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卡贝缩宫素静脉推注与持续输注用于剖宫产术的有效性和安全性比较:双盲、双模拟、随机对照非劣效性试验。

Efficacy and safety of carbetocin given as an intravenous bolus compared with short infusion for Caesarean section - double-blind, double-dummy, randomized controlled non-inferiority trial.

机构信息

Department of Anaesthesiology, Surgical Intensive Care, Prehospital Emergency Medicine and Pain Therapy, Basel, Switzerland.

Basel Institute for Clinical Epidemiology and Biostatistics, Basel, Switzerland.

出版信息

Br J Anaesth. 2017 May 1;118(5):772-780. doi: 10.1093/bja/aex034.


DOI:10.1093/bja/aex034
PMID:28498927
Abstract

BACKGROUND: Carbetocin is a synthetic oxytocin-analogue, which should be administered as bolus according to manufacturer's recommendations. A higher speed of oxytocin administration leads to increased cardiovascular side-effects. It is unclear whether carbetocin administration as short infusion has the same efficacy on uterine tone compared with bolus administration and whether haemodynamic parameters differ. METHODS: In this randomized, double-blind, non-inferiority trial, women undergoing planned or unplanned Caesarean section (CS) under regional anaesthesia received a bolus and a short infusion, only one of which contained carbetocin 100 mcg (double dummy). Obstetricians quantified uterine tone two, three, five and 10 min after cord-clamping by manual palpation using a linear analogue scale from 0 to 100. We evaluated whether the lower limit of the 95% CI of the difference in maximum uterine tone within the first five min after cord-clamping did not include the pre-specified non-inferiority limit of -10. RESULTS: Between December 2014 and November 2015, 69 patients were randomized to receive carbetocin as bolus and 71 to receive it as short infusion. Maximal uterine tone was 89 in the bolus and 88 in the short infusion group (mean difference -1.3, 95% CI -5.7 to 3.1). Bp, calculated blood loss, use of additional uterotonics, and side-effects were comparable. CONCLUSIONS: Administration of carbetocin as short infusion does not compromise uterine tone and has similar cardiovascular side-effects as a slow i.v. bolus. In accordance with current recommendations for oxytocin, carbetocin can safely be administered as short -infusion during planned or unplanned CS. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov NCT02221531 and www.kofam.ch SNCTP000001197.

摘要

背景:卡贝缩宫素是一种合成的催产素类似物,应按照制造商的建议进行推注给药。催产素给药速度加快会导致心血管副作用增加。目前尚不清楚卡贝缩宫素短输注与推注给药相比对子宫收缩的效果是否相同,以及血流动力学参数是否存在差异。

方法:在这项随机、双盲、非劣效性试验中,接受区域麻醉下计划性或计划性剖宫产(CS)的妇女接受了推注和短输注,只有其中一种含有 100μg 卡贝缩宫素(双盲)。产科医生通过使用线性模拟量表从 0 到 100 对脐带夹闭后 2、3、5 和 10 分钟时的子宫收缩进行定量评估。我们评估了在脐带夹闭后 5 分钟内最大子宫收缩的差异的 95%CI 的下限是否不包括预先指定的-10 的非劣效性下限。

结果:2014 年 12 月至 2015 年 11 月期间,69 名患者被随机分配接受卡贝缩宫素推注,71 名患者接受卡贝缩宫素短输注。推注组和短输注组的最大子宫收缩分别为 89 和 88(平均差异-1.3,95%CI-5.7 至 3.1)。血压、计算的失血量、额外使用宫缩剂和副作用相似。

结论:卡贝缩宫素短输注给药不会影响子宫收缩,且与缓慢静脉推注相比具有相似的心血管副作用。根据目前对催产素的建议,卡贝缩宫素可安全地在计划性或计划性 CS 期间进行短输注给药。

临床试验注册:ClinicalTrials.gov NCT02221531 和 www.kofam.ch SNCTP000001197。

相似文献

[1]
Efficacy and safety of carbetocin given as an intravenous bolus compared with short infusion for Caesarean section - double-blind, double-dummy, randomized controlled non-inferiority trial.

Br J Anaesth. 2017-5-1

[2]
Efficacy and safety of carbetocin applied as an intravenous bolus compared to as a short-infusion for caesarean section: study protocol for a randomised controlled trial.

Trials. 2016-3-22

[3]
Carbetocin at elective Cesarean delivery: a randomized controlled trial to determine the effective dose, part 2.

Can J Anaesth. 2013-9-25

[4]
Carbetocin vs. oxytocin at elective caesarean delivery: a double-blind, randomised, controlled, non-inferiority trial of low- and high-dose regimens.

Anaesthesia. 2022-8

[5]
Utilization of carbetocin for prevention of postpartum hemorrhage after cesarean section: a randomized clinical trial.

Arch Gynecol Obstet. 2009-2-20

[6]
Carbetocin at elective Cesarean delivery: a randomized controlled trial to determine the effective dose.

Can J Anaesth. 2012-6-21

[7]
Double-blind, randomized comparison of the effect of carbetocin and oxytocin on intraoperative blood loss and uterine tone of patients undergoing cesarean section.

J Perinatol. 1998

[8]
Haemodynamic effects of carbetocin and oxytocin given as intravenous bolus on women undergoing caesarean delivery: a randomised trial.

BJOG. 2011-6-14

[9]
Uterotonics in elective caesarean delivery: a randomised non-inferiority study comparing carbetocin 20 μg and 100 μg.

Anaesthesia. 2018-12-1

[10]
Comparison of carbetocin and oxytocin infusions in reducing the requirement for additional uterotonics or procedures in women at increased risk of postpartum haemorrhage after Caesarean section.

Hong Kong Med J. 2020-10

引用本文的文献

[1]
Hemodynamic effects of carbetocin administered as an intravenous bolus or infusion during cesarean delivery.

Anesth Pain Med (Seoul). 2020-4-30

[2]
Uterotonic agents for preventing postpartum haemorrhage: a network meta-analysis.

Cochrane Database Syst Rev. 2018-12-19

[3]
Uterotonic agents for preventing postpartum haemorrhage: a network meta-analysis.

Cochrane Database Syst Rev. 2018-4-25

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