磷丙泊酚二钠用于镇静的临床安全性、耐受性和有效性：一项系统综述。
完整摘要 · 中文译文
目的：磷丙泊酚二钠（磷丙泊酚）是一种水溶性的丙泊酚前体药物，具有独特的药理学和耐受性特征。然而，关于磷丙泊酚在更广泛的镇静情境及不同对照药物中的安全性、耐受性和有效性的证据，尚未得到充分综合。本系统评价总结了当前关于磷丙泊酚的研究发现，以明确其临床作用并指导未来研究。 方法：本系统评价在启动前已完成注册（PROSPERO CRD42023477740）。在PubMed、Web of Science、Cochrane对照试验中心注册库（CENTRAL）、通过Ovid检索的MEDLINE、通过Ovid检索的Embase以及ClinicalTrials.gov中进行了全面检索，检索时间从建库至2026年8月26日。纳入评估磷丙泊酚用于镇静并报告可提取的有效性或安全性结果的随机对照试验（RCT）。使用Cochrane RoB 2工具评估偏倚风险，并根据GRADE方法评估证据确定性。对临床可比的证据组进行Meta分析，其他发现根据SWiM原则进行综合。 结果：本系统评价纳入10项原始研究，包括6项操作镇静试验和4项ICU镇静试验。对两个可比证据组进行了定量综合，其余结局进行叙述性综合。在3项内镜操作镇静试验中，磷丙泊酚6.5 mg/kg的镇静成功率高于2 mg/kg（RR 3.27，95% CI 2.62-4.08）。在机械 在通气的ICU患者中，磷丙泊酚与丙泊酚的低血压风险无明显差异（RR 0.93，95% CI 0.67-1.28）。程序性研究显示镇静效果呈剂量依赖性模式，而ICU研究通常报告磷丙泊酚与对照镇静药物在达到目标镇静方面相当。感觉异常/瘙痒常见报告，而心肺不良事件发生率在不同环境和剂量下有所不同，且未显示磷丙泊酚有一致的比较优势。注射痛和满意度的证据有限。证据确定性从高至极低不等，主要由于偏倚风险和精确度不足。 结论：磷丙泊酚可在程序性和ICU环境中提供有效镇静，但其疗效和安全性特征因剂量、对照药物和临床环境而异。较高剂量可能改善程序性镇静效果，但在某些环境中也可能增加不良事件。目前证据未确立磷丙泊酚相对于其他镇静药物具有一致的心肺安全性优势，需进一步充分把握度的随机试验以阐明其比较安全性和最佳临床角色。
完整摘要 · 英文原文
PURPOSE: Fospropofol disodium (fospropofol) is a water-soluble prodrug of propofol with a distinct pharmacological and tolerability profile. However, evidence regarding the safety, tolerability, and efficacy of fospropofol across broader sedation contexts and different comparators remains insufficiently synthesized. This systematic review summarized current research findings on fospropofol to clarify its clinical role and guide future research. METHODS: This systematic review was registered prior to initiation (PROSPERO CRD42023477740). Comprehensive searches were performed in PubMed, Web of Science, the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE via Ovid, Embase via Ovid, ClinicalTrials.gov from inception to 26 August 2026. Randomized controlled trials (RCTs) evaluating fospropofol for sedation and reporting extractable efficacy or safety outcomes were eligible. Risk of bias was assessed using the Cochrane RoB 2 tool, and the certainty of evidence was evaluated according to the GRADE approach. Meta-analysis was performed for clinically comparable evidence groups, with other findings synthesized according to SWiM principles. RESULTS: This systematic review included 10 original studies, comprising six procedural-sedation trials and four trials for ICU sedation. Quantitative synthesis was conducted for two comparable evidence groups, whereas the remaining outcomes were synthesized narratively. In three endoscopic procedural-sedation trials, fospropofol 6.5 mg/kg achieved a higher sedation success than 2 mg/kg (RR 3.27, 95% CI 2.62-4.08). In mechanically ventilated ICU patients, hypotension risk did not clearly differ between fospropofol and propofol (RR 0.93, 95% CI 0.67-1.28). Procedural studies showed a dose-dependent pattern in sedation efficacy, whereas ICU studies generally reported comparable target-sedation attainment between fospropofol and comparator sedatives. Paresthesia/pruritus was commonly reported, while rates of cardiorespiratory adverse events varied across settings and doses and showed no consistent comparative advantage for fospropofol. Evidence for injection pain and satisfaction was limited. Certainty of evidence ranged from high to very low, mainly because of risk of bias and imprecision. CONCLUSIONS: Fospropofol can provide effective sedation across procedural and ICU settings, but its efficacy and safety profiles vary according to dose, comparator, and clinical setting. Higher doses may improve procedural-sedation efficacy but may also increase adverse effects in some settings. Current evidence does not establish a consistent cardiorespiratory safety advantage for fospropofol over other sedatives, and further adequately powered randomized trials are needed to clarify its comparative safety and optimal clinical role.