Sanhan Huashi granules(SHG)demonstrated therapeutic effects against coronavirus disease 2019(COVID-19)in observational studies.In order to compare the effectiveness and safety of SHG and nirmatrelvir–ritonavir in tre...Sanhan Huashi granules(SHG)demonstrated therapeutic effects against coronavirus disease 2019(COVID-19)in observational studies.In order to compare the effectiveness and safety of SHG and nirmatrelvir–ritonavir in treating adults with mild-to-moderate COVID-19,we conducted a randomized,activecontrolled,open-label,multi-center trial conducted between February and July in 2023.The patients were randomized in a 1:1 ratio to the SHG group and the nirmatrelvir–ritonavir group.A total of 400participants were randomized,among which 200 participants ultimately received SHG and 198 received nirmatrelvir–ritonavir.The primary outcome was time to sustained clinical recovery through day 28.SHG significantly shortened the median time to sustained clinical recovery compared to nirmatrelvir–ritonavir(6.0(95%CI,5.0 to 6.0)vs.8.0(95%CI,6.0 to 9.0)d;P=0.001),particularly for individual symptoms including fever,sore throat,cough and fatigue.No participants in either group died and incidence of severe COVID-19 showed no difference between two groups.Participants who received nirmatrelvir–ritonavir demonstrated a higher rate of virus clearance on day 5 compared to those received SHG(46.4%(95%CI,39.1 to 53.7)vs.65.6%(95%CI,58.3 to 72.4);P<0.001).Most adverse events were mild in both groups.In summary,SHG was superior to nirmatrelvir–ritonavir in shortening the time to sustained clinical recovery in participants with mild-to-moderate COVID-19,despite a lower virus clearance rate observed after 5 d of treatment(Chinese Clinical Trial Registry Identifier:Chi CTR2300067872).展开更多
Background:This study assessed the safety and efficacy of nirmatrelvir-ritonavir(Paxlovid®)and azvudine when administered sequentially or concomitantly in patients with coronavirus 2019(COVID-19)caused by the Omi...Background:This study assessed the safety and efficacy of nirmatrelvir-ritonavir(Paxlovid®)and azvudine when administered sequentially or concomitantly in patients with coronavirus 2019(COVID-19)caused by the Omicron variant.Methods:Ninety-three patients confirmed to be infected with the Omicron variant by nucleic acid detection were retrospectively investigated.Informa-tion was collected on general health status,medication,and adverse drug reactions(ADRs)according to whether nirmatrelvir-ritonavir and azvudine were administered sequentially or concomitantly.Data on times of onset,clinical manifestations,and outcomes of ADRs and on conversion to a nega-tive nucleic acid test were also recorded.Results:Possible ADRs were recorded in 41 patients(44.1%).There were 22 gastrointestinal reactions in 18 patients and 18 hematological abnormalities in 16 after sequential or concomitant treatment with nirmatrelvir-ritonavir and azvudine.Liver enzyme levels increased in nine cases and creatinine clearance decreased in two.Cases of atrial fibrillation(n=1),sleep disorder(n=2),rash(n=2),dizziness(n=1),and weakness(n=5)were also documented.Only vomiting,poor appetite,diarrhea,xerostomia,bitter taste,and rash were considered probable ADRs;others were thought to be possible ADRs.In all cases,the nucleic acid test did not turn negative after the first antiviral was applied.The nucleic acid test of 28 patients did not turn negative before discharge.The remaining 65 patients(69.9%)returned a negative nucleic acid test after receiving the second antiviral agent.Conclusions:Treatment with nirmatrelvir-ritonavir and azvudine is safe and effective whether administered sequentially or concomitantly in patients with COVID-19 caused by the Omicron variant.展开更多
帕金森病患者合并新型冠状病毒感染(COVID-19)时,其治疗药物合用的安全性问题受到广泛关注。利物浦药物相互作用数据库、Up To Date数据库的相关数据及国内外药品说明书和指南等有助于评估帕金森病与COVID-19治疗药物之间的相互作用以...帕金森病患者合并新型冠状病毒感染(COVID-19)时,其治疗药物合用的安全性问题受到广泛关注。利物浦药物相互作用数据库、Up To Date数据库的相关数据及国内外药品说明书和指南等有助于评估帕金森病与COVID-19治疗药物之间的相互作用以及其影响程度。本文结合药物的代谢和排泄途径,就帕金森病合并COVID-19治疗药物的相互作用进行概述。展开更多
Data on the viral rebound and safety of nirmatrelvir/ritonavir in lung transplant(LTx)recipients are limited.The study prospectively followed four LTx recipients.Clinical characteristics,viral RNA dynamic in throat sw...Data on the viral rebound and safety of nirmatrelvir/ritonavir in lung transplant(LTx)recipients are limited.The study prospectively followed four LTx recipients.Clinical characteristics,viral RNA dynamic in throat swabs,and tacrolimus blood concentration were monitored regularly.All four LTx recipients,aged 35–74 years,were not vaccinated against severe acute respiratory syndrome coronavirus 2(SARS‐CoV‐2).They got coronavirus disease 2019(COVID‐19)after more than one week of admission during the era of Omicron.All cases received nirmatrelvir/ritonavir(NM/r)within two days of infection,and the relative viral RNA copies dropped quickly.Viral load rebound was observed in all four cases after discontinuation of the first five days of NM/r treatment.Three of them received another 5‐days antiviral therapy with NM/r.The duration of positive viral PCR testing was 25‐28 days.None of them progressed into severe or critical COVID‐19.Tacrolimus was stopped 12 h before NM/r and held during the 5‐day course of antiviral therapy.Blood concentration of tacrolimus were maintained at a baseline level during these five days.Tacrolimus was re‐initiated at its baseline daily dose 3‐4 days after NM/r therapy.However,during the second round of antiviral therapy with NM/r,the concentration of tacrolimus fluctuated wildly.In conclusion,the 5‐day course of NM/r treatment was not sufficient for LTx recipients and the viral rebound was common.More data are needed to clarify whether LTx recipients with SARS‐CoV‐2 viral rebound could benefit from additional treatment with NM/r.展开更多
基金supported by the Jiangsu Kanion Pharmaceutical Co.,Ltd.and partially supported by the Innovation TeamTalents Cultivation Program of National Administration of Traditional Chinese Medicine(ZYYCXTD-D-202208)。
文摘Sanhan Huashi granules(SHG)demonstrated therapeutic effects against coronavirus disease 2019(COVID-19)in observational studies.In order to compare the effectiveness and safety of SHG and nirmatrelvir–ritonavir in treating adults with mild-to-moderate COVID-19,we conducted a randomized,activecontrolled,open-label,multi-center trial conducted between February and July in 2023.The patients were randomized in a 1:1 ratio to the SHG group and the nirmatrelvir–ritonavir group.A total of 400participants were randomized,among which 200 participants ultimately received SHG and 198 received nirmatrelvir–ritonavir.The primary outcome was time to sustained clinical recovery through day 28.SHG significantly shortened the median time to sustained clinical recovery compared to nirmatrelvir–ritonavir(6.0(95%CI,5.0 to 6.0)vs.8.0(95%CI,6.0 to 9.0)d;P=0.001),particularly for individual symptoms including fever,sore throat,cough and fatigue.No participants in either group died and incidence of severe COVID-19 showed no difference between two groups.Participants who received nirmatrelvir–ritonavir demonstrated a higher rate of virus clearance on day 5 compared to those received SHG(46.4%(95%CI,39.1 to 53.7)vs.65.6%(95%CI,58.3 to 72.4);P<0.001).Most adverse events were mild in both groups.In summary,SHG was superior to nirmatrelvir–ritonavir in shortening the time to sustained clinical recovery in participants with mild-to-moderate COVID-19,despite a lower virus clearance rate observed after 5 d of treatment(Chinese Clinical Trial Registry Identifier:Chi CTR2300067872).
基金Analysis of Omicron Variant Mutation Patterns and Research on Prevention and Control,Grant/Award Number:2023YFC3041500。
文摘Background:This study assessed the safety and efficacy of nirmatrelvir-ritonavir(Paxlovid®)and azvudine when administered sequentially or concomitantly in patients with coronavirus 2019(COVID-19)caused by the Omicron variant.Methods:Ninety-three patients confirmed to be infected with the Omicron variant by nucleic acid detection were retrospectively investigated.Informa-tion was collected on general health status,medication,and adverse drug reactions(ADRs)according to whether nirmatrelvir-ritonavir and azvudine were administered sequentially or concomitantly.Data on times of onset,clinical manifestations,and outcomes of ADRs and on conversion to a nega-tive nucleic acid test were also recorded.Results:Possible ADRs were recorded in 41 patients(44.1%).There were 22 gastrointestinal reactions in 18 patients and 18 hematological abnormalities in 16 after sequential or concomitant treatment with nirmatrelvir-ritonavir and azvudine.Liver enzyme levels increased in nine cases and creatinine clearance decreased in two.Cases of atrial fibrillation(n=1),sleep disorder(n=2),rash(n=2),dizziness(n=1),and weakness(n=5)were also documented.Only vomiting,poor appetite,diarrhea,xerostomia,bitter taste,and rash were considered probable ADRs;others were thought to be possible ADRs.In all cases,the nucleic acid test did not turn negative after the first antiviral was applied.The nucleic acid test of 28 patients did not turn negative before discharge.The remaining 65 patients(69.9%)returned a negative nucleic acid test after receiving the second antiviral agent.Conclusions:Treatment with nirmatrelvir-ritonavir and azvudine is safe and effective whether administered sequentially or concomitantly in patients with COVID-19 caused by the Omicron variant.
文摘帕金森病患者合并新型冠状病毒感染(COVID-19)时,其治疗药物合用的安全性问题受到广泛关注。利物浦药物相互作用数据库、Up To Date数据库的相关数据及国内外药品说明书和指南等有助于评估帕金森病与COVID-19治疗药物之间的相互作用以及其影响程度。本文结合药物的代谢和排泄途径,就帕金森病合并COVID-19治疗药物的相互作用进行概述。
基金CAMS Innovation Fund for Medical Sciences(CIFMS)(2021‐I2M‐1‐049).
文摘Data on the viral rebound and safety of nirmatrelvir/ritonavir in lung transplant(LTx)recipients are limited.The study prospectively followed four LTx recipients.Clinical characteristics,viral RNA dynamic in throat swabs,and tacrolimus blood concentration were monitored regularly.All four LTx recipients,aged 35–74 years,were not vaccinated against severe acute respiratory syndrome coronavirus 2(SARS‐CoV‐2).They got coronavirus disease 2019(COVID‐19)after more than one week of admission during the era of Omicron.All cases received nirmatrelvir/ritonavir(NM/r)within two days of infection,and the relative viral RNA copies dropped quickly.Viral load rebound was observed in all four cases after discontinuation of the first five days of NM/r treatment.Three of them received another 5‐days antiviral therapy with NM/r.The duration of positive viral PCR testing was 25‐28 days.None of them progressed into severe or critical COVID‐19.Tacrolimus was stopped 12 h before NM/r and held during the 5‐day course of antiviral therapy.Blood concentration of tacrolimus were maintained at a baseline level during these five days.Tacrolimus was re‐initiated at its baseline daily dose 3‐4 days after NM/r therapy.However,during the second round of antiviral therapy with NM/r,the concentration of tacrolimus fluctuated wildly.In conclusion,the 5‐day course of NM/r treatment was not sufficient for LTx recipients and the viral rebound was common.More data are needed to clarify whether LTx recipients with SARS‐CoV‐2 viral rebound could benefit from additional treatment with NM/r.
