RESUMO
Objective:To observe the efficacy and safety of Fuzheng Huayu tabletsFHTfor treating pulmonary inflammation in patients with coronavirus disease 2019COVID-19. Method(s):A total of 704 cases were lost to follow-up, and 66 cases were finally completedCOVID-19 patients were recruited from February 1 to April 15 in 2020. They were assigned to a control group35 patientsand a FHT group31 patients. The patients in the control group received routine treatment alone and those in the FHT group received FHT in addition to routine treatment. The primary outcome was the ratio of patients showing improvement in chest computed tomographic manifestations after 14 days. The secondary outcome measures included remission rate or progression rate of critical illness,clinical remission rate of respiratory symptoms,routine blood examination, C-reactive proteinCPRlevel,procalcitoninPCTlevel,and blood oxygen saturationSPO2 . The safety was assessed based on liver and kidney functions and adverse events. Result(s): After the 14-day treatment,the ratio of patients showing improvement in the FHT group100%was higher than that in the control group 77.1%chi2 =8.063,P<0.01. The ratio of disease stages after treatment showed no significant difference between two groups. In the FHT group,the symptoms including cough,dyspnea,and fatigue were alleviated after treatmentP<0.01. In the control group,the symptoms including fever,cough,and dyspnea were alleviatedP<0.01,while the fatigue was not relieved after treatment. No significant difference was observed in the clinical symptoms between the two groups after treatment. After treatment,the FHT group showed decreased white blood cellWBCcount and neutrophil-to-lymphocyte ratioNLRP<0.01,elevated plateletPLTlevelP<0.05,lowered CRP levelP<0.05,and no significant difference in lymphocyte LYM,hemoglobinHb,SPO2 or PCT level. The control group showed decreased NLRP<0.05and WBC countP<0.01,elevated PCT levelP<0.05,and no significant change in LYM,Hb,PLT,SPO2 or CRP level after treatment. Furthermore,the FHT group had higher PLT level than the control groupP<0.05after treatment,and other indicators had no significant differences between the two groups. The liver and kidney functions had no significant difference between the two groups after treatment. Conclusion(s): FHT can safely promote the absorption of acute pulmonary inflammation in COVID-19 patients.Copyright © 2022, China Academy of Chinese Medical Sciences Institute of Chinese Materia Medica. All rights reserved.
RESUMO
Objective：To observe the efficacy and safety of Fuzheng Huayu tablets（FHT）for treating pulmonary inflammation in patients with coronavirus disease 2019（COVID-19）. Method：A total of 70（4 cases were lost to follow-up, and 66 cases were finally completed）COVID-19 patients were recruited from February 1 to April 15 in 2020. They were assigned to a control group（35 patients）and a FHT group（31 patients）. The patients in the control group received routine treatment alone and those in the FHT group received FHT in addition to routine treatment. The primary outcome was the ratio of patients showing improvement in chest computed tomographic manifestations after 14 days. The secondary outcome measures included remission rate or progression rate of critical illness，clinical remission rate of respiratory symptoms，routine blood examination， C-reactive protein（CPR）level，procalcitonin（PCT）level，and blood oxygen saturation（SPO2 ）. The safety was assessed based on liver and kidney functions and adverse events. Result： After the 14-day treatment，the ratio of patients showing improvement in the FHT group（100%）was higher than that in the control group （77.1%）（χ2 =8.063，P<0.01）. The ratio of disease stages after treatment showed no significant difference between two groups. In the FHT group，the symptoms including cough，dyspnea，and fatigue were alleviated after treatment（P<0.01）. In the control group，the symptoms including fever，cough，and dyspnea were alleviated（P<0.01），while the fatigue was not relieved after treatment. No significant difference was observed in the clinical symptoms between the two groups after treatment. After treatment，the FHT group showed decreased white blood cell（WBC）count and neutrophil-to-lymphocyte ratio（NLR）（P<0.01），elevated platelet（PLT）level（P<0.05），lowered CRP level（P<0.05），and no significant difference in lymphocyte （LYM），hemoglobin（Hb），SPO2 or PCT level. The control group showed decreased NLR（P<0.05）and WBC count（P<0.01），elevated PCT level（P<0.05），and no significant change in LYM，Hb，PLT，SPO2 or CRP level after treatment. Furthermore，the FHT group had higher PLT level than the control group（P<0.05）after treatment，and other indicators had no significant differences between the two groups. The liver and kidney functions had no significant difference between the two groups after treatment. Conclusion： FHT can safely promote the absorption of acute pulmonary inflammation in COVID-19 patients. © 2022, China Academy of Chinese Medical Sciences Institute of Chinese Materia Medica. All rights reserved.
RESUMO
OBJECTIVE: To evaluate systematically the efficacy and safety of COVID-19 vaccines. METHODS: PubMed, Embase, Cochrane Library, Clinicaltrial.gov, CNKI, Wanfang Data, China Biomedical Literature Service System, and China Clinical Trial Registry were searched for randomized controlled trials of COVID-19 vaccines published up to December 31, 2020. The Cochrane bias risk assessment tool was used to assess the quality of studies. A qualitative analysis was performed on the results of clinical trials. RESULTS: Thirteen randomized, blinded, controlled trials, which involved the safety and efficacy of 11 COVID-19 vaccines, were included. In 10 studies, the 28-day seroconversion rate of subjects exceeded 80%. In two 10 000-scale clinical trials, the vaccines were effective in 95% and 70.4% of the subjects, respectively. The seroconversion rate was lower than 60% in only one study. In six studies, the proportion of subjects who had an adverse reaction within 28 days after vaccination was lower than 30%. This proportion was 30%-50% in two studies and > 50% in the other two studies. Most of the adverse reactions were mild to moderate and resolved within 24 hours after vaccination. The most common local adverse reaction was pain or tenderness at the injection site, and the most common systemic adverse reaction was fatigue, fever, or bodily pain. The immune response and incidence of adverse reactions to the vaccines were positively correlated with the dose given to the subjects. The immune response to the vaccines was worse in the elderly than in the younger population. In 6 studies that compared single-dose and double-dose vaccination, 4 studies showed that double-dose vaccination produced a stronger immune response than single-dose vaccination. CONCLUSIONS: Most of the COVID-19 vaccines appear to be effective and safe. Double-dose vaccination is recommended. However, more research is needed to investigate the long-term efficacy and safety of the vaccines and the influence of dose, age, and production process on the protective efficacy.