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口服六神丸治疗新型冠状病毒肺炎患者:一项前瞻性随机对照试验。

Oral Liushen pill for patients with COVID-19: A prospective randomized controlled trial.

作者信息

Zhang Jianping, Liu Yian, Lei Wei, Shen Junheng, Lu Jing, Tao Tao, Cao Xu, Yang Zhong, Huang Jianan, Shi Cuilin

机构信息

The Fifth People's Hospital of Suzhou Suzhou China.

Department of Pulmonary and Critical Care Medicine The First Affiliated Hospital of Soochow University Suzhou China.

出版信息

Pulm Circ. 2023 Jan 1;13(1):e12187. doi: 10.1002/pul2.12187. eCollection 2023 Jan.

DOI:10.1002/pul2.12187
PMID:36733313
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC9886519/
Abstract

We examined the efficacy and safety of Liushen pill combined with basic treatment for patients with COVID-19. In total, 181 patients hospitalized with COVID-19, classified as asymptomatic mild type, were randomly divided into the experimental ( = 91) and control ( = 90) groups and were administered placebo (Maizao decoction) and Maizao decoction and Liushen pill, in addition to standard care, respectively. The negative conversion rate of nucleic acid (Day 7), hospital discharge rate (Days 8, 10, and 14), symptom disappearance rate (Days 3, 5, and 7), inflammatory cytokine levels, and adverse events were compared between the groups. The negative viral conversion rate was significantly higher in the experimental than in the control group (48.35 vs. 31.11%,  < 0.05). Subgroup analysis showed a similar significant trend when the value was ≤30 at baseline. After 10 days, the hospital discharge rate was significantly higher in the experimental than in the control group (69.23 vs. 53.33%,  < 0.05). After 3-day medication, the headache symptoms significantly disappeared in the experimental (88.57%) compared to the control group (63.33%) ( < 0.05). After 5 days, the symptom disappearance rates of headache and cough were significantly higher in the experimental (97.14%) than in the control group (97.14 vs. 80.00,  < 0.05; 82.65 vs. 58.93%,  < 0.01, respectively). Posttreatment, the procalcitonin level was significantly lower in the experimental than in the control group (0.09 ± 0.00 vs. 0.14 ± 0.05 ng/L;  < 0.05). There were no significant between-group differences in clinical safety test indices. Early intervention with Liushen pill improved cough and headache and increased negative viral conversion and discharge rate.

摘要

我们研究了六神丸联合基础治疗对新型冠状病毒肺炎(COVID-19)患者的疗效和安全性。总共181例住院的COVID-19患者,分类为无症状轻型,被随机分为试验组(n = 91)和对照组(n = 90),除标准护理外,分别给予安慰剂(麦枣汤)、麦枣汤和六神丸。比较两组之间核酸转阴率(第7天)、出院率(第8、10和14天)、症状消失率(第3、5和7天)、炎症细胞因子水平及不良事件。试验组病毒转阴率显著高于对照组(48.35% 对31.11%,P < 0.05)。亚组分析显示,当基线时数值≤30时,有类似的显著趋势。10天后,试验组出院率显著高于对照组(69.23% 对53.33%,P < 0.05)。用药3天后,试验组头痛症状显著消失(88.57%),而对照组为(63.33%)(P < 0.05)。5天后,试验组头痛和咳嗽症状消失率显著高于对照组(分别为97.14% 对80.00%,P < 0.05;82.65% 对58.93%,P < 0.01)。治疗后,试验组降钙素原水平显著低于对照组(0.09±0.00对0.14±0.05 ng/L;P < 0.05)。临床安全性测试指标组间无显著差异。六神丸早期干预可改善咳嗽和头痛,提高病毒转阴率和出院率。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/5c66/9886519/2c0ae7a87cfc/PUL2-13-e12187-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/5c66/9886519/2c0ae7a87cfc/PUL2-13-e12187-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/5c66/9886519/2c0ae7a87cfc/PUL2-13-e12187-g001.jpg

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Liushen Capsules, a promising clinical candidate for COVID-19, alleviates SARS-CoV-2-induced pulmonary in vivo and inhibits the proliferation of the variant virus strains in vitro.六神胶囊是一种有前景的治疗新冠肺炎的临床候选药物,可在体内减轻新冠病毒诱导的肺部损伤,并在体外抑制变异病毒株的增殖。
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