通信作者:王倩,523199780@qq.com(ORCID:0009-0003-8598-1169)
摘要:目的探討經頸靜脈肝內門體分流術(TIPS)的肝硬化食管胃底靜脈曲張破裂出血患者出院30 d內發(fā)生非計劃再入院危險因素,并構建風險預測列線圖模型。方法選取2020年1月—2023年6月在南京大學醫(yī)學院附屬鼓樓醫(yī)院因肝硬化食管胃底靜脈曲張破裂出血行TIPS的241例患者作為研究對象。分析患者30 d內非計劃再入院情況,并依據是否發(fā)生非計劃再入院分為再入院組(n=36)和未再入院組(n=198)。收集患者臨床資料,符合正態(tài)分布的計量資料2組間比較采用成組t檢驗,偏態(tài)分布的計量資料2組間比較采Mann-Whitney U檢驗;計數資料2組間比較采用χ2檢驗。Logistic回歸分析篩選出與非計劃再入院相關的獨立危險因素。建立列線圖預測模型,繪制受試者工作特征曲線(ROC曲線)評估列線圖模型預測非計劃再入院發(fā)生的區(qū)分度;繪制校準曲線評估列線圖模型預測非計劃再入院發(fā)生的一致性,采用R語言ResourceSelection包進行Hosmer-Lemeshow評估模型的擬合度,決策曲線分析評估模型的實用性。結果年齡(OR=2.664,95%CI:1.139~6.233)、CTP評分(OR=1.655,95%CI:1.098~2.495)、血氨(OR=1.032,95%CI:1.016~1.048)是行TIPS患者出院30 d內非計劃再入院的獨立危險因素(P值均lt;0.05)。依據多因素分析結果,構建風險預測列線圖模型,通過Bootstrap法重復抽樣1 000次展開內部驗證,ROC曲線下面積為0.773,高于年齡(0.582)、CTP評分(0.675)、血氨(0.641),校準曲線顯示列線圖模型預測非計劃再入院的概率與實際概率具有較好一致性,Hosmer-Lemeshow顯示擬合優(yōu)度良好(χ2=5.647 3,P=0.686 7)。結論年齡、CTP評分和血氨是TIPS術后30 d非計劃再入院的獨立危險因素,以此建立的列線圖預測模型有助于預測行TIPS患者非計劃再入院發(fā)生風險,為早期預防提供較為準確的決策依據。
關鍵詞:肝硬化;門體分流術,經頸靜脈肝內;危險因素
基金項目:國家自然科學基金(82100652);南京大學醫(yī)學院附屬鼓樓醫(yī)院護理科研項目(ZSA796-1)
Risk factors for unplanned readmission after transjugular intrahepatic portosystemic shunt in cirrhotic patients with esophagogastric variceal bleeding and construction of a nomogram model
YIN Qin,WU Zhaorong,ZHANG Feng,JIN Chunyan,CAO Yanping,XIAO Jiangqiang,ZHUGE Yuzheng,WANG Qian.(Department of Gastroenterology,Affiliated Drum Tower Hospital of Nanjing University Medical School,Nanjing 210008,China)
Corresponding author:WANG Qian,523199780@qq.com(ORCID:0009-0003-8598-1169)
Abstract:Objective To investigate the risk factors for unplanned readmission within 30 days after discharge incirrhotic patients with esophagogastric variceal bleeding undergoing transjugular intrahepatic portosystemic shunt(TIPS),and to construct a nomogram predictive model.Methods A total of 241 cirrhotic patients who underwent TIPS due to esophagogastric variceal bleeding in Affiliated Drum Tower Hospital of Nanjing University Medical School from January 2020 to June 2023 were enrolled as subjects,and unplanned readmission within 30 days was analyzed.According to the presence or absence of unplanned readmission,they were divided into readmission group with 36 patients and non-readmission group with 198 patients,and related clinical data were collected from all patients.The independent-samples t test was used for comparison of normally distributed continuous data between two groups,and the Mann-Whitney U test was used for comparison of non-normally distributed continuous data between two groups;the chi-square test was used for comparison of categorical data between two groups.A logistic regressionanalysis was used to identify independent risk factors for unplanned readmission.A nomogram prediction model was constructed,and the receiver operating characteristic(ROC)curve was plotted to assess its discriminatory ability for unplanned readmission;the calibration curve was plotted to evaluate the consistency of the nomogram model in predicting unplanned readmission;the ResourceSelection package of R language was used for the Hosmer-Lemeshow goodness-of-fit test to evaluate the degree of fitting of the mode;the decision curve analysis was used to investigate the practicality of the model.Results Age(odds ratio[OR]=2.664,95%confidence interval[CI]:1.139—6.233,Plt;0.05),CTP score(OR=1.655,95%CI:1.098—2.495,Plt;0.05),and blood ammonia(OR=1.032,95%CI:1.016—1.048,Plt;0.05)were independent risk factors for unplanned readmission within 30 days after discharge in the patients undergoing TIPS.The multivariate analysis showed that for the nomogram predictive model constructed in this study,repeated sampling for 1 000 times using the Bootstrap method was performed for internal validation,and the area under the ROC curve was 0.773,which was significantly higher than that of age(0.582),CTP score(0.675),and blood ammonia(0.641).The calibration curve showed good consistency between the probability of unplanned readmission predicted by the nomogram model and the actual probability,and the Hosmer-Lemeshow goodness-of-fit test showed good degree of fitting(c2=5.647 3,P=0.686 7).Conclusion Age,CTP score,and blood ammonia are independent risk factors for unplanned readmission within 30 days after TIPS,and the nomogram prediction model constructed based on these factors can help to predict the risk of unplanned readmission in TIPS patients and provide an accurate decision-making basis for early prevention.
Key words:Liver Cirrhosis;Portasystemic Shunt,Transjugular Intrahepatic;Risk Factors
Research funding:National Natural Science Found of China(82100652);Affiliated Drum Tower Hospital of Nanjing University Medical School Nursing Research Project(ZSA796-1)
經頸靜脈肝內門體分流術(transjugular intrahepatic portosystemic shunt,TIPS)能夠顯著降低門靜脈壓力,具有創(chuàng)傷小、恢復快的優(yōu)點[1],已被廣泛應用于肝硬化門靜脈高壓失代償期患者[2-4],但術后常有肝性腦病、肝衰竭、支架狹窄或閉塞引起再出血等并發(fā)癥的發(fā)生[5-6],使患者遠期獲益受到影響[7],且部分患者由于并發(fā)癥發(fā)生短期內需要再次住院治療。30 d內非計劃再入院是指前次住院診療結束,患者在出院后30 d內無法預測的再入院,且再入院的原因是相同或相關疾?。?],再入院的發(fā)生影響患者的生活質量、身心健康,給患者、醫(yī)院及社會帶來沉重負擔。2011年,我國衛(wèi)生部辦公廳把它作為重返類敏感指標[9],國際上也將這項指標用于評價各大醫(yī)院醫(yī)療和護理質量[10]。國外的最新研究[11]顯示,TIPS患者出院30 d內非計劃再入院發(fā)生率高達21%,再入院原因主要為肝性腦病和胸腹水;國內關于非計劃再入院研究主要集中在外科手術、心血管系統(tǒng)、呼吸系統(tǒng)等慢性疾?。?2-14],尚缺乏關于肝硬化食管胃底靜脈曲張破裂出血行TIPS的患者非計劃再入院相關研究。為此,本研究擬分析本院行TIPS患者出院30 d內非計劃再入院的危險因素,并建立預測模型,為臨床醫(yī)護人員進行早期預測和及時干預提供參考。
1資料與方法
1.1一般資料選取2020年1月—2023年6月在本院因肝硬化食管胃底靜脈曲張破裂出血行TIPS的241例患者作為研究對象。納入標準:(1)年齡≥18歲;(2)因肝硬化食管胃底靜脈曲張破裂出血二級預防行TIPS;(3)病歷資料完整。排除標準:(1)30 d內有計劃再入院;(2)TIPS術后未能在常規(guī)時間內正常出院;(3)失訪或因非肝硬化相關原因再入院;(4)合并惡性腫瘤;(5)資料不完整;(6)因頑固性腹水、復發(fā)性腹水以及肝腎綜合征行TIPS。
1.2資料收集從TIPS數據庫中提取。(1)一般資料:包括年齡、性別、合并癥(高血壓、糖尿?。?、主要支付類型;(2)臨床資料:包括入院方式、總住院天數、脾切除病史、有無門靜脈血栓、既往出血次數、腹水、靜脈曲張類型及術中是否聯(lián)合側支血管栓塞等;(3)TIPS術前術后實驗室檢查:終末期肝病模型(MELD)評分、Child-Turcotte-Pugh(CTP)評分、WBC、Hb、PLT、ALT、AST、PT、INR及血氨;(4)30 d天內再入院情況、原因及支架通暢情況。
1.3統(tǒng)計學方法采用SPSS 26.0軟件進行數據分析。符合正態(tài)分布的計量資料以±s表示,2組間比較采用成組t檢驗,偏態(tài)分布的計量資料以M(P25~P75)表示,2組間比較采用Mann-Whitney U檢驗;計數資料2組間比較采用χ2檢驗。以是否非計劃性再入院為因變量,將單因素分析中Plt;0.1的變量作為自變量進行Logistic回歸分析,最終篩選出與非計劃再入院相關的獨立危險因素。應用R軟件(4.2.2)建立列線圖預測模型;采用Bootstrap法重復抽樣1 000次展開內部驗證,繪制受試者工作特征曲線(ROC曲線)評估列線圖模型預測非計劃再入院發(fā)生的區(qū)分度;繪制校準曲線評估列線圖模型預測非計劃再入院發(fā)生的一致性,采用R語言ResourceSelection包進行Hosmer-Lemeshow評估模型的擬合度,Pgt;0.05說明擬合良好;決策曲線分析評估模型的實用性。Plt;0.05為差異有統(tǒng)計學意義。
2結果
2.1一般資料本研究共納入241例患者,去除住院期間死亡患者1例,未按計劃出院2例,資料不完整4例,最終納入234例患者。234例患者中男135例,女99例,年齡21~84歲,平均(57.72±11.19)歲。出院后30 d內發(fā)生非計劃再入院患者共36(15.38%)例。再入院原因包括肝性腦病25例、消化道出血8例及腹水3例。本隊列無因TIPS支架失功再入院的患者。
2.2單因素分析將可能影響患者非計劃再入院的相關因素納入單因素分析,年齡、CTP評分、腹水、術前Alb及術后血氨是行TIPS患者出院30天內非計劃再入院影響因素(P值均lt;0.05)(表1)。
2.3非計劃再入院多因素分析將單因素分析中Plt;0.1的因素納入二元Logistic回歸分析。結果顯示,年齡、CTP評分及術后血氨是行TIPS患者出院30 d內非計劃再入院獨立危險因素(P值均lt;0.05)(表2)。
2.4風險預測列線圖模型的構建根據多因素Logistic回歸結果,將年齡、CTP評分、術后血氨指標構建行TIPS患者出院30 d內非計劃再入院的風險預測列線圖模型(圖1)。將列線圖中每個變量進行評分并求和,再根據總分評估非計劃再入院的概率。
2.5列線圖內部驗證通過Bootstrap法重復抽樣1000次,AUC為0.773(圖2)。此外,與單個指標相比,ROC曲線分析提示該模型的AUC為0.777,高于年齡(0.582)、CTP評分(0.675)、術后血氨(0.641)(圖3)。采用R語言ResourceSelection包,對真實值和預測值進行Hosmer-Lemeshow檢驗發(fā)現(xiàn),實際非計劃再入院的發(fā)生概率和預測概率比較,差異無統(tǒng)計學意義(χ2=5.647 3,P=0.686 7),校準曲線顯示列線圖模型預測非計劃再入院的概率與實際非計劃再入院發(fā)生的概率具有較好一致性(圖4);決策曲線評估模型的臨床有效性,分析提示當該模型預測的概率閾值為0.04~0.85時,模型預測具有臨床實用價值,患者凈獲益高(圖5)。
3討論
本研究發(fā)現(xiàn),我國肝硬化伴食管胃靜脈曲張破裂出血患者接受TIPS治療后順利出院30 d內非計劃再入院率為15.38%,低于既往國外的研究[11]。首次發(fā)現(xiàn),年齡、CTP評分、TIPS術后高血氨是非計劃再住院的獨立危險因素,并以此建立預測模型,能夠提高臨床醫(yī)護人員對高危非計劃再住院患者的早期識別。
張家齊等[15]研究顯示:年齡與乙型肝炎肝硬化失代償患者肝性腦病的發(fā)生有一定關聯(lián),本研究顯示,年齡≥65歲是TIPS術后患者發(fā)生非計劃再入院的危險因素(Plt;0.05,OR=2.664)。CTP評分包括白蛋白、腹水、肝性腦病、凝血酶原時間和血清膽紅素[16],被廣泛用于評估肝功能不全的嚴重程度,CTP評分越高,肝臟儲備功能越差[17-18]。一項單中心回歸分析[19]表明,高CTP評分是肝硬化上消化道出血患者并發(fā)肝性腦病的獨立危險因素。本研究也納入了此項指標,結果顯示:CTP評分是TIPS術后患者發(fā)生非計劃再入院的獨立危險因素,CTP評分每增加1分,非計劃再入院風險增加了0.655倍(Plt;0.05,OR=1.655)。因此,臨床上應加強術前圍術期患者肝功能的動態(tài)評估,遵醫(yī)囑給予保肝藥物治療和用藥指導,督促患者增加門診隨訪頻次,定期監(jiān)測肝功能水平,對降低非計劃性再入院發(fā)生率具有重要的臨床意義。國外研究[20]表明,血氨濃度與術后肝性腦病發(fā)生關系密切,患者術后血氨值越高,肝性腦病發(fā)生率越高,非計劃再入院的風險越大。本研究顯示,術后血氨水平也是發(fā)生非計劃再入院的獨立危險因素,血氨值每增加1單位,發(fā)生非計劃再入院風險增加0.032倍(Plt;0.05,OR=1.032)。由于TIPS術后大量含氨豐富的血液未經肝臟的解毒,直接進入體循環(huán),增多的氨通過血腦屏障進入大腦,對中樞神經系統(tǒng)產生毒性作用,導致肝性腦病發(fā)生[21]。
有研究顯示,25%的患者出院后30 d再住院可通過早期風險識別和及時干預避免[22];12%~75%的非計劃再入院是可以通過醫(yī)護人員對患者的健康教育、出院前評估及出院后良好家庭照顧而避免[23]。本研究在單因素分析的基礎上進行多因素Logistic回歸分析,獲得了3個影響因素,并以此建立了列線圖預測模型,整合并量化多個非計劃再入院發(fā)生的高危因素進行綜合性風險評估,并通過Bootstrap法重復抽樣1 000次展開內部驗證,證實本研究建立的列線圖預測模型有較高的準確度與區(qū)分度,校準曲線具有良好的一致性,決策曲線具有較高臨床應用價值。且本研究中模型的預測指標在臨床中能直接獲取,易于操作性,醫(yī)護人員可通過客觀量化的指標進行病情評估,識別高?;颊撸瑸閷嵤﹤€體化、預見性的措施提供依據,減少非計劃再入院發(fā)生,保障患者安全。
本研究的不足之處包括:首先,本研究是單中心研究,可能無法完全應用于其他TIPS中心,例如,本隊列中并無患者因TIPS支架失功再次入院,但通常說來,TIPS支架失功是患者術后再次入院的原因之一,由于本中心患者在出院前常規(guī)復查支架通暢情況,對于急性支架失功患者出院前行支架再通,所以本隊列未出現(xiàn)支架失功再入院患者。其次,本研究只進行了內部驗證,沒有進行外部驗證,在今后的研究中需要進一步進行外部驗證來證實模型的實用性和外推性。
本研究通過對234例肝硬化食管胃靜脈曲張破裂出血行TIPS患者的臨床資料進行統(tǒng)計分析,得出患者出院30 d內非計劃再入院的危險因素,構建了簡單實用的風險預測模型,能夠為臨床識別TIPS術后非計劃入院高危人群提供幫助。但未來還需進行多中心、大樣本、前瞻性的隊列研究,以獲得普適性的預測模型,進行臨床推廣。
倫理學聲明:本研究方案于2021年1月6日經南京大學醫(yī)
學院附屬鼓樓醫(yī)院倫理委員會審批,批號:2021-004-01。
利益沖突聲明:本研究不存在任何利益沖突。
作者貢獻聲明:殷芹、肖江強負責課題設計,資料分析,撰寫論文;吳兆榮、金春燕、曹燕平負責數據收集、統(tǒng)計學分析;張峰、諸葛宇征、王倩負責擬定寫作思路,論文修改,指導撰寫文章并最后定稿。
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收稿日期:2024-01-15;錄用日期:2024-04-11
本文編輯:林姣
引 證 本 文:YIN Q, WU ZR, ZHANG F, et al. Risk factors for unplanned readmission after transjugular intrahepatic portosystemic shunt in cirrhotic patients with esophagogastric variceal bleeding and construction of a nomogram model[J]. J Clin Hepatol, 2024, 40(9): 1796-1801.
殷芹, 吳兆榮, 張峰, 等 . 肝硬化食管胃底靜脈曲張破裂出血患者 經頸靜脈肝內門體分流術后非計劃再入院的危險因素分析及列 線圖模型構建[J]. 臨床肝膽病雜志, 2024, 40(9): 1796-1801.