中华检验医学杂志
中華檢驗醫學雜誌
중화검험의학잡지
CHINESE JOURNAL OF LABORATORY MEDICINE
2014年
2期
96-99
,共4页
李德忠%曾勇彬%苏明宽%刘灿%林锦骠%陈添彬%杨滨%欧启水
李德忠%曾勇彬%囌明寬%劉燦%林錦驃%陳添彬%楊濱%歐啟水
리덕충%증용빈%소명관%류찬%림금표%진첨빈%양빈%구계수
肝炎,乙型,慢性%肝炎表面抗原,乙型%肝炎e抗原,乙型%鸟嘌呤
肝炎,乙型,慢性%肝炎錶麵抗原,乙型%肝炎e抗原,乙型%鳥嘌呤
간염,을형,만성%간염표면항원,을형%간염e항원,을형%조표령
Hepatitis B chronic%Hepatitis B surface antigen%Hepatitis B e antigen%Guanine
目的 监测HBsAg浓度在恩替卡韦(ETV)治疗的HBeAg阳性的慢性乙型肝炎(CHB)患者血清中的动态变化,探讨其对治疗反应的预测价值.方法 回顾性研究.选择2011年1月至2013年7月在福建医科大学附属第一医院肝病中心住院及门诊接受ETV治疗(0.5 mg/d)的HBeAg阳性CHB患者26例,并进行1年的随访研究；于抗病毒治疗的0、3、6、9、12个月分别收集血清；化学发光法定量检测各时间点的HBsAg、HBeAg浓度；实时荧光PCR定量检测血清HBV DNA载量；速率法检测ALT含量；1年病毒学应答定义为抗病毒治疗1年后血清HBV DNA低于检测下限(500 IU/rnl)；统计学分析采用正态性检验、t检验、x2检验、相关性程度分析、绘制ROC曲线.结果 17例患者发生病毒学应答(VR+),9例未发生病毒学应答(VR-)；基线ALT水平VR+组](141.82±77.29) IU/ml]与VR-组[(134.20 ±49.76) IU/ml]无明显差别(t=0.27,P=0.793)；HBV DNA VR+组[(6.76±1.00) lg IU/ml]明显低于VR-组[(7.65±0.87) lg IU/ml](t=-2.27,P=0.033)；HBsAg浓度VR+组[(3.79 ±0.61) lg IU/ml]与VR-组[(4.19 ±0.43) lg IU/ml]无明显差别(t=-1.75,P=0.094)；HBsAg与HBV DNA水平呈正相关(r=0.45,P=0.02).HBsAg在治疗开始的前3个月下降较快,3个月后下降较缓慢.从基线到治疗3个月时,VR+组HBsAg平均下降(0.32±0.29) lg IU/ml,VR-组下降(0.14±0.10) lg IU/ml,差异具有统计学意义(t=2.245,P=0.035)；治疗3个月时lg HBsAg浓度的ROC曲线下面积最大(AUC=0.840,P=0.022),临界值3.865 0 lg IU/ml的Youden指数最大(0.602),其诊断敏感度为82.4％,特异度为77.8％ 结论 ETV治疗3个月时lg HBsAg≤3.865 0 IU/ml可作为预测ETV治疗1年病毒学应答的指标.
目的 鑑測HBsAg濃度在恩替卡韋(ETV)治療的HBeAg暘性的慢性乙型肝炎(CHB)患者血清中的動態變化,探討其對治療反應的預測價值.方法 迴顧性研究.選擇2011年1月至2013年7月在福建醫科大學附屬第一醫院肝病中心住院及門診接受ETV治療(0.5 mg/d)的HBeAg暘性CHB患者26例,併進行1年的隨訪研究；于抗病毒治療的0、3、6、9、12箇月分彆收集血清；化學髮光法定量檢測各時間點的HBsAg、HBeAg濃度；實時熒光PCR定量檢測血清HBV DNA載量；速率法檢測ALT含量；1年病毒學應答定義為抗病毒治療1年後血清HBV DNA低于檢測下限(500 IU/rnl)；統計學分析採用正態性檢驗、t檢驗、x2檢驗、相關性程度分析、繪製ROC麯線.結果 17例患者髮生病毒學應答(VR+),9例未髮生病毒學應答(VR-)；基線ALT水平VR+組](141.82±77.29) IU/ml]與VR-組[(134.20 ±49.76) IU/ml]無明顯差彆(t=0.27,P=0.793)；HBV DNA VR+組[(6.76±1.00) lg IU/ml]明顯低于VR-組[(7.65±0.87) lg IU/ml](t=-2.27,P=0.033)；HBsAg濃度VR+組[(3.79 ±0.61) lg IU/ml]與VR-組[(4.19 ±0.43) lg IU/ml]無明顯差彆(t=-1.75,P=0.094)；HBsAg與HBV DNA水平呈正相關(r=0.45,P=0.02).HBsAg在治療開始的前3箇月下降較快,3箇月後下降較緩慢.從基線到治療3箇月時,VR+組HBsAg平均下降(0.32±0.29) lg IU/ml,VR-組下降(0.14±0.10) lg IU/ml,差異具有統計學意義(t=2.245,P=0.035)；治療3箇月時lg HBsAg濃度的ROC麯線下麵積最大(AUC=0.840,P=0.022),臨界值3.865 0 lg IU/ml的Youden指數最大(0.602),其診斷敏感度為82.4％,特異度為77.8％ 結論 ETV治療3箇月時lg HBsAg≤3.865 0 IU/ml可作為預測ETV治療1年病毒學應答的指標.
목적 감측HBsAg농도재은체잡위(ETV)치료적HBeAg양성적만성을형간염(CHB)환자혈청중적동태변화,탐토기대치료반응적예측개치.방법 회고성연구.선택2011년1월지2013년7월재복건의과대학부속제일의원간병중심주원급문진접수ETV치료(0.5 mg/d)적HBeAg양성CHB환자26례,병진행1년적수방연구；우항병독치료적0、3、6、9、12개월분별수집혈청；화학발광법정량검측각시간점적HBsAg、HBeAg농도；실시형광PCR정량검측혈청HBV DNA재량；속솔법검측ALT함량；1년병독학응답정의위항병독치료1년후혈청HBV DNA저우검측하한(500 IU/rnl)；통계학분석채용정태성검험、t검험、x2검험、상관성정도분석、회제ROC곡선.결과 17례환자발생병독학응답(VR+),9례미발생병독학응답(VR-)；기선ALT수평VR+조](141.82±77.29) IU/ml]여VR-조[(134.20 ±49.76) IU/ml]무명현차별(t=0.27,P=0.793)；HBV DNA VR+조[(6.76±1.00) lg IU/ml]명현저우VR-조[(7.65±0.87) lg IU/ml](t=-2.27,P=0.033)；HBsAg농도VR+조[(3.79 ±0.61) lg IU/ml]여VR-조[(4.19 ±0.43) lg IU/ml]무명현차별(t=-1.75,P=0.094)；HBsAg여HBV DNA수평정정상관(r=0.45,P=0.02).HBsAg재치료개시적전3개월하강교쾌,3개월후하강교완만.종기선도치료3개월시,VR+조HBsAg평균하강(0.32±0.29) lg IU/ml,VR-조하강(0.14±0.10) lg IU/ml,차이구유통계학의의(t=2.245,P=0.035)；치료3개월시lg HBsAg농도적ROC곡선하면적최대(AUC=0.840,P=0.022),림계치3.865 0 lg IU/ml적Youden지수최대(0.602),기진단민감도위82.4％,특이도위77.8％ 결론 ETV치료3개월시lg HBsAg≤3.865 0 IU/ml가작위예측ETV치료1년병독학응답적지표.
Objective To monitor the dynamic changes of quantitative hepatitis B surface antigen concentrations in HBeAg-positive treatment-naive CHB patients and to investigate its potential role in predicting virological response to entecavir therapy.Methods This was a retrospective study.26 HBeAg-positive treatment-naive CHB patients receiving ETV (0.5 mg once a day) were consecutively recruited and followed up for 1 year from the Center of Liver diseases of the First Affiliated Hospital of Fujian Medical University between January 2011 and July 2013.Serums samples were collected at baseline and every 3 months (month 3,month 6,month 9 and month 12,respectively).HBsAg and HBeAg concentrations were measured using commercially available chemiluminescence assay.HBV DNA levels were determined by realtime polymerase chain reaction.ALT levels were measured by velocity method.A VR(virological response)was defined as HBV DNA levels decreased to less than 500 IU/ml through 1 year of ETV treatment.The statistical analyses including Student t-test,x2-test,ROC curve analysis,etc.were performed using statistical analysis software SPSS version 16.0 and GraphPad Prism software version 5.0.Results After 1 year of treatment,17 patients achieved VR,9 patients didn't.Baseline characteristics of the patients were as follows:there was no significant difference of ALT levels between the VR + group and VR-group (141.82 ± 77.29 IU/ml and 134.2 ± 49.76 IU/ml,respectively,t =0.27,P =0.793).HBV DNA levels of VR +group was signi? cantly lower than that of the VR-group (6.76 ± 1.00 lg IU/ml and 7.65 ±0.87 lg IU/ml,respectively,t =-2.27,P =0.033).HBsAg concentration of the VR + group was lower than that of the VR-group,but showed no-statistically significant (3.79 ±0.61 lg IU/ml and 4.19 ±0.43 lg IU/ml,respectively,t =-1.75 P =0.094).A rapid decline in HBsAg concentration during the first 3 months of therapy followed by a much slower decline in the subsequent period was observed.From baseline to month 3,the reductions of HBsAg concentration were 0.32 ± 0.29 and 0.14 ± 0.10 lg IU/ml in VR + and VR-groups (t =2.245,P =0.035),respectively.The lg HBsAg concentration at month 3 showed the biggest area under the curve (AUC) (AUC =0.840,P =0.005).The best cut-off value for the HBsAg concentration at month 3 for the prediction of VR was 3.8650 lg IU/ml,with a diagnostic sensitivity and specificity of 82.4％ and 77.8％,respectively.Conclusions HBsAg level less than or equal to 3.8650 lg IU/ml at month 3 of ETV treatment may be a useful parameter in predicting virological response to ETV in HBeAg-positive CHB patients.
