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静脉输注维生素C对腹腔镜子宫肌瘤切除术中失血的影响:一项随机、双盲、安慰剂对照试验

Effect of intravenous ascorbic acid infusion on blood loss during laparoscopic myomectomy: a randomized, double-blind, placebo-controlled trial.

作者信息

Lee Banghyun, Kim Kidong, Cho Hye Yon, Yang Eun Joo, Suh Dong Hoon, No Jae Hong, Lee Jung Ryeol, Hwang Jung Won, Do Sang Hwan, Kim Yong Beom

机构信息

Department of Obstetrics and Gynecology, Seoul National University, Bundang Hospital, Seongnam-Si, Gyeonggi-Do, Republic of Korea.

Department of Obstetrics and Gynecology, Hallym University, Dongtan Sacred Heart Hospital, Hwaseong-Si, Gyeonggi-do, Republic of Korea.

出版信息

Eur J Obstet Gynecol Reprod Biol. 2016 Apr;199:187-91. doi: 10.1016/j.ejogrb.2016.02.014. Epub 2016 Feb 21.

DOI:10.1016/j.ejogrb.2016.02.014
PMID:26946313
Abstract

OBJECTIVE

Most interventions aimed at reducing bleeding during myomectomy lack sufficient evidence regarding their effectiveness. Recently, it was reported that intraoperative ascorbic acid administration effectively reduced blood loss during abdominal myomectomy. Therefore, this study aimed to investigate whether intravenous ascorbic acid infusion would affect intraoperative blood loss in women undergoing laparoscopic myomectomy.

STUDY DESIGN

A randomized, double-blind, parallel-group, placebo-controlled trial including 50 women undergoing laparoscopic myomectomy was conducted. Women with ≤4 myomas, ≤9cm in maximum diameter were eligible. The study:control group ratio was 1:1. Starting 30minutes before anesthesia, 2g of ascorbic acid or a placebo were administered for 2hours intraoperatively. Intraoperative blood loss, the primary endpoint, was calculated as the difference between the volume of fluids acquired from suction and that used for irrigation of the abdominal cavity during surgery using constant values.

RESULTS

Among the 50 randomized women, 1 and 3 in the study and control groups, respectively, were excluded due to withdrawal of consent, cancelation of surgery, or non-measurement of the primary endpoint. The baseline and operative characteristics were similar between the study and control groups, as was the intraoperative blood loss (193±204mL vs. 159±193mL, P=0.52). In addition, the operating time (95±29min vs. 110±52min; P=0.50) and decrease in hemoglobin level after surgery (1.9±1.31g/dL vs. 1.4±1.4g/dL; P=0.24) were similar between the study and control groups.

CONCLUSIONS

Intravenous ascorbic acid infusion did not reduce intraoperative blood loss in women undergoing laparoscopic myomectomy.

CLINICAL TRIAL REGISTRATION

ClinicalTrials.gov, www.clinicaltrials.gov, NCT01715597.

摘要

目的

大多数旨在减少子宫肌瘤切除术术中出血的干预措施,其有效性缺乏充分证据。最近有报道称,术中给予抗坏血酸可有效减少腹部子宫肌瘤切除术的失血量。因此,本研究旨在探讨静脉输注抗坏血酸是否会影响接受腹腔镜子宫肌瘤切除术女性的术中失血量。

研究设计

进行了一项随机、双盲、平行组、安慰剂对照试验,纳入50例接受腹腔镜子宫肌瘤切除术的女性。肌瘤≤4个、最大直径≤9cm的女性符合条件。研究组与对照组的比例为1:1。从麻醉前30分钟开始,术中给予2g抗坏血酸或安慰剂,持续2小时。术中失血量作为主要终点,通过手术期间使用恒定值计算从吸引获得的液体量与用于腹腔冲洗的液体量之间的差值得出。

结果

在50例随机分组的女性中,研究组和对照组分别有1例和3例因撤回同意、取消手术或未测量主要终点而被排除。研究组和对照组的基线和手术特征相似,术中失血量也相似(193±204mL对159±193mL,P = 0.52)。此外,研究组和对照组的手术时间(95±29分钟对110±52分钟;P = 0.50)以及术后血红蛋白水平下降幅度(1.9±1.31g/dL对1.4±1.4g/dL;P = 0.24)相似。

结论

静脉输注抗坏血酸并未减少接受腹腔镜子宫肌瘤切除术女性的术中失血量。

临床试验注册

ClinicalTrials.gov,www.clinicaltrials.gov,NCT01715597 。

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