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巴西的药物流行病学与沙利度胺胚胎病监测

Pharmacoepidemiology and thalidomide embryopathy surveillance in Brazil.

作者信息

Sales Luiz Vianna Fernanda, de Oliveira Marcelo Zagonel, Sanseverino Maria Teresa Vieira, Morelo Elaine Faria, de Lyra Rabello Neto Dacio, Lopez-Camelo Jorge, Camey Suzi Alves, Schuler-Faccini Lavinia

机构信息

INAGEMP - Instituto Nacional de Genética Médica Populacional, Porto Alegre, Brazil; Teratogen Information Service, Medical Genetics Service, Hospital de Clínicas de Porto Alegre, Brazil; Genetics Department, Universidade Federal do Rio Grande do Sul, Porto Alegre, Brazil; Postgraduate Program in Epidemiology, Universidade Federal do Rio Grande do Sul, Porto Alegre, Rio Grande do Sul, Brazil.

INAGEMP - Instituto Nacional de Genética Médica Populacional, Porto Alegre, Brazil; Genetics Department, Universidade Federal do Rio Grande do Sul, Porto Alegre, Brazil.

出版信息

Reprod Toxicol. 2015 Jun;53:63-7. doi: 10.1016/j.reprotox.2015.03.007. Epub 2015 Mar 28.

DOI:10.1016/j.reprotox.2015.03.007
PMID:25828060
Abstract

INTRODUCTION

Thalidomide causes congenital defects in children, such as limb reduction defects. Currently, it is used for a few indications; in Brazil, where leprosy is endemic, thalidomide is used for the treatment of erythema nodosum leprosum, and recent cases of thalidomide embryopathy have been reported.

METHODS

We analyzed the frequency of births with phenotypes consistent with thalidomide embryopathy (TEP) and correlated this with the distribution of thalidomide and the prevalence of leprosy between 2005 and 2010 in Brazil.

RESULTS

A total of 5,889,210 thalidomide tablets were distributed; the prevalence of limb reduction defects was 1.60 (CI95%: 1.54-1.66) and TEP was 0.11 (CI95%: 0.10-0.13) per 10,000 births. Poisson regression showed an increase in cases of TEP and limb reduction defects per 100,000 tablets dispensed. Clusters and geographical isolates were identified in several regions.

CONCLUSIONS

There is a correlation between thalidomide and TEP showing that thalidomide embryopathy should be monitored in countries where this medication is available.

摘要

引言

沙利度胺会导致儿童先天性缺陷,如肢体短小缺陷。目前,它被用于少数适应症;在麻风病流行的巴西,沙利度胺被用于治疗麻风结节性红斑,并且近期已报告了沙利度胺胚胎病的病例。

方法

我们分析了具有与沙利度胺胚胎病(TEP)相符表型的出生频率,并将其与2005年至2010年巴西沙利度胺的分发情况及麻风病患病率相关联。

结果

共分发了5,889,210片沙利度胺片剂;每10,000例出生中肢体短小缺陷的患病率为1.60(95%置信区间:1.54 - 1.66),TEP为0.11(95%置信区间:0.10 - 0.13)。泊松回归显示每分发100,000片药,TEP和肢体短小缺陷的病例数会增加。在几个地区发现了聚集性病例和地理隔离情况。

结论

沙利度胺与TEP之间存在关联,表明在可获得这种药物的国家应监测沙利度胺胚胎病。

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