Efficacy and safety of Lianhuaqingwen capsules in high-risk common type COVID-19 pneumonia:A multicenter retrospective study

Objective:To evaluate the clinical safety and efficacy of Lianhuaqingwen(LHQW)capsules in patients with high-risk common type COVID-19 pneumonia.Methods:A retrospective multicenter study on 383 high-risk common type COVID-19 pneumonia cases was conducted.Patients were categorized as the standard treatment(SDT)group(n=168)and the LHQW+SDT group(n=215).The primary endpoint was the rate of symptom(fever,fatigue,coughing)recovery and the secondary endpoints included the time to symptom recovery,the proportion of patients with improvement in chest CT images,the proportion of patients with clinical cure,the timing and rate of negative conversion of SARS-CoV-2 RNA assay.Results:The recovery rate was significantly higher in the LHQW+SDT group as compared with the SDT group(89.7%vs.72.0%,P<0.01).The combined use of LHQW+SDT also showed shorter time for symptom recovery,as well as shorter time for individual symptom of fever,fatigue and coughing recovery than use of SDT alone.A higher proportion of patients in the LHQW+SDT group with improvements in chest CT images and clinical cure(77.7%vs.57.1%,P<0.01)but the proportion of patients deteriorating to severe cases(1%vs.25%,P<0.01)in this group was significant lower than those in the SDT group.No significant difference in negative conversion rate of viral assay results was observed(76.8%vs.75.0%,P>0.05).No serious adverse events were reported.Conclusions:LHQW capsules could be recommended to ameliorate clinical symptoms and reduce the rate of deteriorating to severe cases for high-risk common type COVID-19 pneumonia.

Identifying potential anti-COVID-19 pharmacological components of traditional Chinese medicine Lianhuaqingwen capsule based on human exposure and ACE2 biochromatography screening

Lianhuaqingwen(LHQW)capsule,a herb medicine product,has been clinically proved to be effective in coronavirus disease 2019(COVID-19)pneumonia treatment.However,human exposure to LHQW components and their pharmacological effects remain largely unknown.Hence,this study aimed to determine human exposure to LHQW components and their anti-COVID-19 pharmacological activities.Analysis of LHQW component profiles in human plasma and urine after repeated therapeutic dosing was conducted using a combination of HRMS and an untargeted data-mining approach,leading to detection of 132 LHQW prototype and metabolite components,which were absorbed via the gastrointestinal tract and formed via biotransformation in human,respectively.Together with data from screening by comprehensive 2 D angiotensin-converting enzyme 2(ACE2)biochromatography,8 components in LHQW that were exposed to human and had potential ACE2 targeting ability were identified for further pharmacodynamic evaluation.Results show that rhein,forsythoside A,forsythoside I,neochlorogenic acid and its isomers exhibited high inhibitory effect on ACE2.For the first time,this study provides chemical and biochemical evidence for exploring molecular mechanisms of therapeutic effects of LHQW capsule for the treatment of COVID-19 patients based on the components exposed to human.It also demonstrates the utility of the human exposure-based approach to identify pharmaceutically active components in Chinese herb medicines.

Natural herbal medicine Lianhuaqingwen capsule anti-influenza A （H1N1） trial： a randomized, double blind, positive controlled clinical trial

Background The 2009 influenza A （H1N1） virus infection is associated with the high risk of severe complications and is spreading more rapidly throughout the world than other reported seasonal influenzas. This study aimed to evaluate the efficacy and safety of the nature herbal medicine Lianhuaqingwen capsule （LHC） in patients infected with influenza A （H1N1） virus. Methods A total of 244 patients aged 16-65 years confirmed with influenza A （H1N1） virus infection by the real time RT-PCR were randomized to one of two treatment groups of 122 patients each. Each group assigned to receive either LHC or Oseltamivir for five days and observation for seven days. The patients were enrolled within 36 hours of illness onset if they had an axillary temperature of ≥37.4℃ and with at least one of the following symptoms： nasal obstruction, runny nose, cough, sore throat, fatigue, headache, myalgia, chills and sweating. The primary end point was the duration of illness. Results Of 244 patients, 240 （98.36%） patients with a median age 21 years completed the study between October 24, 2009 and November 23, 2009. There were no significant overall differences between LHC treated and Oseltamivir treated patients in the median duration of illness （LHC 69 hours vs. Oseltamivir 85 hours P 〉0.05） or the median duration of viral shedding （LHC 103 hours vs. Oseltamivir 96 hours, P 〉0.05）. However, it was worthwhile to note that LHC significantly reduced the severity of illness and the duration of symptoms including fever, cough, sore throat, and fatigue （P〈0.05）. Both study medications were well tolerated. No drug related serious adverse events occurred during the study. Conclusions Compared with Oseltamivir, LHC achieved a similar therapeutic effectiveness reduction of the duration of illness and duration of viral shedding. Therefore, LHC might be an alternative therapeutic measure for influenza A （H1N1） virus infections.

Efficacy and safety of Reduqing granules in the treatment of common cold with wind-heat syndrome： a randomized, double-blind, double-dummy, positive-controlled trial

OBJECTIVE:To assess the efficacy and safety of Reduqing granules in patients with common cold with wind-heat syndrome(CCWHS).METHODS:A randomized, double-blind, double-dummy, parallel, positive-controlled trial included 72 CCWHS patients was performed.The participants were randomly assigned to two groups,Reduqing(RDQ) group and Lianhuaqingwen(LHQW) group, in a 1∶1 ratio.Patients in RDQ group received Reduqing granules and dummy Lianhuaqingwen capsules three times a day and patients in LHQW group received Lianhuaqingwen capsules and dummy Reduqing granules three times daily.The duration of treatment and follow-up were four days.RESULTS:There were no statistically significant differences in total markedly effective rate and total effective rate between RDQ group and LHQW group after treatment.Traditional Chinese Medicine(TCM) symptom score was significantly reduced after treatment in RDQ group, as well as in LHQW group.However, the difference of change in TCM symptom score between two groups was not statistically significant(P > 0.05).There were no significant differences between two groups in the median time to fever relief [RDQ group(4 ± 8) h vs LHQW group(4 ± 5) h] or the median time to fever clearance(RDQ group 47 h vs LHQW 36 h).No serious adverse events were reported during the study.CONCLUSION:Compared with Lianhuaqingwen capsules, Reduqing granules achieved similar therapeutic effect in the treatment of CCWHS and no drug-related adverse events were reported during the study.Therefore, Reduqing granules might be effective and safe in the treatment of CCWHS.