A randomized double-blind placebo-controlled trial of intravenous thiamine for prevention of delirium following allogeneic hematopoietic stem cell transplantation.
A randomized double-blind placebo-controlled trial of intravenous thiamine for prevention of delirium following allogeneic hematopoietic stem cell transplantation.
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同种异性造血干细胞移植后，静脉硫胺素静脉内硫胺素的随机双盲安慰剂对照试验。
DOI：
10.1016/j.jpsychores.2021.110503
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发表时间：
2021-07
影响因子：
4.7
通讯作者：
Rosenstein DL
中科院分区：
文献类型：
--
作者：
Nakamura ZM;Deal AM;Park EM;Quillen LJ;Chien SA;Stanton KE;McCabe SD;Heiling HM;Wood WA;Shea TC;Rosenstein DL
目的：确定大剂量静脉注射硫胺素是否可以预防同种异体造血干细胞移植术后住院期间的谵妄。其次，我们评估了高剂量静脉注射硫胺素对硫胺素水平的影响，并探讨了谵妄的危险因素。2017年10月至2020年3月在美国学术医疗中心接受同种异体造血干细胞移植的患者进行随机、双盲、安慰剂对照试验。64名参与者以1:1的比例随机分配到每日三次，每次200毫克，连续7天或安慰剂组。我们使用谵妄评定量表来评估谵妄。两组谵妄发生率比较采用卡方检验。用Kaplan-Meier法比较两组谵妄发作时间和持续时间的差异。Fisher’s Exact和Wilcoxon秩和检验用于检查移植前变量与谵妄之间的关系。对61名参与者进行了分析。谵妄发生率（25% vs 21%，卡方(df=1) = 0.12, p=0.73）、发病时间、持续时间和严重程度在研究组之间无差异。干预后立即，硫胺素组的硫胺素水平较高（275对73 nmol/L， t检验(df=57) = 13.63, p<0.0001），但不能预测谵妄。在我们的样本中，与谵妄相关的变量包括疾病严重程度、皮质类固醇暴露、感染和移植前营养指标。大剂量静脉注射硫胺素不能预防接受同种异体造血干细胞移植患者的谵妄。考虑到这一人群中谵妄的多重因素，可能需要进一步研究多组分干预的有效性。临床试验NCT03263442。涨潮临床癌症研究基金会。
To determine if high dose intravenous (IV) thiamine can prevent delirium during hospitalization following allogeneic HSCT. Secondarily, we evaluated the effects of high dose IV thiamine on thiamine levels and explored risk factors for delirium. Randomized, double-blind, placebo-controlled trial in patients undergoing allogeneic HSCT at a U.S. academic medical center between October 2017 and March 2020. 64 participants were randomized 1:1 to thiamine 200 mg IV three times daily for 7 days or placebo. We used the Delirium Rating Scale to assess for delirium. Delirium incidence was compared between groups using the chi-square test. Group differences in time to onset and duration of delirium were compared using the Kaplan-Meier method. Fisher’s Exact and Wilcoxon Rank Sum tests were used to examine associations between pre-transplantation variables and delirium. 61 participants were analyzed. Delirium incidence (25% vs. 21%, Chi-square (df=1) = 0.12, p=0.73), time to onset, duration, and severity were not different between study arms. Immediately following the intervention, thiamine levels were higher in the thiamine arm (275 vs. 73 nmol/L, t-test (df=57) = 13.63, p<0.0001), but not predictive of delirium. Variables associated with delirium in our sample included disease severity, corticosteroid exposure, infection, and pre-transplant markers of nutrition. High dose IV thiamine did not prevent delirium in patients receiving allogeneic HSCT. Given the multiple contributors to delirium in this population, further research regarding the efficacy of multicomponent interventions may be needed. Clinical Trials NCT03263442. Rising Tide Foundation for Clinical Cancer Research.
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影响因子：
158.5
作者：
Inouye, SK;Bogardus, ST;Cooney, LW
通讯作者：
Cooney, LW
影响因子：
4.8
作者：
BleggiTorres, LF;deMedeiros, BC;deMedeiros, CR
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deMedeiros, CR
影响因子：
39
作者：
Hshieh, Tammy T.;Yue, Jirong;Oh, Esther;Puelle, Margaret;Dowal, Sarah;Travison, Thomas;Inouye, Sharon K.
通讯作者：
Inouye, Sharon K.
影响因子：
11
作者：
HARPER, C
通讯作者：
HARPER, C
影响因子：
20.3
作者：
Armand, Philippe;Kim, Haesook T.;Saber, Wael
通讯作者：
Saber, Wael