64%的自闭症儿童接受了精神药物治疗

根据《儿科学》(Pediatrics)10月21日在线发表的一篇报告，在一个包括33,000多例自闭症谱系障碍儿童患者的全美样本中，64%的儿童患者使用至少1种精神药物，35%使用多种精神药物。约15%接受多种精神药物治疗的儿童使用≥3类药物。多重用药的情况甚至在极年幼的儿童也较为常见，见于33%的2~10岁儿童和10%的≤1岁婴儿(Pediatrics 2013 Oct. 21 [doi:10.1542/peds.2012-3774])。

研究者表示，上述结果令人担忧，因为目前缺乏证据证明儿童使用这些药物具有安全性或有效性。在儿童时期，处于发育阶段的大脑和身体可能尤其容易受到环境或生物学方面的影响。



虽然有报道指出，精神药物在一般儿童和自闭症儿童中的使用率日益增加，但目前为止尚无研究得出准确的估计值，因为这些研究存在样本量小、依赖父母报告和评估时间非常短等缺陷。不同研究得出的精神药物在自闭症儿童中的估计使用率存在较大差异，介于27%~83%。

为了获得较为准确的估计值，Donna Spencer博士及其同事采用一个美国大型商业健康计划的索赔数据库进行了这项回顾观察性研究。研究者发现，在8年研究期间，全美有33,565例0~20岁自闭症谱系障碍儿童参与该健康计划，平均参与时间为44个月。

共21,334例(64%)患者被处方至少1次精神药物，11,598例(35%)被多次处方超过1类精神药物。在后一组中，多重用药的平均“次”数为5.6，多重用药的平均天数为525天。

约20%的多重用药儿童被处方2类药物，10%被处方3类药物，5%被处方≥4类药物。常见的药物类别组合是抗抑郁药和注意力缺陷多动障碍(ADHD)药物(38%的患者)；抗精神病药和ADHD药物(28%)；抗精神病药和抗抑郁药(20%)；以及抗精神病药、抗抑郁药和ADHD药物(18%)。45%或约15,000例自闭症谱系障碍患者曾到精神病科就诊，其中85%曾使用任何精神药物。

同时与任何精神药物的使用和多种精神药物的使用有最显著相关性的因素是合并症，特别是合并痫性发作、ADHD、双相障碍、焦虑或抑郁。使用精神药物的情况和使用多种精神药物的情况多见于白人儿童和≤11岁的儿童。

该研究存在一些局限性。例如，根据行政索赔数据无法得知患者实际上是否使用药物或是否遵照医嘱使用。研究者没有检查特定儿童的剂量或剂量的适当性，因为药物用量通常取决于儿童的体重。这一疏漏可能导致，在药物减停但仍处方的情况下，精神药物的使用和多重用药被高估。然而，研究者表示，该研究表明初级保健医生需仔细询问用药史并监测患者的症状，以确保用药有效。

该研究获美国国立精神卫生研究所支持。研究者声明无相关经济利益冲突。

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By: MARY ANN MOON, Clinical Neurology News Digital Network

Sixty-four percent of children with autism spectrum disorders took at least one, and 35% took multiple, psychotropic medications in a national sample of more than 33,000 children with autism spectrum disorders, according to a report published online Oct. 21 in Pediatrics.

Approximately 15% of the children given multiple psychotropic agents took three or more classes of the drugs. Polypharmacy was not uncommon even in the very youngest children, occurring in 33% of those aged 2-10 years and in 10% of babies aged 1 year old or younger, said Donna Spencer, Ph.D., who works for a company that provides analytics, technology, and consulting services in Eden Prairie, Minn., and her associates.

These findings are alarming given the scant evidence that these drugs are safe or effective during childhood, "when developing brains and bodies may be particularly vulnerable to environmental or biological influences," the investigators noted.
 
"Our study underscores an immediate need to develop standards of care around the prescription of psychotropic medications based on the best available evidence and a coordinated, multidisciplinary approach to improving the health and quality of life of children with [autism spectrum disorders] and their families. It [highlights] the need for rigorous trials of psychotropic medications for children with [autism spectrum disorders] and other psychiatric disorders to assess the value of these medications when weighed against their potential for harm," Dr. Spencer and her colleagues said.

Rates of psychotropic drug use are reportedly increasing among children in general and among those with autism specifically, but to date studies have not yielded accurate estimates of use because they’ve been flawed by small sample sizes, reliance on parent reports, and assessment of very short time periods. Current estimates of the proportion of autistic children who receive the drugs vary dramatically, from 27% to 83% in different studies.

To get a more accurate estimate, the researchers performed a retrospective observational study using a claims database for a large U.S. commercial health plan. They identified 33,565 children across the country who were aged 0-20 years, had autism spectrum disorders, and were enrolled in the health plan for a mean of 44 months during the 8-year study period.

A total of 21,334 (64%) of the patients were given at least one prescription for psychotropic drugs, and 11,598 (35%) were given multiple prescriptions for more than one class of psychotropic drugs. In the latter group, the average number of "episodes" of polypharmacy was 5.6, and the average number of days of polypharmacy was 525.

Approximately 20% of the children given polypharmacy filled prescriptions for two classes of drugs, 10% for three classes, and 5% for four or more classes. Common class combinations were antidepressants and [attention-deficit hyperactivity disorder] medications (38% of subjects); antipsychotics and ADHD medications (28%); antipsychotics and antidepressants (20%); and antipsychotic, antidepressant, and ADHD medications (18%), the investigators said (Pediatrics 2013 Oct. 21 [doi:10.1542/peds.2012-3774]). Forty-five percent or about 15,000 of the patients with autism spectrum disorders had visited a psychiatrist, and 85% of those patients had "any psychotropic use," the investigators said.

The factor most strongly associated with both the use of any psychotropic drugs and the use of multiple psychotropic drugs was comorbidity, particularly comorbid seizures, ADHD, bipolar disorder, anxiety, or depression. More white children and more children aged 11 years or under received psychotropic agents as well as multiple psychotropic agents, Dr. Spencer and her associates reported.

The investigators cited several limitations. For example, administrative claims data are not able to capture whether the patient actually took the medication or whether they did so as directed. In addition Dr. Spencer and her colleagues did not examine dose or appropriateness of dose for particular children because "dosing often depends on a child’s weight." This omission might have led to an overestimation of psychotropic use and polypharmacy in cases in which medications were tapered but still prescribed.

Nevertheless, Dr. Spencer and her associates said the study shows that primary care providers must elicit medication histories carefully and monitor patients’ symptoms to make sure that the medications are effective.

This study was supported by the National Institute of Mental Health. No relevant financial conflicts were reported.