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低分子量肝素雾化吸入疗法对新型冠状病毒肺炎所致低氧血症的早期疗效:一项IIb期试验

Early Effects of Low Molecular Weight Heparin Therapy with Soft-Mist Inhaler for COVID-19-Induced Hypoxemia: A Phase IIb Trial.

作者信息

Erelel Mustafa, Kaskal Mert, Akbal-Dagistan Ozlem, Issever Halim, Dagistanli Ahmet Serhan, Balkanci Hilal, Oguz Merve Sinem, Qarayeva Aygun, Culha Meltem, Erturk Aybige, Basarir Nur Sena, Sahin Gokben, Uresin Ali Yagiz, Araman Ahmet Ogul, Medetalibeyoglu Alpay, Tukek Tufan, Oncul Mustafa Oral, Yildiz-Pekoz Ayca

机构信息

Department of Chest Diseases, Faculty of Medicine, Istanbul University, 34104 Istanbul, Turkey.

Department of Pharmacology, Faculty of Medicine, Marmara University, 34854 Istanbul, Turkey.

出版信息

Pharmaceutics. 2021 Oct 22;13(11):1768. doi: 10.3390/pharmaceutics13111768.

Abstract

In COVID-19-induced acute respiratory distress syndrome, the lungs are incapable of filling with sufficient air, leading to hypoxemia that results in high mortality among hospitalized patients. In clinical trials, low-molecular-weight heparin was administered via a specially designed soft-mist inhaler device in an investigator initiated, single-center, open-label, phase-IIb clinical trial. Patients with evidently worse clinical presentations were classed as the "Device Group"; 40 patients were given low-molecular-weight heparin via a soft mist inhaler at a dose of 4000 IU per administration, twice a day. The Control Group, also made up of 40 patients, received the standard therapy. The predetermined severity of hypoxemia and the peripheral oxygen saturation of patients were measured on the 1st and 10th days of treatment. The improvement was particularly striking in cases of severe hypoxemia. In the 10-day treatment, low-molecular-weight heparin was shown to significantly improve breathing capability when delivered via a soft-mist inhaler.

摘要

在新型冠状病毒肺炎(COVID-19)引发的急性呼吸窘迫综合征中,肺部无法充分吸入空气,导致低氧血症,这使得住院患者死亡率很高。在一项由研究者发起的、单中心、开放标签的IIb期临床试验中,通过一种专门设计的软雾吸入器装置给予低分子量肝素。临床表现明显更差的患者被归类为“装置组”;40名患者通过软雾吸入器给予低分子量肝素,每次给药剂量为4000国际单位,每天两次。对照组也由40名患者组成,接受标准治疗。在治疗的第1天和第10天测量患者低氧血症的预定严重程度和外周血氧饱和度。在严重低氧血症的病例中,改善尤为显著。在为期10天的治疗中,低分子量肝素通过软雾吸入器给药时,显示出能显著改善呼吸能力。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ee58/8618458/1a65087f0c35/pharmaceutics-13-01768-g001.jpg

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