镇静剂、止痛剂与心脏手术之后的新生儿不良神经发展结果无关


【24drs.com】January 22, 2010 (迈阿密海滩) — 根据发表于重症照护医学会第39届重症照护研讨会的一篇新世代研究结果,在心脏手术前后给予新生儿的镇静剂与止痛剂,与不良神经发展结果如心智、动作与字汇发展延迟无关。
  
  这项荣获研讨会年度科学奖之一的研究,是由第一作者、西加拿大综合小儿治疗计画追踪小组、Stollery 儿童医院、亚伯达大学小儿科临床助理教授Gonzalo Garcia Guerra医师发表。
  
  根据发表内容,虽然动物研究显示止痛药对于脑部发育有害,但还不清楚这些结果是否可推论于人类新生儿。
  
  共同研究者、西加拿大研究计画成员、Stollery 儿童医院、亚伯达大学小儿科临床副教授、Ari Joffe医师向Medscape Critical Care表示,许多现有的资料显示,前述的关联仅适用于早产婴儿,就我们所知,这是首篇检视进行心脏手术的足月新生儿有无此关联的研究。
  
  【没有药物与不佳结果有关】
  为了进行本研究,研究者回顾评估在2003年4月至2006年12月接受心脏手术且存活的95名新生儿的资料。
  
  Joffe医师解释,我们回顾检视在这段期间内,每名新生儿所接受的所有鸦片类药物、苯二氮平类(benzodiazepines) 药物、k他命与水化氯醛(chloral hydrate) ,且加入我们的资料库,接著,校正心脏手术时的各种因素,如心脏病灶、术前与术后的疾病严重度、手术期间的因素等,看使用这些药物是否与2岁时的发育结果有关。
  
  其它评估的变项包括,住院期间使用的剂量以及使用药物的天数,神经发育结果之测量:适应行为评量系统(ABAS)一般适性复合分数、ABAS动作类分数、贝莱婴儿发展量表(BSID)测量心智与动作延迟(分数<70)以及BSID词汇发展延迟(分数<第15百分位)。
  
  结果显示,给予的镇静和止痛剂中,不论是累积剂量或每日剂量,都与病患的任何不佳的神经发育结果无关。
  
  Joffe医师表示,我们认为这些结果是可靠的,但是我不认为令人感到惊讶,动物模式比较适合于早产者,我们的病患都是足月新生儿,我们的研究并未提及早产儿,但是,至少在这些孩童来说,这些发现是可靠的,当然,理想的话,应进行后续研究来确认这些结果。
  
  他指出,在这些状况中,实际上不太可能不用这些药,这些都是重症婴儿,没有人会想要阻碍镇静剂与止痛药物的使用,所以,我们的研究发现并未指出要改变实务。
  
  他报告指出,研究者计画继续追踪该研究的这些孩童,我们目前着眼于两年的结果,随著孩童长大,我们计画探讨5岁时的神经发展结果,以确保没有更长期的影响。
  
  【令人振奋的结果】
  重症照护研讨会共同主席、会议共同主持人、纽约市康乃尔大学Weill医学院小儿重症照护医疗小组主任、小儿科临床教授Bruce Greenwald医师表示,我认为,作者们辨别使用镇静剂与止痛剂对于这类病患的长期发育结果有无影响是很有趣的研究。
  
  未参与该研究的Greenwald医师表示,对我和SCCM的听众们而言,这是令人振奋的,了解到我们例行性使用的这些药物是安全的,没有任何的负面后遗症,事实上,这会造成许多小儿科专责主治医师的实务改变,如果他们本来认为这些药物与长期发育问题有关的话。
  
  Greenwald医师表示,我们希望,如果有明确的长期负面关联,提出给美国食品药物管理局的报告与证据力将会使大众有所警觉,有趣的是,就我所知,这是第一个直接地回答这个问题的研究。
  
  他指出,虽然该研究的样本数属于合理的范围,如果有更大型的研究,那么结果将更有用也更具说服力,不过,这是一个有难度的研究,特别是新生儿—要在进行这类手术之后追踪他们数年,所以,如果当时可以进行更大型的研究就更好了,总之,这是个好的开始。
  
  Greenwald医师表示,发表时有人提出一些更有趣的问题,例如作者们是否有探讨体外循环的期间或深度低温的期间,这些都是这类病患在手术室中可能会使用的,事实上,他们有许多资料因为发表时间限制而未说明,我认为,有许多人急切地等待文献出版,详述在此未能报告的细节,我自己也期待能早日拜读。
  
  Alberta Health and Wellness资助本追踪研究的登记。Joffe医师与Greenwald医师皆宣告没有相关财务关系。
  
  重症照护医学会(SCCM)第39届重症照护研讨会:摘要25。发表于2010年1月10日。

Sedatives, Analgesics Not Linked to Adverse Neurodevelopment in Neonates After Cardiac Surgery

By Deborah Brauser
Medscape Medical News

January 22, 2010 (Miami Beach, Florida) — Sedatives and analgesics given to neonates right before and after cardiac surgery are not associated with adverse neurodevelopmental outcomes, such as mental, motor, and vocabulary delays, according to the results of a new cohort study presented here at the Society of Critical Care Medicine (SCCM) 39th Critical Care Congress.

The study, which received one of the Congress' Annual Scientific Awards, was presented by first author Gonzalo Garcia Guerra, MD, assistant clinical professor in the Department of Pediatrics at the University of Alberta, Stollery Children's Hospital in Edmonton, and part of the Western Canadian Complex Pediatric Therapies Project Follow-Up Group.

According to the presentation, "although animal models have suggested detrimental effects of anesthetic drugs on the developing brain, it's been unclear whether those results could be extrapolated to human neonates."

"A lot of the current data suggest that that association would apply only to preterm babies," co-investigator Ari Joffe, MD, associate clinical professor of pediatrics at the University of Alberta/Stollery Children's Hospital and fellow member of the Western Canadian research collaborative, told Medscape Critical Care. "To our knowledge, this is the first study to examine this relationship in full-term neonates having cardiac surgery."

No Drugs Associated With Adverse Outcomes

For this study, the investigators retrospectively evaluated data from 95 neonates who underwent open heart surgery between April 2003 and December 2006 and survived.

"We looked back during this time at all the opioids, benzodiazepines, ketamine, and chloral hydrates received by each neonate, and added that to our database," explained Dr. Joffe. "We then adjusted for various factors, such as heart lesion, preoperative and postoperative severity of illness, and intraoperative factors, during the cardiac surgery to see if there was an association between these drug exposures and developmental outcome at 2 years of age."

Other variables evaluated include dose during hospitalization and number of days the drug was given. Neurodevelopmental outcome measures included the Adaptive Behavior Assessment System (ABAS) General Adaptive Composite score, the ABAS motor subscore, Bayley Scale of Infant Development (BSID) measures of mental and motor delay (score <70), and the BSID vocabulary delay (score <15th percentile).

Results showed that none of the drugs given for sedation and analgesia, in terms of their cumulative amount or daily dose, were associated with any adverse neurodevelopmental outcomes in the patients.

"We thought these results were reassuring, but I don't think they were really surprising," said Dr. Joffe. "The animal models are probably more equivalent to humans who are preterm, and our patients were all term neonates. Our study does not address preterm babies, but at least in these children, the findings are reassuring. Of course, ideally, these results should be confirmed by further studies."

He noted that it would be "virtually impossible not to give these drugs in these situations. These babies are critically ill and no one would want to hold back sedation and analgesia drugs. So it's a relief to see that in our findings there's no indication to change practice."

He reported that the investigators plan to continue following up with the children from the study. "We were looking at 2-year outcomes. As the children get older, we plan to look at their 5-year neurodevelopmental outcomes to make sure there's nothing more subtle there."

Heartening Results

"I thought it was of great interest that the authors were able to discern whether or not the use of sedatives and analgesics in this patient population had an impact on their long-term development," said session comoderator Bruce Greenwald, MD, FCCM, FAAP, professor of clinical pediatrics and chief of the Division of Pediatric Critical Care Medicine at Cornell University Weill Medical College in New York City, and Critical Care Congress cochair.

"It was heartening for me and the [SCCM] audience to learn that these drugs that we use regularly appear to be safe and that the authors were unable to find any negative consequences of their use. In fact, it would cause a great change in many of the practices of pediatric intensivists if they had found that these drugs are associated with long-term developmental problems," said Dr. Greenwald, who was not involved with the study.

"One would hope that if there was a consistent long-term negative association, reports to the [US Food and Drug Administration] and the weight of the evidence would alert the public," added Dr. Greenwald. "Interestingly, this was the first study that I know of that was directly geared toward answering this question."

He noted that although the study was of reasonable size, the results would be more useful and convincing if the study had been larger. "However, this is a difficult study to do, especially in neonates — to follow them for several years after this type of surgery. So although it would be wonderful if a larger study could be done at some point, this is a nice beginning."

Dr. Greenwald said that some of the more interesting questions that came up during the presentation included whether the authors looked at the duration of cardiopulmonary bypass or the duration of deep hypothermia that might have been used in the operating room on these patients. "In fact, they have a whole lot of data that they did not present because of the time constraints of the presentation format. I think many anxiously await the publication of an article that details some the aspects of the study not reported here. I look forward to reading that myself."

The registry from this follow-up study was funded by Alberta Health and Wellness. Dr. Joffe and Dr. Greenwald have disclosed no relevant financial relationships.

Society of Critical Care Medicine (SCCM) 39th Critical Care Congress: Abstract?25. Presented January?10, 2010.

    
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