Fernández de Palencia-Espinosa M A, Cárceles-Barón M D, Blázquez-Álvarez M J, Arocas-Casañ V, de la Rubia-Nieto A
Servicio de Farmacia, Hospital Universitario Virgen de la Arrixaca, Murcia, España.
Rev Esp Anestesiol Reanim. 2012 Nov;59(9):489-96. doi: 10.1016/j.redar.2012.06.002. Epub 2012 Sep 12.
To describe the use of levosimendan for compassionate use in children undergoing surgery for congenital heart disease, as well as survival rates, and the variations in the haemodynamic and analytical variables studied.
An observational retrospective descriptive study was performed, using a review of clinical histories, from May 2005 to January 2010. Haemodynamic and analytical variables pre- and post- levosimendan administration, drugs used, and their dosages, and any adverse reactions were recorded.
Forty two children, 38 of them undergoing surgical correction, between the ages of four days and 5.75 years (median 92 days) were included. The drug was infused on 46 occasions. Four children received two doses. The infusion rate was among 0.1 to 0.6 μg × kg⁻¹ × min⁻¹. Only one patient received a loading dose. In 15 administrations (32.6%), the same dose was maintained throughout the infusion period. In 19 cases (41.3%), the dose was increased or decreased according to the need for vasoactive support. In surgical patients, overall survival after 30 days of the administration, calculated using the Kaplan-Meier method, was 80%. Blood lactate levels were statistically associated with mortality (P<.001).
There were no uniform criteria for using levosimendan, and it was only used as a rescue drug. Overall survival was similar to that reported in adult clinical trials. Clinical trials also need to be carried out in paediatric patients to determine the role of levosimendan in surgical practice, in order to develop and establish a clinical protocol for its use in children.
描述左西孟旦在先天性心脏病手术患儿中的同情用药情况、生存率以及所研究的血流动力学和分析变量的变化。
进行了一项观察性回顾性描述性研究，回顾了2005年5月至2010年1月的临床病历。记录了左西孟旦给药前后的血流动力学和分析变量、使用的药物及其剂量以及任何不良反应。
纳入了42名年龄在4天至5.75岁（中位数92天）之间的儿童，其中38名接受了手术矫正。该药物共输注46次。4名儿童接受了两剂。输注速率在0.1至0.6μg×kg⁻¹×min⁻¹之间。只有1名患者接受了负荷剂量。在15次给药（32.6%）中，在整个输注期间维持相同剂量。在19例（41.3%）中，根据血管活性支持的需要增加或减少剂量。在手术患者中，使用Kaplan-Meier方法计算，给药30天后的总体生存率为80%。血乳酸水平与死亡率有统计学关联（P<0.001）。
使用左西孟旦没有统一标准，且仅用作抢救药物。总体生存率与成人临床试验报告的相似。还需要在儿科患者中进行临床试验，以确定左西孟旦在手术实践中的作用，从而制定并建立其在儿童中使用的临床方案。
