Department of Clinical Pharmacy, Faculty of pharmacy, Mazandaran University of Medical Sciences, Sari, Iran.
Department of Infectious Disease, Ibne Sina Medical and Educational Center, Mazandaran University of Medical Sciences, Sari, Iran.
Int Immunopharmacol. 2021 Dec;101(Pt B):108227. doi: 10.1016/j.intimp.2021.108227. Epub 2021 Oct 6.
Pentoxifylline (PTX) has broad-spectrum properties such as anti-inflammatory, anticoagulant, and antiviral effects. The aim of this study was to evaluate the efficacy and safety of PTX in hospitalized patients with COVID-19. This double-blind, placebo-controlled randomized clinical trial was conducted on hospitalized patients with COVID-19. The recruited patients were randomly (1:1) assigned to the PTX group and the placebo group. The intervention group received PTX capsules at a dose of 400 mg three times a day for 10 days along with the national regimen, including interferon plus lopinavir/ritonavir and hydroxychloroquine. The primary outcome was the improvement of clinical scores. The secondary outcomes, on the other hand, were improvement in inflammatory and oxidative stress factors and hospital complications. From a total of 102 patients who met the inclusion criteria, 72 individuals completed the study and were analyzed. No significant differences were shown in demographics and baseline clinical characteristics. Clinical scores was not significant between the two groups (P = 0.31 and 0.07 for day 5 and 11, respectively). Although the mean serum levels of interleukin-6 (IL-6) and glutathione changed significantly after 5 days in the PTX group (P = 0.03 and p = 0.04), ICU admission, intubation, and hospital stay did not differ between the two groups. The results of our study did not show any superiority of PTX over placebo in improving the clinical outcomes of patients with COVID-19. Although PTX had a beneficial effect on IL-6 and showed an acceptable safety profile, it did not offer any clinical benefit for COVID-19 complications.
己酮可可碱（PTX）具有广泛的特性，如抗炎、抗凝和抗病毒作用。本研究旨在评估 PTX 对 COVID-19 住院患者的疗效和安全性。这是一项双盲、安慰剂对照的随机临床试验，在 COVID-19 住院患者中进行。招募的患者被随机（1:1）分配到 PTX 组和安慰剂组。干预组接受 PTX 胶囊，剂量为 400mg，每日 3 次，持续 10 天，同时采用国家方案，包括干扰素加洛匹那韦/利托那韦和羟氯喹。主要结局是临床评分的改善。另一方面，次要结局是炎症和氧化应激因素及住院并发症的改善。从符合纳入标准的 102 例患者中，有 72 例完成了研究并进行了分析。两组患者在人口统计学和基线临床特征方面无显著差异。两组患者的临床评分无显著差异（第 5 天和第 11 天分别为 P=0.31 和 0.07）。尽管 PTX 组在第 5 天血清白细胞介素-6（IL-6）和谷胱甘肽水平显著变化（P=0.03 和 p=0.04），但两组患者 ICU 入院、插管和住院时间无差异。我们的研究结果表明，PTX 在改善 COVID-19 患者的临床结局方面并不优于安慰剂。尽管 PTX 对 IL-6 有有益作用，且具有可接受的安全性特征，但对 COVID-19 并发症没有提供任何临床益处。
