国家儿童风湿病生物制剂注册中心的构想：当下的需求与前进的方向。
Conception of National Biologics Registry for Pediatric Rheumatology: Need of the Hour and the Way Forward.
机构信息
Division of Pediatric Rheumatology, Department of Pediatrics, All India Institute of Medical Sciences, New Delhi, India. Correspondence to: Dr Narendra Kumar Bagri, Division of Pediatric Rheumatology, Department of Pediatrics, All India Institute of Medical Sciences, New Delhi.
Pediatric Rheumatology, Department of Pediatrics, Christian Medical College, Vellore, Tamil Nadu, India.
出版信息
Indian Pediatr. 2022 Dec 15;59(12):913-915. doi: 10.1007/s13312-022-2661-8. Epub 2022 Sep 9.
Abstract
The outcome for children with rheumatic diseases has been dramatically altered by the use of biological therapies. Increasing use of these agents will need careful monitoring for long term safety, particularly in children. Current data on safety of these drugs stem exclusively from Western literature. There is clear need for a registry of all children with rheumatic diseases who are commenced on biological agents to ensure appropriate pharmacovigilance. In this perspective, we discuss the need for and the role of a biologics registry for children with rheumatic diseases in India.
摘要
生物疗法的使用极大地改变了儿童风湿性疾病的预后。这些药物的使用不断增加，需要对长期安全性进行仔细监测，尤其是在儿童中。目前这些药物安全性的数据完全来源于西方文献。显然需要建立一个登记处，登记所有开始使用生物制剂的风湿性疾病患儿，以确保适当的药物警戒。从这一角度出发，我们讨论了在印度建立一个儿童风湿性疾病生物制剂登记处的必要性和作用。
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