TREATMENT OF LEAD EXPOSED CHILDREN FOLLOW UP

在四家大型城市儿科开展了铅暴露儿童治疗（TLC）临床试验。该研究旨在验证这样一种假设，即接受琥珀酸盐治疗的血铅浓度适中的儿童在治疗三年后的一系列认知和行为发展测试中得分高于接受安慰剂治疗的儿童。TLC在1994年8月至1997年1月间，将384名儿童随机分配给安慰剂组，396名儿童随机分配给琥珀酸盐组。认识到早期铅暴露的最重要影响很难在学龄前评估，TLC-Plus旨在评估口服琥珀酸盐螯合治疗的长期发展益处。该研究的主要目的是确定二聚体是否有效改善早期铅中毒对神经心理功能行为和社会适应的不利影响。所有临床中心的TLC-Plus受试者将在他们7岁生日后的两个疗程中接受最先进、最有效的评估。在这个年龄段，可以检查更广泛、更有差异的能力范围，心理测量的分数更精确、更可靠，早期的学业成绩和家庭环境之外的社会功能也可以进行评估。当TLC受试者达到7岁和7.5岁时，将对他们进行心理测量、心理教育、社会适应和神经功能的评估。意向治疗数据分析将使用协方差分析和重复测量方法检查治疗对这些领域的影响。

The Treatment of Lead-Exposed Children (TLC) clinical trial was carried out in four large urban pediatric departments. The study was designed to test the hypothesis that children with moderate blood lead concentrations who were treated with succimer would have higher scores than placebo treated children on a range of tests measuring cognitive and behavioral development three years after treatment. TLC randomized 384 children to placebo and 396 to succimer between August 1994, and January, 1997. Recognizing that the most important effects of early lead exposure are difficult to assess prior to school age, TLC-Plus is designed to assess the long-term developmental benefits of oral chelation therapy with succimer. The study's principal aim is to determine whether succimer is effective in ameliorating the adverse impact of early lead toxicity on neuropsychological functioning behavior and social adjustment. A state of the art, efficient assessment battery will be administered to TLC-Plus subjects at all Clinical Centers in two sessions following their seventh birthday. At this age, a wider and more differentiated range of abilities can be examined, scores on psychometric measures are more precise and reliable, and early academic performance and social functioning outside of the home environment can be evaluated. Assessments of psychometric, psycho educational, social-adaptive, and neurological functioning will be made Instruments tapping these domains will be administered to TLC subjects when they attain 7 and 7.5 years of age. Intent-to-treat data analyses will examine the impact of treatment on these domains using analysis of covariance and repeated measures methods.