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Asclepius Meditec's 83rd Global Paper Published... Joint Clinical Trial by Top Hospitals Including Ruijin, Zhongshan, and Huashan

Asclepius Meditec's 83rd Global Paper Published... Joint Clinical Trial by Top Hospitals Including Ruijin, Zhongshan, and Huashan
Oct 22nd,2023 128 Views

During the Spring Festival of 2022,a sudden outbreak of COVID-19 in Shanghai gripped the nation's attention.Experts such as Professor Qu Jieming from Shanghai Ruijin Hospital and Professor Zhang Wenhong from Huashan Hospital led medical staff in combating the pandemic.As a homegrown Shanghai medical device enterprise,Asclepius Meditec resolutely shouldered the social responsibility entrusted to it,actively cooperating with government leadership and coordinating medical resources to fight against COVID-19.

In 2020,during the COVID-19 pandemic in Wuhan,the hydrogen-oxygen nebulizer was proven to alleviate symptoms such as dyspnea,cough,and expectoration in COVID-19 patients,making a significant contribution.During the rampant spread of COVID-19,the hydrogen-oxygen nebulizer returned to the battlefield,and simultaneously,Professors Qu Jieming,Zhang Wenhong,and Song Yuanlinconducted"a prospective,multicenter,randomized controlled clinical trial to evaluate the efficacy and safety of the hydrogen-oxygen nebulizer as an adjuvant therapy for novel coronavirus pneumonia(COVID-19),"once again verifyingthe safety and efficacy of the hydrogen-oxygen nebulizer as an adjuvant therapy for COVID-19.The research results have been published recently.

Without further ado,let's get straight to the key points.

List of participating research institutions—a gathering of stars:


[Trial Process]

A total of 76 subjects were recruited for this study,with 12 subjects failing screening.The enrolled subjects were randomly divided into a hydrogen-oxygen group(32 subjects)and an oxygen group(32 subjects).On the basis of receiving standard treatment,subjects in the hydrogen-oxygen group received hydrogen-oxygen inhalation therapy,inhaling a mixed gas via nasal cannula at a flow rate of 3 L/min(for at least 7 hours per day);while the oxygen group received oxygen inhalation therapy(Figure 1).Enrolled subjects underwent treatment and visits,including a screening visit(within 3 days before enrollment),randomization and treatment visit(Day 0),and post-treatment visits on Day 1,Day 2,Day 3,Day 5,Day 7,Day 10,and a discharge visit.


Figure 1 Study Flowchart

Statistical analysis showed that,except for gender and height,there was no statistically significant difference in the baseline data between the two groups of subjects(prior to receiving hydrogen-oxygen or oxygen therapy,there was no significant difference in the baseline data between the two patient groups).The baseline data are as follows:


The main symptoms of patients before enrollment were cough,followed by expectoration,and there was also no statistical significance before enrollment:



[Trial Results]

The results of this study show that,compared with oxygen inhalation alone,inhaling hydrogen-oxygen mixture can shorten the time for SARS-CoV-2 nucleic acid to turn negative,reduce the levels of inflammatory factors,alleviate lung lesions,thereby reducing the occurrence of early severe cases.

(1)The effect of inhaling hydrogen-oxygen mixture on the negative conversion rate of SARS-CoV-2 nucleic acid.We found:The time to negative conversion in the hydrogen-oxygen group was shorter than that in the oxygen inhalation group,and the cumulative negative conversion rate in the hydrogen-oxygen group gradually increased after the third day.


Figure 2 Analysis of Viral Shedding Time

(2)The effect of inhaling hydrogen-oxygen mixture on inflammatory markers.Interleukin-6(Figure A below):

On day 3,the hydrogen-oxygen inhalation group showed a 22.8%decrease from baseline,while the oxygen inhalation group showed a 59.8%increase from baseline.

On day 5,the hydrogen-oxygen inhalation group showed a 20.1%decrease from baseline,while the oxygen inhalation group showed a 13.1%decrease from baseline.Lymphocyte count(Figure B below):

On day 3,the hydrogen-oxygen inhalation group showed a 61.1%increase from baseline,while the oxygen inhalation group showed a 51.0%increase from baseline.

On day 5,the hydrogen-oxygen inhalation group showed a 62.5%increase from baseline,while the oxygen inhalation group showed a 62.6%increase from baseline.Neutrophil-to-lymphocyte absolute count ratio(Figure C below):

On day 3,the hydrogen-oxygen inhalation group showed a 16.8%decrease from baseline,while the oxygen inhalation group showed a 19.8%decrease from baseline.

On day 5,the hydrogen-oxygen inhalation group showed a 20.0%decrease from baseline,while the oxygen inhalation group showed a 20.3%increase from baseline.Lymphocyte percentage(Figure D below):

On day 3,the hydrogen-oxygen inhalation group showed a 67.4%increase from baseline,while the oxygen inhalation group showed a 42.4%increase from baseline.

On day 5,the hydrogen-oxygen inhalation group showed a 69.1%increase from baseline,while the oxygen inhalation group showed a 31.1%increase from baseline.



Figure 3 Changes in inflammatory markers(A)IL-6 levels,(B)Lymphocyte count,(C)Neutrophil-to-lymphocyte ratio,(D)Lymphocyte percentage

(3)Effect of hydrogen/oxygen inhalation on lung lesions.On day 7,more patients in the hydrogen-oxygen group showed regression of lung lesions compared to the oxygen inhalation group(Figure 4,p=0.711).


Figure 4 Changes in chest CT images:lesion absorption greater than 50%compared to baseline(score:3 points),between 10%and 50%(score:2 points),less than 10%(score:1 point),and progression of lung lesions(score:-3 points).

Discussion:

The study demonstrates a beneficial trend of hydrogen-oxygen therapy in COVID-19 patients,but limitations remain.Due to the rapidly evolving pandemic situation,the study enrolled a relatively small number of participants.The limited sample size only suggests an anti-inflammatory trend following hydrogen-oxygen inhalation.

Looking back:

Hydrogen has been demonstrated to possess antioxidant,anti-inflammatory,hormone-regulating,and anti-apoptotic properties.The use of hydrogen can reduce the destructive cytokine storm and lung injury caused by SARS-CoV-2 in the early stages of COVID-19,thereby lowering the incidence of severe disease.

Looking ahead:

Asclepius Meditec,in collaboration with clinical experts,has once again contributed to validating the safety and efficacy of hydrogen-oxygen inhalation for COVID-19 treatment.Hydrogen-oxygen inhalation may offer a promising adjunctive therapy for patients with COVID-19.[1]Shi M M,Chen Y T,Wang X D,et al.The efficacy of hydrogen/oxygen therapy favored the recovery of omicron SARS-CoV-2 variant infection:results of a multicenter,randomized,controlled trial[J].Journal of Clinical Biochemistry and Nutrition,2023:23-32.