Using the Influenza Patient-reported Outcome (FLU-PRO) diary to evaluate symptoms of influenza viral infection in a healthy human challenge model
Using the Influenza Patient-reported Outcome (FLU-PRO) diary to evaluate symptoms of influenza viral infection in a healthy human challenge model
复制标题
DOI：
10.1186/s12879-018-3220-8
复制
发表时间：
2018-07-28
影响因子：
3.7
通讯作者：
Memoli, Matthew J.
中科院分区：
文献类型：
--
作者：
Han, Alison;Poon, Jiat-Ling;Memoli, Matthew J.
背景资料：在涉及健康志愿者人类攻毒模型的临床研究中，有必要采用有效和可靠的措施来评估病毒暴露后患者报告的症状类型和严重程度的演变。本研究探讨了使用InFLUenza患者报告的结果（FLU-PRO）日记作为一个标准化的措施，症状严重程度在一个健康的志愿者人类challenge model.Methods：健康成年人承认美国国立卫生研究院临床中心（第1天）进行了为期9天的住院隔离后，鼻内挑战与野生型流感A/H1N1 pdm病毒（第0天）。参与者每天两次完成32项FLU-PRO日记，持续14天，以评估六个身体系统症状的存在，严重程度和持续时间。二次分析包括描述性统计，检查FLU-PRO评分在病程和方差分析，以比较第3天的病毒脱落的存在下，挑战后的分数，和挑战前血凝素和神经氨酸酶抑制（HAI和NAI）titers.Results：所有，但一个主题（99%），谁是失去了后续行动，完成每日两次FLU-PRO日记的所有研究评估日。FLU-PRO证明65例受试者中有61例报告了症状（天数：中位数5天，平均值6 +/- 7），其中37例（61%）出现病毒脱落。攻毒前，分别有39例（64%）和10例（16%）受试者的HAI和NAI滴度较低（< 1：40）。鼻、喉、身体和胃肠道（GI）症状在第3天达到峰值强度，随后在第4天出现胸部/呼吸道和眼部症状。除眼部和GI领域外，有病毒排出的受试者的平均FLU-PRO评分高于无病毒排出的受试者（p
Background: In clinical studies involving a healthy volunteer human challenge model, a valid and reliable measure to assess the evolution of patient-reported symptom type and severity following viral exposure is necessary. This study examines the use of the InFLUenza Patient-Reported Outcome (FLU-PRO) diary as a standardized measure of symptom severity in a healthy volunteer human challenge model.Methods: Healthy adults admitted to the NIH Clinical Center (Day - 1) underwent a 9-day inpatient quarantine after intranasal challenge with a wild-type influenza A/H1N1pdm virus (Day 0). Participants completed the 32-item FLU-PRO diary twice daily for 14 days to assess presence, severity, and duration of symptoms across six body systems. Secondary analyses included descriptive statistics to examine FLU-PRO scores over the course of illness and analysis of variance to compare scores on Day 3 post-challenge by presence of viral shedding, and pre-challenge hemagglutinin and neuraminidase inhibition (HAI and NAI) titers.Results: All but one subject (99%), who was lost to follow-up, completed twice daily FLU-PRO diaries on all study assessment days. FLU-PRO demonstrated that 61 of 65 subjects reported symptoms (Days: Median 5, Mean 6 +/- 7), of whom 37 (61%) had viral shedding. Pre-challenge, 39 (64%) and 10 (16%) subjects had low (< 1:40) HAI and NAI titers, respectively. Nose, throat, body, and gastrointestinal (GI) symptoms reached peak intensity at Day 3, followed by chest/ respiratory and eye symptoms at Day 4. Subjects with viral shedding had higher mean FLU-PRO scores compared to those without except for Eye and GI domains (p