Department of Palliative, Rehabilitation and Integrative Medicine, The University of Texas MD Anderson Cancer Center, 1515 Holcombe Blvd, Unit 1414, Houston, TX, 77030, USA.
Department of Biostatistics, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.
Support Care Cancer. 2021 Dec;29(12):7887-7894. doi: 10.1007/s00520-021-06384-6. Epub 2021 Jun 29.
Few studies have examined how the use of rescue medications could be used to inform on the efficacy of interventions in delirium clinical trials. The objective of this study was to determine the association among rescue medication use, Richmond Agitation-Sedation Scale (RASS), and perceived comfort by the nurses and caregivers.
This was a pre-planned secondary analysis of a double-blind, randomized clinical trial comparing the use of a single dose of lorazepam plus haloperidol versus placebo plus haloperidol in patients with agitated delirium. Rescue medications were considered the gold standard for this analysis. The optimal cutoff for RASS analysis was calculated by using general linear regression models and determining the area of the curve and using the top left approach. We used 2 × 2 tables to examine the association between rescue medication use and perceived comfort.
Fifty-eight patients received the study medications and 52 (89%) completed the 8-h observation period. There were 26 (50%) patients in each arm. The lorazepam/haloperidol arm required fewer rescue doses (4/26 (15%)) vs. 16/26 (62%), p = 0.004). Patients with a greater initial RASS reduction required fewer rescue doses. The cutoff value for RASS improvement was 4 points, area under the curve (AUC) 0.64 (95% CI 0.49-0.79) for those who required no rescue doses, and 3 points, AUC 0.74 (95% CI 0.52-0.96) for those who required more than one rescue dose.
Rescue medication use was responsive to change and associated with both RASS scores and perceived patient comfort by the nurse and caregiver.
很少有研究探讨如何使用解救药物来反映谵妄临床试验中干预措施的疗效。本研究的目的是确定解救药物使用、Richmond 意识-镇静量表（RASS）和护士及护理人员感知舒适度之间的关系。
这是一项双盲、随机临床试验的预先计划的二次分析，比较了在躁动性谵妄患者中使用劳拉西泮联合氟哌啶醇与安慰剂联合氟哌啶醇的效果。在这项分析中，解救药物被认为是金标准。使用一般线性回归模型计算 RASS 分析的最佳截断值，并确定曲线面积和使用左上角方法。我们使用 2×2 表来检验解救药物使用与感知舒适度之间的关联。
58 名患者接受了研究药物治疗，52 名（89%）完成了 8 小时观察期。每个手臂各有 26 名（50%）患者。劳拉西泮/氟哌啶醇组需要的解救剂量较少（4/26（15%））与 16/26（62%），p=0.004）。初始 RASS 降低幅度较大的患者需要较少的解救剂量。RASS 改善的截断值为 4 分，曲线下面积（AUC）为 0.64（95%CI 0.49-0.79），对于不需要解救剂量的患者；3 分，AUC 为 0.74（95%CI 0.52-0.96），对于需要超过一剂解救药物的患者。
解救药物的使用对变化敏感，并与 RASS 评分以及护士和护理人员对患者的感知舒适度相关。
