【原】【罂粟摘要】磷丙泊酚二钠与丙泊酚在有创机械通气期间长期镇静的比较：一项随机临床试验

磷丙泊酚二钠与丙泊酚在有创机械通气期间长期镇静的比较：一项随机临床试验

贵州医科大学              麻醉与心脏电生理课题组

翻译：王璐             编辑：田明德    审校：曹莹

背景：异丙酚二钠是一种水溶性异丙酚前药，与异丙酚相比，其细菌污染和高甘油三酯血症的风险较低。在实施一项大型随机试验之前，我们调查了磷异丙酚二钠与异丙酚在重症监护病房(icu)长期轻度至中度镇静中的可行性、初步疗效和安全性。设计:单中心、前瞻性、非盲、随机、平行组临床试验。单位:大学附属教学医院普通ICU。

方法：患者:纳入预期机械通气24小时的成年患者(n = 60)，随机分配到磷异丙酚组或异丙酚组。干预措施:异丙酚组连续输注磷异丙酚，异丙酚组连续输注异丙酚。镇静目标为里士满躁动和镇静量表(RASS)得分- 3到0分。主要结局是在没有急救镇静的情况下在目标镇静范围内花费的时间百分比。安全性结果基于不良事件。采集血样测定血浆中甲酸盐浓度

结果：中位剂量:磷异丙酚组为4.33 (IQR, 3.08-4.94) mg/kg/h，异丙酚组为1.96 (IQR, 1.44-2.94) mg/kg/h。两组在无抢救镇静情况下停留在目标RASS范围内的时间中位数百分比相同，磷异丙酚组为83.33% (IQR, 74.43% ~ 100.00%)，异丙酚组为83.33% (IQR, 77.45% ~ 100.00%) (p = 0.887)。23例(76.7%)磷异丙酚患者和27例(90.0%)异丙酚患者至少有一次不良事件。最常见的不良事件是心动过速和低血压。两组均未见感觉异常、导管相关血流感染或异丙酚输注综合征。磷丙泊酚组3例患者出现轻度高甘油三酯血症，丙泊酚组9例患者出现高甘油三酯血症(8例为轻度，1例为中度)(10% vs 30%， p = 0.104)。血浆中甲酸浓度很低，两组在任何时间点均无显著差异。

结论：对于接受有创机械通气并长期镇静的患者，磷丙酚二钠似乎是一种可行、有效和安全的镇静剂。

原始文献来源：Xianhui Gao,Xiaobo Yang,Yun Tang, et al. Fospropofol disodium versus propofol for long-term sedation during invasive mechanical ventilation: A pilot randomized clinical trial .[J].Journal of Clinical Anesthesia. 2024;95 (0):111442-111442. doi:10.1016/j.jclinane.2024.111442

Fospropofol disodium versus propofol for long-term sedation during invasive mechanical ventilation: A pilot randomized clinical trial

Abstract

Background: Fospropofol disodium is a propofol prodrug that is water-soluble and has a reduced risk of bacterial contamination and hypertriglyceridemia compared with propofol. Prior to implementing a large randomized trial, we investigated the feasibility, initial efficacy, and safety of fospropofol disodium compared with propofol in long-term mild-to-moderate sedation in intensive care units (ICUs). Design: Single-centered, prospective, unblind, randomized, parallel-group clinical trial. Setting: The general ICU of university-affiliated teaching hospital.

Method: Patients: Adult patients (n = 60) expected to have mechanical ventilation for >24 h were enrolled and randomlyassigned to the fospropofol or propofol group. Interventions: The fospropofol group received continuous fospropofol disodium infusions and the propofol group received continuous propofol infusions. The sedation goal was a score of − 3 to 0 on the Richmond Agitation and Sedation Scale (RASS). The primary outcome was the percentage of time spent in the target sedation range without rescue sedation. Safety outcomes were based on adverse events. Blood samples were collected to measure formate concentration in plasma.

Results: The median dose was 4.33 (IQR, 3.08–4.94) mg/kg/h in the fospropofol group and 1.96 (IQR, 1.44–2.94) mg/kg/h in the propofol group. The median percentage of time spent in the target RASS range without rescue sedation was identical in both groups, with 83.33% (IQR, 74.43%–100.00%) in the fospropofol group and 83.33% (IQR, 77.45%–100.00%) in the propofol group (p = 0.887). At least one adverse event was identifed in 23 (76.7%) fospropofol patients and 27 (90.0%) propofol patients.The most common adverse events were tachycardia and hypotension. No paresthesia,catheter-related bloodstream infection or propofol infusion syndrome in both groups was reported. Three patients in the fospropofol group had mild hypertriglyceridemia, and nine patients in propofol group had hypertriglyceridemia (mild in eight patients and moderate in one patient) (10% versus 30%, p = 0.104). The formate concentration in plasma was very low, and no significant difference was identified at any time point between the two groups.

Conclusion: Fospropofol disodium appears to be a feasible, effective and safe sedative for patients receiving invasive mechanical ventilation with long-term sedation.