Division of Minimally Invasive Gynecologic Surgery, Brigham and Women's Hospital, Boston, MA, USA.
Division of Gynecological Pain and Minimally Invasive Surgery, NorthShore University HealthSystem, Evanston IL & Pritzker School of Medicine, University of Chicago, Chicago, IL, USA.
BJOG. 2017 Jan;124(2):262-268. doi: 10.1111/1471-0528.14179. Epub 2016 Jun 30.
To determine if higher-volume, fixed-dose administration of vasopressin further reduces blood loss at the time of minimally invasive myomectomy.
Randomised multicentre clinical trial.
Tertiary-care academic centres in the USA.
Women undergoing conventional laparoscopic or robot-assisted laparoscopic myomectomy.
All participants received the same 10-unit (U) dose of vasopressin, but were randomly assigned to one of two groups: (i) received 200 ml of diluted vasopressin solution (20 U in 400 ml normal saline), and (ii) received 30 ml of concentrated vasopressin solution (20 U in 60 ml normal saline).
The primary study outcome was estimated blood loss; the study was powered to detect a 100-ml difference.
A total of 152 women were randomised; 76 patients in each group. Baseline demographics were similar between groups. The primary outcome of intraoperative blood loss was not significantly different, as measured by three parameters: surgeon estimate (mean estimated blood loss 178 ± 265 ml and 198 ± 232 ml, dilute and concentrated groups respectively, P = 0.65), suction canister-calculated blood loss, or change in haematocrit levels. There were no vasopressin-related adverse events.
Both dilute and concentrated vasopressin solutions that use the same drug dosing demonstrate comparable safety and tolerability when administered for minimally invasive myomectomy; however, higher volume administration of vasopressin does not reduce blood loss.
This randomised trial failed to show benefit of high-volume dilute vasopression.
确定大剂量、固定剂量给予加压素是否能进一步减少微创子宫肌瘤切除术时的出血量。
随机多中心临床试验。
美国三级保健学术中心。
接受传统腹腔镜或机器人辅助腹腔镜子宫肌瘤切除术的妇女。
所有参与者均接受相同的 10 单位（U）加压素剂量，但随机分为两组：（i）接受 200ml 稀释加压素溶液（20U 溶于 400ml 生理盐水），（ii）接受 30ml 浓缩加压素溶液（20U 溶于 60ml 生理盐水）。
主要研究结果为估计出血量；该研究的目的是检测 100ml 的差异。
共有 152 名妇女被随机分组；每组 76 例。两组间的基线人口统计学特征相似。术中出血量的主要结局无显著差异，以三种参数衡量：外科医生估计（稀释组平均估计出血量为 178±265ml，浓缩组为 198±232ml，P=0.65）、吸引罐计算的出血量或血细胞比容水平的变化。没有加压素相关的不良事件。
在微创子宫肌瘤切除术中使用相同药物剂量的稀释和浓缩加压素溶液均具有相似的安全性和耐受性；然而，加压素的高容量给药并不能减少出血量。
这项随机试验未能显示大剂量稀释加压素的益处。
