BACKGROUND Alpha-fetoprotein(AFP)is one of the diagnostic standards for primary liver cancer(PLC);however,AFP exhibits insufficient sensitivity and specificity for diagnosing PLC.AIM To evaluate the effects of high-ri...BACKGROUND Alpha-fetoprotein(AFP)is one of the diagnostic standards for primary liver cancer(PLC);however,AFP exhibits insufficient sensitivity and specificity for diagnosing PLC.AIM To evaluate the effects of high-risk factors and the diagnostic value of AFP in stratified PLC.METHODS In total,289 PLC cases from 2013 to 2019 were selected for analysis.First,the contributions of high-risk factors in stratifying PLC were compared according to the following criteria:Child–Pugh score,clinical stage of liver cirrhosis,tumor size,and Barcelona Clinic Liver Cancer(BCLC)stage.Then,the diagnostic value of AFP was evaluated in different stratifications of PLC by receiver operating characteristic curves.For PLC cases in which AFP played little role,the diagnostic values of carcinoembryonic antigen(CEA),carbohydrate antigen 19-9(CA 19-9),gamma-glutamyl transferase(GGT),and AFP were analyzed.RESULTS The roles of high-risk factors differed in stratified PLC.The incidence of smoking and drinking history was higher in PLC with Child–Pugh scores of C(P<0.0167).The hepatitis B virus(HBV)infection rate in PLC with cirrhosis was more than in PLC without cirrhosis(P<0.0167).Small tumors were more prone to cirrhosis than large tumors(P<0.005).BCLC stage D PLC was more likely to be associated with HBV infection and cirrhosis(P<0.0083).AFP levels were higher in PLC with cirrhosis,diffuse tumors,and BCLC stage D disease.In diagnosing PLC defined as Child–Pugh A,B,and C,massive hepatoma,diffuse hepatoma,BCLC stage B,C,and D,and AFP showed significant diagnostic value[all area under the curve(AUC)>0.700].However,these measures were meaningless(AUC<0.600)in small hepatomas and BCLC A stage PLC,but could be replaced by the combined detection of CEA,CA 19-9,GGT,and AFP(AUC=0.810 and 0.846,respectively).CONCLUSION Stratification of PLC was essential for precise diagnoses and benefited from evaluating AFP levels.展开更多
Objective:This article systematically analyses the effects of adverse drug events/adverse drug reactions(ADEs/ADRs)of oral Indigo Naturalis(Qingdai)preparations in order to provide references for its rational clinical...Objective:This article systematically analyses the effects of adverse drug events/adverse drug reactions(ADEs/ADRs)of oral Indigo Naturalis(Qingdai)preparations in order to provide references for its rational clinical application.Methods:All clinical studies reporting ADE/ADR related to the oral administration of Qingdai preparations were searched through electronic databases,including PubMed,the Cochrane Library,Embase,China National Knowledge Infrastructure(CNKI),China Biology Medicine disc(CBM),VIP Information Chinese Journal Service Platform(VIP),and Wanfang database,from inception to September 27,2020.Information were extracted from these literatures,including primary disease,type of adverse reactions,dose,treatment,outcomes and so on.Incidence of ADE/ADR was estimated,as well as distribution of primary diseases and victim organs and systems were analyzed.Results:A total of 682 articles were included,with 651 clinical population studies and 31 case reports.Among them,604 detailed ADR/AE involving 33459 patients using oral Qingdai preparations,and a total of 5061 cases were found to present adverse events,including 2827 cases of digestive system(abdominal pain,diarrhea,etc.),469 cases of blood system damage(thrombocytopenia,leukopenia,anemia,etc.),313 cases of liver damage(abnormal liver function,liver toxicity,elevated liver enzymes,etc.),327 cases of nervous system reactions(headache,dizziness,poor sleep,etc.)and 1186 cases of other systems and organs.Severe adverse events(SAEs)mainly were liver damage,and could be relived after symptomatic treatment.Conclusion:From the systematic information retrieval and analysis,it is found that oral Qingdai preparations application may clinically cause ADEs/ADRs in terms of gastrointestinal tract and liver damage.Therefore,when using oral Qingdai preparations,liver and stomach protection should be done.At the same time,pay close attention to various biochemical indicators and the patient's drug response during the treatment process,and,if necessary,deal with it in time so as not to deteriorate the condition.Moreover,active surveillance system should be conducted to monitor ADE/ADR,so as to establish a clearer causal relationship between the drug and the adverse event.展开更多
基金Supported by High-End Talent Funding Project in Hebei Province,No.A202003005Hebei Provincial Health Commission Office,No.G2019074+1 种基金Science and Technology Research Project of Hebei Higher Education Institutions(ZD2018090)Natural Science Foundation of Hebei Province,No.H2019209355。
文摘BACKGROUND Alpha-fetoprotein(AFP)is one of the diagnostic standards for primary liver cancer(PLC);however,AFP exhibits insufficient sensitivity and specificity for diagnosing PLC.AIM To evaluate the effects of high-risk factors and the diagnostic value of AFP in stratified PLC.METHODS In total,289 PLC cases from 2013 to 2019 were selected for analysis.First,the contributions of high-risk factors in stratifying PLC were compared according to the following criteria:Child–Pugh score,clinical stage of liver cirrhosis,tumor size,and Barcelona Clinic Liver Cancer(BCLC)stage.Then,the diagnostic value of AFP was evaluated in different stratifications of PLC by receiver operating characteristic curves.For PLC cases in which AFP played little role,the diagnostic values of carcinoembryonic antigen(CEA),carbohydrate antigen 19-9(CA 19-9),gamma-glutamyl transferase(GGT),and AFP were analyzed.RESULTS The roles of high-risk factors differed in stratified PLC.The incidence of smoking and drinking history was higher in PLC with Child–Pugh scores of C(P<0.0167).The hepatitis B virus(HBV)infection rate in PLC with cirrhosis was more than in PLC without cirrhosis(P<0.0167).Small tumors were more prone to cirrhosis than large tumors(P<0.005).BCLC stage D PLC was more likely to be associated with HBV infection and cirrhosis(P<0.0083).AFP levels were higher in PLC with cirrhosis,diffuse tumors,and BCLC stage D disease.In diagnosing PLC defined as Child–Pugh A,B,and C,massive hepatoma,diffuse hepatoma,BCLC stage B,C,and D,and AFP showed significant diagnostic value[all area under the curve(AUC)>0.700].However,these measures were meaningless(AUC<0.600)in small hepatomas and BCLC A stage PLC,but could be replaced by the combined detection of CEA,CA 19-9,GGT,and AFP(AUC=0.810 and 0.846,respectively).CONCLUSION Stratification of PLC was essential for precise diagnoses and benefited from evaluating AFP levels.
基金This research was financially supported by The National Key R&D Program of China(Grant No.2019YFC1709802).
文摘Objective:This article systematically analyses the effects of adverse drug events/adverse drug reactions(ADEs/ADRs)of oral Indigo Naturalis(Qingdai)preparations in order to provide references for its rational clinical application.Methods:All clinical studies reporting ADE/ADR related to the oral administration of Qingdai preparations were searched through electronic databases,including PubMed,the Cochrane Library,Embase,China National Knowledge Infrastructure(CNKI),China Biology Medicine disc(CBM),VIP Information Chinese Journal Service Platform(VIP),and Wanfang database,from inception to September 27,2020.Information were extracted from these literatures,including primary disease,type of adverse reactions,dose,treatment,outcomes and so on.Incidence of ADE/ADR was estimated,as well as distribution of primary diseases and victim organs and systems were analyzed.Results:A total of 682 articles were included,with 651 clinical population studies and 31 case reports.Among them,604 detailed ADR/AE involving 33459 patients using oral Qingdai preparations,and a total of 5061 cases were found to present adverse events,including 2827 cases of digestive system(abdominal pain,diarrhea,etc.),469 cases of blood system damage(thrombocytopenia,leukopenia,anemia,etc.),313 cases of liver damage(abnormal liver function,liver toxicity,elevated liver enzymes,etc.),327 cases of nervous system reactions(headache,dizziness,poor sleep,etc.)and 1186 cases of other systems and organs.Severe adverse events(SAEs)mainly were liver damage,and could be relived after symptomatic treatment.Conclusion:From the systematic information retrieval and analysis,it is found that oral Qingdai preparations application may clinically cause ADEs/ADRs in terms of gastrointestinal tract and liver damage.Therefore,when using oral Qingdai preparations,liver and stomach protection should be done.At the same time,pay close attention to various biochemical indicators and the patient's drug response during the treatment process,and,if necessary,deal with it in time so as not to deteriorate the condition.Moreover,active surveillance system should be conducted to monitor ADE/ADR,so as to establish a clearer causal relationship between the drug and the adverse event.
