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印度医学研究理事会关于新冠病毒病(Covid-19)靶向羟氯喹预防的公告:需谨慎解读。

The ICMR bulletin on targeted hydroxychloroquine prophylaxis for Covid-19: Need to interpret with caution.

作者信息

D'Cruz Migita

机构信息

Senior Resident, Geriatric Clinic and Services, Department of Psychiatry, National Institute of Mental Health and Neurosciences (NIMHANS), Bengaluru, 56 0029, INDIA.

出版信息

Indian J Med Ethics. 2020 Apr-Jun;V(2):100-102. doi: 10.20529/IJME.2020.040.

Abstract

The National Task Force for Covid-19 of the Indian Council of Medical Research (ICMR) in a bulletin dated March 21, 2020 recommended the use of hydroxychloroquine for prophylaxis in asymptomatic health care workers caring for suspected or confirmed patients and household contacts of confirmed patients. This is cause for concern with regard to bioethics and good clinical practice. The evidence for the efficacy of chloroquine and hydroxychloroquine is currently derived from open label trials and cell culture studies with no conclusive evidence available from randomised clinical trials. Hydroxychloroquine also carries contraindications in the case of conditions such as maculopathy, retinopathy and QTc prolongation and should be used with caution in vulnerable populations such as children, pregnancy, lactation and the elderly. Despite this, there has been a rush to procure and self-medicate with hydroxychloroquine, which has been addressed by the National Task Force. The WHO and the FDA have not found adequate evidence to recommend any specific medication for the treatment of Covid-19. While further evidence is awaited, including from trials registered with the FDA and the ICMR, it is recommended that the administration of hydroxychloroquine for chemo-prophylaxis be considered on a case by case basis with monitoring by a registered medical practitioner including electrocardiography (ECG). The potential for retinal and cardiac toxicity must also be borne in mind. It is further recommended that a public advisory regarding the need for caution in chemo-prophylaxis be made available in the public domain. Keywords: Coronavirus, Covid-19, SARS-CoV-2, hydroxychloroquine, chloroquine, chemoprophylaxis, bioethics, evidence- based medicine.

摘要

印度医学研究理事会(ICMR)的新冠疫情国家特别工作组在2020年3月21日发布的一份公告中建议,为疑似或确诊患者提供护理的无症状医护人员以及确诊患者的家庭接触者使用羟氯喹进行预防。这引发了对生物伦理和良好临床实践的关注。氯喹和羟氯喹疗效的证据目前来自开放标签试验和细胞培养研究,尚无随机临床试验的确凿证据。羟氯喹在黄斑病变、视网膜病变和QTc延长等情况下也有禁忌,在儿童、孕妇、哺乳期妇女和老年人等弱势群体中应谨慎使用。尽管如此,仍有人急于采购羟氯喹并自行用药,国家特别工作组已对此加以应对。世界卫生组织(WHO)和美国食品药品监督管理局(FDA)尚未找到足够证据来推荐任何用于治疗新冠的特定药物。在等待包括FDA和ICMR注册试验的进一步证据时,建议由注册医生进行监测(包括心电图检查),逐案考虑使用羟氯喹进行化学预防。还必须牢记视网膜和心脏毒性的可能性。进一步建议在公共领域发布关于化学预防需谨慎的公共咨询。关键词:冠状病毒、新冠、严重急性呼吸综合征冠状病毒2、羟氯喹、氯喹、化学预防、生物伦理、循证医学

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