产后出血宫内球囊填塞6小时与18小时非劣效随机试验
这项非劣效随机试验比较阴道分娩后产后出血（PPH）使用宫内球囊填塞6小时与18小时的效果。主要结局为填塞放置时至放置后18小时的总定量失血量。结果显示6小时组非劣效于18小时组，提示6小时后移除球囊可能是合理的。
要点
- 阴道分娩后PPH宫内球囊填塞6小时在控制失血上非劣效于18小时。
- 主要结局为填塞放置至放置后18小时的总定量失血量。
- 两组球囊治疗均成功，次要结局无差异。
核心结论
- 阴道分娩后PPH使用宫内球囊填塞6小时在减少失血方面非劣效于18小时。
- 6小时后移除宫内球囊填塞可能是合理的。
研究设计与样本
- 实用型非劣效随机试验，纳入阴道分娩后子宫收缩乏力所致PPH的参与者。
- 按球囊放置时定量失血量分层区组随机，1:1分配至6小时组或18小时组。
- 估算需64例以判断组间总定量失血量是否超过预设非劣效界值250 mL。
主要发现
- 2020年10月至2023年5月随机64例，球囊放置时平均定量失血量为2,133 mL。
- 18小时组31例，6小时组33例；所有参与者均接受分配干预，2例因方案违背被排除。
- 球囊放置后18小时中位（IQR）定量失血量：18小时组135.0 mL（81-184 mL），6小时组110.0 mL（60-172 mL），P <.001。
- 宫内球囊填塞成功治疗所有随机参与者，两组次要结局无差异。
关键数值与推荐
- 非劣效界值为总定量失血量250 mL。
- 非劣效t检验以P <.05认为非劣效。
- 主要结局为球囊放置时至放置后18小时的总定量失血量。
临床怎么用
- 阴道分娩后PPH使用宫内球囊填塞控制出血时，可考虑6小时后移除球囊。
- 决策需结合患者临床状况与出血控制情况个体化评估。
局限性
- 样本量较小，共随机64例，2例因方案违背被排除。
- 仅纳入阴道分娩后子宫收缩乏力所致PPH，结果外推需谨慎。
以上解读依据论文摘要（全文未开放获取或许可不允许翻译转载）。
原文
OBJECTIVE: To determine whether an intrauterine balloon tamponade duration of 6 hours is noninferior to a duration of 18 hours for controlling bleeding after vaginal delivery, as measured by quantitative blood loss. METHODS: In this pragmatic randomized trial of noninferiority, a 6-hour duration of intrauterine balloon tamponade usage for postpartum hemorrhage (PPH) control was compared with an 18-hour duration. We randomized participants with PPH due to uterine atony after vaginal delivery to an intrauterine balloon tamponade duration of 6 hours or 18 hours in a 1:1 ratio using stratified block randomization based on quantitative blood loss at the time of intrauterine balloon tamponade placement. The primary outcome was the total quantitative blood loss from the placement of the intrauterine balloon tamponade to 18 hours postplacement. Sixty-four participants were estimated to be required to determine whether total quantitative blood loss between groups was above our chosen noninferiority margin of 250 mL. Noninferiority t tests were considered noninferior at P <.05. Secondary outcomes included measures of escalation in PPH management. RESULTS: From October 2020 through May 2023, we randomized 64 participants with a mean quantitative blood loss at time of intrauterine balloon tamponade placement of 2,133 mL, with 31 individuals placed in the 18-hour duration group and 33 placed in the 6-hour duration group. All received their assigned intervention; however, two participants were excluded due to protocol violation. Characteristics were similar between groups. The median (IQR) quantitative blood loss 18 hours after intrauterine balloon tamponade placement was 135.0 mL in the 18-hour group (81-184 mL) and 110.0 mL in the 6-hour group (60-172 mL) ( P <.001). Intrauterine balloon tamponade was successful in treating all randomized participants, with no difference in secondary outcomes between groups. CONCLUSION: Intrauterine balloon tamponade usage for 6 hours was noninferior to 18 hours of usage for mitigating blood loss after vaginal delivery PPH. It may be reasonable to remove an intrauterine balloon tamponade after 6 hours. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, NCT04467996.
引用
- Larrea N, Adkins K, Durfee J, et al. Intrauterine Balloon Tamponade Duration for Postpartum Hemorrhage: A Randomized Controlled Trial. Obstet Gynecol. 2026. PMID: 42096713. doi:10.1097/AOG.0000000000006295
供执业医师工作参考，不替代临床判断；数值与分级以指南原文为准。