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肌肉注射缩宫素与合成缩宫素及卡贝缩宫素预防阴道分娩后原发性产后出血的比较:一项关于有效性、副作用及生活质量的随机双盲临床试验

Intramuscular oxytocin versus Syntometrine versus carbetocin for prevention of primary postpartum haemorrhage after vaginal birth: a randomised double-blinded clinical trial of effectiveness, side effects and quality of life.

作者信息

van der Nelson H, O'Brien S, Burnard S, Mayer M, Alvarez M, Knowlden J, Winter C, Dailami N, Marques E, Burden C, Siassakos D, Draycott T

机构信息

North Bristol NHS Trust, Bristol, UK.

University of Bristol, Bristol, UK.

出版信息

BJOG. 2021 Jun;128(7):1236-1246. doi: 10.1111/1471-0528.16622. Epub 2021 Jan 12.

Abstract

OBJECTIVE

To compare intramuscular oxytocin, Syntometrine and carbetocin for prevention of postpartum haemorrhage after vaginal birth.

DESIGN

Randomised double-blinded clinical trial.

SETTING

Six hospitals in England.

POPULATION

A total of 5929 normotensive women having a singleton vaginal birth.

METHODS

Randomisation when birth was imminent.

MAIN OUTCOME MEASURES

Primary: use of additional uterotonic agents. Secondary: weighed blood loss, transfusion, manual removal of placenta, adverse effects, quality of life.

RESULTS

Participants receiving additional uterotonics: 368 (19.5%) oxytocin, 298 (15.6%) Syntometrine and 364 (19.1%) carbetocin. When pairwise comparisons were made: women receiving carbetocin were significantly more likely to receive additional uterotonics than those receiving Syntometrine (odds ratio [OR] 1.28, 95% CI 1.08-1.51, P = 0.004); the difference between carbetocin and oxytocin was non-significant (P = 0.78); Participants receiving Syntometrine were significantly less likely to receive additional uterotonics than those receiving oxytocin (OR 0.75, 95% CI 0.65-0.91, P = 0.002). Non-inferiority between carbetocin and Syntometrine was not shown. Use of Syntometrine reduced non-drug PPH treatments compared with oxytocin (OR 0.64, 95% CI 0.42-0.97) but not carbetocin (P = 0.64). Rates of PPH and blood transfusion were not different. Syntometrine was associated with an increase in maternal adverse effects and reduced ability of the mother to bond with her baby.

CONCLUSIONS

Non-inferiority of carbetocin to Syntometrine was not shown. Carbetocin is not significantly different to oxytocin for use of additional uterotonics. Use of Syntometrine reduced use of additional uterotonics and need for non-drug PPH treatments compared with oxytocin. Increased maternal adverse effects are a disadvantage of Syntometrine.

TWEETABLE ABSTRACT

IM carbetocin does not reduce additional uterotonic use compared with IM Syntometrine or oxytocin.

摘要

目的

比较肌内注射缩宫素、欣母沛和卡贝缩宫素预防阴道分娩后产后出血的效果。

设计

随机双盲临床试验。

地点

英国的六家医院。

研究对象

总共5929名单胎阴道分娩的血压正常的女性。

方法

在即将分娩时进行随机分组。

主要观察指标

主要指标:使用额外宫缩剂的情况。次要指标:称重失血、输血、徒手剥离胎盘、不良反应、生活质量。

结果

接受额外宫缩剂治疗的参与者:缩宫素组368例(19.5%),欣母沛组298例(15.6%),卡贝缩宫素组364例(19.1%)。进行两两比较时:接受卡贝缩宫素治疗的女性比接受欣母沛治疗的女性更有可能接受额外宫缩剂治疗(优势比[OR]1.28,95%可信区间1.08 - 1.51,P = 0.004);卡贝缩宫素与缩宫素之间的差异无统计学意义(P = 0.78);接受欣母沛治疗的女性比接受缩宫素治疗的女性接受额外宫缩剂治疗的可能性显著降低(OR 0.75,95%可信区间0.65 - 0.91,P = 0.002)。未显示卡贝缩宫素与欣母沛之间的非劣效性。与缩宫素相比,欣母沛的使用减少了非药物性产后出血治疗(OR 0.64,95%可信区间0.42 - 0.97),但与卡贝缩宫素相比无差异(P = 0.64)。产后出血和输血率无差异。欣母沛与产妇不良反应增加以及母亲与婴儿建立亲密关系的能力降低有关。

结论

未显示卡贝缩宫素相对于欣母沛的非劣效性。在使用额外宫缩剂方面,卡贝缩宫素与缩宫素无显著差异。与缩宫素相比,欣母沛的使用减少了额外宫缩剂的使用以及非药物性产后出血治疗的需求。产妇不良反应增加是欣母沛的一个缺点。

可发推文摘要

与肌内注射欣母沛或缩宫素相比,肌内注射卡贝缩宫素并不能减少额外宫缩剂的使用。

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