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OBJECTIVE To summarize the basic information, mechanism of action, pharmacokinetics, efficacy, safety, interactions, and precautions of azvudine, to provide references for its clinical use. METHODS Literatures related to azvudine from the official website of Chinese clinical trial regi stry, clinicaltrials.gov, Pubmed, CNKI and Wanfang were systematically searched and summarized. RESULTS Azvudine is an oral small-molecule corona virus disease(COVID-19) treatment drug independently developed by China. As a nucleoside analogue targeting to viral RNA-dependent RNA polymerases (RdRp), it can inhibit RNA virus reverse transcription process and replication process. The results of phase III clinical trials showed that azvudine could significantly shorten the time of nucleic acid conversion in patients with mild to moderate corona virus disease (COVID-19). Compared with the control group, the azvudine group can significantly shorten the improvement time of pneumonia. For moderate and severe patients, azvudine treatment also showed significant therapeutic effects in the time of nucleic acid conversion, discharge, and rehabilitation. CONCLUSION The drug possesses good safety and tolerability in patients, which provide a choice for the clinical treatment of COVID-19.Copyright © 2022 Chinese Pharmaceutical Association. All rights reserved.
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OBJECTIVE To summarize the basic information, mechanism of action, pharmacokinetics, efficacy, safety, interactions, and precautions of azvudine, to provide references for its clinical use. METHODS Literatures related to azvudine from the official website of Chinese clinical trial regi stry, clinicaltrials.gov, Pubmed, CNKI and Wanfang were systematically searched and summarized. RESULTS Azvudine is an oral small-molecule corona virus disease(COVID-19) treatment drug independently developed by China. As a nucleoside analogue targeting to viral RNA-dependent RNA polymerases (RdRp), it can inhibit RNA virus reverse transcription process and replication process. The results of phase III clinical trials showed that azvudine could significantly shorten the time of nucleic acid conversion in patients with mild to moderate corona virus disease (COVID-19). Compared with the control group, the azvudine group can significantly shorten the improvement time of pneumonia. For moderate and severe patients, azvudine treatment also showed significant therapeutic effects in the time of nucleic acid conversion, discharge, and rehabilitation. CONCLUSION The drug possesses good safety and tolerability in patients, which provide a choice for the clinical treatment of COVID-19.
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OBJECTIVE To summarize the basic information, mechanism of action, pharmacokinetics, efficacy, safety, interactions, and precautions of azvudine, to provide references for its clinical use. METHODS Literatures related to azvudine from the official website of Chinese clinical trial regi stry, clinicaltrials.gov, Pubmed, CNKI and Wanfang were systematically searched and summarized. RESULTS Azvudine is an oral small-molecule corona virus disease(COVID-19) treatment drug independently developed by China. As a nucleoside analogue targeting to viral RNA-dependent RNA polymerases (RdRp), it can inhibit RNA virus reverse transcription process and replication process. The results of phase III clinical trials showed that azvudine could significantly shorten the time of nucleic acid conversion in patients with mild to moderate corona virus disease (COVID-19). Compared with the control group, the azvudine group can significantly shorten the improvement time of pneumonia. For moderate and severe patients, azvudine treatment also showed significant therapeutic effects in the time of nucleic acid conversion, discharge, and rehabilitation. CONCLUSION The drug possesses good safety and tolerability in patients, which provide a choice for the clinical treatment of COVID-19. Copyright © 2022 Chinese Pharmaceutical Association. All rights reserved.
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OBJECTIVE To summarize the basic information, mechanism of action, pharmacokinetics, efficacy, safety, interactions, and precautions of azvudine, to provide references for its clinical use. METHODS Literatures related to azvudine from the official website of Chinese clinical trial regi stry, clinicaltrials.gov, Pubmed, CNKI and Wanfang were systematically searched and summarized. RESULTS Azvudine is an oral small-molecule corona virus disease(COVID-19) treatment drug independently developed by China. As a nucleoside analogue targeting to viral RNA-dependent RNA polymerases (RdRp), it can inhibit RNA virus reverse transcription process and replication process. The results of phase III clinical trials showed that azvudine could significantly shorten the time of nucleic acid conversion in patients with mild to moderate corona virus disease (COVID-19). Compared with the control group, the azvudine group can significantly shorten the improvement time of pneumonia. For moderate and severe patients, azvudine treatment also showed significant therapeutic effects in the time of nucleic acid conversion, discharge, and rehabilitation. CONCLUSION The drug possesses good safety and tolerability in patients, which provide a choice for the clinical treatment of COVID-19. Copyright © 2022 Chinese Pharmaceutical Association. All rights reserved.
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OBJECTIVE: To review the mechanism and the clinical research progress of nirmatrelvir tablets/ritonavir tablets(PaxlovidTM), so as to provide references for its rational usage. METHODS: Literatures related to nirmatrelvir tablets/ritonavir tablets in the official website of US Food and Drug Administration, Pubmed, Embase, CNKI, CBM and Wanfang were systematically searched. The basic information, mechanism of action, pharmacokinetics, pharmacodynamics, clinical efficacy evaluation, safety, drug interaction, drug use in special populations were reviewed. RESULTS AND CONCLUSIONS: Nirmatrelvir tablets/ritonavir tablets inhibit the replication of SARS-COV-2 virus by inhibiting the processing of SARS-CoV-2 protein precursor mediated by the main protease. Based on current trial results, nirmatrelvir tablets/ritonavir tablets can significantly reduce hospitalization and mortality rates in adult patients with mild and moderate COVID-19. More research is required to determine whether the drug is appropriate for the clinical treatment of all COVID-19 patients.
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As of May 2021, 6 new vaccines against coronavirus disease 2019 (COVID-19) have been conditionally approved and urgently used in China, including products of 4 new inactivated vaccines, 1 new adenovirus vaccine and 1 new recombinant vaccine. All the six vaccine products have been under different stages of clinical trials in global scale, and the results of the clinical trials have demonstrated the safety of the vaccines and the efficacy against COVID-19. Focusing on the above products, this paper deeply summarizes the characteristics of different new vaccine products and the clinical trial results as the key evidence supporting the approval of the products. In addition, facing the current severe situation of COVID-19, the status and challenges regarding the research and development of new vaccines and therapeutics are analyzed. © 2022, Chinese Journal of New Drugs Co. Ltd. All right reserved.
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Introduction: Chronic stress is associated with incident hypertension and is a promising intervention target for lowering blood pressure (BP), particularly in women. Growing evidence suggests that mindfulness-based interventions can reduce BP and improve psychological outcomes but the in-person format of traditional programs limits access. The goal of this study was to evaluate the feasibility, acceptability and effects of telephone-delivered mindfulness-based cognitive therapy (MBCT-T) in women with prehypertension. Methods: We conducted a pilot RCT in which 37 women meeting JNC 7 criteria for prehypertension (SBP 120-139 mmHg or DBP 80-89 mmHg) and not taking antihypertensive medication were recruited from outpatient clinics or via the EHR. Eligible participants were randomized to usual care or MBCT-T, which involved 8 weekly 1-hour phone sessions delivered to small groups by a trained instructor. Outcomes included feasibility (session completion), acceptability (Client Satisfaction Questionnaire [CSQ]), SBP (mean of 3 clinic BP measurements), perceived stress (PSS-10) and depressive symptoms (PHQ-8). Linear mixed models with a random effect of intervention cohort were performed to compare 3-month changes in outcomes between study arms, adjusting for age and ethnicity. Results: The mean age was 50.7±17.7, 68% of participants were racial/ethnic minorities, and baseline SBP/DBP was 127.8±6.2/77.5±7.2 mmHg. There were no significant differences between study arms in demographics or baseline characteristics. The median number of sessions completed was 6 of 8. Fewer sessions were completed by employed vs. unemployed women (4.5 vs. 7.8,t=3.55, p=.003) and by foreign-born vs. U.S.-born women (2.8 vs. 5.9, t=1.87, p=.08). Overall 3-month retention was 89% but follow-up BP was missing in ∼50% of participants due to COVID-19research restrictions. Three-quarters of MBCT-T participants reported high satisfaction with theintervention (CSQ24). In the subgroup with complete follow-up data, SBP declined in both studyarms but there was no significant between-group difference (p=0.51). Conversely, greater reductionsin perceived stress and depressive symptoms were observed in the MBCT-T arm vs. usual care(between-group differences of 3.63 [PSS-10;p=.163] and 2.90 [PHQ-8;p=.008]). In per-protocolanalyses limited to MBCT-T participants who completed ≥4 sessions, effects were larger forperceived stress and similar for depressive symptoms (between-group differences of 6.17 [PSS-10;p=.012] and 2.77 [PHQ-8;p=.025]). Conclusions: Results support the feasibility and acceptability of telephone-based mindfulnesstraining in diverse women with prehypertension. Promising findings for stress and depressivesymptoms suggest further studies are warranted. Strategies to address barriers to participation, particularly among working women and minorities, are needed.
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OBJECTIVE: To evaluate the safety and rationality of Reduning injection in the treatment of COVID-19. METHODS: Through consulting, summarizing and analyzing literatures, the rapid HTA evaluation of Reduning was carried out, and its pharmacological rationality and drug monitoring for COVID-19 were discussed. RESULTS: Literature analysis indicated that COVID-19 belongs to the pestilence of TCM. It was characterized by “dampness, heat, deficiency, toxin and stasis”, and its clinical manifestations involved inflammatory factor storm, immune system damage, etc. Reduning injection was approved to the treatment of influenza, cough and respiratory tract infections caused by exopathic wind-heat, and a typical drug for heat-clearing and detoxifying. CONCLUSION: The rapid HTA evaluation showed that Reduning injection has good safety, effectiveness and economy. The mechanisms of Reduning in antipyretic and anti-inflammatory, immune regulation and anti-virus suggest the rationality of Reduning in treating COVID-19, but drug monitoring should be done well in the use process.
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Novel coronavirus 2019 (SARS-CoV-2) infection outbreak has occurred in Wuhan since December 2019.Cytokine storm (inflammatory factor storm)was suggested to be involved in the sudden deterioration of some SARS-CoV-2 infectors in the recent reports.However, no medicine was specific to the treatment of cytokine storm so far. This paper summarized the mechanism and potential therapeutic drugs of cytokine storm based on literature review and analysis, so as to provide references for the treatment of SARS-CoV-2.