Liu Xianchen, Dietrich Kim N, Radcliffe Jerilynn, Ragan N Beth, Rhoads George G, Rogan Walter J
Epidemiology Branch, National Institute of Environmental Health Sciences, Research Triangle Park, North Carolina 27709, USA.
Pediatrics. 2002 Oct;110(4):787-91. doi: 10.1542/peds.110.4.787.
Exposure to lead at levels encountered by urban children impairs cognitive development. An observational study suggested improvement in IQ when blood lead level fell, but the only randomized trial of chelation showed no benefit in IQ.
We did a new analysis of the data from the clinical trial using change in blood lead level as the independent variable. The 741 children began with blood lead levels between 20 and 44 microg/dL, and were 13 to 33 months old at randomization to chelation or placebo. Blood lead levels were measured repeatedly, and cognitive tests were given at baseline, 6 months, and 36 months follow-up.
By 6 months after randomization, blood lead levels had fallen by similar amounts in both chelated and placebo children, despite the immediate drops in the chelated group; there was no association between change in blood lead level and change in cognitive test score. Blood lead levels continued to fall. At 36 months follow-up, in the placebo group only, cognitive test scores had increased 4.0 points per 10 microg/dL fall in blood lead level from baseline to 36 months follow-up and 5.1 points from 6 to 36 months.
The improvement in scores in the placebo group only implies that factors other than declining blood lead levels per se are responsible for cognitive improvement; it is possible but less likely that succimer, the active drug, impairs cognition.
城市儿童接触到的铅水平会损害认知发展。一项观察性研究表明,血铅水平下降时智商有所提高,但唯一一项螯合疗法的随机试验显示对智商并无益处。
我们以血铅水平的变化作为自变量,对该临床试验的数据进行了新的分析。741名儿童开始时血铅水平在20至44微克/分升之间,随机分组接受螯合疗法或安慰剂时年龄为13至33个月。多次测量血铅水平,并在基线、6个月和36个月随访时进行认知测试。
随机分组后6个月,螯合组和安慰剂组儿童的血铅水平下降幅度相似,尽管螯合组血铅水平立即下降;血铅水平变化与认知测试分数变化之间无关联。血铅水平持续下降。在36个月随访时,仅在安慰剂组中,从基线到36个月随访期间,血铅水平每下降10微克/分升,认知测试分数增加4.0分,从6个月到36个月增加5.1分。
仅安慰剂组分数的提高意味着血铅水平本身下降以外的因素是认知改善的原因;活性药物二巯基琥珀酸可能损害认知,但可能性较小。