俄罗斯 COVID-19 大流行中直接口服抗凝剂的消费和支出及其临床实践指南

Elena Baybulatova, Mikhail Chenkurov, Elina Korovyakova, S. Zyryanov, L. Ziganshina
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Aim: The objective of this study was to assess DOAC consumption and expenditure in the Russian Federation during the COVID-19 pandemic and to analyze whether it was supported by the domestic evidence base for the use of DOACs in COVID-19 patients through identifying all publicly available Russian-produced CPGs (Clinical practice guidelines) for the treatment of COVID-19 and assessing their quality as the source of recommendations for the use of oral anticoagulants for the prevention of thrombotic complications in COVID-19 patients. We searched Russian databases for CPGs, published between 2020 and 2023. We identified seven relevant documents that met our inclusion criteria. Three authors analyzed Russian clinical guidelines using an AGREE II questionnaire. We calculated DOAC DDD (defined daily dose) consumption according to Russian clinical guidelines and DDD consumption in patients with COVID-19 for the period 2020–2022. 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Consumption of apixaban in the Russian Federation in 2020 and 2021 corresponds to the indicators presented in clinical recommendations (in 2020—26.59 DDD per patient with COVID-19; in 2021—15.75 DDD per patient with COVID-19), and in 2022—10.67 DDD, which is below the recommended values. In 2020, consumption of rivaroxaban in the Russian Federation was 26.59 which corresponds to data from clinical recommendations; in 2021, consumption decreased to 7.87 DDD; in 2022 it decreased to 5.48 DDD, which is 2.74 times less than recommended. Conclusions: Analysis of seven clinical recommendations revealed that such sections of clinical recommendations as scope, purpose, and clarity of presentation had the highest degree of assessment in accordance with AGREE II. The lowest scores were given for the sections on stakeholder involvement, rigour of development, applicability, and editorial independence. 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引用次数: 0

摘要

背景:冠状病毒大流行促使许多专业医疗团体制定了临床指南。然而,俄罗斯临床指南的质量和制定方法却鲜有研究。研究 COVID-19 患者使用 DOAC(直接口服抗凝剂)的持续相关性是开展本研究的基础。目的:本研究的目的是评估 COVID-19 大流行期间俄罗斯联邦的 DOAC 消耗量和支出情况,并通过识别所有公开发布的用于治疗 COVID-19 的俄罗斯 CPG(临床实践指南),评估其作为 COVID-19 患者使用口服抗凝剂预防血栓并发症的建议来源的质量,从而分析 COVID-19 患者使用 DOAC 是否得到国内证据基础的支持。我们在俄罗斯数据库中检索了 2020 年至 2023 年间发表的 CPG。我们找到了七份符合纳入标准的相关文件。三位作者使用 AGREE II 问卷对俄罗斯临床指南进行了分析。我们根据俄罗斯临床指南计算了 DOAC DDD(定义日剂量)的消耗量,并计算了 2020-2022 年期间 COVID-19 患者的 DDD 消耗量。结果:使用 AGREE II 工具分析了七项临床 CPG。结果显示,专家对范围和目的部分(从 62.98% 到 100%)以及表述清晰度部分(从 96.30% 到 100%)给予了最高分。得分最低的是利益相关者参与(33.33% 至 64.81%)、开发的严谨性(从 0% 至 49.31%)、适用性(从 23.61% 至 50%)和编辑独立性(从 0% 至 50%)。在比较总得分时发现,有两份临床指南得分最高--ROPNIZ(Livzan)和 ROPNIZ(Drapkina)。得分最低的是 NIIOZMM(Khripun)临床指南。没有一份指南的总得分超过 70%。根据临床建议,阿哌沙班和利伐沙班的用量为 15 日剂量(30 天疗程)或 22.5 日剂量(45 天疗程)。2020 年和 2021 年,俄罗斯联邦的阿哌沙班用药量与临床建议中提出的指标相符(2020 年,每名 COVID-19 患者用药量为 26.59DD ;2021 年,每名 COVID-19 患者用药量为 15.75DD ),而 2022 年的用药量为 10.67DDD,低于建议值。2020 年,俄罗斯联邦利伐沙班的消耗量为 26.59 个 DDD,与临床建议数据相符;2021 年,消耗量降至 7.87 个 DDD;2022 年,消耗量降至 5.48 个 DDD,比建议值低 2.74 倍。结论对 7 项临床建议的分析表明,根据 AGREE II,临床建议的范围、目的和表述清晰度等部分的评估程度最高。而利益相关者参与、制定的严谨性、适用性和编辑独立性等部分得分最低。在比较总分时发现,有两份临床指南得分最高--俄罗斯非传染性疾病预防协会(Livzan)和俄罗斯非传染性疾病预防协会(Drapkina)。得分最低的是莫斯科医疗保健部医疗保健组织和医疗管理研究所的临床指南。没有一项指南的总得分超过 70%。在大流行期间,2020 年的 DOAC 消耗量最高,超过了俄罗斯临床指南推荐的 DOAC 消耗量。到 2022 年,DOAC 的消耗量有所下降。在冠状病毒大流行期间,利伐沙班的用量有所减少,而阿哌沙班在 DOAC 用量结构中的份额有所增加。获得的数据表明,2021 年俄罗斯联邦的阿哌沙班用量与国家指南中推荐的 DDD 相符,这表明根据俄罗斯的 GPGs,阿哌沙班的使用是最正确的。
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Direct Oral Anticoagulants’ Consumption and Expenditure in the COVID-19 Pandemic in Russia and Clinical Practice Guidelines for Their Use
Background: The coronavirus pandemic has led to the creation of clinical guidelines by a large number of professional medical communities. However, the quality and methodology of development of Russian clinical guidelines has been little studied. The continued relevance of studying the use of DOACs (Direct oral anticoagulants) in patients with COVID-19 was the basis for conducting this study. Aim: The objective of this study was to assess DOAC consumption and expenditure in the Russian Federation during the COVID-19 pandemic and to analyze whether it was supported by the domestic evidence base for the use of DOACs in COVID-19 patients through identifying all publicly available Russian-produced CPGs (Clinical practice guidelines) for the treatment of COVID-19 and assessing their quality as the source of recommendations for the use of oral anticoagulants for the prevention of thrombotic complications in COVID-19 patients. We searched Russian databases for CPGs, published between 2020 and 2023. We identified seven relevant documents that met our inclusion criteria. Three authors analyzed Russian clinical guidelines using an AGREE II questionnaire. We calculated DOAC DDD (defined daily dose) consumption according to Russian clinical guidelines and DDD consumption in patients with COVID-19 for the period 2020–2022. Results: Seven clinical CPGs were analyzed with the AGREE II tool. It was revealed that experts gave the highest scores for the sections on scope and purpose (from 62.98% to 100%), and clarity of presentation (from 96.30% to 100%). The lowest scores were given for the sections on stakeholder involvement (33.33% to 64.81%), rigour of development (from 0% to 49.31%), applicability (from 23.61% to 50%), and editorial independence (from 0% to 50%). When comparing the total score, it was found that two clinical guidelines received the highest scores—ROPNIZ (Livzan), and ROPNIZ (Drapkina). The minimum score was registered with the NIIOZMM (Khripun) clinical guideline. No guideline received a total score of more than 70%. According to clinical recommendations, the consumption of apixaban and rivaroxaban is 15 DDD (30-day course of therapy), or 22.5 DDD (45-day course of therapy). Consumption of apixaban in the Russian Federation in 2020 and 2021 corresponds to the indicators presented in clinical recommendations (in 2020—26.59 DDD per patient with COVID-19; in 2021—15.75 DDD per patient with COVID-19), and in 2022—10.67 DDD, which is below the recommended values. In 2020, consumption of rivaroxaban in the Russian Federation was 26.59 which corresponds to data from clinical recommendations; in 2021, consumption decreased to 7.87 DDD; in 2022 it decreased to 5.48 DDD, which is 2.74 times less than recommended. Conclusions: Analysis of seven clinical recommendations revealed that such sections of clinical recommendations as scope, purpose, and clarity of presentation had the highest degree of assessment in accordance with AGREE II. The lowest scores were given for the sections on stakeholder involvement, rigour of development, applicability, and editorial independence. When comparing the total score, it was found that two clinical guidelines received the highest scores—the Russian Society for the Prevention of Non-communicable Diseases (Livzan), and the Russian Society for the Prevention of Non-communicable Diseases (Drapkina). The minimum score was registered with the Research Institute for Healthcare Organization and Medical Management of Moscow Healthcare Department clinical guideline. No guideline received a total score of more than 70%. During the pandemic, the highest DDD consumption of DOACs was in 2020, which exceeded the DOACs’ recommended DDD by Russian clinical guidelines. DOAC consumption had decreased by 2022. There was a decrease in the consumption of rivaroxaban, with an increase in apixaban’s share in the structure of DOAC consumption during the coronavirus pandemic. Obtained data indicate that in 2021 the apixaban consumption in the Russian Federation corresponded to the recommended DDD in the national guidelines, which indicates the most correct use of apixaban according to Russian GPGs.
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