静脉溶栓治疗中专业指南与产品标签选择：来自SITS注册研究的分析
Professional guideline versus product label selection for treatment with IV thrombolysis: An analysis from SITS registry.
作者信息
Cameron Alan C, Bogie James, Abdul-Rahim Azmil H, Ahmed Niaz, Mazya Michael, Mikulik Robert, Hacke Werner, Lees Kennedy R
机构信息
1Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow, UK.
2Institute of Neuroscience and Psychology, University of Glasgow, Glasgow, UK.
出版信息
Eur Stroke J. 2018 Mar;3(1):39-46. doi: 10.1177/2396987317747737. Epub 2017 Dec 8.
INTRODUCTION
Thrombolysis usage in ischaemic stroke varies across sites. Divergent advice from professional guidelines and product labels may contribute.
PATIENTS AND METHODS
We analysed SITS-International registry patients enrolled January 2010 through June 2016. We grouped sites into organisational tertiles by number of patients arriving ≤2.5 h and treated ≤3 h, percentage arriving ≤2.5 h and treated ≤3 h, and numbers treated ≤3 h. We assigned scores of 1-3 (lower/middle/upper) per variable and 2 for onsite thrombectomy. We classified sites as lower efficiency (summed scores 3-5), medium efficiency (6-8) or higher efficiency (9-11). Sites were also grouped by adherence with European product label and ESO guideline: 'label adherent' (>95% on-label), 'guideline adherent' (≥5% off-label, ≥95% on-guideline) or 'guideline non-adherent' (>5% off-guideline). We cross-tabulated site-efficiency and adherence. We estimated the potential benefit of universally selecting by ESO guidance, using onset-to-treatment time-specific numbers needed to treat for day 90 mRS 0-1.
RESULTS
A total of 56,689 patients at 597 sites were included: 163 sites were higher efficiency, 204 medium efficiency and 230 lower efficiency. Fifty-six sites were 'label adherent', 204 'guideline adherent' and 337 'guideline non-adherent'. There were strong associations between site-efficiency and adherence (P < 0.001). Almost all 'label adherent' sites (55, 98%) were lower efficiency. If all patients were treated by ESO guidelines, an additional 17,031 would receive alteplase, which translates into 1922 more patients with favourable three-month outcomes.
DISCUSSION
Adherence with product labels is highest in lower efficiency sites. Closer alignment with professional guidelines would increase patients treated and favourable outcomes.
CONCLUSION
Product labels should be revised to allow treatment of patients ≤4.5 h from onset and aged ≥80 years.
引言
缺血性卒中溶栓治疗的应用在不同地点存在差异。专业指南和产品标签的不同建议可能是原因之一。
患者与方法
我们分析了2010年1月至2016年6月纳入SITS-国际注册研究的患者。我们根据到达时间≤2.5小时且治疗时间≤3小时的患者数量、到达时间≤2.5小时且治疗时间≤3小时的患者百分比以及治疗时间≤3小时的患者数量，将各地点分为组织三分位数。我们为每个变量赋予1 - 3分（低/中/高），现场进行血栓切除术的地点赋予2分。我们将各地点分类为低效率（总分3 - 5分）、中等效率（6 - 8分）或高效率（9 - 11分）。各地点还根据对欧洲产品标签和欧洲卒中组织（ESO）指南的遵循情况进行分组：“标签遵循”（>95%符合标签）、“指南遵循”（≥5%不符合标签，≥95%符合指南）或“指南不遵循”（>5%不符合指南）。我们对地点效率和遵循情况进行交叉制表。我们使用90天改良Rankin量表（mRS）评分为0 - 1时特定治疗时间所需治疗人数，估计普遍按照ESO指南选择治疗的潜在益处。
结果
共纳入597个地点的56689例患者：163个地点为高效率，204个为中等效率，230个为低效率。56个地点“标签遵循”，204个“指南遵循”，337个“指南不遵循”。地点效率与遵循情况之间存在强关联（P < 0.001）。几乎所有“标签遵循”的地点（55个，98%）为低效率地点。如果所有患者都按照ESO指南进行治疗，将有额外17,031例患者接受阿替普酶治疗，这意味着三个月预后良好的患者将增加1922例。
讨论
低效率地点对产品标签的遵循程度最高。更紧密地遵循专业指南将增加接受治疗的患者数量并改善预后。
结论
应修订产品标签，以允许对发病时间≤4.5小时且年龄≥80岁的患者进行治疗。
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