The tenth edition of the treatment plan was introduced, clarifying cough, fever and other upper respiratory tract infections as light

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In the afternoon of January 6, according to the new coronavirus infection category B B tube and the requirements related to the optimization of epidemic prevention and control measures, the National Health Commission and the National Bureau of Traditional Chinese Medicine Integrated Department jointly released the “New Coronavirus Infection Treatment Plan (Trial 10th Edition)”.

The notice of the National Health Commission pointed out that since 2022, the novel coronavirus Omicron variant has gradually become the absolute dominant epidemic strain, and its transmission and immune escape ability have significantly increased, but its pathogenicity has significantly weakened. In order to further scientific and standardize the diagnosis and treatment of novel coronavirus infection, the National Health Commission organized experts to revise the relevant content of the “Novel Coronavirus Pneumonia Diagnosis and Treatment Protocol (Trial 9th Edition)” to form the “Novel Coronavirus Infection Diagnosis and Treatment Protocol (Trial 10th Edition)”.

Compared with the ninth edition of the treatment plan released in mid-March 2022, several doctors told China Newsweek that the new version of the plan is closer to the current treatment reality; since January 8, the new coronavirus infection has been adjusted from “Class B, Tube A” to “Class B, Tube B”. The 10th edition of the treatment plan also adjusts some requirements so that the medical system can carry out treatment according to the unified rules.

Over 65 years old and not fully vaccinated are included in the high-risk group

Cai Weiping, chief expert of the Infectious Disease Center of the city’s eighth hospital affiliated with Guangzhou Medical University, told China Newsweek that some of the adjustments in the new edition are more in line with clinical reality.

For example, the ninth edition states that the incubation period of infected persons is 1 to 14 days, mostly 3 to 7 days. Clinical manifestations are mainly fever, dry cough, malaise, and some patients present with nasal congestion, runny nose, sore throat, decreased or lost sense of smell and taste, conjunctivitis, and diarrhea. Severely ill patients tend to develop respiratory distress and/or hypoxemia one week after the onset of the disease.

And the 10th edition was revised to show that the incubation period of infected patients is mostly 2 to 4 days. The main manifestations are dry throat, sore throat, cough, fever, etc. The fever is mostly low to moderate, and in some cases it can also be high fever, and the fever duration does not exceed 3 days; some patients can be accompanied by muscle aches, loss of smell and taste, nasal congestion, runny nose, diarrhea, etc. Severely ill patients tend to develop respiratory distress and/or hypoxemia 5 to 7 days after the onset of the disease.

“These clinical features describe changes that are closer to the symptoms that people currently feel.” Cai Weiping pointed out that, moreover, the new version of the diagnosis and treatment protocol emphasizes that the febrile course mostly does not exceed 3 days, and that severe patients tend to develop respiratory distress or hypoxemia 5 to 7 days later, which was previously thought to be a week later. This more accurate description will help primary care workers to be alert to high-risk groups in a timely manner and detect serious illnesses at an early stage.

On December 26, 2022, the National Health Commission announced that on January 8, 2023, novel coronavirus infection will be adjusted from “Category B, Tube A” to “Category B, Tube B” and “novel coronavirus pneumonia” will be renamed to “novel coronavirus pneumonia. The name was changed from “Novel Coronavirus Pneumonia” to “Novel Coronavirus Infection”. The overall plan of “Category B B” clearly states that the goal of epidemic prevention after downgrading is “to protect health and prevent serious illness”. In the 10th edition of the treatment plan, the diagnostic criteria and early warning indicators for severe and critical cases have been adjusted accordingly.

For example, the criteria for defining high-risk groups of heavy/critical cases. Previously, the ninth edition of the protocol was defined as elderly people aged 60 years or older; in contrast, the new protocol raises the lower age limit of high-risk groups from 60 to 65 years, and emphasizes those who are older than 65 years, especially those who have not received full vaccination against the new coronavirus.

At the same time, the 10th edition of the program adjusted the clinical typing from light, normal, heavy and critical to light, medium, heavy and critical. The interpretation of the National Health Commission pointed out that with the continuous mutation of the virus, especially since the prevalence of the Omicron strain, the pathogenicity of the virus has gradually diminished and the characteristics of the disease have changed significantly, with the majority of infected patients having mild symptoms and the proportion of pneumonia occurring being significantly reduced, so the clinical typing was adjusted to take the severity of the infected patient’s illness as the standard, taking into account the clinical reality.

The ninth edition of the treatment protocol defined mild clinical symptoms and no pneumonia on imaging as mild; those with the above clinical symptoms and pneumonia on imaging were considered ordinary. In the latest version of the treatment protocol, symptoms such as dry throat, sore throat, cough, fever and other upper respiratory tract infections are classified as mild, and no imaging results are needed.

Cai Weiping pointed out that the distinction between “mild”, “moderate” and “severe” is now more in line with people’s cognitive habits, and the previous common type is not easy to understand. And, more importantly, the previous light cases specifically emphasized the need for imaging to be able to diagnose. However, when a large number of people are infected, such as a large number of people in a city, it is obviously impractical to take a CT to determine whether the case is mild or not, so the new treatment plan eliminates this requirement.

In terms of treatment, the latest version of the protocol introduces three antiviral drugs currently approved for marketing in China. Based on Paxlovid, Azulfidine and Monoprevir capsules are included.

Monoravir, an oral neo-coronary drug developed by Merck Sharp & Dohme for the treatment of adults with mild to moderate neo-coronary with high risk factors for progression to severe disease, received emergency use authorization in the United States in December 2021 and was approved for conditional marketing in China on December 30, 2022. Azulfidine tablets were developed by Henan Real Biotechnology Co., Ltd. and received emergency conditional marketing approval on July 25, 2022.

In terms of diagnostic criteria, Cai Weiping particularly pointed out that a very important change is the addition of positive neo-coronavirus antigen testing as a diagnostic criterion, which means that both positive nucleic acid and positive antigen can be used as diagnostic criteria. He said that previously inpatients were required to have nucleic acid testing to confirm the diagnosis, but now it will be much easier and faster to carry out nucleic acid testing only for those patients with highly suspected infection that cannot be detected by antigen.

Emphasis is now on how to maximize patient admissions

With the adjustment of the new crown epidemic prevention and control measures, the focus of the epidemic response has changed from prevention of infection to prevention of serious illness, and a series of practices regarding nosocomial infections, isolation of infected patients, and flow transfer are changing. In fact, Cai Weiping pointed out that after the “new ten”, many hospitals have already managed NICU infections according to category B in practice, but the treatment protocols have not yet kept up.

This new adjustment, this aspect of the provisions are also reflected. In the case of hospital-acquired infections, for example, the ninth edition of the treatment plan requires hospitals to implement hospital-acquired infection prevention and control in strict accordance with the requirements of the Technical Guidelines for Prevention and Control of Novel Coronavirus Infections in Medical Institutions (Third Edition) issued by the National Health and Wellness Commission, which was released on September 8, 2021 and aims to minimize the occurrence of infections.

In the past, nosocomial infection prevention and control of neo-coronavirus was an absolute red line. However, following the shift in the epidemic, the director of the hospital-acquired infection department at a large tertiary hospital in Shanghai told China Newsweek that the hospital now no longer considers nosocomial transmission of neo-crown as a nosocomial event, and that the emphasis is now on how to maximize patient admissions rather than preventing infection.

“After the adjustment of the epidemic prevention and control policy, all medical institutions have the possibility of receiving cases of neo-crown virus infection, and we have adjusted the content related to infection prevention and control within medical institutions in the 10th edition of the treatment plan to make the infection prevention and control measures more scientific and precise, and more targeted and operable.” The State Health and Welfare Commission’s interpretation reads. The latest version of the treatment plan lists four articles among hospital infection prevention and control, emphasizing cleanliness, ventilation and mask wearing.

“Some hospitals, like our unit, no longer need to wear protective clothing to enter the wards, but some places may still follow the original Class A management implementation. Now after the introduction of this document, it means that the national medical institutions can be implemented in accordance with this standard.” Cai Weiping said.

Likewise, the latest version of the treatment plan no longer requires cases to be centrally isolated for treatment and no longer determines suspected cases. The National Health Commission pointed out that, with the implementation of the Class B B control measures, people infected with the new coronavirus can choose to be treated at home or go to a medical institution according to the need for medical treatment, and all types of medical institutions can admit and treat people infected with the new coronavirus. For this reason, the 10th edition of the program adjusted the admission strategy according to the time and situation, and no longer requires cases to be admitted in centralized isolation.

Patient discharge criteria have been adjusted. Because it no longer strengthens the isolation management of infected patients, the National Health Commission pointed out in its interpretation that neo-coronavirus infection is diagnosed and treated as a category B infectious disease, and no longer requires nucleic acid test results for the discharge of infected patients. According to the new protocol, patients may be considered for discharge when their condition has significantly improved, their vital signs are stable, their body temperature is normal for more than 24 hours, their lung imaging shows significant improvement in acute exudative lesions, they can be switched to oral medication, and there are no complications that require further management.

Both the 10th and 9th editions of the protocol mention sedation of COVID-19 human immunoglobulin and recovery plasma for recovered patients among the antiviral treatments. But an infection doctor said, “In fact, internationally, including in the World Health Organization, like the recovered person recovery plasma is no longer recommended for treatment, but we still have it in our treatment protocol.”

For monoclonal antibodies, it is also important to look at them in two ways. In fact, as virus mutations accelerate, monoclonal antibodies are actually lagging behind, and antibody drugs developed for previous strains of the virus are very ineffective when used for new mutant strains, “even if they are written in the treatment protocol, it should be clearly stated how effective they are against Omicron, giving evidence-based evidence.” He said.