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产科术中自体血回输:一项前瞻性随机对照临床试验。

Intraoperative cell salvage for obstetrics: a prospective randomized controlled clinical trial.

作者信息

Liu Ye, Li Xiaoguang, Che Xiangming, Zhao Guosheng, Xu Mingjun

机构信息

Department of Anaesthesiology, Beijing Obstetrics and Gynecology Hospital, Capital Medical University, 100026, Beijing, China.

出版信息

BMC Pregnancy Childbirth. 2020 Aug 7;20(1):452. doi: 10.1186/s12884-020-03138-w.

Abstract

BACKGROUND

The latest basic studies and clinical evidence have confirmed the safety and efficacy of intraoperative autologous blood cell transfusion in cardiac surgery and orthopaedics. However, in caesarean section, there are still concerns about the contamination of amniotic fluid and foetal components, and consequently the application of intraoperative autologous blood cell transfusion is not universal. Therefore, this study aimed to evaluate the clinical value of intraoperative autologous blood cell transfusion in obstetric surgery.

METHODS

A prospective, randomized, controlled, feasibility study was performed in women undergoing caesarean section. One hundred sixteen participants were randomly assigned at a 1:1 ratio into either the intraoperative cell salvage group or the control group. Allogeneic blood cells were transfused into patients with haemoglobin concentrations < 80 g/dL in both the intraoperative cell salvage group and the control group.

RESULTS

No significant differences were found between the two groups in age, weight, maternal parity, history of previous caesarean section, gestational weeks of delivery, etc. However, compared with the control group, patients in the intraoperative cell salvage group had a significantly lower amount of allogeneic blood cell transfusion, lower incidence of postoperative incision infection, delayed wound healing, perioperative allergy, adverse cardiovascular events, hypoproteinaemia and shorter hospital stay.

CONCLUSION

The results of this study suggest that the use of autologous blood cell transfusion is safe and effective for patients with obstetric haemorrhage.

TRIAL REGISTRATION

All procedures performed in studies involving human participants were in accordance with the ethical standards of the Institutional and/or National Research Committee of Beijing Obstetrics and Gynecology Hospital, Capital Medical University (2016-XJS-003-01) as well as the 1964 Helsinki Declaration and its later amendments or other comparable ethical standards. The clinical trials were registered (ChiCTR-ICC-15,007,096) on September 28, 2015.

摘要

背景

最新的基础研究和临床证据已证实术中自体血细胞回输在心脏手术和骨科手术中的安全性和有效性。然而,在剖宫产术中,人们仍担心羊水和胎儿成分的污染,因此术中自体血细胞回输的应用并不普遍。因此,本研究旨在评估术中自体血细胞回输在产科手术中的临床价值。

方法

对行剖宫产术的女性进行一项前瞻性、随机、对照、可行性研究。116名参与者按1:1的比例随机分为术中细胞回收组或对照组。术中细胞回收组和对照组中血红蛋白浓度<80g/dL的患者均输注异体血细胞。

结果

两组在年龄、体重、产妇 parity、既往剖宫产史、分娩孕周等方面无显著差异。然而,与对照组相比,术中细胞回收组患者的异体血细胞输血量显著降低,术后切口感染、伤口愈合延迟、围手术期过敏、心血管不良事件、低蛋白血症的发生率较低,住院时间较短。

结论

本研究结果表明,自体血细胞回输用于产科出血患者是安全有效的。

试验注册

涉及人类参与者的研究中所进行的所有程序均符合首都医科大学附属北京妇产医院机构和/或国家研究委员会的伦理标准(2016 - XJS - 003 - 01)以及1964年《赫尔辛基宣言》及其后修订版或其他类似的伦理标准。该临床试验于2015年9月28日注册(ChiCTR - ICC - 15,007,096)。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/18cb/7412832/66e61c97f3a9/12884_2020_3138_Fig1_HTML.jpg

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