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社区环境中新冠病毒病抗病毒药物和中和单克隆抗体接受者的趋势、变异及临床特征:OpenSAFELY中2340万人的回顾性描述性队列研究

Trends, variation, and clinical characteristics of recipients of antiviral drugs and neutralising monoclonal antibodies for covid-19 in community settings: retrospective, descriptive cohort study of 23.4 million people in OpenSAFELY.

作者信息

Green Amelia C A, Curtis Helen J, Higgins Rose, Nab Linda, Mahalingasivam Viyaasan, Smith Rebecca M, Mehrkar Amir, Inglesby Peter, Drysdale Henry, DeVito Nicholas J, Croker Richard, Rentsch Christopher T, Bhaskaran Krishnan, Tazare John, Zheng Bang, Andrews Colm D, Bacon Sebastian C J, Davy Simon, Dillingham Iain, Evans David, Fisher Louis, Hickman George, Hopcroft Lisa E M, Hulme William J, Massey Jon, MacDonald Orla, Morley Jessica, Morton Caroline E, Park Robin Y, Walker Alex J, Ward Tom, Wiedemann Milan, Bates Christopher, Cockburn Jonathan, Parry John, Hester Frank, Harper Sam, Douglas Ian J, Evans Stephen J W, Goldacre Ben, Tomlinson Laurie A, MacKenna Brian

机构信息

Bennett Institute for Applied Data Science, Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK.

London School of Hygiene and Tropical Medicine, London, UK.

出版信息

BMJ Med. 2023 Jan 13;2(1):e000276. doi: 10.1136/bmjmed-2022-000276. eCollection 2023.

Abstract

OBJECTIVE

To ascertain patient eligibility status and describe coverage of antiviral drugs and neutralising monoclonal antibodies (nMAB) as treatment for covid-19 in community settings in England.

DESIGN

Retrospective, descriptive cohort study, approved by NHS England.

SETTING

Routine clinical data from 23.4 million people linked to data on covid-19 infection and treatment, within the OpenSAFELY-TPP database.

PARTICIPANTS

Outpatients with covid-19 at high risk of severe outcomes.

INTERVENTIONS

Nirmatrelvir/ritonavir (paxlovid), sotrovimab, molnupiravir, casirivimab/imdevimab, or remdesivir, used in the community by covid-19 medicine delivery units.

RESULTS

93 870 outpatients with covid-19 were identified between 11 December 2021 and 28 April 2022 to be at high risk of severe outcomes and therefore potentially eligible for antiviral or nMAB treatment (or both). Of these patients, 19 040 (20%) received treatment (sotrovimab, 9660 (51%); molnupiravir, 4620 (24%); paxlovid, 4680 (25%); casirivimab/imdevimab, 50 (<1%); and remdesivir, 30 (<1%)). The proportion of patients treated increased from 9% (190/2220) in the first week of treatment availability to 29% (460/1600) in the latest week. The proportion treated varied by high risk group, being lowest in those with liver disease (16%; 95% confidence interval 15% to 17%); by treatment type, with sotrovimab favoured over molnupiravir and paxlovid in all but three high risk groups (Down's syndrome (35%; 30% to 39%), rare neurological conditions (45%; 43% to 47%), and immune deficiencies (48%; 47% to 50%)); by age, ranging from ≥80 years (13%; 12% to 14%) to 50-59 years (23%; 22% to 23%); by ethnic group, ranging from black (11%; 10% to 12%) to white (21%; 21% to 21%); by NHS region, ranging from 13% (12% to 14%) in Yorkshire and the Humber to 25% (24% to 25%) in the East of England); and by deprivation level, ranging from 15% (14% to 15%) in the most deprived areas to 23% (23% to 24%) in the least deprived areas. Groups that also had lower coverage included unvaccinated patients (7%; 6% to 9%), those with dementia (6%; 5% to 7%), and care home residents (6%; 6% to 7%).

CONCLUSIONS

Using the OpenSAFELY platform, we were able to identify patients with covid-19 at high risk of severe outcomes who were potentially eligible to receive treatment and assess the coverage of these new treatments among these patients. In the context of a rapid deployment of a new service, the NHS analytical code used to determine eligibility could have been over-inclusive and some of the eligibility criteria not fully captured in healthcare data. However targeted activity might be needed to resolve apparent lower treatment coverage observed among certain groups, in particular (at present): different NHS regions, ethnic groups, people aged ≥80 years, those living in socioeconomically deprived areas, and care home residents.

摘要

目的

确定患者的资格状态,并描述在英格兰社区环境中作为新冠治疗药物的抗病毒药物和中和单克隆抗体(nMAB)的覆盖情况。

设计

经英国国民健康服务体系(NHS)批准的回顾性描述性队列研究。

背景

来自OpenSAFELY-TPP数据库中2340万人的常规临床数据与新冠感染和治疗数据相关联。

参与者

有严重后果高风险的新冠门诊患者。

干预措施

由新冠药物配送单位在社区使用的奈玛特韦/利托那韦(帕罗韦德)、索托维单抗、莫努匹拉韦、卡西瑞韦单抗/伊德维单抗或瑞德西韦。

结果

在2021年12月11日至2022年4月28日期间,共识别出93870名有严重后果高风险的新冠门诊患者,因此他们可能有资格接受抗病毒治疗或nMAB治疗(或两者)。在这些患者中,19040名(20%)接受了治疗(索托维单抗,9660名(51%);莫努匹拉韦,4620名(24%);帕罗韦德,4680名(25%);卡西瑞韦单抗/伊德维单抗,50名(<1%);瑞德西韦,30名(<1%))。接受治疗的患者比例从治疗可用第一周的9%(190/2220)增加到最近一周的29%(460/1600)。接受治疗的比例因高风险组而异,在肝病患者中最低(16%;95%置信区间15%至17%);因治疗类型而异,除三个高风险组(唐氏综合征(35%;30%至39%)、罕见神经系统疾病(45%;43%至47%)和免疫缺陷(48%;47%至50%))外,索托维单抗在所有高风险组中比莫努匹拉韦和帕罗韦德更受青睐;因年龄而异,从≥80岁(13%;12%至14%)到50 - 59岁(23%;22%至23%);因种族而异,从黑人(11%;10%至12%)到白人(21%;21%至21%);因NHS地区而异,从约克郡和亨伯地区的13%(12%至14%)到英格兰东部的25%(24%至25%);因贫困程度而异,从最贫困地区的15%(14%至15%)到最不贫困地区的23%(23%至24%)。覆盖率也较低的群体包括未接种疫苗的患者(7%;6%至9%)、患有痴呆症的患者(6%;5%至7%)和养老院居民(6%;6%至7%)。

结论

利用OpenSAFELY平台,我们能够识别出有严重后果高风险且可能有资格接受治疗的新冠患者,并评估这些新疗法在这些患者中的覆盖情况。在快速部署新服务的背景下,用于确定资格的NHS分析代码可能包容性过强,且一些资格标准未在医疗数据中完全体现。然而,可能需要有针对性的行动来解决某些群体中观察到的明显较低的治疗覆盖率问题,特别是(目前):不同的NHS地区、种族群体、≥80岁的人群、生活在社会经济贫困地区的人群以及养老院居民。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/295e/9951378/8ee8d3770cfb/bmjmed-2022-000276f01.jpg

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