Silvestri Gerard A, Vincent Brad D, Wahidi Momen M, Robinette Emory, Hansbrough James R, Downie Gordon H
Division of Pulmonary and Critical Care Medicine, Medical University of South Carolina, Charleston, SC.
Division of Pulmonary and Critical Care Medicine, Medical University of South Carolina, Charleston, SC.
Chest. 2009 Jan;135(1):41-47. doi: 10.1378/chest.08-0623. Epub 2008 Jul 18.
Fospropofol disodium is a water-soluble prodrug of propofol with unique pharmacokinetic/pharmacodynamic properties. This randomized, double-blind, multicenter study evaluated the use of fospropofol in patients undergoing flexible bronchoscopy.
Patients >or= 18 years of age were randomized (2:3) to receive fospropofol, 2 mg/kg or 6.5 mg/kg, after pretreatment with fentanyl, 50 microg. Supplemental doses of each were given per protocol. The primary end point was sedation success, which was defined as follows: three consecutive Modified Observer's Assessment of Alertness/Sedation scores of <or= 4 plus procedure completion without alternative sedative medication and/or mechanical ventilation. Other end points included treatment success, patient/physician satisfaction, and safety.
Of 252 patients, 150 were randomized to receive 6.5 mg/kg fospropofol; 102 were randomized to receive 2 mg/kg fospropofol. Sedation success rates were 88.7% and 27.5%, respectively (p < 0.0001). Treatment successes (91.3% vs 41.2%, respectively; p < 0.001), willingness to be treated again (94.6% vs 78.2%, respectively; p < 0.001), and absence of procedural recall (83.3% vs 55.4%, respectively; p < 0.001) were significantly better with the administration of 6.5 mg/kg fospropofol. The median time to full alertness was slightly longer for the 6.5 mg/kg dose (5.5 vs 3.0 min, respectively). The proportion of patients requiring supplemental therapy with analgesics (16.7% vs 37.3%, respectively) and the use of alternative sedative medications (8.0% vs 58.8%, respectively) were lower for patients in the 6.5 mg/kg dose group (all comparisons, p < 0.001). The most frequent adverse events (AEs) were transient and self-limited paresthesias and pruritus of mild-to-moderate severity. Hypoxemia (predominantly mild-to-moderate) was the most common sedation-related AE, and occurred in 15.4% and 12.6% of patients, respectively, in the 6.5 and 2 mg/kg fospropofol dose groups.
Fospropofol provided safe and effective sedation for patients undergoing flexible bronchoscopy.
Clinical Trials.gov Identifier: NCT00306722.
磷丙泊酚二钠是丙泊酚的水溶性前体药物，具有独特的药代动力学/药效学特性。这项随机、双盲、多中心研究评估了磷丙泊酚在接受可弯曲支气管镜检查患者中的应用。
年龄≥18岁的患者按2:3随机分组，在给予50μg芬太尼预处理后，分别接受2mg/kg或6.5mg/kg的磷丙泊酚。每种药物均按方案给予补充剂量。主要终点为镇静成功，定义如下：连续三次改良的观察者警觉/镇静评分≤4分，且手术完成，无需使用其他镇静药物和/或机械通气。其他终点包括治疗成功、患者/医生满意度和安全性。
252例患者中，150例随机接受6.5mg/kg磷丙泊酚；102例随机接受2mg/kg磷丙泊酚。镇静成功率分别为88.7%和27.5%（p<0.0001）。给予6.5mg/kg磷丙泊酚时，治疗成功率（分别为91.3%和41.2%；p<0.001）、再次接受治疗的意愿（分别为94.6%和78.2%；p<0.001）以及无术中回忆（分别为83.3%和55.4%；p<0.001）均显著更好。6.5mg/kg剂量组达到完全清醒的中位时间稍长（分别为5.5分钟和3.0分钟）。6.5mg/kg剂量组患者需要补充镇痛药治疗的比例（分别为16.7%和37.3%）以及使用其他镇静药物的比例（分别为8.0%和58.8%）较低（所有比较，p<0.001）。最常见的不良事件（AE）为短暂性、自限性的轻至中度感觉异常和瘙痒。低氧血症（主要为轻至中度）是最常见的与镇静相关的AE，在6.5mg/kg和2mg/kg磷丙泊酚剂量组患者中的发生率分别为15.4%和12.6%。
磷丙泊酚为接受可弯曲支气管镜检查的患者提供了安全有效的镇静作用。
ClinicalTrials.gov标识符：NCT00306722。
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