White Lung' and cilvelestat sodium

Cao Yunlong, an associate researcher at the Center for Biomedical Frontier Innovation (BIOPIC) of Peking University and a leading scientist at Changping Laboratory in Beijing, has been named as a "COVID-19 forecaster" in a list of the top 10 influential people in science in 2022 published by the journal Nature. He said there may be multiple infection peaks every year.

The outbreak has opened up and massive infections have followed. There has been a run on health care. In order to cope with the tight situation of "short supply" of severe medical resources, beds are constantly expanded. By December 25, the total number of ICU beds in China reached 181,000, equivalent to 12.8 beds per 100,000 people. Although beds have been greatly adjusted within half a month, it is still "difficult to find one bed" for the overall trend of all regions. Emergency, intensive care, respiratory and other mainstream departments are still anxious.

Recently, the word "white lung" has been reported by various major media networks, and the popularity of it has not decreased. Although the clinical proportion is not high, it is undeniable that the mortality rate of severe white lung patients is as high as 40%.

On December 27, Jiao Yahui, director of the medical administration Department of the National Health Commission, introduced at the National Defense Joint Control meeting that the inflammation of the lungs is not called white lung, and white lung should be a relatively serious manifestation of pneumonia. Generally speaking, when the inflammation of the lung is relatively heavy and there is more exudation, the area of the white image reaches 70%-80%, which is colloquially called the white lung in clinical practice. At this stage, patients may develop hypoxemia or respiratory distress, especially in the current wave, in older patients with serious underlying diseases.

"White lung" is a typical imaging manifestation of acute respiratory distress syndrome (ARDS). It is named after the large white shape of severe pneumonia developed under X-ray or CT examination. The clinical manifestations are chest tightness and shortness of breath, and it is one of the most common and serious respiratory complications of COVID-19.

Clinical study data found that among 417 COVID-19 positive patients, ARDS patients accounted for 21%[1]. Another study from Zhongnan Hospital of Wuhan University showed that 26.1% of positive patients were transferred to ICU due to complications, and 61.1% of them developed ARDS[2]. The mortality rate of patients with moderate-severe ARDS in COVID-19 is as high as 81.3%[3], and another study published in the Lancet showed a higher incidence of ARDS in patients who died of COVID-19 compared with survivors (81% vs 45%)[4].

The annual report of CDE evaluated that cilvelestat sodium (the core link of inflammatory storm - neutrophil elastase - targeted inhibitor) is the only drug in the world for ALI/ARDS (acute lung injury/acute respiratory distress syndrome), and its approval filled the gap in the drug treatment of ALI/ARDS in China. Since it was approved by NMPA at the beginning of COVID-19 in March 2020, it has been used by doctors in respiratory, emergency, ICU and other fields in China for more than 2 years.

Clinical data have shown that cilverestat sodium can improve the respiratory status and lung imaging changes of severe COVID-19 patients, and promote their successful withdrawal from ventilator [5]. In addition, the first evidence-based study on sepsis in Chinese people showed [6] that cilvelestat sodium could reduce the length of ICU stay by 4.56 days and mechanical ventilation time by 52 hours, while cilvelestat sodium could increase oxygenation index by 37.1mmHg, reduce APACHE II score by 3.89 points and SOFA score by 3 points.

The results of the Japanese Phase III trial [7] showed that cilverestat sodium could significantly improve lung function and shorten the median ICU time by 12.5 days, equivalent to increasing ICU bed turnover by 71.4%. Another large sample size retrospective analysis of 4276 ALI/ARDS patients [8] showed that cilvelestat sodium significantly improved 30-day, 60-day, and 90-day survival (p=0.0022). And the 90-day risk of death fell by 17 percent.

Our population is aging seriously, however, the vaccination rate of the aging population is not high. When the peak of severe infection is approaching, the society has begun to panic buying medicine, medical resources expansion, medical care with illness on duty and other situations.

All the signs show that even though the majority of Omicron patients are mild cases, due to the huge population base in China, the challenge of severe medical forces still cannot be ignored.