目的 运用数据挖掘的方法检测奥马珠单抗上市后的不良反应信号,为临床安全合理用药提供参考。方法 本研究采用报告比值比法（ROR）和贝叶斯判别可信区间递进神经网络法（BCPNN）对美国FDA不良事件报告系统（FAERS）中2004年第1季度至2023年第2季度的奥马珠单抗相关不良事件（ADE）报告进行数据挖掘和信号检测。结果 通过数据挖掘和信号检测,涉及奥马珠单抗的ADE报告中提取了186,353份报告,涉及45,383例患者。在这些报告中,女性（65.31%）比例远高于男性（24.97%）。主要报告国家为美国（64.93%）和加拿大（11.96%）。报告者中以消费者（41.35%）和医师（36.97%）为主要群体。研究发现了621个ADE阳性信号,涉及25个系统器官分类（SOC）,主要包括呼吸系统、胸部和纵隔疾病（21.29%）以及感染和侵染类疾病（10.91%）。其中,183个信号被评定为高风险信号,其中包括57个新的高风险信号,如血压升高、易醒型失眠和心律失常等。这些发现有助于更全面地了解奥马珠单抗的安全性和潜在风险。结论 在奥马珠单抗的临床应用过程中,除了要注意药品说明中提到的已知不良反应外,还需特别警惕潜在的不良药物事件,如血压升高、心率升高、中间易醒型失眠、体位性心动过速综合征等。

Objective To use data mining method to detect the adverse reaction signal of omalizumab after marketing,and to provide reference for clinical safety and rational drug use．Methods In this study,the report odds ratio method（ROR）and Bayesian confidence propagation neural network（BCPNN）were used to conduct data mining and signal detection for omalizumab-related adverse event（ADE）reports from the FDA Adverse Event Reporting System（FAERS）from the first quarter of 2004 to the second quarter of 2023．Results Through data mining and signal detection,186,353 reports of ADE involving omalizumab were extracted,involving 45,383 patients．Among these reports,the proportion of women（65.31%）was much higher than that of men（24.97%）．The main reporting countries were the United States（64.93%）and Canada（11.96%）．consumers（41.35%）and doctors（36.97%）were the main groups of reporters．The study identified 621 ADE positive signals across 25 system organ classes（SOCs）,including respiratory,chest,and mediastinal diseases（21.29%）and infectious and infectious diseases（10.91%）．Of these,183 signals were assessed as high risk,including 57 new high-risk signals．These findings contribute to a more complete understanding of the safety and potential risks of omalizumab．Conclusions In the clinical application of omalizumab,in addition to the known adverse reactions mentioned in the drug description,special attention should be paid to potential adverse drug events,such as elevated blood pressure,elevated heart rate,intermediate insomnia,and postatic tachycardia syndrome．

目的 挖掘使用美托洛尔后的药物不良事件（ADE）,为临床合理用药提供参考意见。方法 对美国食品药品管理局（FDA）FDA药物ADE报告系统（FAERS）数据库进行信号挖掘,采用报告比值比法和比例报告比值法,分析FAERS数据库中2004年第1季度至2023年第2季度关于美托洛尔的ADE报告。结果 在FAERS数据库中收集到美托洛尔相关ADE共24 184例、667个阳性信号,共涉及27个系统器官分类。ADE严重报告共16 766（占69.33%）,ADE报告频次排名前3的分别是头晕、心动过缓、呼吸困难。结论 美托洛尔的不良反应主要集中在全身性疾病及给药部位各种反应、心脏器官疾病和各类损伤。在使用美托洛尔过程中发生ADE时,应该及时采取相应的干预措施。

Objective To explore the adverse drug events（ADEs）after the use of metoprolol and provide reference opinions for clinical rational drug use．Methods Signal mining was conducted on the FDA Adverse Event Reporting System（FAERS）database in the United States．The reporting ratio method and proportional reporting ratio method were used to analyze ADEs reports related to metoprolol in the FAERS database from the first quarter of 2019 to the second quarter of 2023．Results A total of 24 184 cases of metoprolol related ADEs were collected in the FAERS database,with 667 positive signals and a total of 27 system organ class involved．Conclusions The adverse reactions of metoprolol mainly focus on systemic diseases,various reactions at the administration site,heart organ diseases,and various injuries．It is recommended that timely intervention measures should be taken when ADE occurs during the use of metoprolol．

目的 探讨肝脏衰弱程度联合肝功能分级预测肝硬化患者肝病复合不良事件的价值,作为识别和干预不良结局的依据。方法 选择2022年12月—2023年12月医院接收的肝硬化患者80例进行研究,随访6个月观察患者不良事件发生情况,将出现2个及以上肝病并发症的肝病复合不良事件患者25例作为观察组,将出现1个肝病并发症或未出现并发症的患者55例作为对照组,比较两组患者的基本资料、实验室指标、营养指标、体力活动水平、肝脏衰弱指数（LFI）、肝功能Child-Turcotte-Pugh（CTP）评分,采用单因素和多因素Cox回归分析评估肝硬化患者肝病复合不良事件的危险因素,使用受试者工作特征（ROC）曲线下面积评估LFI联合CTP评分预测肝硬化患者肝病复合不良事件的价值。结果 观察组年龄、丙氨酸氨基转移酶（ALT）高于对照组,红细胞计数（RBC）、血红蛋白（Hb）、血肌酐（Scr）、总胆红素（TBIL）、步速、小腿围低于对照组（t分别为4.235、6.500、3.826、3.989、4.289、8.878、2.474,均P<0.05）。观察组营养风险48.00%、LFI≥4.5分52.00%、CTP分级B/C级76.00%高于对照组18.18%、14.55%、27.27%（χ²分别为7.664、12.454、16.699,均P<0.05）。单因素Cox回归分析显示年龄、ALT、营养风险、LFI≥4.5分、CTP分级B/C级、RBC、Scr、TBIL、Hb、步速、小腿围为肝硬化患者发生肝病复合不良事件的危险因素（HR分别为2.251、1.578、1.626、1.981、1.715、1.428、1.443、1.419、1.336、1.332、1.254,均P<0.05）。多因素Cox回归分析显示年龄、营养风险、LFI≥4.5分、CTP分级B/C级为肝硬化患者发生肝病复合不良事件的独立危险因素（HR分别为2.275、1.746、2.025、1.895,P均<0.05）。ROC曲线结果显示LFI、CTP、LFI联合CTP预测肝硬化患者肝病复合不良事件的AUC分别为0.82、0.79、0.88（P<0.05）。结论 年龄、肝脏衰弱、CTP分级B/C级、营养风险为肝硬化患者肝病复合不良事件的危险因素,肝脏衰弱程度联合肝功能分级预测肝硬化患者肝病复合不良事件具有更高的效能。

Objective To explore the value of predicting liver disease complex adverse events in patients with liver cirrhosis by combining the degree of liver frailty with liver function grading,as a basis for identifying and intervening in adverse outcomes．Methods A study was conducted on 80 patients with liver cirrhosis admitted to the hospital from December 2022 to December 2023． Patients were followed up for six months to observe the occurrence of adverse events．Twenty-five patients with liver disease complex adverse events with two or more liver disease complications were selected as the observation group,and 55 patients with one or no liver disease complication were selected as the control group．The basic information,laboratory indicators,nutritional indicators,physical activity levels,liver frailty index（LFI）,Child Turcotte Pugh（CTP）scores,univariate and multivariate Cox regression analysis were used to evaluate the risk factors for liver disease complex adverse events in liver cirrhosis patients．The value of combining LFI and CTP score in predicting liver disease complex adverse events in patients with liver cirrhosis was assessed by Receiver Operating Characteristic（ROC）curve area．Results The age,alanine aminotransferase（ALT）,red blood cell count（RBC）,hemoglobin（Hb）,serum creatinine（Scr）,total bilirubin（TBIL）,walking speed,and calf circumference of the observation group were higher than those of the control group（t=4.235,6.500,3.826,3.989,4.289,8.878,2.474,all P<0.05）．The nutritional risk of the observation group was 48.00%,LFI score≥4.5 was 52.00%,CTP grade B/C was 76.00%,which was higher than that of the control group at 18.18%,14.55%,and 27.27%（χ²=7.664,12.454,16.699,all P<0.05）．Univariate Cox regression analysis showed age,ALT,nutritional risk,LFI ≥ 4.5,CTP grade B/C,RBC,Scr,TBIL,Hb,step speed and calf circumference were risk factors for the occurrence of liver disease complex adverse events in patients with liver cirrhosis（HR values=2.251,1.578,1.626,1.981,1.715,1.428,1.443,1.419,1.336,1.332,1.254,all P<0.05）．Multivariate Cox regression analysis showed that age,nutritional risk,LFI ≥ 4.5,and CTP grade B/C were independent risk factors for liver disease complex adverse events in patients with liver cirrhosis（HR values=2.275,1.746,2.025,1.895,all P<0.05）．The ROC curve results showed that the AUC of LFI,CTP,and LFI combined with CTP in predicting liver disease composite adverse events in patients with liver cirrhosis were 0.82,0.79,and 0.88,respectively（P<0.05）．Conclusions Age,liver frailty,CTP grade B/C,and nutritional risk are risk factors for liver disease complex adverse events in patients with liver cirrhosis．The combination of LFI and liver function grade has higher efficacy in predicting liver disease complex adverse events in patients with liver cirrhosis．

目的 探讨标准化沟通（SBAR）模式交接班联合护理质量指标管理在胆管结石患者中的应用效果及护理质量、不良事件及并发症影响。方法 选取天津市人民医院2021年1月—2022年12月收治的80例胆管结石患者,应用抽签法分为观察组与对照组,每组各40例。所有患者均采取手术治疗,其中对照组患者实施常规护理,观察组患者在对照组基础上增加SBAR沟通模式交接班联合护理质量指标管理。对比两组患者的护理质量、护理不良事件发生率、护理满意度及术后并发症发生率。结果 观察组基础护理、护理态度、护理责任心、风险识别能力、风险防范能力护理质量评分高于对照组（P<0.05）;两组注射、口服给药差错、换药、抽血差错、病例书写错误以及执行医嘱不及时等护理不良事件发生率对比差异无统计学意义（P>0.05）,观察组患者护理满意度高于对照组（P<0.05）;观察组患者压疮、感染、静脉血栓等并发症发生率均低于对照组（P<0.05）。结论 SBAR沟通模式交接班联合护理质量指标管理针对胆管结石患者应用效果显著,可改善临床护理质量,同时患者护理满意度较高,进一步降低患者术后并发症发生率。

Objective To investigate the application effect of SBAR communication mode shift combined with the management of care quality indicators on patients with bile duct stones and their influence on postoperative complications. Methods Eighty patients with bile duct stones admitted to our hospital from January 2021 to December 2022 were selected,and divided into observation group and control group by drawing lots,40 cases each．All the patients were treated by surgery,and the control group patients received routine care,and the observation group patients added the SBAR communication mode．The quality of care,incidence of adverse events,satisfaction with care and incidence of postoperative complications of the two groups were compared. Results The quality of care values of basic care,nursing care,nursing responsibility,risk identification and risk prevention in the observation group were significantly higher than in the control group（P<0.05）．There was no difference in the incidence of nursing side effects such as injection and oral administration errors,dressing changes,blood sampling errors,case clerk errors and delayed execution of medical orders between the two groups（P>0.05）．Patient satisfaction in the observation group was significantly higher than that in the control group（P<0.05）．The incidence of complications such as pressure ulcers,infections and venous thrombosis in the observation group was significantly lower than that in the control group（P<0.05）. Conclusions SBAR communication mode and combined nursing quality index management for patients with bile duct stones,which can improve the quality of clinical nursing and patient nursing satisfaction,and further reduce the incidence of postoperative complications in patients．

       目的   探讨肝脏衰弱程度联合肝功能分级预测肝硬化患者肝病复合不良事件的价值，作为识别和干预不良结局的依据。方法   选择2022年12月—2023年12月医院接收的肝硬化患者80例进行研究，随访6个月观察患者不良事件发生情况，将出现2个及以上肝病并发症的肝病复合不良事件患者25例作为观察组，将出现1个肝病并发症或未出现并发症的患者55例作为对照组，比较两组患者的基本资料、实验室指标、营养指标、体力活动水平、肝脏衰弱指数（LFI）、肝功能Child-Turcotte-Pugh（CTP）评分，采用单因素和多因素Cox回归分析评估肝硬化患者肝病复合不良事件的危险因素，使用受试者工作特征（ROC）曲线下面积评估LFI联合CTP评分预测肝硬化患者肝病复合不良事件的价值。结果   观察组年龄、丙氨酸氨基转移酶（ALT）高于对照组，红细胞计数（RBC）、血红蛋白（Hb）、血肌酐（Scr）、总胆红素（TBIL）、步速、小腿围低于对照组（t分别为4.235、6.500、3.826、3.989、4.289、8.878、2.474，均P＜0.05）。观察组营养风险48.00%、LFI≥4.5分52.00%、CTP分级B/C级76.00%高于对照组18.18%、14.55%、27.27%（χ ² 分别为7.664、12.454、16.699，均P＜0.05）。单因素Cox回归分析显示年龄、ALT、营养风险、LFI≥4.5分、CTP分级B/C级、RBC、Scr、TBIL、Hb、步速、小腿围为肝硬化患者发生肝病复合不良事件的危险因素（HR分别为2.251、1.578、1.626、1.981、1.715、1.428、1.443、1.419、1.336、1.332、1.254，均P＜0.05）。多因素Cox回归分析显示年龄、ALT、营养风险、LFI≥4.5分、CTP分级B/C级为肝硬化患者发生肝病复合不良事件的独立危险因素（HR分别为2.275、1.746、2.025、1.895，P均＜0.05）。ROC曲线结果显示LFI、CTP、LFI联合CTP预测肝硬化患者肝病复合不良事件的AUC分别为0.82、0.79、0.88（P＜0.05）。结论  年龄、肝脏衰弱、CTP分级B/C级、营养风险为肝硬化患者肝病复合不良事件的危险因素，肝脏衰弱程度联合肝功能分级预测肝硬化患者肝病复合不良事件具有更高的效能。

       Objective  To explore the value of predicting liver disease complex adverse events in patients with liver cirrhosis by combining the degree of liver frailty with liver function grading，as a basis for identifying and intervening in adverse outcomes．Methods  A study was conducted on 80 patients with liver cirrhosis admitted to the hospital from December 2022 to December 2023．Patients were followed up for six months to observe the occurrence of adverse events．Twenty-five patients with liver disease complex adverse events with two or more liver disease complications were selected as the observation group，and 55 patients with one or no liver disease complication were selected as the control group．The basic information，laboratory indicators，nutritional indicators，physical activity levels，liver frailty index（LFI），Child Turcotte Pugh（CTP）scores，univariate and multivariate Cox regression analysis were used to evaluate the risk factors for liver disease complex adverse events in liver cirrhosis patients．The value of combining LFI and CTP score in predicting liver disease complex adverse events in patients with liver cirrhosis was assessed by Receiver Operating Characteristic （ROC）curve area．Results  The age，alanine aminotransferase（ALT），red blood cell count（RBC），hemoglobin（Hb），serum creatinine（Scr），total bilirubin（TBIL），walking speed，and calf circumference of the observation group were higher than those of the control group（t=4.235，6.500，3.826，3.989，4.289，8.878，2.474，all P＜0.05）．The nutritional risk of the observation group was 48.00%，LFI score≥4.5 was 52.00%，CTP grade B/C was 76.00%，which was higher than that of the control group at 18.18%，14.55%，and 27.27%（χ ² =7.664，12.454，16.699，all P＜0.05）．Univariate Cox regression analysis showed age，nutritional risk，LFI ≥  4.5，CTP grade B/C，RBC，Scr，TBIL，Hb，step speed and calf circumference were  risk factors for the occurrence of liver disease complex adverse events in patients with liver cirrhosis（HR values=2.251，1.578，1.626，1.981，1.715，1.428，1.443，1.419，1.336，1.332，1.254，all P＜0.05）．Multivariate Cox regression analysis showed that age，ALT，nutritional risk，LFI ≥ 4.5，and CTP grade B/C were independent risk factors for liver disease complex adverse events in patients with liver cirrhosis（HR values=2.275，1.746，2.025，1.895，all P＜0.05）．The ROC curve results showed that the AUC of LFI，CTP，and LFI combined with CTP in predicting liver disease composite adverse events in patients with liver cirrhosis were 0.82，0.79，and 0.88，respectively（P＜0.05）．Conclusions  Age，liver frailty，CTP grade B/C，and nutritional  risk are  risk factors for liver disease complex adverse events in patients with liver cirrhosis．The combination of LFI and liver function grade has higher efficacy in predicting liver disease complex adverse events in patients with liver cirrhosis．

       目的   挖掘使用美托洛尔后的药物不良事件（ADE），为临床合理用药提供参考意见。方法   对美国食品药品管理局（FDA）FDA药物ADE报告系统（FAERS）数据库进行信号挖掘，采用报告比值比法和比例报告比值法，分析FAERS数据库中2004年第1季度至2023年第2季度关于美托洛尔的ADE报告。结果   在FAERS数据库中收集到美托洛尔相关ADE共24 184例、667个阳性信号，共涉及27个系统器官分类。ADE严重报告共16 766（占69.33%），ADE报告频次排名前3的分别是头晕、心动过缓、呼吸困难。结论   美托洛尔的不良反应主要集中在全身性疾病及给药部位各种反应、心脏器官疾病和各类损伤。在使用美托洛尔过程中发生ADE时，应该及时采取相应的干预措施。

       Objective  To explore the adverse drug events（ADEs）after the use of metoprolol and provide  reference opinions for clinical rational drug use．Methods  Signal mining was conducted on the FDA Adverse Event Reporting System（FAERS）database in the United States．The  reporting  ratio method and proportional  reporting  ratio method were used to analyze ADEs reports related to metoprolol in the FAERS database from the first quarter of 2019 to the second quarter of 2023．Results  A total of 24 184 cases of metoprolol related ADEs were collected in the FAERS database，with 667 positive signals and a total of 27 system organ class involved．Conclusions  The adverse reactions of metoprolol mainly focus on systemic diseases，various reactions at the administration site，heart organ diseases，and various injuries．It is recommended that timely intervention measures should be taken when ADE occurs during the use of metoprolol．