Article(id=1320438100250178439, tenantId=1146029695717560320, journalId=1319373219989389464, issueId=1320438090615862080, articleNumber=null, orderNo=null, doi=10.11847/zgggws1148301, pmid=null, cstr=null, oa=null, hot=null, price=null, onlineType=0, articleFormat=0, articleType=null, articleTypeStr=null, receivedDate=1750608000000, receivedDateStr=2025-06-23, revisedDate=1756137600000, revisedDateStr=2025-08-26, acceptedDate=1762790400000, acceptedDateStr=2025-11-11, onlineDate=1792746575652, onlineDateStr=2026-10-23, pubDate=1775750400000, pubDateStr=2026-04-10, doiRegisterDate=null, doiRegisterDateStr=null, onlineIssueDate=1792746575652, onlineIssueDateStr=2026-10-23, onlineJustAcceptDate=null, onlineJustAcceptDateStr=null, onlineFirstDate=null, onlineFirstDateStr=null, sourceXml=null, magXml=null, createTime=1792746575652, creator=13701087609, updateTime=1792746575652, updator=13701087609, issue=Issue{id=1320438090615862080, tenantId=1146029695717560320, journalId=1319373219989389464, year='2026', volume='42', issue='4', pageStart='385', pageEnd='512', issueExtLink='null', onlineDate='null', pubDate='1775750400000', pubDateStr='2026-04-10', beforeIssueId=null, nextIssueId=null, price=null, status=1, issueComplete=1, articleOrder=1, issueType=-1, specialIssue=null, createTime=1792746573356, creator='13701087609', updateTime=1792748076043, updator='13701087609', preIssue=null, nextIssue=null, articleTotal=null, ext={EN=IssueExt(id=1320444393430040620, tenantId=1146029695717560320, journalId=1319373219989389464, issueId=1320438090615862080, language=EN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=), CN=IssueExt(id=1320444393430040621, tenantId=1146029695717560320, journalId=1319373219989389464, issueId=1320438090615862080, language=CN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=)}, issueFiles=null, downloadFileDto=null}, startPage=435, endPage=439, ext={EN=ArticleExt(id=1320438100493448072, articleId=1320438100250178439, tenantId=1146029695717560320, journalId=1319373219989389464, language=EN, title=Evaluation of the applicability in China of three overseas simplified assessment models for initiating antiviral therapy in chronic hepatitis B virus carriers:a cross-sectional screening study, columnId=1320427686514770171, journalTitle=Chinese Journal of Public Health, columnName=Survey and Report, runingTitle=null, highlight=null, articleAbstract=
Objective

This study evaluates the applicability of three overseas simplified assessment models–the Treatment Eligibility in Africa for the Hepatitis B Virus (TREAT-B), the Hepatitis B in Africa Collaborative Network (HEPSANET), and the HBeAg, Platelet count, ALT, and Albumin (HePAA) score–for guiding antiviral therapy initiation in chronic hepatitis B virus (HBV) carriers in China. The findings are expected to inform the development of a simplified assessment tool for antiviral therapy initiation tailored to chronic HBV carriers in China.

Methods

The clinical data of 870 chronic HBV carriers who underwent regular follow-up by the Shandong Provincial Center for Disease Control and Prevention in Zhangqiu district, Jinan city, in November 2023 were retrospectively collected. Two hepatitis B specialists from a tertiary-level hospital assessed whether these chronic HBV carriers required antiviral therapy based on the Guidelines for the Prevention and Treatment of Chronic Hepatitis B (2022 Edition), and the assessment results served as the actual values. The simplified assessment models REAT-B, HEPSANET, and HePAA were used to determine whether chronic HBV carriers required antiviral therapy, with the results serving as predicted values. The actual values and predicted values were compared, and the area under the receiver operating characteristic curve (AUROC), sensitivity, and specificity of the three assessment models were calculated to evaluate their discriminatory ability.

Results

Among the 706, 358, and 715 chronic HBV carriers who met the inclusion criteria for the TREAT-B, HEPSANET, and HePAA models, respectively, the number of carriers identified as eligible for antiviral therapy was 562 (79.6%), 282 (78.8%), and 571 (79.9%). The comparison between the predicted values and the actual values showed that REAT-B had the AUROC of 0.640 (95%CI: 0.597–0.683), the sensitivity of 26.3% (95%CI: 22.7%–30.2%), and the specificity of 92.4% (95%CI: 86.7%–96.1%). HEPSANET showed the AUROC of 0.568 (95%CI: 0.520–0.615), the sensitivity of 12.8% (95%CI: 9.1%–17.2%), and the specificity of 94.7% (95%CI: 87.1%–98.5%). HePAA showed the AUROC of 0.590 (95%CI: 0.553–0.625), the sensitivity of 22.8% (95%CI: 19.4%–26.4%), and the specificity of 92.4% (95%CI: 86.7%–96.1%). All the three models exhibited low accuracy in determining antiviral therapy eligibility for the HBV carriers in China.

Conclusions

The predictive accuracy of the REAT-B, HEPSANET, and HePAA models is low in China, and thus they are not suitable for use in China at present.

, authors=Zheng ZHANG1, Yi LIU2, Bingyu YAN2, Yi FENG2, Shuai ZHANG2, Li ZHANG1, 2, authorsList=Zheng ZHANG, Yi LIU, Bingyu YAN, Yi FENG, Shuai ZHANG, Li ZHANG, authorCompany=null, correspAuthors=Li ZHANG, authorNote=null, correspAuthorsNote=
ZHANG Li, E-mail:
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目的

评价非洲乙肝治疗资格评分系统(TREAT-B)、非洲乙肝协作网络(HEPSANET)、泰国乙肝e抗原、血小板计数、丙氨酸氨基转移酶和白蛋白评分系统(HePAA)3种国外已建立的慢性乙型肝炎病毒(HBV)感染者启动抗病毒治疗简易评估模型在中国的适用性,为开发适合我国慢性HBV感染者启动抗病毒治疗的简易评估工具提供参考依据。

方法

回顾性收集山东省疾病预防控制中心2023年11月在山东省济南市章丘区定期随访的870例慢性HBV感染者的临床资料,由2名三级甲等医院乙肝专科医生根据中国《慢性乙型肝炎防治指南(2022年版)》对慢性HBV感染者是否需要抗病毒治疗进行判断,判断结果作为实际值;采用TREAT-B、HEPSANET和HePAA简易评估模型判断慢性HBV感染者是否需要抗病毒治疗,判断结果作为预测值;比较实际值与预测值,计算3种评估模型的受试者工作特征曲线下面积(AUROC)、灵敏度和特异度,评价模型区分度。

结果

符合TREAT-B、HEPSANET和HePAA模型纳入标准的706、358和715例慢性HBV感染者中,符合抗病毒治疗判断抗病毒治疗资格者分别为562例(79.6%)、282例(78.8%)和571例(79.9%);相对于实际值,TREAT-B模型预测的AUROC为0.640(95%CI=0.597~0.683)、灵敏度为26.3%(95%CI=22.7%~30.2%)、特异度为92.4%(95%CI=86.7%~96.1%);HEPSANET模型预测的AUROC为0.568(95%CI=0.520~0.615)、灵敏度为12.8%(95%CI=9.1%~17.2%)、特异度为94.7%(95%CI=87.1%~98.5%);HePAA模型预测的AUROC为0.590(95%CI=0.553~0.625)、灵敏度为22.8%(95%CI=19.4%~26.4%)、特异度为92.4%(95%CI=86.7%~96.1%)。此3种模型判断中国HBV感染者启动抗病毒治疗资格的准确性均较低。

结论

TREAT-B、HEPSANET和HePAA这3种模型在中国使用时的预测准确度较低,不适于我国现阶段使用。

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张政(2001—),硕士在读,研究方向:传染病流行病学

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张丽,E-mail:
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Baseline characteristics of chronic HBV carriers included for different assessment models (categorical data)

, figureFileSmall=null, figureFileBig=null, tableContent=
特征分类TREAT-B模型(n=706)HEPSANET模型(n=358)HePAA模型(n=715)
例数构成比/%例数构成比/%例数构成比/%
性别男性33447.317248.034047.6
女性37252.718652.037552.4
HBeAg阳性9413.34813.49713.6
阴性61286.731086.661886.4
符合指南治疗资格者/例中国指南56279.628278.857179.9
美国指南314.4164.5344.8
欧洲指南11516.35415.111916.6
WHO指南33347.111732.633747.1
), ArticleFig(id=1320438105442726846, tenantId=1146029695717560320, journalId=1319373219989389464, articleId=1320438100250178439, language=CN, label=表1, caption=

纳入各评估模型慢性HBV感染者计数资料一般特征

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特征分类TREAT-B模型(n=706)HEPSANET模型(n=358)HePAA模型(n=715)
例数构成比/%例数构成比/%例数构成比/%
性别男性33447.317248.034047.6
女性37252.718652.037552.4
HBeAg阳性9413.34813.49713.6
阴性61286.731086.661886.4
符合指南治疗资格者/例中国指南56279.628278.857179.9
美国指南314.4164.5344.8
欧洲指南11516.35415.111916.6
WHO指南33347.111732.633747.1
), ArticleFig(id=1320438105514030015, tenantId=1146029695717560320, journalId=1319373219989389464, articleId=1320438100250178439, language=EN, label=Tab.2, caption=

Baseline characteristics of chronic HBV carriers included for different assessment models (continuous data)

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特征TREAT-B模型(n=706)HEPSANET模型(n=358)HePAA模型(n=715)
年龄/岁55(48,66)52(45,61)55(48,66)
丙氨酸氨基转移酶/(U/L)22.00(16.00,33.00)21.55(32.00,16.00)22.00(16.50,33.00)
天门冬氨酸氨基转移酶/(U/L)24.00(20.00,31.00)24.25(20.83,32.00)24.10(20.00,31.00)
白蛋白/(g/L)44.00(38.90,47.00)44.60(39.40,47.93)44.00(38.90,47.00)
血小板计数/(109/L)229(187,270)230(187,268)228(186,270)
), ArticleFig(id=1320438105610499008, tenantId=1146029695717560320, journalId=1319373219989389464, articleId=1320438100250178439, language=CN, label=表2, caption=

纳入各评估模型慢性HBV感染者计量资料一般特征

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特征TREAT-B模型(n=706)HEPSANET模型(n=358)HePAA模型(n=715)
年龄/岁55(48,66)52(45,61)55(48,66)
丙氨酸氨基转移酶/(U/L)22.00(16.00,33.00)21.55(32.00,16.00)22.00(16.50,33.00)
天门冬氨酸氨基转移酶/(U/L)24.00(20.00,31.00)24.25(20.83,32.00)24.10(20.00,31.00)
白蛋白/(g/L)44.00(38.90,47.00)44.60(39.40,47.93)44.00(38.90,47.00)
血小板计数/(109/L)229(187,270)230(187,268)228(186,270)
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Validation results of three simplified assessment models: TREAT-B, HEPSANET, and HePAA

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模型抗病毒治疗指征
判断标准
AUROC
(95%CI)
灵敏度/%
(95%CI)
特异度/%
(95%CI)
阳性预测值/%
(95%CI)
阴性预测值/%
(95%CI)
阳性似然比阴性似然比
TREAT-B中国指南0.640
(0.597~0.683)
26.3
(22.7~30.2)
92.4
(86.7~96.1)
93.1
(88.0~96.5)
24.3
(20.8~28.1)
3.450.80
美国指南0.964
(0.947~0.981)
100
(88.8~100)
81.0
(77.9~83.9)
19.5
(13.6~26.5)
100
(99.3~100)
5.270.00
欧洲指南0.951
(0.933~0.968)
92.2
(85.7~96.4)
91.0
(88.4~93.2)
66.7
(58.8~73.9)
98.4
(96.9~99.2)
10.300.08
WHO指南0.678
(0.641~0.715)
36.6
(31.5~41.8)
90.1
(87.0~93.1)
76.7
(70.2~83.3)
61.4
(57.3~65.5)
3.690.70
HEPSANET中国指南0.568
(0.520~0.615)
12.8
(9.1~17.2)
94.7
(87.1~98.5)
90.0
(76.3~97.2)
22.6
(18.2~27.6)
2.430.92
美国指南0.979
(0.960~0.998)
93.8
(69.8~99.8)
92.7
(89.4~95.2)
37.5
(22.7~54.2)
99.7
(98.3~99.99)
12.830.07
欧洲指南0.824
(0.760~0.888)
48.1
(34.3~62.1)
95.3
(92.4~97.5)
65.0
(48.3~79.4)
91.2
(87.5~94.1)
10.460.54
WHO指南0.667
(0.615~0.718)
24.8
(17.0~32.6)
95.4
(92.8~98.1)
72.5
(58.7~86.3)
72.3
(67.4~77.2)
5.430.79
HePAA中国指南0.590
(0.553~0.625)
22.8
(19.4~26.4)
92.4
(86.7~96.1)
92.2
(86.5~96.0)
23.2
(19.8~26.8)
2.980.84
美国指南0.976
(0.967~0.986)
100
(89.7~100)
84.3
(81.3~86.9)
24.1
(17.3~32.0)
100
(99.4~100)
6.360.00
欧洲指南0.951
(0.937~0.965)
77.3
(68.7~84.5)
91.8
(89.3~93.9)
65.2
(56.8~73.1)
95.3
(93.2~96.9)
9.400.25
WHO指南0.667
(0.615~0.718)
11.1
(5.40~16.8)
98.3
(96.7~100)
76.5
(56.3~96.6)
69.5
(64.6~74.4)
6.690.90
), ArticleFig(id=1320438105769882562, tenantId=1146029695717560320, journalId=1319373219989389464, articleId=1320438100250178439, language=CN, label=表3, caption=

TREAT-B、HEPSANET和HePAA 3种模型验证结果

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模型抗病毒治疗指征
判断标准
AUROC
(95%CI)
灵敏度/%
(95%CI)
特异度/%
(95%CI)
阳性预测值/%
(95%CI)
阴性预测值/%
(95%CI)
阳性似然比阴性似然比
TREAT-B中国指南0.640
(0.597~0.683)
26.3
(22.7~30.2)
92.4
(86.7~96.1)
93.1
(88.0~96.5)
24.3
(20.8~28.1)
3.450.80
美国指南0.964
(0.947~0.981)
100
(88.8~100)
81.0
(77.9~83.9)
19.5
(13.6~26.5)
100
(99.3~100)
5.270.00
欧洲指南0.951
(0.933~0.968)
92.2
(85.7~96.4)
91.0
(88.4~93.2)
66.7
(58.8~73.9)
98.4
(96.9~99.2)
10.300.08
WHO指南0.678
(0.641~0.715)
36.6
(31.5~41.8)
90.1
(87.0~93.1)
76.7
(70.2~83.3)
61.4
(57.3~65.5)
3.690.70
HEPSANET中国指南0.568
(0.520~0.615)
12.8
(9.1~17.2)
94.7
(87.1~98.5)
90.0
(76.3~97.2)
22.6
(18.2~27.6)
2.430.92
美国指南0.979
(0.960~0.998)
93.8
(69.8~99.8)
92.7
(89.4~95.2)
37.5
(22.7~54.2)
99.7
(98.3~99.99)
12.830.07
欧洲指南0.824
(0.760~0.888)
48.1
(34.3~62.1)
95.3
(92.4~97.5)
65.0
(48.3~79.4)
91.2
(87.5~94.1)
10.460.54
WHO指南0.667
(0.615~0.718)
24.8
(17.0~32.6)
95.4
(92.8~98.1)
72.5
(58.7~86.3)
72.3
(67.4~77.2)
5.430.79
HePAA中国指南0.590
(0.553~0.625)
22.8
(19.4~26.4)
92.4
(86.7~96.1)
92.2
(86.5~96.0)
23.2
(19.8~26.8)
2.980.84
美国指南0.976
(0.967~0.986)
100
(89.7~100)
84.3
(81.3~86.9)
24.1
(17.3~32.0)
100
(99.4~100)
6.360.00
欧洲指南0.951
(0.937~0.965)
77.3
(68.7~84.5)
91.8
(89.3~93.9)
65.2
(56.8~73.1)
95.3
(93.2~96.9)
9.400.25
WHO指南0.667
(0.615~0.718)
11.1
(5.40~16.8)
98.3
(96.7~100)
76.5
(56.3~96.6)
69.5
(64.6~74.4)
6.690.90
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张政 1 , 刘毅 2 , 颜丙玉 2 , 冯艺 2 , 张帅 2 , 张丽 1, 2, *, *
中国公共卫生 | 调查报告与分析 2026,42(4): 435-439
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中国公共卫生 |调查报告与分析 2026 , 42 (4) : 435 -439
慢性HBV感染者启动抗病毒治疗3种国外简易评估模型在中国适用性评价:基于筛检设计的横断面研究
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张政1, 刘毅2, 颜丙玉2, 冯艺2, 张帅2, 张丽1, 2, *, *
作者信息
  • 1山东大学公共卫生学院,济南 250012
  • 2山东省疾病预防控制中心免疫预防管理所,济南 250014
通讯作者:
张丽,E-mail:
作者简介:

张政(2001—),硕士在读,研究方向:传染病流行病学

Evaluation of the applicability in China of three overseas simplified assessment models for initiating antiviral therapy in chronic hepatitis B virus carriers:a cross-sectional screening study
Zheng ZHANG1, Yi LIU2, Bingyu YAN2, Yi FENG2, Shuai ZHANG2, Li ZHANG1, 2
Affiliations
  • 1School of Public Health, Shandong University, Jinan 250012, China
  • 2Immunization Department, Shandong Center for Disease Control and Prevention, Jinan 250014, China
  • Corresponding Author:
    ZHANG Li, E-mail:
出版时间: 2026-04-10 doi: 10.11847/zgggws1148301
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目的

评价非洲乙肝治疗资格评分系统(TREAT-B)、非洲乙肝协作网络(HEPSANET)、泰国乙肝e抗原、血小板计数、丙氨酸氨基转移酶和白蛋白评分系统(HePAA)3种国外已建立的慢性乙型肝炎病毒(HBV)感染者启动抗病毒治疗简易评估模型在中国的适用性,为开发适合我国慢性HBV感染者启动抗病毒治疗的简易评估工具提供参考依据。

方法

回顾性收集山东省疾病预防控制中心2023年11月在山东省济南市章丘区定期随访的870例慢性HBV感染者的临床资料,由2名三级甲等医院乙肝专科医生根据中国《慢性乙型肝炎防治指南(2022年版)》对慢性HBV感染者是否需要抗病毒治疗进行判断,判断结果作为实际值;采用TREAT-B、HEPSANET和HePAA简易评估模型判断慢性HBV感染者是否需要抗病毒治疗,判断结果作为预测值;比较实际值与预测值,计算3种评估模型的受试者工作特征曲线下面积(AUROC)、灵敏度和特异度,评价模型区分度。

结果

符合TREAT-B、HEPSANET和HePAA模型纳入标准的706、358和715例慢性HBV感染者中,符合抗病毒治疗判断抗病毒治疗资格者分别为562例(79.6%)、282例(78.8%)和571例(79.9%);相对于实际值,TREAT-B模型预测的AUROC为0.640(95%CI=0.597~0.683)、灵敏度为26.3%(95%CI=22.7%~30.2%)、特异度为92.4%(95%CI=86.7%~96.1%);HEPSANET模型预测的AUROC为0.568(95%CI=0.520~0.615)、灵敏度为12.8%(95%CI=9.1%~17.2%)、特异度为94.7%(95%CI=87.1%~98.5%);HePAA模型预测的AUROC为0.590(95%CI=0.553~0.625)、灵敏度为22.8%(95%CI=19.4%~26.4%)、特异度为92.4%(95%CI=86.7%~96.1%)。此3种模型判断中国HBV感染者启动抗病毒治疗资格的准确性均较低。

结论

TREAT-B、HEPSANET和HePAA这3种模型在中国使用时的预测准确度较低,不适于我国现阶段使用。

慢性乙型肝炎病毒(HBV)  /  感染者  /  抗病毒治疗  /  资格  /  简易评估模型  /  适用性评价  /  中国
Objective

This study evaluates the applicability of three overseas simplified assessment models–the Treatment Eligibility in Africa for the Hepatitis B Virus (TREAT-B), the Hepatitis B in Africa Collaborative Network (HEPSANET), and the HBeAg, Platelet count, ALT, and Albumin (HePAA) score–for guiding antiviral therapy initiation in chronic hepatitis B virus (HBV) carriers in China. The findings are expected to inform the development of a simplified assessment tool for antiviral therapy initiation tailored to chronic HBV carriers in China.

Methods

The clinical data of 870 chronic HBV carriers who underwent regular follow-up by the Shandong Provincial Center for Disease Control and Prevention in Zhangqiu district, Jinan city, in November 2023 were retrospectively collected. Two hepatitis B specialists from a tertiary-level hospital assessed whether these chronic HBV carriers required antiviral therapy based on the Guidelines for the Prevention and Treatment of Chronic Hepatitis B (2022 Edition), and the assessment results served as the actual values. The simplified assessment models REAT-B, HEPSANET, and HePAA were used to determine whether chronic HBV carriers required antiviral therapy, with the results serving as predicted values. The actual values and predicted values were compared, and the area under the receiver operating characteristic curve (AUROC), sensitivity, and specificity of the three assessment models were calculated to evaluate their discriminatory ability.

Results

Among the 706, 358, and 715 chronic HBV carriers who met the inclusion criteria for the TREAT-B, HEPSANET, and HePAA models, respectively, the number of carriers identified as eligible for antiviral therapy was 562 (79.6%), 282 (78.8%), and 571 (79.9%). The comparison between the predicted values and the actual values showed that REAT-B had the AUROC of 0.640 (95%CI: 0.597–0.683), the sensitivity of 26.3% (95%CI: 22.7%–30.2%), and the specificity of 92.4% (95%CI: 86.7%–96.1%). HEPSANET showed the AUROC of 0.568 (95%CI: 0.520–0.615), the sensitivity of 12.8% (95%CI: 9.1%–17.2%), and the specificity of 94.7% (95%CI: 87.1%–98.5%). HePAA showed the AUROC of 0.590 (95%CI: 0.553–0.625), the sensitivity of 22.8% (95%CI: 19.4%–26.4%), and the specificity of 92.4% (95%CI: 86.7%–96.1%). All the three models exhibited low accuracy in determining antiviral therapy eligibility for the HBV carriers in China.

Conclusions

The predictive accuracy of the REAT-B, HEPSANET, and HePAA models is low in China, and thus they are not suitable for use in China at present.

chronic hepatitis B virus (HBV)  /  carrier  /  antiviral therapy  /  eligibility  /  simplified assessment model  /  evaluation of adaptability  /  China
张政, 刘毅, 颜丙玉, 冯艺, 张帅, 张丽. 慢性HBV感染者启动抗病毒治疗3种国外简易评估模型在中国适用性评价:基于筛检设计的横断面研究. 中国公共卫生, 2026 , 42 (4) : 435 -439 . DOI: 10.11847/zgggws1148301
Zheng ZHANG, Yi LIU, Bingyu YAN, Yi FENG, Shuai ZHANG, Li ZHANG. Evaluation of the applicability in China of three overseas simplified assessment models for initiating antiviral therapy in chronic hepatitis B virus carriers:a cross-sectional screening study[J]. Chinese Journal of Public Health, 2026 , 42 (4) : 435 -439 . DOI: 10.11847/zgggws1148301
2022年研究显示,全球有慢性乙型肝炎病毒(hepatitis B virus, HBV)感染者2.57亿[1],若不进行抗病毒治疗,约15%~40%的慢性HBV感染者将发展为肝硬化或肝细胞癌[2]。2016年,世界卫生组织(World Health Organization, WHO)提出“2030年消除病毒性肝炎作为公共卫生危害”的目标[3],要求到2030年慢性HBV感染者抗病毒治疗率达80%[4]。中国是HBV感染的高发国家[5],乙肝仍是我国最主要的卫生问题之一[6],目前我国抗病毒治疗率仅为17.33%[7],距WHO要求的80%的抗病毒治疗率[4]差距较大。有研究表明,在医疗资源有限的地区,评估慢性HBV感染者抗病毒治疗资格模型的可用性是开始治疗的重大障碍[8],目前国外已报道了3种抗病毒治疗资格评估简易模型,分别是针对非洲地区开发的乙肝治疗资格评分系统(Treatment Eligibility in Africa for The Hepatitis B Virus, TREAT-B)[9]、非洲乙肝协作网络(Hepatitis B in Africa Collaborative Network, HEPSANET)[10]和针对泰国地区开发的乙肝e抗原、血小板计数、丙氨酸氨基转移酶和白蛋白评分系统(Hepatitis B e Antigen, Platelet Count, ALT, and Albumin Score, HePAA)[11],而我国尚未开发出基层适用的抗病毒治疗资格评估模型。为评价TREAT-B、HEPSANET和HePAA 3种国外已建立的慢性HBV感染者启动抗病毒治疗简易评估模型在中国的适用性,为开发适合我国慢性HBV感染者启动抗病毒治疗的简易评估工具提供参考依据,本研究回顾性收集山东省疾病预防控制中心2023年11月在山东省济南市章丘区定期随访的870例慢性HBV感染者的临床资料,由2名三级甲等医院乙肝专科医生以我国《慢性乙型肝炎防治指南(2022年版)》[12]作为是否需要抗病毒治疗的金标准,与此3种国外简易评估模型判断慢性HBV感染者是否需要抗病毒治疗的结果进行比较,计算评估模型的受试者工作特征曲线下面积(area under the receiver operating characteristic curve, AUROC)、灵敏度和特异度,评价模型的区分度。结果报告如下。
回顾性收集山东省疾病预防控制中心2023年11月在济南市章丘区定期随访的870例慢性HBV感染者的临床资料,内容包括性别、疾病史、家族史、抗HBV治疗情况、乙肝相关症状、体征检查、腹部B超检查、血常规检测(血小板计数等)和肝功能(包括乙型肝炎病毒E抗原、丙氨酸氨基转移酶、天门冬氨酸氨基转移酶、白蛋白等)。本研究经山东省疾病预防控制中心伦理委员会审查批准,批号为:SDJK(K)2025-025-01。
纳入排除标准按照模型开发时制定的标准。TREAT-B模型的纳入标准为乙肝病毒表面抗原阳性的成年人,排除标准为肝硬化或肝癌患者、妊娠期妇女、既往接受过抗HBV治疗者以及临床或病毒学资料缺失的个体[9];HEPSANET模型的纳入标准为既往或目前无抗HBV治疗、纤维化分期确定且性别、血小板计数、乙肝病毒脱氧核糖核酸(hepatitis B virus deoxyribonucleic acid,HBV DNA)水平等资料完整的成年人,排除标准为肝硬化患者、存在肝硬化或肝细胞癌家族史者以及既往代谢紊乱(如糖尿病、肝脂肪变性、高血压、高脂血症)者[10];HePAA模型的纳入标准为慢性HBV单一感染的成年患者,排除标准为既往接受过抗HBV治疗者、肝癌患者和妊娠期妇女[11]。
由2名山东省三甲医院肝病专家分别根据美国肝病研究协会指南(简称“美国指南”)[13]、欧洲肝脏研究协会指南(简称“欧洲指南”)[2]、《慢性乙型肝炎患者的预防、诊断、关怀和治疗指南》(简称“WHO指南”)[14]和我国《慢性乙型肝炎防治指南(2022年版)》(简称“中国指南”)[12]对慢性HBV感染者是否需要启动治疗进行判断,若专家意见不一致,则由第3名专家对慢性HBV感染者重新进行全面评估,包括疾病史、实验室检测(如HBV DNA定量、肝功能指标等)和影像学检查等,明确专家意见分歧点及产生分歧的原因后再进行判断,根据模型对慢性HBV感染者的治疗资格进行评估。TREAT-B模型纳入变量为乙型肝炎病毒E抗原(hepatitis B virus e antigen,HBeAg)和丙氨酸氨基转移酶,评分标准为HBeAg阴性得0分、阳性得1分,丙氨酸氨基转移酶<20得0分、20~39得1分、40~79得2分、≥80得3分,总分≥2分建议进行抗病毒治疗,总分<2分则暂不建议,但需定期监测[9];HEPSANET模型纳入变量为丙氨酸氨基转移酶、天门冬氨酸氨基转移酶、血小板计数和HBeAg,丙氨酸氨基转移酶<40得0分、40~79得1分、≥80得2分,天门冬氨酸氨基转移酶<40得0分、40~79得1分、≥80得2分,血小板计数<100得2分、100~149得1分、≥150得0分,总分≥2分认为符合抗病毒治疗资格,总分<2分则不符合[10]。HePAA模型纳入变量为HBeAg、血小板计数、丙氨酸氨基转移酶和白蛋白,评分标准为HBeAg阴性得0分、阳性得1分,血小板计数<150得1分、≥150得0分,丙氨酸氨基转移酶<30得0分、30~39得1分、40~49得2分、≥50得3分,白蛋白<4得1分、≥4得0分,总分≥3分建议进行抗病毒治疗,总分<3分则暂不建议,但需定期监测[11]。由研究人员根据3种评估模型的评分标准计算得分,按照模型推荐的截断值,根据得分判断慢性HBV感染者是否需要启动抗病毒治疗。
应用SPSS 26.0和R 4.4.1软件进行数据处理和统计分析。计数资料采用数n和%表示,计量资料因不符合正态分布采用M(P25,P75)表示。以中国指南作为金标准,使用pROC包计算不同评估模型的AUROC,使用caret包计算灵敏度、特异度、阳性预测值、阴性预测值、阳性似然比和阴性似然比,同时以美国指南、欧洲指南和WHO指南作为启动抗病毒治疗的标准对3种评估模型进行验证,AUROC值0.50~0.70为准确度较低,0.71~0.90为准确度中等,>0.90为准确度较高[15]。
2023年济南市章丘区定期随访的870例慢性HBV感染者中,纳入TREAT-B、HEPSANET和HePAA模型者分别为706、358和715例,纳入各评估模型慢性HBV感染者一般特征见表1和表2。
以中国指南作为判断是否需要抗病毒治疗的金标准,纳入TREAT-B、HEPSANET和HePAA模型的慢性HBV感染者中符合抗病毒治疗判断抗病毒治疗资格者分别为562例(79.6%)、228例(63.7%)和571例(79.9%);纳入TREAT-B模型的慢性HBV感染者中得0分者259例(36.7%),得1分者288例(40.8%),得2分者103例(14.6%),得3分者49例(6.9%),得4分者7例(1.0%);纳入HEPSANET模型的慢性HBV感染者中得0分者269例(75.2%),得1分者49例(13.7%),得2分者23例(6.4%),得3分者8例(2.2%),得4分者5例(1.4%),得5分者4例(1.1%);纳入HePAA模型慢性HBV感染者中得1分者473例(66.2%),得2分者101例(14.1%),得3分者64例(8.9%),得4分者47例(6.6%),得5分者30例(4.2%)。相较于实际值,TREAT-B、HEPSANET和HePAA 3种模型判断中国HBV感染者启动抗病毒治疗资格的准确性均较低。
2024年中国血清流行病学调查结果显示,中国1~69岁人群乙肝表面抗原(hepatitis B surface antigen, HBsAg)阳性率为5.86%,现有慢性HBV感染者7500万[7]。2023年5月,中华医学会发布的《慢性乙型肝炎防治指南(2022年版)》[12]进一步扩大了慢性HBV感染者抗病毒治疗指征,推测我国应治已治的慢性HBV感染者比例将进一步下降。中国作为世界上乙肝负担较重的国家,将成为实现2030年全球消除乙肝目标的重要力量[16]。我国新版指南对慢性HBV感染者抗病毒治疗资格需要根据HBV DNA、肝脏组织学等指标判断,但基层医疗单位多数不具备以上检测条件,从而无法及时对需要进行抗病毒治疗者进行治疗,因此探索适合我国慢性HBV感染者的启动抗病毒治疗简易评估模型十分必要。截至目前,国际仅开发了TREAT-B[9]、HEPSANET[10]和HePAA[11] 3个慢性HBV感染者抗病毒治疗的简易评估模型,其中HEPSANET模型分为Tier0/1、Tier2和Tier3三级,由于Tier0/1是在有肝硬化或肝细胞癌家族史及临床诊断为黄疸患者中根据性别直接判断是否需要抗病毒治疗,Tier3是针对省级医疗机构开发,并不适合我国基层使用,因此本研究未对Tier0/1和Tier3进行验证,仅对针对基层医疗机构开发的Tier2进行了验证。
本研究收集了2023年济南市章丘区定期随访的慢性HBV感染者的数据,按照评估模型开发时制定的纳入排除标准进行筛选后,根据中国指南、美国指南、欧洲指南和WHO指南对TREAT-B、HEPSANET和HePAA 这3种乙肝治疗指征评估简易评分模型进行评价,结果显示,由于各国家或地区的慢性HBV感染者人口学特征不同或治疗理念略有不同,其推荐的适应证也略有不同,所以在使用不同指南作为标准对评估模型进行评价时结果也略有不同。在使用美国指南和欧洲指南作为标准对模型进行评估时3种模型的准确性、灵敏度和特异度均较好,在使用WHO指南作为标准对模型进行评估时3种模型的准确度和灵敏度较差,特异度较好,与既往研究[8–11, 17–24]结果相似。如,TREAT-B模型在以欧洲指南为金标准的非洲、欧洲和澳大利亚等地区的验证中,AUROC为0.76~0.89[9, 20–21, 23–24];在泰国以美国指南为金标准的验证中,TREAT-B模型的AUROC为0.80[8];在越南、泰国和欧洲等国家和地区以WHO指南为金标准的验证中,TREAT-B模型的AUROC为0.61~0.69[8, 17, 19, 21, 24];Geeratragool T等[11]在泰国地区以欧洲指南为金标准对HePAA模型的验证中,推导集和验证集的AUROC分别为0.932和0.878;Minier N等[10]在非洲地区以欧洲指南为金标准对HEPSANET模型的验证中,推导集和验证集的AUROC分别为0.88和0.83。而在使用中国指南作为金标准时,由于中国指南中抗病毒治疗适应证与上述3种指南差距较大,故虽然3种评估模型的特异度较好,但其准确度和灵敏度均较差,这就会导致在国内使用上述评估模型会使得较多需要抗病毒治疗的慢性HBV感染者被漏诊,从而增加肝硬化或肝癌的风险,加重我国慢性HBV感染者的疾病负担。因此,3种国外已建立的慢性HBV感染者启动抗病毒治疗简易评估模型并不适合我国现阶段使用。
本研究存在一定的局限性:第一,缺乏慢性HBV感染者的一级肝硬化或肝细胞癌家族史数据,但在患者纳入排除阶段已经排除了有肝硬化或肝细胞癌家族史者,因此对验证结果的影响不大;第二,未排除合并丙型肝炎病毒(hepatitis C virus,HCV)、丁型肝炎病毒(hepatitis D virus,HDV)或艾滋病病毒(human immunodeficiency virus ,HIV)感染者,但有研究表明HBV感染者中HIV阳性率为1.3‰[25]、HCV阳性率为5%~20%[26]、HDV阳性率为0.28%~1.81%[27],提示HBV感染者中合并感染HIV、HCV、HDV的患者比例并不大,因此亦不会对本研究验证结果产生影响。
综上所述,本研究通过对国外已建立的TREAT-B、HEPSANET和HePAA 3种慢性HBV感染者启动抗病毒治疗简易评估模型在中国慢性HBV感染者中的适用性验证,揭示了此3种评估模型现阶段在我国人群中并不适用。下一步计划开发专为中国慢性HBV感染者设计的简易评估模型,该模型将结合中国最新指南的治疗标准,利用易于获取的临床指标(如天门冬氨酸氨基转移酶和丙氨酸氨基转移酶等),并优化评估模型的准确性和适用性,确保其能够有效识别需要抗病毒治疗的慢性HBV感染者,同时减少漏诊和误诊。

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2026年第42卷第4期
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doi: 10.11847/zgggws1148301
  • 接收时间:2025-06-23
  • 首发时间:2026-10-23
  • 出版时间:2026-04-10
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  • 收稿日期:2025-06-23
  • 修回日期:2025-08-26
  • 录用日期:2025-11-11
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    1山东大学公共卫生学院,济南 250012
    2山东省疾病预防控制中心免疫预防管理所,济南 250014

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2种不同金属材料的力学参数
科
Family
属数
Number of
genus
种数
Number of
species
占总种数比例
Percentage of
total species (%)
属
Genus
种数
Number of
species
占总种数比例
Percentage of total
species (%)
鹅膏菌科Amanitaceae 2 11 5.26 鹅膏菌属 Amanita 10 4.78
小菇科 Mycenaceae 2 12 5.74 丝盖伞属 Inocybe 5 2.39
多孔菌科 Polyporaceae 8 14 6.70 蜡蘑属 Laccaria 5 2.39
红菇科 Russulaceae 3 23 11.00 小皮伞属 Marasmius 6 2.87
小菇属 Mycena 11 5.26
光柄菇属 Pluteus 5 2.39
红菇属 Russula 17 8.13
栓菌属 Trametes 5 2.39
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