摘要:目的代償期乙型肝炎肝硬化顯著門靜脈高壓患者發(fā)生食管胃靜脈曲張(GOV)風(fēng)險(xiǎn)較大,通過評(píng)價(jià)不同無創(chuàng)診斷模型對(duì)GOV的診斷價(jià)值,為早期診斷GOV提供依據(jù)。方法選取2017年11月—2023年11月廣東省中醫(yī)院就診的代償期乙型肝炎肝硬化顯著門靜脈高壓患者108例,根據(jù)胃鏡下是否伴發(fā)GOV將患者分為GOV組和非GOV組(NGOV組)。收集患者的年齡、性別、影像學(xué)、實(shí)驗(yàn)室指標(biāo)等結(jié)果。計(jì)數(shù)資料組間比較采用χ2檢驗(yàn);正態(tài)分布的計(jì)量資料兩組間比較采用成組t檢驗(yàn);非正態(tài)分布的數(shù)據(jù)兩組間比較采用Mann-Whitney U檢驗(yàn)。采用受試者操作特征曲線(ROC曲線)評(píng)估FIB-4、LOK指數(shù)、LPRI、APRI、AAR等5種評(píng)分模型的診斷價(jià)值;利用二元Logistic回歸構(gòu)建聯(lián)合模型,將聯(lián)合模型與5種評(píng)分模型單獨(dú)應(yīng)用時(shí)的ROC曲線下面積(AUC)比較;采用Delong檢驗(yàn)對(duì)各無創(chuàng)診斷模型的AUC值進(jìn)行兩兩比較。結(jié)果GOV組55例,NGOV組53例。GOV組的年齡高于NGOV組[(52.64±1.44)歲vs(47.96±1.68)歲],ALT[42.00(24.00~117.00)U/L vs 82.00(46.00~271.00)U/L]、AST[44.00(32.00~96.00)U/L vs 62.00(42.50~154.50)U/L]、PLT[100.00(69.00~120.00)×109/L vs 119.00(108.50~140.50)×109/L]低于NGOV組,差異均有統(tǒng)計(jì)學(xué)意義(統(tǒng)計(jì)值分別為3.230、?3.065、?2.351、?3.667,P值均lt;0.05)。ROC曲線分析顯示,F(xiàn)IB-4、LOK指數(shù)、LPRI、AAR單獨(dú)診斷GOV的AUC分別為0.667、0.681、0.730、0.639(P值均lt;0.05),GOV陽性診斷率分別為69.97%、65.28%、67.33%、58.86%,AUC值比較差異均無統(tǒng)計(jì)學(xué)意義(P值均gt;0.05),APRI單獨(dú)應(yīng)用無診斷價(jià)值(Pgt;0.05)。利用二元Logistic回歸構(gòu)建聯(lián)合模型LAF,AUC為0.805,GOV陽性診斷率為75.80%,明顯高于FIB-4、LOK指數(shù)、LPRI、AAR單獨(dú)應(yīng)用時(shí)的AUC值(Z值分別為?2.773、?2.479、?2.206、?2.672,P值均lt;0.05)。結(jié)論FIB-4、LOK指數(shù)、LPRI、AAR對(duì)代償期乙型肝炎肝硬化顯著門靜脈高壓患者發(fā)生GOV診斷價(jià)值相似,APRI單獨(dú)應(yīng)用無診斷價(jià)值,聯(lián)合模型LAF的診斷效能最佳,對(duì)臨床推廣和應(yīng)用具有一定參考價(jià)值。
關(guān)鍵詞:肝硬化;乙型肝炎;高血壓,門靜脈;食管和胃靜脈曲張
基金項(xiàng)目:國(guó)家“十三五”重大傳染病專項(xiàng)課題(2018ZX10725506-003,2018ZX10725505-004);廣東省中醫(yī)藥防治難治性慢病重點(diǎn)實(shí)驗(yàn)室項(xiàng)目(中醫(yī)二院[2023]200號(hào));廣東省自然科學(xué)基金(2022A1515220188,2023A1515011092,2022A1515110825);廣東省院內(nèi)專項(xiàng)(YN10101903,YN2016XP03,YN2022DB04,YN2023MB04);池曉玲國(guó)家中醫(yī)藥管理局名老中醫(yī)藥專家傳承工作室項(xiàng)目(國(guó)中醫(yī)藥人教函[2022]75號(hào));第五批全國(guó)中醫(yī)臨床優(yōu)秀人才研修項(xiàng)目(國(guó)中醫(yī)藥人教函[2022]1號(hào))
Value of different noninvasive diagnostic models in the diagnosis of esophageal and gastric varices with significant portal hypertension in compensated hepatitis B cirrhosis
LIU Cheng1,ZENG Jiayi1,F(xiàn)ANG Mengbing1,CHEN Zhiheng1,GUI Bei1,ZHAO Fengming1,YUAN Jingkai1,ZHANG Chaozhen2,SHI Meijie2,XIE Yubao2,CHI Xiaoling2,XIAO Huanming2
1.The Second Clinical Medical College of Guangzhou University of Chinese Medicine,Guangzhou 510006,China;2.The Liver Department,Guangdong Provincial Hospital of Traditional Chinese Medicine,The Second Affiliated Hospital of Guangzhou University of Chinese Medicine,Guangzhou 510006,China
Corresponding author:XIAO Huanming,xiaohuanming@163.com(ORCID:0000-0002-8739-0720)
Abstract:Objective To investigate the value of different noninvasive diagnostic models in the diagnosis of esophageal and gastric varices since there is a high risk of esophageal and gastric varices in patients with compensated hepatitis B cirrhosis and significant portal hypertension,and to provide a basis for the early diagnosis of esophageal and gastric varices.Methods A total of 108 patients with significant portal hypertension due to compensated hepatitis B cirrhosis who attended Guangdong Provincial Hospital of Traditional Chinese Medicine from November 2017 to November 2023 were enrolled,and according to the presence or absence of esophageal and gastric varices under gastroscopy,they were divided into esophageal and gastric varices group(GOV group)and non-esophageal and gastric varices group(NGOV group).Related data were collected,including age,sex,imaging findings,and laboratory markers.The chi-square test was used for comparison of categorical data between groups;the least significant difference t-test was used for comparison of normally distributed continuous data between groups,and the Mann-Whitney U test was used for comparison of non-normally distributed continuous data between groups.The receiver operating characteristic(ROC)curve was plotted to evaluate the diagnostic value of five scoring models,i.e.,fibrosis-4(FIB-4),LOK index,LPRI,aspartate aminotransferase-to-platelet ratio index(APRI),and aspartate aminotransferase/alanine aminotransferase ratio(AAR).The binary logistic regression method was used to establish a combined model,and the area under the ROC curve(AUC)was compared between the combined model and each scoring model used alone.The Delong test was used to compare the AUC value between any two noninvasive diagnostic models.Results There were 55 patients in the GOV group and 53 patients in the NGOV group.Compared with the NGOV group,the GOV group had a significantly higher age(52.64±1.44 years vs 47.96±1.68 years,t=0.453,Plt;0.05)and significantly lower levels of alanine aminotransferase[42.00(24.00—17.00)U/L vs 82.00(46.00—271.00)U/L,Z=?3.065,Plt;0.05],aspartate aminotransferase[44.00(32.00—96.00)U/L vs 62.00(42.50—154.50)U/L,Z=?2.351,Plt;0.05],and platelet count[100.00(69.00—120.00)×109/L vs 119.00(108.50—140.50)×109/L,Z=?3.667,Plt;0.05].The ROC curve analysis showed that FIB-4,LOK index,LPRI,and AAR used alone had an accuracy of 0.667,0.681,0.730,and 0.639,respectively,in the diagnosis of esophageal and gastric varices(all Plt;0.05),and the positive diagnostic rates of GOV were 69.97%,65.28%,67.33%,and 58.86%,respectively,with no significant differences in AUC values(all Pgt;0.05),while APRI used alone had no diagnostic value(Pgt;0.05).A combined model(LAF)was established based on the binary logistic regression analysis and had an AUC of 0.805 and a positive diagnostic rate of GOV of 75.80%,with a significantly higher AUC than FIB-4,LOK index,LPRI,and AAR used alone(Z=?2.773,?2.479,?2.206,and?2.672,all Plt;0.05).Conclusion FIB-4,LOK index,LPRI,and AAR have a similar diagnostic value for esophageal and gastric varices in patients with compensated hepatitis B cirrhosis and significant portal hypertension,and APRI alone has no diagnostic value.The combined model LAF had the best diagnostic efficacy,which provides a certain reference for clinical promotion and application.
Key words:Liver Cirrhosis;Hepatitis B;Hypertension,Portal;Esophageal and Gastric Varices
Research funding:The Thirteenth Five-Year Plan for Major and Special Programs of the National Science and Technologyof China(2018ZX10725506-003,2018ZX10725505-004);Guangdong Provincial Key Laboratory of Chinese Medicine for Prevention and Treatment of Refractory Chronic Diseases(the Second Hospital of Chinese Medicine[2023]200);Guangdong Provincial Natural Science Foundation(2022A1515220188,2023A1515011092,2022A1515110825);The Clinical Research Projects of Guangdong Provincial Hospital of Chinese Medicine(YN10101903,YN2016XP03,YN2022DB04,YN2023MB04);Chi Xiaoling of Project of Inheritance Workshop of Famous Old Chinese Medicine Experts of State Administration of Traditional Chinese Medicine(Guozhong Pharmaceutical Human Education Letter[2022]No.75);The Fifth Batch of National Research and Training Programs for Clinical Talents of Traditional Chinese Medicine(Guozhong Pharmaceutical Human Education Letter[2022]No.1)
肝硬化患者大約一半合并有食管胃靜脈曲張(gastroe-sophagealvarices,GOV)[1],GOV破裂出血年發(fā)生率為5%~15%,6周病死率為20%,因此,代償期肝硬化患者應(yīng)盡早確定是否存在GOV[2]。BavenoⅦ共識(shí)[3]建議將肝硬度值(liver stiffness measurernents,LSM)≥25.0 kPa作為確定乙型肝炎肝硬化患者伴有顯著門靜脈高壓的無創(chuàng)診斷標(biāo)準(zhǔn),并建議此類患者行胃鏡檢查篩查GOV。有研究表明肝纖維化4因子指數(shù)(FIB-4)、LOK指數(shù)、AST/PLT比值(APRI指數(shù))、AST/ALT比值(AAR)等常見肝纖維化無創(chuàng)診斷模型,對(duì)乙型肝炎、丙型肝炎或酒精性相關(guān)肝硬化患者的GOV無創(chuàng)診斷有一定臨床價(jià)值,但診斷準(zhǔn)確度一般,胃鏡作為侵入性檢查仍是目前確定GOV的主要方法[4-5]。存在顯著門靜脈高壓肝硬化患者發(fā)生GOV風(fēng)險(xiǎn)較高[6],而以上模型針對(duì)代償期乙型肝炎肝硬化顯著門靜脈高壓患者GOV診斷價(jià)值是未知的,所以探索這類模型對(duì)GOV的診斷價(jià)值是有必要的。關(guān)于LSM和PLT建立的評(píng)分指數(shù)(LPRI),目前有研究表明其對(duì)慢性乙型肝炎患者肝纖維化的診斷和分期有一定價(jià)值[7],而對(duì)代償期乙型肝炎肝硬化顯著門靜脈高壓患者GOV的診斷價(jià)值尚待研究。故本研究以胃鏡檢查為GOV診斷金標(biāo)準(zhǔn),評(píng)估不同無創(chuàng)診斷模型對(duì)BavenoⅦ共識(shí)中有胃鏡檢查指征人群GOV的診斷價(jià)值。
1資料與方法
1.1研究對(duì)象選取2017年11月—2023年11月廣東省中醫(yī)院肝病科門診或住院部治療的代償期乙型肝炎肝硬化顯著門靜脈高壓患者,根據(jù)胃鏡下是否伴發(fā)GOV將患者分為GOV組和非GOV組(NGOV組)。慢性HBV感染診斷標(biāo)準(zhǔn):血清HBsAg和/或血清HBV DNA陽性6個(gè)月以上[8];肝硬化診斷標(biāo)準(zhǔn):組織學(xué)、B超、LSM、CT或磁共振成像(MRI)等檢查提示肝硬化[9];顯著門靜脈高壓診斷標(biāo)準(zhǔn):LSM≥25.0 kPa[3]。納入標(biāo)準(zhǔn):(1)符合慢性HBV感染診斷標(biāo)準(zhǔn);(2)符合肝硬化診斷標(biāo)準(zhǔn);(3)符合顯著門靜脈高壓診斷標(biāo)準(zhǔn);(4)臨床資料完整。排除標(biāo)準(zhǔn):(1)合并其他病因?qū)е碌母螕p傷(如酒精性肝病、藥物性肝損傷、自身免疫性肝?。?;(2)合并其他嗜肝病毒感染;(3)既往有腹水、食管靜脈曲張破裂出血或肝性腦病等肝硬化失代償期事件;(4)伴有肝癌或其他系統(tǒng)腫瘤;(5)既往有如肝移植、經(jīng)頸靜脈肝內(nèi)門體分流術(shù)、脾切除、食管胃靜脈套扎等手術(shù)史。
1.2研究方法
1.2.1收集資料包括人口學(xué)資料、姓名、性別、年齡、臨床診斷、現(xiàn)病史、既往史、個(gè)人史;血清學(xué)指標(biāo):ALT、AST、TBil、Alb、ALP、GGT、PLT、國(guó)際標(biāo)準(zhǔn)化比值(INR);FibroScan檢測(cè)的LSM;腹部B超/CT/MRI、肝組織病理學(xué)、胃鏡檢查結(jié)果。
1.2.2計(jì)算公式(1)FIB-4=年齡×AST/(PLT×ALT1/2);(2)LPRI=LSM×100/PLT;(3)LOK指數(shù)=(1.26×AST/ALT)+(5.27×INR)-(0.008 9×PLT)-5.56;(4)APRI=[(AST/AST正常值上限)×100]/PLT;(5)AAR=AST/ALT;(6)陽性預(yù)測(cè)值=(Se×P)/[Se×P+(1-Sp)×(1-P)];陰性預(yù)測(cè)值=(Sp×P)/[(1-Se)×P+Sp×(1-P)](P為樣本人群患病率,Se和Sp分別代表診斷試驗(yàn)的敏感度和特異度)。
1.3統(tǒng)計(jì)學(xué)方法利用SPSS 26.0進(jìn)行數(shù)據(jù)分析。正態(tài)分布的計(jì)量資料以±s表示,兩組間比較采用成組t檢驗(yàn)。非正態(tài)分布的計(jì)量資料用M(P25~P75)表示,兩組間比較采用Mann-Whitney U檢驗(yàn)。計(jì)數(shù)資料組間比較采用χ2檢驗(yàn)。采用受試者操作特征曲線(ROC曲線)評(píng)估模型的診斷價(jià)值;使用Spearman進(jìn)行評(píng)分模型與GOV的相關(guān)性分析;利用二元Logistic回歸構(gòu)建聯(lián)合模型,將聯(lián)合模型與各種評(píng)分模型單獨(dú)使用情況下的ROC曲線下面積(AUC)進(jìn)行比較,采用Delong檢驗(yàn)對(duì)各診斷模型AUC進(jìn)行兩兩比較。利用公式計(jì)算AUC的陽性預(yù)測(cè)值和陰性預(yù)測(cè)值。Plt;0.05為差異具有統(tǒng)計(jì)學(xué)意義。
2結(jié)果
2.1一般資料共納入108例患者,GOV組55例,NGOV組53例。其中男87例(80.56%),女21例(19.44%),平均(50.34±11.67)歲。GOV組患者年齡高于NGOV組,而ALT、AST、PLT水平低于NGOV組,差異均有統(tǒng)計(jì)學(xué)意義(P值均lt;0.05);兩組患者其余指標(biāo)差異均無統(tǒng)計(jì)學(xué)意義(P值均gt;0.05)(表1)。
2.2 FIB-4、LOK指數(shù)、LPRI、APRI、AAR單獨(dú)或聯(lián)合應(yīng)用對(duì)GOV的診斷價(jià)值比較ROC曲線分析顯示,F(xiàn)IB-4、LOK指數(shù)、LPRI、AAR單獨(dú)應(yīng)用對(duì)GOV有診斷價(jià)值(P值均lt;0.05),AUC分別為0.667、0.681、0.730、0.639,AUC值兩兩比較差異均無統(tǒng)計(jì)學(xué)意義(Z值分別為1.165、0.857、1.173、?0.237、0.386、0.834,P值均gt;0.05);APRI單獨(dú)應(yīng)用對(duì)GOV無診斷價(jià)值(Pgt;0.05);利用二元Logistic回歸分析構(gòu)建LPRI、APRI、FIB-4聯(lián)合模型LAF,LAF=?2.357+0.058×LPRI-0.329×APRI+0.334×FIB-4,聯(lián)合模型LAF與FIB-4、LOK指數(shù)、LPRI、APRI、AAR的AUC值比較發(fā)現(xiàn),聯(lián)合模型LAF的AUC值最大,為0.805,且比較差異均有統(tǒng)計(jì)學(xué)意義(Z值分別為?2.773、?2.479、?2.206、?4.885、?2.672,P值均lt;0.05)(表2,圖1)。
3討論
《指南》[2]指出,代償期乙型肝炎肝硬化顯著門靜脈高壓患者易發(fā)生腹水、GOV及破裂出血、肝性腦病等失代償事件,GOV破裂出血死亡率高,因此早期識(shí)別GOV對(duì)于阻斷疾病發(fā)生發(fā)展極為重要。胃鏡為GOV診斷金標(biāo)準(zhǔn),因其為有創(chuàng)檢查,有一定出血風(fēng)險(xiǎn),無創(chuàng)診斷模型的研究一直是臨床研究熱點(diǎn)。關(guān)于代償期乙型肝炎肝硬化患者GOV無創(chuàng)診斷模型,目前尚無指南或是共識(shí)推薦,而不同研究[4,10-13]對(duì)FIB-4、LOK指數(shù)、APRI、AAR關(guān)于代償期乙型肝炎肝硬化人群的GOV診斷價(jià)值的認(rèn)識(shí)也存在分歧。因此,重新評(píng)估FIB-4、LOK指數(shù)、APRI、AAR對(duì)于BavenoⅦ共識(shí)中有胃鏡檢查指征人群GOV診斷價(jià)值是有必要的。本研究以胃鏡檢查為GOV診斷的金標(biāo)準(zhǔn),探討不同無創(chuàng)診斷模型對(duì)BavenoⅦ共識(shí)有胃鏡檢查指征人群GOV的診斷價(jià)值。
本研究發(fā)現(xiàn)GOV組和NGOV組患者在年齡、ALT、AST、PLT方面差異顯著,其余指標(biāo)差異無統(tǒng)計(jì)學(xué)意義。進(jìn)一步建立ROC曲線以評(píng)價(jià)診斷效能,發(fā)現(xiàn)各指標(biāo)單獨(dú)應(yīng)用時(shí),LPRI評(píng)分最佳,LOK指數(shù)、FIB-4、AAR、APRI次之。相關(guān)文獻(xiàn)[14]報(bào)道,LSM聯(lián)合APRI、FIB-4,在一定程度上能夠提高肝硬化患者食管靜脈曲張的診斷效能。利用二元Logistic回歸構(gòu)建LPRI、APRI、FIB-4聯(lián)合模型LAF,并將聯(lián)合模型LAF和其他模型單獨(dú)應(yīng)用時(shí)的AUC比較,結(jié)果顯示聯(lián)合模型LAF診斷效能更優(yōu),差異均具有統(tǒng)計(jì)學(xué)意義。
FIB-4、APRI、AAR、LOK指數(shù)和LPRI[7,15-20]最初用于評(píng)估病毒性肝炎患者肝纖維化及其程度,后來有研究[21-22]表明,F(xiàn)IB-4、APRI、AAR、LOK指數(shù)可用于乙型肝炎肝硬化患者GOV診斷。本研究發(fā)現(xiàn),F(xiàn)IB-4、LOK指數(shù)、AAR的AUC值均在0.6~0.7,對(duì)代償期乙型肝炎肝硬化顯著門靜脈高壓患者的GOV診斷效能相似,有一定臨床價(jià)值,但準(zhǔn)確度一般。Deng等[23]在一項(xiàng)薈萃分析中發(fā)現(xiàn),F(xiàn)IB-4、LOK指數(shù)、AAR對(duì)代償期乙型肝炎肝硬化患者GOV診斷效能相似,與本研究結(jié)論一致。Deng等[23]研究中納入的人群和本研究中的研究對(duì)象存在交叉,這可能是影響研究結(jié)果的原因,但仍需要更多的研究論證。另外,本研究還發(fā)現(xiàn)APRI單獨(dú)應(yīng)用對(duì)GOV無診斷價(jià)值,這與Deng等[4]研究結(jié)論截然不同,本研究只納入乙型肝炎肝硬化患者,Deng等研究人群中還納入了丙型肝炎、酒精性相關(guān)肝硬化患者,這可能是造成這一結(jié)果偏差的原因[24]。本研究首次探索了LPRI對(duì)代償期乙型肝炎肝硬化顯著門靜脈高壓患者GOV診斷效能,發(fā)現(xiàn)LPRI單獨(dú)應(yīng)用診斷GOV的AUC超過0.7,對(duì)臨床診斷GOV有一定價(jià)值,但有待更多的代償期乙型肝炎肝硬化顯著門靜脈高壓患者的研究進(jìn)一步驗(yàn)證。聯(lián)合FIB-4、APRI、LPRI構(gòu)建模型LAF,AUC達(dá)到最大,具有較好的敏感度和特異度,這表明幾個(gè)無創(chuàng)診斷模型中聯(lián)合模型LAF的診斷效能最佳,而且ALT、AST、PLT、LSM、年齡、INR等指標(biāo)容易獲得,值得臨床推廣。
綜上所述,F(xiàn)IB-4、LOK指數(shù)、LPRI、AAR對(duì)代償期乙型肝炎肝硬化顯著門靜脈高壓患者GOV診斷價(jià)值相似,APRI單獨(dú)應(yīng)用無診斷價(jià)值,聯(lián)合模型LAF診斷效能最佳,對(duì)臨床實(shí)際診斷GOV提供了參考價(jià)值。本研究?jī)?yōu)勢(shì)在于基于BavenoⅦ共識(shí)顯著門靜脈高壓無創(chuàng)診斷標(biāo)準(zhǔn)和胃鏡“金標(biāo)準(zhǔn)”下獲得的樣本量,但僅為回顧性、單中心研究,樣本量尚少,未來仍需大樣本、多中心數(shù)據(jù)進(jìn)一步研究驗(yàn)證。
倫理學(xué)聲明:本研究方案于2024年2月20日經(jīng)由廣東省中醫(yī)院倫理委員會(huì)批準(zhǔn)同意,批號(hào):YF2024-011-01。
利益沖突聲明:本文不存在任何利益沖突。
作者貢獻(xiàn)聲明:劉誠負(fù)責(zé)資料收集與分析,撰寫論文;方夢(mèng)冰、曾嘉旖、陳智恒、桂蓓、趙鳳鳴、袁靖凱參與數(shù)據(jù)收集,修改論文;張朝臻、施梅姐、謝玉寶、池曉玲、蕭煥明負(fù)責(zé)課題設(shè)計(jì),指導(dǎo)撰寫論文并最后定稿。
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收稿日期:2024-06-29;錄用日期:2024-07-22
本文編輯:王亞南