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评估个性化阿育吠陀辅助疗法对依赖氧气的糖尿病COVID-19患者的疗效:一项关于症状、炎症和影像学变化的60天研究

Evaluating Personalized Add-On Ayurveda Therapy in Oxygen-Dependent Diabetic COVID-19 Patients: A 60-Day Study of Symptoms, Inflammation, and Radiological Changes.

作者信息

Kumar Somit, Ramaraju Karthikeyan, Kakarla Mitravinda S, Eranezhath Sujith S, Chenthamarakshan Chaithanya, Alagesan Murali, Satheesan Balagopal, Unniappan Indulal, Wilhalme Holly, Pīrāgs Valdis, Furst Daniel E

机构信息

Clinical Research, AVP Research Foundation, Coimbatore, IND.

Research and Development, The Arya Vaidya Pharmacy, Coimbatore, IND.

出版信息

Cureus. 2024 Sep 1;16(9):e68392. doi: 10.7759/cureus.68392. eCollection 2024 Sep.

Abstract

Background Effective management of both acute and post-acute sequelae of SARS-CoV-2 is essential, particularly for type 2 diabetes mellitus (T2DM) patients, who are at increased risk of severe pro-inflammatory responses and complications. Persistent symptoms and residual lung and cardiovascular damage in post-coronavirus disease (COVID-19) individuals highlight the need for comprehensive long-term treatment strategies. Conventional treatments, including Remdesivir and glucocorticoids, have limitations, suggesting that further investigation into Ayurvedic therapies could be beneficial, though controlled trials are currently limited. Objectives Evaluate the effectiveness and safety of Ayurveda with the standard of care (SOC) versus SOC in improving symptoms, moderating immune responses (interleukin-6 (IL-6), C-reactive protein (CRP), neutrophil-lymphocyte ratio (NLR), and radiological outcomes in oxygen-dependent, high-risk, non-vaccinated type 2 diabetes COVID-19 patients over 60 days, and thus addressing their heightened vulnerability to severe infections. Methods A controlled trial with 50 diabetic COVID-19 patients, aged 18-80, with an NLR of >= 4, primarily on Remdesivir, was assigned to Group 1 (Add-on Ayurveda+SOC, n=30) or Group 2 (SOC, n=20) based on their voluntary choice with follow-up on days 14, 28, and 60. Parametric outcomes in group analysis were assessed with robust regression and non-parametric outcomes with Cochran-Mantel-Haenszel, log-rank test, and chi-square tests at 95% confidence interval (CI). Results Group 1 exhibited statistically significant improvements in fever, cough, diarrhea, as well as NLR, IL-6, and CRP by 14 days, and in anosmia, loss of taste, shortness of breath, general weakness, and headache by 60 days. Though the sample size is small, notable improvements can be seen in troponin levels in Group 1 at 28 and 60 days. High-resolution computer tomography COVID-19 reporting and data system (HRCT CO-RADS) scores improved more slowly in Group 2 than in Group 1. Survival rates were 96.4% for Group 1 and 90% for Group 2. Numbers were too small for reliable comparisons at 60 days.  Conclusion The add-on Ayurveda group showed a better symptomatic response, and faster normalization in inflammatory markers, including IL-6 and NLR by 14 days, and cardiac markers by 28 days. Minimal clinical and no laboratory adverse events were observed. This study supports the need for a randomized, double-blind trial.

摘要

背景

有效管理新冠病毒2型(SARS-CoV-2)的急性和急性后遗症至关重要,尤其是对于2型糖尿病(T2DM)患者,他们发生严重促炎反应和并发症的风险更高。新冠病毒病(COVID-19)患者持续出现症状以及肺部和心血管的残留损伤凸显了制定全面长期治疗策略的必要性。包括瑞德西韦和糖皮质激素在内的传统治疗方法存在局限性,这表明对阿育吠陀疗法进行进一步研究可能有益,尽管目前对照试验有限。

目的

评估阿育吠陀疗法联合标准治疗(SOC)与单纯标准治疗相比,在改善60天以上依赖氧气、高危、未接种疫苗的2型糖尿病COVID-19患者的症状、调节免疫反应(白细胞介素-6(IL-6)、C反应蛋白(CRP)、中性粒细胞与淋巴细胞比值(NLR))以及放射学结果方面的有效性和安全性,从而解决他们对严重感染的更高易感性问题。

方法

对50名年龄在18 - 80岁、NLR≥4且主要接受瑞德西韦治疗的糖尿病COVID-19患者进行对照试验,根据他们的自愿选择分为第1组(阿育吠陀疗法联合标准治疗,n = 30)或第2组(标准治疗,n = 20),并在第14天、28天和60天进行随访。在组间分析中,参数结果采用稳健回归评估,非参数结果采用 Cochr an-Mantel-Haenszel检验、对数秩检验和卡方检验,置信区间为95%(CI)。

结果

第1组在第14天时发热、咳嗽、腹泻以及NLR、IL-6和CRP有统计学显著改善,在第60天时嗅觉丧失、味觉丧失、呼吸急促、全身无力和头痛有改善。尽管样本量较小,但第1组在第28天和60天时肌钙蛋白水平有明显改善。第2组的高分辨率计算机断层扫描COVID-19报告和数据系统(HRCT CO-RADS)评分改善比第1组更慢。第1组的生存率为96.4%,第2组为90%。60天时数量过少,无法进行可靠比较。

结论

阿育吠陀疗法联合治疗组显示出更好的症状反应,炎症标志物(包括IL-6和NLR)在14天内更快恢复正常,心脏标志物在28天内恢复正常。观察到的临床不良反应极少,实验室无不良事件。本研究支持进行随机双盲试验的必要性。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/5e85/11444340/a6e8013b04f8/cureus-0016-00000068392-i01.jpg

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