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Guide
Oral small molecule drugs are one of the current hot spots in the research and development of anti-novel coronavirus drugs, on July 25, 2022, the State Food and Drug Administration approved the application of azvudine tablets to increase the indication for the treatment of new coronavirus pneumonia, marking the application of azvudine (Azvudine, FNC) became China's first oral small molecule drug
for the treatment of new coronary pneumonia independently developed and owned a global patent (Chinese patent number: ZL200710137548.
0; European patent number: EP08772992.
7; US patent number: US8835615B2).
On August 9, 2022, azvudine was included in the "Diagnosis and Treatment Plan for Novel Coronavirus Pneumonia (9th Edition)
" as a treatment drug for new coronavirus pneumonia.
patients with new coronavirus pneumonia.
Case features
➢Patients: elderly, history of multiple underlying diseases, high-risk groups of severe new coronary pneumonia; The new crown pneumonia revived
➢ Real-world experience: This case verifies the effectiveness of azvudine in treating patients with new coronavirus pneumonia
I.
Basic information
●Female, 84 years old
●20-year history of "hypertension.
"
●Patients diagnosed with new coronavirus pneumonia have a history of close contact, have not been fully vaccinated with the new crown vaccine, and have not received a booster shot
2.
Initial visit
● First visit time: 2022-08-18
● Complaints: cough for 1 day, positive new crown nucleic acid test for 1 day
● Related inspections
➢ Coronary pneumonia related symptoms/signs: cough
➢ New crown nucleic acid test: 4 positive apheresis
➢ Chest CT: subpleural ground-glass exudation lesions of the mediastinal subpleural in the apical segment of the upper lobe of the right lung, fibrotic lesions of the middle lobe of the right lung and the lower lobe of the left lung
➢ Positive results of other key tests for underlying diseases: mild hypertension (BP 142/86mmHg); Atrial fibrillation; Cranial CT considered cerebral infarction, demyelinating lesions and other lesions; Renal insufficiency
● Diagnosis:
1.
Novel coronavirus pneumonia ordinary type
2.
Hypertensive disease grade 1 (low risk)
3.
Atrial fibrillation
● After treatment
3.
Second visits
● Revisit time: 2022-08-31
● Complaints: cough for 2 days, positive new crown nucleic acid retest for 1 day
● Related inspections
➢ Coronary pneumonia related symptoms/signs: cough
➢ Biochemical indicators:
Positive indexes of routine initial diagnosis: C-reactive protein 32.
35↑, hypersensitive C-reactive protein >5↑, lymphocytes 0.
98*10^9/L↓, eosinophils 0.
01*10^9/L↓, platelets 113*10^9/L↓;
Positive results of comorbidities: liver and kidney function electrolytes: albumin 33.
9g/l↓, creatinine 83umol/l↑; Coagulation: fibrinogen 3.
63g/l↑; Arterial blood gas analysis: PH 7.
404, PCO231.
5mmhg, PO260mmhg, HCO319.
6mmhg
Positive immunoassay result: interleukin-6 42.
0pg/ml↑
➢ New crown nucleic acid test: 8.
31 retest positive
➢Chest CT: the shadows of both lungs are more than 2022.
8.
21, and there is a small amount of fluid in both lungs
➢ Other key test results of underlying diseases: atrial fibrillation, some lead T wave changes: I.
, aVL, II.
, aVF, V4, V5, V6 flat, aorta, coronary calcification; Cerebral infarction possible;
● Correction of diagnosis:
1.
Rehabilitation period of novel coronavirus pneumonia
2.
Atrial fibrillation [atrial fibrillation]
3.
Hypertension grade 1 low-risk group
4.
Hypoproteinemia
● Treatment plan:
➢ Preliminary treatment plan: 8.
31 Lianhua Qingwen capsules to promote lung qi and detoxification treatment; 9.
1 Thymic method to regulate immunity; 9.
2 Ward rounds consultation, thymus method for injection to regulate immunity, azvudine 5mg/day antiviral therapy, low molecular weight heparin calcium injection 2500IU subcutaneous injection 2 times/day anticoagulation
➢ Final treatment plan: Add azvudine to inhibit viral replication
1) The main considerations for the selection of treatment plan: advanced age, more underlying diseases, and increased lung lesions
2) Date of first azvudine treatment: September 3, 2022
4.
Treatment effect and evaluation of azvudine
1) Summary of the efficacy of azvudine treatment in this patient
✓Low-dose oral, obvious therapeutic effect, rapid symptom improvement, no imaging progression;
✓ Fast virus clearance, fast conversion of nucleic acid;
✓ Well tolerated with no significant adverse effects
2) Detailed efficacy records
Case summary and reviews
Elderly patients with new coronary pneumonia are often complicated with underlying lesions, such as hypertension and diabetes, and are also prone to bacterial infection, which increases the difficulty of treatment, and is one of the dangerous groups that transform from ordinary type to critical type2.
This patient is an ordinary type, took 3CL protease inhibitor (nematevir tablets/ritonavir tablets) nucleic acid turned negative and discharged, soon revived and appeared new crown symptoms again, the effect of the primary treatment plan such as Lianhua Qingwen was not obvious again, chest CT progressed from early single-lung involvement to double-lung lesions, and the range was slightly increased, and the density of some was slightly increased
.
The treatment regimen was adjusted and treated with the antiviral drug RdRp inhibitor azvudine, and the nucleic acid turned negative on the 5th day, the symptoms subsided, the imaging was stable, and there were no obvious adverse reactions
.
Small molecule oral drugs targeting key enzymes in the process of viral replication are mainly divided into two categories, RdRp inhibitors and 3CL protease inhibitors, which act on two different targets, and the small molecule oral drugs that have been marketed in China include real biological azvudine (RdRp inhibitor) and Pfizer's nematevir tablets/ritonavir tablets (3CL protease inhibitors), All of them are drugs recommended by the ninth edition of the National Health
Commission's guidelines for novel coronavirus pneumonia.
The nucleic acid finally turned negative after adding azvudine to this new coronavirus pneumonia revival patient, which is worth further study
.
Previous clinical studies of azvudine have shown that it inhibits viral replication with a significant difference from the control group on day five compared with placebo1
.
Studies in Brazil and Russia have shown significant improvements in clinical symptoms; shorten the negative time of nucleic acids; Reduce the length of hospital stay in patients with moderate to severe disease, and have good tolerability and safety.
Since the outbreak of the new crown pneumonia epidemic, Chinese scientists have achieved world-leading research results
in the analysis of the structure of the new crown virus and the discovery of drug targets.
Azvudine is the first domestic anti-new coronavirus small molecule oral drug, easy to use, once a day, the course of treatment is up to 14 days, it should be emphasized that antiviral drugs need to be taken early, like anti-influenza drugs
.
Antiviral drugs are an important part of controlling the epidemic, and it is hoped that Azvudine will play a solid "Chinese power"
in China's fight against the new crown epidemic as soon as possible.
Introduction from review experts
Prof.
Zhang Fujie
Director of the AIDS Clinical and Research Center of Capital Medical University, medical doctor and doctoral supervisor
Member of the World Health Organization (WHO) Resistance Committee
He has been engaged in clinical, teaching and scientific research of infectious diseases for 37 years
He pioneered and led free antiretroviral treatment for AIDS in China, which is treating more than 1.
06 million peoplePresided over the clinical trial of the first approved anti-novel coronavirus small molecule drug azvudine
In 2021, he was awarded the "Advanced Individual in the National Science and Technology System to Fight the New Crown Pneumonia Epidemic" by the Ministry of Science and Technology
He has presided over the national "Eleventh Five-Year Plan", "Twelfth Five-Year Plan" and "Thirteenth Five-Year Plan" major AIDS projects, key research and development projects of the Ministry of Science and Technology and a number of research projects of the National Institutes of Health
He has published more than 200 guiding scientific papers in Lancet and other journals, cited more than 5,000 times, and won 6 provincial and ministerial awards such as H-Index34 as the first completer
Professor Wang Bo
Communist Party member, graduate student, chief physician
Director of the tuberculosis department of Xi'an Chest Hospital and director of the fourth echelon of the new crown ward
Member of Clinical Trial Professional Branch of Chinese Antituberculosis Association
Member of the Standing Committee of the Respiratory Intervention Branch of Shaanxi Antituberculosis Association
Member of the Standing Committee of the Special Committee of Integrated Traditional Chinese and Western Medicine of Shaanxi Antituberculosis Association
Member of the Standing Committee of the Tuberculosis Branch of the Shaanxi Women's Health Promotion Association
Member of the Standing Committee of the Respiratory Disease Professional Committee of Shaanxi Association of Integrative Medicine
Member of the Standing Committee of the Geriatrics Association of Shaanxi Health Care Association
References
1.
Chang Junbiao.
Research progress of oral small molecule drugs for the treatment of new coronary pneumonia[J].
China Science Foundation,2022,36(04):630-634.
)
2.
LUO Dan, CHEN Tianyan, ZHANG Wei, et al.
Diagnosis and treatment of novel coronavirus pneumonia in the elderly and the elderly[J].
Chinese Journal of Geriatric Multi-organ Diseases,2020,19(4):262-263.
