Hu Bijie interprets the new version of the new crown diagnosis and treatment plan: medical resources are reserved for those who really need treatment

Recently, the National Health Commission issued the "Diagnosis and Treatment Plan for Novel Coronavirus Pneumonia (Trial Version 9)" (hereinafter referred to as the new version of the Diagnosis and Treatment Plan). Compared with the previous version of the diagnosis and treatment plan, the new version has made many adjustments and caused extensive discussion.

On March 17, Professor Hu Bijie, a member of the National Expert Group on the Medical Treatment of Novel Coronavirus Pneumonia and director of the Department of Infectious Diseases of Zhongshan Hospital Affiliated to Fudan University, interpreted www.thepaper.cn the ninth edition of the diagnosis and treatment plan from many aspects such as case classification and admission, antiviral treatment, lifting isolation and discharge standards, case detection and reporting procedures, etc.

"Compared with the previous revisions, the ninth edition of the diagnosis and treatment plan that is now launched, I think it is the most changed, involving many core key points of revision." Hu Bijie said that the new version of the plan is very scientific and very reasonable, and will better benefit patients who really need treatment.

Hu Bijie Zhongshan Hospital Affiliated to Fudan University

Classified Admission: Leave medical resources to the patients who need them most

At this time, the revision and introduction of the new version of the diagnosis and treatment plan has an important background. Hu Bijie said that the National Health Commission has mentioned in the relevant notice that the new version of the diagnosis and treatment plan is formed on the basis of carefully studying the transmission characteristics and case characteristics of the most popular mutant strains such as Aomi Kerong and Delta in the world, and in-depth analysis of relevant research results.

Reviewing the previous Diagnosis and Treatment Plan for Novel Coronavirus Pneumonia, the first eight editions were issued in 2020. On April 15, 2021, the National Health Commission announced the Diagnosis and Treatment Plan for Novel Coronavirus Pneumonia (Trial Eighth Revised Edition).

Today, the new coronavirus variants, mainly Delta and Olmikron, are prevalent around the world. Since March, more than 20,000 cases of infection have been reported in China, mainly the Aomi Kerong mutation.

Hu Bijie said that compared with the original strain of the new crown virus, the biological characteristics of the Olmikron strain have undergone many changes, the transmission force is stronger, the virulence is lower, and the infection of the population caused by it is mainly mild, and there are even a large number of asymptomatic infected people. The vast majority of these patients do not require much treatment.

"Under such a huge data, if asymptomatic infected people, mild patients, and patients with pneumonia in imaging diagnosis are treated the same, then medical resources are easily squeezed." Hu Bijie said that the new version of the diagnosis and treatment plan is to leave more medical resources to patients who really need treatment.

The new version of the diagnosis and treatment plan proposes to classify and treat cases. It is clear that mild cases are subject to centralized isolation management, and relevant centralized isolation places cannot isolate people entering the country, close contacts and other groups at the same time. During the isolation and management period, symptomatic treatment and disease monitoring should be done, and if the condition worsens, it should be transferred to a designated hospital for treatment.

Ordinary, severe, critical cases and cases with severe high risk factors should be treated intensively in designated hospitals, of which severe and critical cases should be admitted to the ICU for treatment as soon as possible, and patients with high risk factors and severe disease tendencies should also be admitted to the ICU for treatment.

Hu Bijie believes that in this way, it can be guaranteed that patients who should be treated will be admitted in a timely manner, and infected people who do not need treatment for the time being will be isolated for medical observation first, and medical resources will not be squeezed.

Ct values range from 40 to 35: Patients are discharged faster

The new version of the diagnosis and treatment plan has optimized and adjusted the criteria for lifting isolation and discharge.

The criteria for the management of lifting isolation are: two consecutive nucleic acid detection N gene and ORF gene Ct values of the novel coronavirus in mild cases are ≥35 (fluorescence quantitative PCR method, the limit value is 40, the sampling time interval is at least 24 hours), or two consecutive negative nucleic acid tests for the new coronavirus (fluorescence quantitative PCR method, the limit value is less than 35, the sampling time interval is at least 24 hours), the isolation management can be lifted.

Hu Bijie explained that the Ct value is the number of nucleic acid amplifications of the Xianyang, and the lower the Ct value, the higher the viral load of the subject specimen. Previously, China used 40 as the limit to distinguish between positive and negative nucleic acids, or threshold criteria. Internationally, when the Ct value exceeds 35, it is judged to be negative, while the mainland requires that the Ct value exceed 40 to be judged negative.

In the process of clinical treatment, some patients have been cured, there is no manifestation of the disease, the virus has been cleared, but there may be a very small amount of dead virus or nucleic acid fragments of the virus left in the body, there is no contagiousness, the Ct value reaches 36, 37, and the subsequent changes may be very slow, so it leads to delay in discharging.

"Now that the criteria for lifting isolation and discharge, that is, the ct value standard for nucleic acid negatives, are set to 35, the time for patients to be released from isolation and discharge will be earlier, saving unnecessary isolation and hospitalization time, and freeing up more medical resources to receive serious patients." Hu Bijie said.

Some people will ask, after the standard is adjusted, what if these people continue to infect people after they are discharged from the hospital? Hu Bijie explained that relevant domestic studies have shown that when the recovering period of infected people ≥ 35 nucleic acid Ct value, the virus will not be isolated from the sample, close contacts have not been found to be infected, and patients are basically not infectious.

In addition, according to the new version of the standard, two consecutive negative nucleic acid test results, patients can be discharged. After discharge, it used to be required for 14 days of isolation and control, but now only 7 days of home health monitoring are required. "It doesn't seem to change much, but it actually falls on specific patients, and the experience is very obvious." Hu Bijie said that it has also reduced the pressure on the relevant medical system.

Two new antiviral drugs are written into the protocol

Hu Bijie mentioned that the new version of the plan also has a big difference in treatment, and two new antiviral drugs have been introduced.

This time, PF-07321332/ritonavir tablets (Paxlovid) and domestic monoclonal antibodies (amphavir monoclonal antibody/romimab injection) were written into the new version of the protocol.

Among them, Pfizer's new coronavirus treatment drug Paxlovid, the first approved small molecule antiviral drug in mainland China, was approved for import registration by emergency conditional approval on February 11. The ampavirinumab/romimab, the first approved domestic neutralizing antibody combination therapy drug in mainland China, was approved on December 8, 2021.

Hu Bijie stressed that in the previous versions of the diagnosis and treatment plan, some antiviral drugs failed to prove their effectiveness in evidence-based medicine for more than two years in the New Year, and this time they were all excluded, which also shows the scientific nature of the new version of the plan.

In addition to this, the new version of the protocol optimizes the case detection and reporting process. On the basis of nucleic acid detection, antigen detection is added as a supplement to further improve the early detection capacity of cases. At the same time, the efficiency of diagnosis or exclusion of suspected cases is improved, and nucleic acid testing is required to be carried out immediately for suspected cases or antigens.

"After the previous suspected cases appeared, the first thing to do was to conduct a consultation with an expert in the hospital or a consultation with the attending physician, report directly to the network within 2 hours, and transfer to the designated hospital at the same time." Hu Bijie said that the process is now more efficient.

According to the new version of the plan, as long as it meets the diagnosis of suspected cases, (or antigen-positive), no longer requires in-hospital consultation, and nucleic acid confirmation should be seized as soon as possible, aiming to improve the efficiency of diagnosis or exclusion. Moreover, only those who are positive for nucleic acid are isolated or sent to designated hospitals.