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单剂量伊维菌素对血液系统疾病合并新冠病毒疾病患者无效:一项II B期开放标签随机对照试验

Single Dose of Ivermectin is not Useful in Patients with Hematological Disorders and COVID-19 Illness: A Phase II B Open Labelled Randomized Controlled Trial.

作者信息

George Biju, Moorthy Mahesh, Kulkarni Uday, Selvarajan Sushil, Rupali Priscilla, Christopher D J, Balamugesh T, Rose Winsley, Lakshmi Kavitha M, Devasia Anup J, Fouzia N A, Korula Anu, Lionel Sharon, Abraham Aby, Mathews Vikram

机构信息

Department of Haematology, Christian Medical College, Vellore, India.

Department of Clinical Virology, Christian Medical College, Vellore, India.

出版信息

Indian J Hematol Blood Transfus. 2022 Oct;38(4):615-622. doi: 10.1007/s12288-022-01546-w. Epub 2022 May 27.

Abstract

Repurposed drugs may reduce morbidity and mortality in patients with hematological disorders who develop COVID-19 illness. 112 patients with predominantly hematological illnesses were randomized to receive standard of care, ivermectin 12 mg [Iv 12] or 24 mg [Iv24] for asymptomatic, mild, or moderate COVID 19 illness. Serial respiratory samples for rRT-PCR samples were sent on Day 3, 5 and 7. rRT-PCR negativity and ≥ 2 log reduction in viral loads on day 3, 5 and 7 were similar between the 3 treatment groups across all disease categories. Symptom progression occurred in 26 patients [21.6%] with no difference across 3 treatment groups. Twenty-two patients [18.3%] have expired while 98 [81.7%] survived. Survival rates were similar across treatment groups [controls-80.5%, Iv12-77.5%, Iv24-87.2% respectively]. Overall, poorer survival was seen with moderate illness compared to others [51.6% vs 92.1%;  = 0.000] and was the only significant risk factor identified on multivariate analysis. In this Phase II randomised trial, single dose of 12 or 24 mg of ivermectin did not reduce viral loads, prevent symptom progression, or reduce mortality in patients with predominantly haematological illnesses who develop mild to moderate COVID 19 illness.

摘要

重新利用的药物可能会降低患有血液系统疾病且感染新冠病毒疾病患者的发病率和死亡率。112名主要患有血液系统疾病的患者被随机分配接受标准治疗、12毫克伊维菌素[Iv 12]或24毫克伊维菌素[Iv24],用于治疗无症状、轻度或中度新冠病毒疾病。在第3天、第5天和第7天采集系列呼吸道样本用于逆转录聚合酶链反应(rRT-PCR)检测。在所有疾病类别中,三个治疗组在第3天、第5天和第7天的rRT-PCR阴性以及病毒载量降低≥2个对数相似。26名患者(21.6%)出现症状进展,三个治疗组之间无差异。22名患者(18.3%)死亡,98名患者(81.7%)存活。各治疗组的生存率相似(对照组-80.5%,Iv12-77.5%,Iv24-87.2%)。总体而言,与其他患者相比,中度疾病患者的生存率较低(51.6%对92.1%;P = 0.000),这是多变量分析中唯一确定的显著风险因素。在这项II期随机试验中,单剂量12毫克或24毫克伊维菌素并不能降低主要患有血液系统疾病且感染轻度至中度新冠病毒疾病患者的病毒载量、预防症状进展或降低死亡率。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/455c/9569256/097ed2243f6b/12288_2022_1546_Fig1_HTML.jpg

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