Subhedar N V, Shaw N J
Neonatal Intensive Care Unit, Liverpool Women's Hospital, Crown Street, Liverpool, UK, L8 7SS.
Cochrane Database Syst Rev. 2000;2003(2):CD001242. doi: 10.1002/14651858.CD001242.
Inotropes are widely used in preterm infants to treat systemic hypotension. The most commonly used drugs are dopamine and dobutamine. These agents have different modes of action which may result in different haemodynamic effects.
To compare the effectiveness and safety of dopamine and dobutamine in the treatment of systemic hypotension in preterm infants.
The standard search method of the Cochrane Neonatal Review Group was used. Searches of electronic and other databases were performed. Previous reviews were searched for references to relevant trials and leading authors in the field were contacted for information about other published and unpublished studies.
Randomised controlled trials where short and/or long term effects of treatment with dopamine and dobutamine for the treatment of systemic arterial hypotension were compared were selected for this review. Trials studying newborn infants born before 37 completed weeks gestation and less than 28 days of age were eligible for inclusion. Systemic arterial hypotension was not defined specifically, but accepted as defined in individual studies. Studies were not limited by birthweight, lower gestational age threshold or by route or duration of administration of inotropic agents. Study quality and eligibility were assessed independently by each reviewer.
The standard method of the Cochrane Collaboration described in the Cochrane Collaboration Handbook was used to perform this systematic review. Data extraction was performed independently by each reviewer, with differences being resolved by discussion. The following outcomes were determined: mortality in the neonatal period, long term neurodevelopmental outcome, radiological evidence of severe neurological injury, short term haemodynamic changes and incidence of adverse effects. The effect of interventions is expressed either as Relative Risk (RR), Risk Difference (RD) or as Weighted Mean Difference (WMD) with their 95% Confidence Interval (CI).
Four trials met the pre-defined criteria for inclusion in this review. There was no evidence of a significant difference between dopamine and dobutamine in terms of neonatal mortality (RD 0.02 95% CI -0.12 to 0.16), incidence of periventricular leukomalacia (RD -0.08, 95% CI -0.19 to 0.04), or severe periventricular haemorrhage (RD -0.02, 95% CI -0.13 to 0.09). Dopamine was more successful than dobutamine in treating systemic hypotension, with fewer infants having treatment failure (RD -0.29, 95% CI -0.42 to -0.17; NNT = 3.5, 95% CI 2.4 to 5.9). There was no evidence of a significant difference in change in left ventricular output when dopamine was compared with dobutamine (WMD -83 ml/kg/min, 95% CI -174 to 8 ml/kg/min). There was no evidence of a significant difference between the two agents with respect to the incidence of tachycardia (RD -0.06, 95% CI -0.25 to 0.14). None of the studies reported the incidence of adverse long term neurodevelopmental outcome.
REVIEWER'S CONCLUSIONS: Dopamine is more effective than dobutamine in the short term treatment of systemic hypotension in preterm infants. There was no evidence of an effect on the incidence of adverse neuroradiological sequelae (severe periventricular haemorrhage and/or periventricular leucomalacia), or on the incidence of tachycardia. However, in the absence of data confirming long term benefit and safety of dopamine compared to dobutamine, no firm recommendations can be made regarding the choice of drug to treat hypotension.
正性肌力药物在早产儿中广泛用于治疗全身性低血压。最常用的药物是多巴胺和多巴酚丁胺。这些药物具有不同的作用方式,可能导致不同的血流动力学效应。
比较多巴胺和多巴酚丁胺治疗早产儿全身性低血压的有效性和安全性。
采用Cochrane新生儿综述组的标准检索方法。对电子数据库和其他数据库进行检索。检索以前的综述以查找相关试验的参考文献,并联系该领域的主要作者以获取其他已发表和未发表研究的信息。
本综述选择了比较多巴胺和多巴酚丁胺治疗全身性动脉低血压的短期和/或长期效果的随机对照试验。研究孕周小于37周且年龄小于28天的新生儿的试验符合纳入标准。全身性动脉低血压未作具体定义,但以各研究中的定义为准。研究不受出生体重、较低孕周阈值或正性肌力药物给药途径或持续时间的限制。每位评审员独立评估研究质量和纳入资格。
采用Cochrane协作手册中描述的Cochrane协作的标准方法进行本系统综述。每位评审员独立进行数据提取,如有分歧通过讨论解决。确定了以下结局:新生儿期死亡率、长期神经发育结局、严重神经损伤的影像学证据、短期血流动力学变化和不良反应发生率。干预效果以相对危险度(RR)、危险度差值(RD)或加权均数差值(WMD)及其95%置信区间(CI)表示。
四项试验符合本综述预先设定的纳入标准。在新生儿死亡率(RD 0.02,95%CI -0.12至0.16)、脑室周围白质软化症发生率(RD -0.08,95%CI -0.19至0.04)或重度脑室周围出血(RD -0.02,95%CI -0.13至0.09)方面,没有证据表明多巴胺和多巴酚丁胺之间存在显著差异。在治疗全身性低血压方面,多巴胺比多巴酚丁胺更成功,治疗失败的婴儿更少(RD -0.29,95%CI -0.42至-0.17;NNT = 3.5,95%CI 2.4至5.9)。与多巴酚丁胺相比,多巴胺在左心室输出量变化方面没有显著差异的证据(WMD -83 ml/kg/min,95%CI -174至8 ml/kg/min)。在心动过速发生率方面,没有证据表明两种药物之间存在显著差异(RD -0.06,95%CI -0.25至0.14)。没有研究报告不良长期神经发育结局的发生率。
在早产儿全身性低血压的短期治疗中,多巴胺比多巴酚丁胺更有效。没有证据表明对不良神经放射学后遗症(重度脑室周围出血和/或脑室周围白质软化症)的发生率或心动过速的发生率有影响。然而,由于缺乏与多巴酚丁胺相比多巴胺长期益处和安全性的确切数据,关于治疗低血压药物的选择无法给出明确建议。