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卡贝缩宫素与缩宫素对剖宫产患者术中失血及子宫收缩力影响的双盲随机对照研究

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

作者信息

Boucher M, Horbay G L, Griffin P, Deschamps Y, Desjardins C, Schulz M, Wassenaar W

机构信息

Department of Obstetrics and Gynecology, Université de Montréal, Québec.

出版信息

J Perinatol. 1998 May-Jun;18(3):202-7.

PMID:9659650
Abstract

OBJECTIVES

A double-blind randomized study involving pregnant women undergoing cesarean section was conducted to compare the effectiveness of a single 100 micrograms intravenous injection of the long-acting oxytocin analog, carbetocin, with that of a standard infusion of oxytocin with respect to intraoperative blood loss. The two treatments also were compared for safety and ability to maintain adequate uterine tone.

STUDY DESIGN

The study drug was administered to 57 women during elective cesarean section after placental delivery; blood was collected until abdominal closure. Intraoperative blood loss was calculated with a sensitive colorimetric method. Position, tone of the fundus, and vital signs were assessed up to 24 hours after the operation. The need for additional uterotonic agents was recorded.

RESULTS

A single 100 micrograms intravenous injection of carbetocin was as effective as a continuous 16 hour infusion of oxytocin in controlling intraoperative blood loss after placental delivery. Mean blood loss after carbetocin administration was 29 ml less than after oxytocin administration (p = 0.3). Subset analysis deleting two patients who received oxytocic intervention in the operating room and one extreme outlier revealed a mean blood loss of 41 ml less in the carbetocin group (p = 0.14) with lower variances (p = 0.02). The percentage of patients with blood loss of 200 ml or less was greater with carbetocin (79% vs 53%; p = 0.041). Carbetocin enhanced early postpartum uterine involution. The fundus was below the umbilicus in more patients who received carbetocin at 0, 2, 3, and 24 hours on the ward (p < 0.05). There were no significant differences in uterine tone or type or amount of lochia. Additional oxytocin was used to treat three patients for postpartum hemorrhage or persistent uterine atony. All interventions were in the oxytocin group. Vital signs and hematologic values were comparable in each group, confirming similar safety profiles.

CONCLUSIONS

A single 100 micrograms intravenous injection of carbetocin is as effective and more reliable than a standard continuous infusion of oxytocin in maintaining adequate uterine tone and preventing excessive intraoperative blood loss during cesarean section after delivery of the placenta. Patients receiving carbetocin required less intervention. Carbetocin was well tolerated.

摘要

目的

开展一项双盲随机研究,纳入接受剖宫产的孕妇,比较单次静脉注射100微克长效缩宫素类似物卡贝缩宫素与标准缩宫素输注在控制术中失血方面的有效性。还比较了两种治疗方法的安全性及维持子宫适度收缩的能力。

研究设计

在57例择期剖宫产孕妇胎盘娩出后给予研究药物;在关腹前采集血液。采用灵敏的比色法计算术中失血量。术后24小时内评估子宫位置、宫底张力及生命体征。记录是否需要追加宫缩剂。

结果

单次静脉注射100微克卡贝缩宫素在控制胎盘娩出后的术中失血方面与持续16小时输注缩宫素效果相当。卡贝缩宫素给药后的平均失血量比缩宫素给药后少29毫升(p = 0.3)。剔除在手术室接受宫缩干预的2例患者及1例极端异常值进行亚组分析,结果显示卡贝缩宫素组平均失血量少41毫升(p = 0.14),且方差更低(p = 0.02)。失血量200毫升及以下的患者比例,卡贝缩宫素组更高(79%对53%;p = 0.041)。卡贝缩宫素可促进产后早期子宫复旧。在病房0、2、3及24小时,接受卡贝缩宫素治疗的更多患者宫底位于脐下(p < 0.05)。子宫张力、恶露类型或量方面无显著差异。有3例患者因产后出血或持续性子宫收缩乏力使用了追加缩宫素治疗。所有干预均在缩宫素组。每组的生命体征和血液学值具有可比性,证实了相似的安全性。

结论

单次静脉注射100微克卡贝缩宫素在剖宫产胎盘娩出后维持子宫适度收缩及预防术中失血过多方面与标准持续输注缩宫素效果相当且更可靠。接受卡贝缩宫素治疗的患者需要的干预更少。卡贝缩宫素耐受性良好。

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