Compassionate drug (mis)use during pandemics: lessons for COVID-19 from 2009
Compassionate drug (mis)use during pandemics: lessons for COVID-19 from 2009
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DOI：
10.1186/s12916-020-01732-5
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发表时间：
2020-08-21
期刊：
影响因子：
9.3
通讯作者：
Horby, Peter W.
中科院分区：
文献类型：
--
作者：
Rojek, Amanda M.;Martin, Genevieve E.;Horby, Peter W.
背景新出现的感染没有已知的治疗方法。评估潜在药物的安全性和有效性使临床医生能够做出循证治疗决策，并有助于全面控制疫情。然而，在疫情不可预测的环境下，很难启动临床试验。我们对2009年流感大流行进行了文献计量学系统评价，以确定治疗证据生成的速度和质量。这为在这次和未来的大流行中产生高质量证据的方法提供了信息。方法我们检索PubMed中描述甲型H1N1流感患者治疗的所有临床数据（包括临床试验、观察性和病例系列）pdm09和ClinicalTrials.gov中旨在招募该疾病患者的研究。结果160篇文献详细描述了33869例甲型H1N1流感pdm09住院患者的治疗疗程。大多数是回顾性观察性研究或病例系列。592名患者作为注册的干预性临床试验的参与者接受治疗（或安慰剂），结果公开。在大流行期间，这些注册的试验结果均不可用，发表的中位日期为国际关注的突发公共卫生事件结束后213天。结论患者经常使用未注册的药物治疗大流行性流感，但在高质量数据采集的情况下很少。结果是依赖于在同情的情况下使用，导致抗病毒治疗的潜在益处和危害的持续不确定性。快速扩大临床试验规模对于在大流行期间建立高质量的证据基础至关重要。
Background New emerging infections have no known treatment. Assessing potential drugs for safety and efficacy enables clinicians to make evidence-based treatment decisions and contributes to overall outbreak control. However, it is difficult to launch clinical trials in the unpredictable environment of an outbreak. We conducted a bibliometric systematic review for the 2009 influenza pandemic to determine the speed and quality of evidence generation for treatments. This informs approaches to high-quality evidence generation in this and future pandemics. Methods We searched PubMed for all clinical data (including clinical trial, observational and case series) describing treatment for patients with influenza A(H1N1)pdm09 and ClinicalTrials.gov for research that aimed to enrol patients with the disease. Results Thirty-three thousand eight hundred sixty-nine treatment courses for patients hospitalised with A(H1N1)pdm09 were detailed in 160 publications. Most were retrospective observational studies or case series. Five hundred ninety-two patients received treatment (or placebo) as participants in a registered interventional clinical trial with results publicly available. None of these registered trial results was available during the timeframe of the pandemic, and the median date of publication was 213 days after the Public Health Emergency of International Concern ended. Conclusion Patients were frequently treated for pandemic influenza with drugs not registered for this indication, but rarely under circumstances of high-quality data capture. The result was a reliance on use under compassionate circumstances, resulting in continued uncertainty regarding the potential benefits and harms of anti-viral treatment. Rapid scaling of clinical trials is critical for generating a quality evidence base during pandemics.