Background:Tuberculosis(TB)causedMycobacterium tuberculosis(M.tb)is one of infectious disease that lead a large number of morbidity and mortality all over the world.Although no reliable evidence has been found,it is c...Background:Tuberculosis(TB)causedMycobacterium tuberculosis(M.tb)is one of infectious disease that lead a large number of morbidity and mortality all over the world.Although no reliable evidence has been found,it is considered that combining chemotherapeutic drugs with Chinese herbs can significantly improves the cure rate and the clinical therapeutic effect.Methods:Multi-drug resistant pulmonary tuberculosis(MDR-PTB,n=258)patients with Qi-yin deficiency syndrome will be randomly assigned into a treatment group(n=172)or control/placebo group(n=86).The treatment group will receive the chemotherapeutic drugs combined with Chinese herbs granules(1+3 granules),while the control group will receive the chemotherapeutic drugs combined with Chinese herbs placebo(1+3 placebo granules).In addition,MDR-PTB(n=312)patients with Yin deficiency lung heat syndrome will be randomly assigned to a treatment(n=208)or control/placebo(n=104)group.The treatment group will receive the chemotherapeutic regimen combined with Chinese herbs granules(2+4 granules),while the control group will receive the chemotherapeutic drugs and Chinese herbs placebo(2+4 placebo granules).The primary outcome is cure rate,the secondary outcomes included time to sputum culture conversion,lesion absorption rate and cavity closure rate.BACTEC^(TM)MGIT^(TM)automated mycobacterial detection system will be used to evaluate theM.tb infection and drug resistance.Chi-square test and Cox regression will be conducted with SAS 9.4 Statistical software to analyze the data.Discussion:The treatment cycle for MDR-PTB using standardized modern medicine could cause lengthy substantial side effects.Chinese herbs have been used for many years to treat MDR-PTB,but are without high-quality evidence.Hence,it is unknown whether Chinese herbs enhances the clinical therapeutic effect of synthetic drugs for treating MDR-PTB.Therefore,this study will be conducted to evaluate the clinical therapeutic effect of combining Chinese herbs and chemotherapeutic drugs to treat MDR-PTB cases.It will assist in screening new therapeutic drugs and establishing treatment plan that aims to improve the clinical therapeutic effect for MDR-PTB patients.Trial registration This trial was registered at ClinicalTrials.gov(ChiCTR1900027720)on 24 November 2019(prospective registered).展开更多
Background We collected neonatal neurological,clinical,and imaging data to study the neurological manifestations and imaging characteristics of neonates with coronavirus disease 2019(COVID-19).Methods This case-contro...Background We collected neonatal neurological,clinical,and imaging data to study the neurological manifestations and imaging characteristics of neonates with coronavirus disease 2019(COVID-19).Methods This case-control study included newborns diagnosed with COVID-19 in Wuhan,China from January 2020 to July 2020.All included newborns had complete neurological evaluations and head magnetic resonance imaging.We normalized the extracted T2-weighted imaging data to a standard neonate template space,and segmented them into gray matter,white matter,and cerebrospinal fluid.The comparison of gray matter volume was conducted between the two groups.Results A total of five neonates with COVID-19 were included in this study.The median reflex scores were 2 points lower in the infected group than in the control group(P=0.0094),and the median orientation and behavior scores were 2.5 points lower in the infected group than in the control group(P=0.0008).There were also significant differences between the two groups in the total scale score(P=0.0426).The caudate nucleus,parahippocampal gyrus,and thalamus had the strongest correlations with the Hammersmith neonatal neurologic examination(HNNE)score,and the absolute correlation coefficients between the gray matter volumes and each part of the HNNE score were all almost greater than 0.5.Conclusions We first compared the neurological performance of neonates with and without COVID-19 by quantitative neuroimaging and neurological examination methods.Considering the limited numbers of patients,more studies focusing on the structural or functional aspects of the virus in the central nervous system in different age groups will be carried out in the future.展开更多
基金The data analysis of the study was supported by the fund of Medical Innova‑tion Research Special Project of the Science and Technology Innovation Action Plan of the Shanghai Municipal Science and Technology Commission(Grant No.21Y11922500)This randomized controlled trial was supported by the fund of the 13th Five-Year National Science and Technology Major Project for Infectious Diseases(Grant Nos.2017ZX10305501-002,2018ZX10725-509)The English writing was supported by the fund of the talent introduction research funding(Grant No.LH001.007).
文摘Background:Tuberculosis(TB)causedMycobacterium tuberculosis(M.tb)is one of infectious disease that lead a large number of morbidity and mortality all over the world.Although no reliable evidence has been found,it is considered that combining chemotherapeutic drugs with Chinese herbs can significantly improves the cure rate and the clinical therapeutic effect.Methods:Multi-drug resistant pulmonary tuberculosis(MDR-PTB,n=258)patients with Qi-yin deficiency syndrome will be randomly assigned into a treatment group(n=172)or control/placebo group(n=86).The treatment group will receive the chemotherapeutic drugs combined with Chinese herbs granules(1+3 granules),while the control group will receive the chemotherapeutic drugs combined with Chinese herbs placebo(1+3 placebo granules).In addition,MDR-PTB(n=312)patients with Yin deficiency lung heat syndrome will be randomly assigned to a treatment(n=208)or control/placebo(n=104)group.The treatment group will receive the chemotherapeutic regimen combined with Chinese herbs granules(2+4 granules),while the control group will receive the chemotherapeutic drugs and Chinese herbs placebo(2+4 placebo granules).The primary outcome is cure rate,the secondary outcomes included time to sputum culture conversion,lesion absorption rate and cavity closure rate.BACTEC^(TM)MGIT^(TM)automated mycobacterial detection system will be used to evaluate theM.tb infection and drug resistance.Chi-square test and Cox regression will be conducted with SAS 9.4 Statistical software to analyze the data.Discussion:The treatment cycle for MDR-PTB using standardized modern medicine could cause lengthy substantial side effects.Chinese herbs have been used for many years to treat MDR-PTB,but are without high-quality evidence.Hence,it is unknown whether Chinese herbs enhances the clinical therapeutic effect of synthetic drugs for treating MDR-PTB.Therefore,this study will be conducted to evaluate the clinical therapeutic effect of combining Chinese herbs and chemotherapeutic drugs to treat MDR-PTB cases.It will assist in screening new therapeutic drugs and establishing treatment plan that aims to improve the clinical therapeutic effect for MDR-PTB patients.Trial registration This trial was registered at ClinicalTrials.gov(ChiCTR1900027720)on 24 November 2019(prospective registered).
文摘Background We collected neonatal neurological,clinical,and imaging data to study the neurological manifestations and imaging characteristics of neonates with coronavirus disease 2019(COVID-19).Methods This case-control study included newborns diagnosed with COVID-19 in Wuhan,China from January 2020 to July 2020.All included newborns had complete neurological evaluations and head magnetic resonance imaging.We normalized the extracted T2-weighted imaging data to a standard neonate template space,and segmented them into gray matter,white matter,and cerebrospinal fluid.The comparison of gray matter volume was conducted between the two groups.Results A total of five neonates with COVID-19 were included in this study.The median reflex scores were 2 points lower in the infected group than in the control group(P=0.0094),and the median orientation and behavior scores were 2.5 points lower in the infected group than in the control group(P=0.0008).There were also significant differences between the two groups in the total scale score(P=0.0426).The caudate nucleus,parahippocampal gyrus,and thalamus had the strongest correlations with the Hammersmith neonatal neurologic examination(HNNE)score,and the absolute correlation coefficients between the gray matter volumes and each part of the HNNE score were all almost greater than 0.5.Conclusions We first compared the neurological performance of neonates with and without COVID-19 by quantitative neuroimaging and neurological examination methods.Considering the limited numbers of patients,more studies focusing on the structural or functional aspects of the virus in the central nervous system in different age groups will be carried out in the future.
