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卡贝缩宫素预防子痫前期及非子痫前期患者剖宫产术中宫缩乏力的最小有效剂量:一项倾向性序贯分配研究

Minimum effective dose of carbetocin for preventing uterine atony during Cesarean delivery in patients with and without preeclampsia: a biased sequential allocation study.

作者信息

Tyagi Asha, Sasi Thamburu, Nigam Chanchal, Rautela Rajesh S, Malhotra Rajeev K, Suneja Amita

机构信息

Department of Anaesthesiology & Critical Care, University College of Medical Sciences & Guru Teg Bahadur (GTB) Hospital, New Delhi, India.

Delhi Cancer Registry, Dr. BR Ambedkar Institute-Rotary Cancer Hospital, All India Institute of Medical Sciences, New Delhi, India.

出版信息

Can J Anaesth. 2025 Aug;72(8):1305-1313. doi: 10.1007/s12630-025-03005-2. Epub 2025 Jul 11.

Abstract

PURPOSE

The aggregate data for successful use of carbetocin in patients at high risk of postpartum hemorrhage is fairly large. Nevertheless, there are scant data evaluating carbetocin in patients with preeclampsia and no established optimal dose. Therefore, we aimed to determine the minimum effective dose (the dose effective in 90% of the studied population [ED]) of carbetocin to prevent intraoperative uterine atony in patients with preeclampsia undergoing Cesarean delivery.

METHODS

We based this nonrandomized triple-blinded dose finding study on biased coin sequential allocation design. We enrolled all consenting nonlabouring parturients aged > 18 yr with singleton pregnancy posted for Cesarean delivery under spinal anesthesia (with and without preeclampsia). Doses of carbetocin included 10 μg, 20 μg, 40 μg, 60 μg, 80 μg, 100 μg, or 120 μg, with 20 μg for the first patient of either group and then successively decided by response to the bolus in the previous patient in the respective group. After a "failed" dose of carbetocin bolus, the subsequent patient in that group received the next highest dose. In the case of a "successful" dose, we decreased it to the lower dose with a probability of 1/9; otherwise, it remained unchanged. The determinant of a successful dose was satisfactory uterine tone at 2 min after carbetocin, along with no need for any additional uterotonic intraoperatively.

RESULTS

The ED of carbetocin for patients with and without preeclampsia was 96 µg (95% confidence interval [CI], 59 to 114) vs 68 µg (95% CI, 46 to 76).

CONCLUSION

The dose requirement of carbetocin to prevent intraoperative uterine atony in patients with preeclampsia is 1.5 times greater than in those without the disease.

摘要

目的

卡贝缩宫素成功用于产后出血高危患者的总体数据相当多。然而,评估卡贝缩宫素在子痫前期患者中的数据很少,且尚未确定最佳剂量。因此,我们旨在确定卡贝缩宫素预防子痫前期剖宫产患者术中子宫收缩乏力的最小有效剂量(在90%的研究人群中有效的剂量[ED])。

方法

我们基于偏倚硬币序贯分配设计进行了这项非随机三盲剂量探索研究。我们纳入了所有年龄>18岁、单胎妊娠、拟在脊髓麻醉下进行剖宫产(有或无子痫前期)且同意参与的未临产产妇。卡贝缩宫素的剂量包括10μg、20μg、40μg、60μg、80μg、100μg或120μg,每组的第一名患者给予20μg,然后根据各自组中前一名患者对推注的反应依次决定剂量。在卡贝缩宫素推注剂量“无效”后,该组的下一名患者接受下一个更高的剂量。在“有效”剂量的情况下,我们以1/9的概率将其降至较低剂量;否则,保持不变。成功剂量取决于卡贝缩宫素给药后2分钟时子宫张力良好,且术中无需任何额外的宫缩剂。

结果

有子痫前期和无子痫前期患者的卡贝缩宫素ED分别为96μg(95%置信区间[CI],59至114)和68μg(95%CI,46至76)。

结论

子痫前期患者预防术中子宫收缩乏力所需的卡贝缩宫素剂量比无该病的患者高1.5倍。

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