针刺治疗新生儿缺氧缺血性脑病
Acupuncture for hypoxic ischemic encephalopathy in neonates.
作者信息
Sibrecht Greta, Wong Ming Yin, Shrestha Rujan, Bruschettini Matteo
机构信息
II Department of Neonatology, Poznan University of Medical Sciences, Poznan, Poland.
MY Dental Clinic, Bukit Mertajam, Malaysia.
出版信息
Cochrane Database Syst Rev. 2024 Dec 18;12(12):CD007968. doi: 10.1002/14651858.CD007968.pub3.
BACKGROUND
Peripartum asphyxia affects three to five per 1000 live births, with moderate or severe hypoxic ischemic encephalopathy (HIE) occurring in 0.5 to 1 per 1000 live births, and is associated with high mortality and morbidity. Therapeutic hypothermia is an effective treatment, but alternative therapies such as acupuncture are also used.
OBJECTIVES
To determine the benefits and harms of acupuncture (e.g. needle acupuncture with or without electrical stimulation; laser acupuncture; non-penetrating types of manual or embedded acupressure) on mortality and morbidity in neonates with HIE, compared with 1) no treatment, 2) placebo or sham treatment, 3) any pharmacologic treatment, or 4) different types of acupuncture.
SEARCH METHODS
We searched CENTRAL, PubMed, Embase, ClinicalTrials.gov, and the WHO ICTRP in March 2023. We conducted a search of the grey literature to identify reports of trials conducted by or referenced in research by CORDIS EU, National Institute for Health and Care Excellence (NICE), and NHSGGC Paediatrics for Health Professionals. We also checked the reference lists of relevant articles to identify additional studies.
SELECTION CRITERIA
We included randomized controlled trials (RCTs) or quasi-RCTs and cluster-randomized trials. We included studies where participants were term infants (37 weeks or greater) and late preterm infants (34 + 0 to 36 + 6 weeks' gestation) 10 days of age or less, with evidence of peripartum asphyxia. We included studies on acupuncture (e.g. needle acupuncture with or without electrical stimulation; laser acupuncture; non-penetrating types of manual or embedded acupressure). We included studies where acupuncture was compared with: 1) no treatment; 2) placebo or sham treatment; 3) any pharmacologic treatment; or 4) different types of acupuncture.
DATA COLLECTION AND ANALYSIS
We used standard Cochrane methods. Our primary outcomes were all-cause mortality at the latest follow-up, major neurodevelopmental disability in children aged 18 to 24 months and aged 3 to 5 years, adverse events until hospital discharge, and length of hospital stay.
MAIN RESULTS
We included four studies (enrolling 464 infants) that compared acupuncture with no treatment. The studies ranged in size from 60 to 200 infants. Three studies were conducted in China and one in Russia. None of the four studies reported on any of the prespecified outcomes of our review. We did not identify any ongoing studies.
AUTHORS' CONCLUSIONS: There is limited availability of studies addressing this specific population. The included studies did not assess mortality, long-term neurodevelopmental outcomes, or adverse effects of acupuncture. We are unable to draw any conclusions about the benefits and harms of acupuncture for HIE in neonates. In light of the current limitations, clinicians are urged to approach the use of acupuncture in neonates with HIE cautiously, as there is no evidence to support its routine application. The available trials assessed surrogate outcomes that have a relatively small impact on newborns, and failed to report important outcomes such as mortality and long-term neurodevelopmental outcomes. Other available trials were performed on older infants who had experienced neonatal HIE. Given the lack of available evidence, well-designed randomized controlled trials with relevant outcomes such as mortality and neurodevelopmental outcomes are essential to evaluate the efficacy and safety of acupuncture for HIE in neonates.
背景
围产期窒息影响每1000例活产中的3至5例,其中每1000例活产中有0.5至1例发生中度或重度缺氧缺血性脑病(HIE),且与高死亡率和高发病率相关。治疗性低温是一种有效的治疗方法,但也会使用诸如针灸等替代疗法。
目的
与1)不治疗、2)安慰剂或假治疗、3)任何药物治疗或4)不同类型的针灸相比,确定针灸(如带或不带电刺激的针刺;激光针灸;非穿透性的手动或嵌入式指压)对HIE新生儿死亡率和发病率的利弊。
检索方法
我们于2023年3月检索了Cochrane中心对照试验注册库(CENTRAL)、PubMed、Embase、ClinicalTrials.gov和世界卫生组织国际临床试验注册平台(WHO ICTRP)。我们对灰色文献进行了检索,以识别欧盟第七框架计划(CORDIS EU)、英国国家卫生与临床优化研究所(NICE)以及NHSGGC儿科专业健康机构开展或引用的试验报告。我们还检查了相关文章的参考文献列表以识别其他研究。
选择标准
我们纳入了随机对照试验(RCT)、半随机对照试验和整群随机试验。我们纳入的研究中,参与者为足月儿(37周或以上)和晚期早产儿(妊娠34⁺⁰至36⁺⁶周),年龄在10日龄及以下,且有围产期窒息的证据。我们纳入了关于针灸的研究(如带或不带电刺激的针刺;激光针灸;非穿透性的手动或嵌入式指压)。我们纳入的研究中,针灸与以下情况进行了比较:1)不治疗;2)安慰剂或假治疗;3)任何药物治疗;或4)不同类型的针灸。
数据收集与分析
我们采用了标准的Cochrane方法。我们的主要结局为最新随访时的全因死亡率、18至24个月龄及3至5岁儿童的主要神经发育障碍、出院前的不良事件以及住院时间。
主要结果
我们纳入了四项研究(共464名婴儿),这些研究将针灸与不治疗进行了比较。研究规模从60名至200名婴儿不等。三项研究在中国进行,一项在俄罗斯进行。这四项研究均未报告我们综述中预先设定的任何结局。我们未识别到任何正在进行的研究。
作者结论
针对这一特定人群的研究有限。纳入的研究未评估针灸的死亡率、长期神经发育结局或不良反应。我们无法得出关于针灸对新生儿HIE利弊的任何结论。鉴于目前的局限性,敦促临床医生谨慎对待在HIE新生儿中使用针灸,因为没有证据支持其常规应用。现有的试验评估了对新生儿影响相对较小的替代结局,且未报告诸如死亡率和长期神经发育结局等重要结局。其他现有的试验是在经历过新生儿HIE的较大婴儿身上进行的。鉴于缺乏可用证据,设计良好的、具有死亡率和神经发育结局等相关结局的随机对照试验对于评估针灸治疗新生儿HIE的疗效和安全性至关重要。