列的大学附属产科病房

Participants 研究人群

1075 women aged 18 years or older, at term with a singleton pregnancy who were aiming for a vaginal delivery with an actively managed third stage of labour.

1075名18岁以上女性,单胎妊娠足月,第三产程活跃准备阴道分娩

Interventions 干预措施

Women were allocated to an intravenous bolus of oxytocin (10 IU in 1 mL given slowly over one minute) and placebo intramuscular injection (1 mL 0.9% saline) or an intramuscular bolus of oxytocin (10 IU in 1 mL) and placebo intravenous injection (1 mL 0.9% saline given slowly over one minute) at vaginal delivery. Allocation was by a secure web based randomisation service with masking of participants and clinicians to the trial intervention.

将入选孕妇随机分组,分别为阴道分娩时静脉注射催产素(10 IU/ml,一分钟内缓慢注射)及肌内注射安慰剂(1 ml 0.9%盐水),或肌内注射催产素(10 IU/ml)及静脉注射安慰剂(1 ml 0.9%盐水,一分钟内缓慢注射)。基于网络进行随机分组,保证试验干预对研究人群及临床医生的分配隐藏。

Main outcome measures 主要预后指标

The primary outcome was postpartum haemorrhage (PPH, measured blood loss ≥500 mL). Secondary outcomes were severe PPH (measured blood loss ≥1000 mL), need for blood transfusion, admission to a high dependency unit, and side effects to oxytocin.

主要预后指标为产后出血(PPH,失血量 ≥500 mL)。次要预后指标为严重PPH(失血量 ≥1000 mL),需要输血,收入过渡病房,及催产素的不良反应。

Results 结果

Between 4 January 2016 and 13 December 2017, 1075 women were randomised and 1035 (96.3%) included in the primary and secondary analyses (517 in the intravenous oxytocin group and 518 in the intramuscular oxytocin group). The incidence of PPH was not significantly lower in the intravenous group (18.8%, 97/517) compared with intramuscular group (23.2%, 120/518): adjusted odds ratio 0.75 (95% confidence interval 0.55 to 1.03). The incidence of severe PPH, however, was significantly lower in the intravenous group (4.6%, 24/517) compared with intramuscular group (8.1%, 42/518): 0.54 (0.32 to 0.91) as was the need for blood transfusion (1.5% v 4.4%, 0.31, 0.13 to 0.70) and admission to a high dependency unit (1.7% v 3.7%, 0.44, 0.20 to 0.98). The number needed to treat to prevent one case of severe PPH was 29 (95% confidence interval 16 to 201) and to prevent one case of blood transfusion was 35 (20 to 121). The incidence of side effects to oxytocin was not increased in the intravenous group compared with intramuscular group (4.1% v 5.2%, 0.75, 0.42 to 1.35).

在2016年1月4日至2017年12月13日间,共有1075名孕妇接受随机分组,1035名孕妇(96.3%)纳入主要及次要分析(静脉催产素组517名,肌内注射催产素组518名)。静脉组PPH发生率无显著降低(18.8% [97/517] vs. 23.2% [120/518]);校正后比数比 0.75(95% 可信区间0.55 to 1.03)。然而,静脉组严重PPH发生率显著降低(4.6% [24/517] vs. 8.1% [42/518]), 0.54 [0.32 to 0.91]),输血需求减少 (1.5% v 4.4%, 0.31, 0.13 to 0.70),收入过渡病房风险降低(1.7% v 3.7%, 0.44, 0.20 to 0.98)。为预防1例严重PPH需要治疗孕妇数目为29(95%可信区间 16 to 201),预防1例输血需要治疗孕妇数目为 35 (20 to 121)。静脉组催产素的不良事件发生率并未增加 (4.1% v 5.2%, 0.75, 0.42 to 1.35)。

Conclusion 结论

Intravenous oxytocin for the third stage of labour results in less frequent severe PPH, blood transfusion, and admission to a high dependency unit than intramuscular oxytocin, and without excess side effects.

与肌内注射催产素相比,在第三产程静脉注射催产素可减少严重PPH,输血需求以及收入过渡病房的风险,且没有更多的不良事件。

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