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抗感颗粒治疗轻度新型冠状病毒肺炎患者的疗效:一项随机、四盲、安慰剂对照试验

Efficacy of Kan Jang in Patients with Mild COVID-19: A Randomized, Quadruple-Blind, Placebo-Controlled Trial.

作者信息

Ratiani Levan, Pachkoria Elene, Mamageishvili Nato, Shengelia Ramaz, Hovhannisyan Areg, Panossian Alexander

机构信息

Department of Infectious Diseases, The First University Clinic, Tbilisi State Medical University, Gudamakari St., Tbilisi 0141, Georgia.

Department for History of Medicine and Bioethics, Faculty of Medicine, Tbilisi State Medical University, Vazha-Pshavela Ave. 33, Tbilisi 0162, Georgia.

出版信息

Pharmaceuticals (Basel). 2023 Aug 22;16(9):1196. doi: 10.3390/ph16091196.

Abstract

. This study aimed to assess the efficacy of the treatment of Kan Jang, a fixed combination of (Burm. F.) Wall. ex. Nees and (Rupr. & Maxim.) Maxim extracts in patients with mild symptoms of COVID-19. . One hundred and forty patients received six capsules of Kan Jang ( = 68, daily dose of andrographolides-90 mg) or placebo ( = 72) and supportive treatment (paracetamol) for 14 consecutive days in a randomized, quadruple-blinded, placebo-controlled, two-parallel-group design. The efficacy outcomes were the rate of cases turning to severe, the detection rate of coronavirus SARS-CoV-2 over the time of treatment, the duration, and the severity of symptoms (sore throat, runny nose, cough, headache, fatigue, loss of smell, taste, pain in muscles) in the acute phase of the disease. Other efficacy measures included improving cognitive and physical performance, quality of life, and the levels of inflammatory blood markers-interleukin 6 (IL-6), C-reactive protein, and D-dimer. . Kan Jang significantly ( < 0.05) reduced the rate of cases turning to severe (5.36%) compared to the placebo (17.86%) and decreased the detection rate of SARS-CoV-2 virus over the time of the treatment. The statistical difference in the rates of patients with clinical deterioration in the Kan Jang treatment and placebo control groups was significant ( = 0.0176) both in the 112 patients in the included-per-protocol (IPP) analysis and in the 140 patients in the intended-to-treat (ITT) analysis ( = 0.0236); the absolute risk reduction in cases thanks to the Kan Jang treatment was 12.5%, and the number we needed to treat with Kan Jang was 8. The patient's recovery time (number of sick days at the home/clinic) was shorter in the Kan Jang group compared with the placebo group. The rate of attenuation of inflammatory symptoms in the Kan Jang group was significantly higher, decreasing the severity of cough, sore throat/pain, runny nose, and muscle soreness compared with the placebo group. Kan Jang significantly decreased the Wisconsin Upper Respiratory Symptoms scores compared to the placebo in the sample size of 140 patients. However, the relief of fatigue and headache and the decrease in IL-6 in the blood were observed only in a subset of 86 patients infected during the second three waves of the pandemic. Kan Jang significantly increased physical activity and workout; however, it did not affect cognitive functions (attention and memory), quality of life score, inflammatory marker D-dimer, and C-reactive protein compared with the placebo group. . Overall, the results of this study suggest that Kan Jang is effective in treating mild and moderate COVID-19 irrespective of the SARS-CoV-2 variant of infection.

摘要

本研究旨在评估贯叶连翘(一种由毛叶鸡骨常山(Burm. F.)Wall. ex. Nees和狭叶红景天(Rupr. & Maxim.)Maxim提取物组成的固定复方制剂)对新冠肺炎轻症患者的治疗效果。140例患者采用随机、四重盲法、安慰剂对照、双平行组设计,连续14天接受6粒贯叶连翘胶囊治疗(n = 68,穿心莲内酯每日剂量90 mg)或安慰剂治疗(n = 72)以及支持性治疗(对乙酰氨基酚)。疗效指标包括转为重症的病例率、治疗期间冠状病毒SARS-CoV-2的检出率、疾病急性期症状的持续时间和严重程度(咽痛、流涕、咳嗽、头痛、疲劳、嗅觉丧失、味觉丧失、肌肉疼痛)。其他疗效指标包括改善认知和身体机能、生活质量以及血液炎症标志物白细胞介素6(IL-6)、C反应蛋白和D-二聚体水平。与安慰剂组(17.86%)相比,贯叶连翘显著(P < 0.05)降低了转为重症的病例率(5.36%),并降低了治疗期间SARS-CoV-2病毒的检出率。在符合方案分析(IPP)的112例患者和意向性分析(ITT)的140例患者中,贯叶连翘治疗组和安慰剂对照组临床恶化患者率的统计学差异均显著(P = 0.(此处原文有误,推测应为P = 0.0176)0176);由于贯叶连翘治疗,病例的绝对风险降低了12.5%,需要用贯叶连翘治疗以预防1例重症病例的患者数为8。与安慰剂组相比,贯叶连翘组患者的恢复时间(在家/诊所的患病天数)更短。贯叶连翘组炎症症状的减轻率显著更高,与安慰剂组相比,咳嗽、咽痛/疼痛、流涕和肌肉酸痛的严重程度降低。在140例患者的样本量中,与安慰剂相比,贯叶连翘显著降低了威斯康星上呼吸道症状评分。然而,仅在疫情第二至三波期间感染的86例患者亚组中观察到疲劳和头痛的缓解以及血液中IL-6的降低。与安慰剂组相比,贯叶连翘显著增加了身体活动和锻炼;然而,它对认知功能(注意力和记忆力)、生活质量评分、炎症标志物D-二聚体和C反应蛋白没有影响。总体而言,本研究结果表明贯叶连翘对治疗轻、中度新冠肺炎有效,无论感染的SARS-CoV-2变体如何。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/9115/10535596/2a1d2f08ca84/pharmaceuticals-16-01196-g001.jpg

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