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Optimizing the safety and efficacy of the awake venovenous extracorporeal membrane oxygenation in patients with COVID-19-related ARDS. 优化 COVID-19 相关 ARDS 患者清醒状态下静脉体外膜氧合的安全性和有效性。
IF 3.3 3区 医学 Q2 RESPIRATORY SYSTEM Pub Date : 2024-01-01 DOI: 10.1177/17534666241282590
Peter Sklienka, Filip Burša, Michal Frelich, Jan Máca, Vojtech Vodička, Hana Straková, Markéta Bílená, Tereza Romanová, Hana Tomášková

Background: Maintaining the patient awake and not intubated during the venovenous extracorporeal membrane oxygenation (VV ECMO) reduces the risk of ventilation-induced lung injury in patients with ARDS. Currently, there is a lack of data on outcomes and complications associated with the awake ECMO approach.

Objectives: To evaluate outcomes and the occurrence of complications of awake ECMO approach guided by local safety protocol comprising ultrasound-guided cannulation, argatroban-based anticoagulation, respiratory support, and routine sedation targeted to reduce respiratory effort and keeping nurse-to-patient ratio of 1:1.

Design: A single-center retrospective case series analysis.

Methods: Consecutive patients with COVID-19-related acute respiratory distress syndrome (ARDS) (CARDS) treated by full awake VV ECMO approach from April 2019 to December 2023 were eligible.

Results: Our center treated 10 patients (mean age 54.7 ± 11.6 years) with CARDS with an awake ECMO approach. The reasons for awake ECMO included the presence of barotrauma in six patients, a team consensus to prefer awake ECMO instead of mechanical ventilation in three patients, and the patient's refusal to be intubated in one case. Before ECMO, patients were severely hypoxemic, with a mean value of Horowitz index of 48.9 ± 9.1 mmHg and a mean respiratory rate of 28.8 ± 7.3 breaths per minute on high-flow nasal cannula or noninvasive ventilation support. The mean duration of awake VV ECMO was 558.0 ± 173.6 h. Seven patients (70%) were successfully disconnected from ECMO and fully recovered. Intubation from respiratory causes was needed in three patients (30%), all of whom died eventually. In total, three episodes of delirium, two episodes of significant bleeding, one pneumothorax requiring chest tube insertion, and one oxygenator acute exchange occurred throughout the 5580 h of awake ECMO. No complications related to cannula displacement or malposition occurred.

Conclusion: The awake ECMO strategy guided by safety protocol appears to be a safe approach in conscious, severely hypoxemic, non-intubated patients with COVID-19-related ARDS.

背景:在静脉体外膜氧合(VV ECMO)过程中保持患者清醒且不插管可降低 ARDS 患者通气诱发肺损伤的风险。目前,缺乏与清醒 ECMO 方法相关的疗效和并发症的数据:目的:评估在当地安全方案(包括超声引导插管、阿加曲班抗凝、呼吸支持、常规镇静以降低呼吸强度并保持护士与患者的比例为 1:1)指导下进行清醒 ECMO 的疗效和并发症发生情况:设计:单中心回顾性病例系列分析:2019年4月至2023年12月期间连续接受全清醒VV ECMO方法治疗的COVID-19相关急性呼吸窘迫综合征(ARDS)(CARDS)患者:本中心采用清醒 ECMO 法治疗了 10 例 CARDS 患者(平均年龄为 54.7 ± 11.6 岁)。采用清醒 ECMO 的原因包括:6 例患者存在气压创伤;3 例患者团队一致同意采用清醒 ECMO 代替机械通气;1 例患者拒绝插管。ECMO 前,患者严重低氧血症,霍洛维茨指数(Horowitz index)平均值为 48.9 ± 9.1 mmHg,高流量鼻插管或无创通气支持下的平均呼吸频率为 28.8 ± 7.3 次/分钟。七名患者(70%)成功脱离 ECMO 并完全康复。三名患者(30%)因呼吸系统原因需要插管,最终全部死亡。在 5580 小时的清醒 ECMO 过程中,总共发生了 3 次谵妄、2 次大量出血、1 次需要插入胸管的气胸和 1 次氧合器急性交换。没有发生与插管移位或错位有关的并发症:结论:对于意识清醒、严重低氧血症、未插管的 COVID-19 相关 ARDS 患者,在安全协议指导下的清醒 ECMO 策略似乎是一种安全的方法。
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引用次数: 0
Correlation of gastro-esophageal reflux disease with asthma control and quality of life: a cross-sectional study from a low-middle income country. 胃食管反流病与哮喘控制和生活质量的相关性:一项来自中低收入国家的横断面研究。
IF 4.3 3区 医学 Q2 RESPIRATORY SYSTEM Pub Date : 2024-01-01 DOI: 10.1177/17534666241297879
Nousheen Iqbal, Atiqa Amirali, Ghulam Ullah Lail, Maria Ali Khan, Rabia Sial, Muhammad Irfan

Background: Gastro-esophageal reflux disease (GERD) is a chronic disease that coexists with asthma and is often responsible for repeated exacerbations, as well as has a negative impact on the quality of life (QoL). However, from our continent, there is limited data available on the exact prevalence of GERD in asthma and its association with asthma control and QoL.

Objective: To determine the prevalence of GERD in asthma and see its association with asthma control and QoL.

Design: A prospective, cross-sectional study was conducted over 8 months from September 2020 to April 2021.

Methods: Patients with a confirmed diagnosis of asthma aged 18 years and above were recruited from the outpatient department of pulmonology. Patients' GERD score was calculated using the FSSG SCALE (Frequency Scale for Symptoms of GERD) questionnaire and the Asthma Control Test (ACT) was used to determine asthma control. To assess the QoL, the short form of health survey (SF-36) questionnaire was used. Patients were recruited through a convenience sampling technique.

Results: A total of 190 patients were enrolled, the mean age was 33.7 ± 13.3 years and 55.8% were female. Prevalence of GERD was (136) 71.6%. According to the ACT score, 81 (42.6%) patients had very poorly controlled asthma (mean GERD score of 13.73 ± 7.66), compared to 59 (31.1%) asthmatic patients who had well-controlled asthma (mean GERD score of 11.97 ± 7.39, p = 0.43). SF-36 questionnaire was used to measure QoL showed GERD patients had statistically lower scores in the following domains of QoL: "Role Limitations due to Physical Functioning" (37.78 vs 57.44, p = 0.003), "Energy/Fatigue" (47.47 vs 55.07, p = 0.02), and "Bodily Pain" (63.40 vs 72.84, p = 0.01).

Conclusion: This study showed a high prevalence of GERD among asthmatic patients with a negative impact on QoL but did not demonstrate a statistically significant relationship between GERD and asthma control.

背景:胃食管反流病(GERD胃食管反流病(GERD)是一种与哮喘并存的慢性疾病,经常导致哮喘反复加重,并对患者的生活质量(QoL)产生负面影响。然而,在我们大陆,关于哮喘患者胃食管反流病的确切患病率及其与哮喘控制和 QoL 的关系的数据非常有限:确定哮喘患者胃食管反流病的发病率,并了解其与哮喘控制和 QoL 的关系:2020年9月至2021年4月,进行了为期8个月的前瞻性横断面研究:方法:从肺科门诊部招募 18 岁及以上确诊为哮喘的患者。使用胃食管反流症状频率量表(FSSG SCALE)问卷计算患者的胃食管反流评分,并使用哮喘控制测试(ACT)确定哮喘控制情况。为了评估患者的 QoL,采用了健康调查简表(SF-36)问卷。患者是通过方便抽样技术招募的:结果:共招募了 190 名患者,平均年龄(33.7±13.3)岁,55.8% 为女性。胃食管反流病的患病率为(136)71.6%。根据 ACT 评分,81 名(42.6%)患者的哮喘控制极差(胃食管反流病平均得分为 13.73 ± 7.66),而 59 名(31.1%)哮喘患者的哮喘控制良好(胃食管反流病平均得分为 11.97 ± 7.39,P = 0.43)。SF-36问卷用于测量QoL,结果显示胃食管反流病患者在以下QoL领域的得分较低:"身体功能导致的角色限制"(37.78 vs 57.44,p = 0.003)、"能量/疲劳"(47.47 vs 55.07,p = 0.02)和 "身体疼痛"(63.40 vs 72.84,p = 0.01):这项研究表明,胃食管反流病在哮喘患者中的发病率很高,会对患者的生活质量产生负面影响,但胃食管反流病与哮喘控制之间并没有统计学意义上的显著关系。
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引用次数: 0
Post-reflux swallow-induced peristaltic wave index: a new parameter for the identification of non-acid gastroesophageal reflux-related chronic cough. 反流后吞咽诱发蠕动波指数:识别非酸性胃食管反流相关慢性咳嗽的新参数。
IF 4.3 3区 医学 Q2 RESPIRATORY SYSTEM Pub Date : 2024-01-01 DOI: 10.1177/17534666231220819
Bingxian Sha, Wanzhen Li, Haodong Bai, Tongyangzi Zhang, Shengyuan Wang, Linyang Wu, Wenbo Shi, Yiqing Zhu, Li Yu, Xianghuai Xu

Background: The current available diagnostic criteria for gastroesophageal reflux-related chronic cough (GERC) dominated by non-acid reflux is imperfect. The post-reflux swallow-induced peristaltic wave index (PSPWI) is a parameter reflecting esophageal clearance function.

Objectives: This study aims to investigate its diagnostic value for non-acid GERC.

Design: This study sought to compare the diagnostic value of PSPWI in different types of GERC, particularly non-acid GERC, and explore the clinical significance of PSPWI in the diagnosis of non-acid GERC through diagnostic experiments.

Methods: A retrospective analysis was performed based on 223 patients with suspected GERC who underwent multichannel intraluminal impedance-pH monitoring (MII-pH) in the outpatient clinic of our department from August 2016 to June 2021. Their clinical information, laboratory test results, and treatment responses were assessed and the underlying etiologies of chronic cough were categorized. The predictive value of the PSPWI in diagnosing different types of GERC, especially non-acid GERC, was analyzed and compared.

Results: A total of 195 patients with chronic cough who met the inclusion criteria underwent MII-pH monitoring. 143 patients had a definitive diagnosis of GERC, including 98 with acid GERC and 45 with non-acid GERC. The diagnostic value of PSPWI alone was moderate for GERC with an area under the working curve (AUC) 0.760, but poor for non-acid GERC with an AUC of 0.569. However, PSPWI < 39.8% combining with acid exposure time (AET) ⩽ 6.2% demonstrated a moderate diagnostic value for non-acid GERC, with an AUC of 0.722. When PSPWI < 39.8% combined with a non-acid reflux ratio >68.75%, the diagnostic value for non-acid GERC was improved (AUCROC = 0.80 versus AUCROC = 0.722, p < 0.05), which was significantly superior to non-acid symptom index (AUCROC = 0.804 versus AUCROC = 0.550, p < 0.05) and non-acid symptom association probability (AUCROC = 0.804 versus AUCROC = 0.571, p < 0.05).

Conclusion: PSPWI < 39.8% and AET ⩽ 6.2% have demonstrated good diagnostic value for non-acid GERC. The diagnostic value was further improved when combined with non-acid reflux ratio >68.75%.

背景:胃食管反流相关慢性咳嗽(GERC)以非酸性反流为主,目前可用的诊断标准并不完善。反流后吞咽诱发蠕动波指数(PSPWI)是反映食管清除功能的一个参数:本研究旨在探讨其对非酸性 GERC 的诊断价值:本研究旨在比较 PSPWI 在不同类型 GERC(尤其是非酸性 GERC)中的诊断价值,并通过诊断实验探讨 PSPWI 在非酸性 GERC 诊断中的临床意义:对2016年8月至2021年6月在我科门诊接受多通道腔内阻抗-血压监测(MII-pH)的223例疑似GERC患者进行回顾性分析。对他们的临床信息、实验室检查结果和治疗反应进行评估,并对慢性咳嗽的潜在病因进行分类。分析并比较了PSPWI在诊断不同类型的GERC,尤其是非酸性GERC方面的预测价值:共有 195 名符合纳入标准的慢性咳嗽患者接受了 MII-pH 监测。143名患者被明确诊断为GERC,其中98名为酸性GERC,45名为非酸性GERC。单独使用 PSPWI 对 GERC 的诊断价值中等,工作曲线下面积 (AUC) 为 0.760,但对非酸性 GERC 的诊断价值较低,AUC 为 0.569。然而,PSPWI 68.75% 对非酸性 GERC 的诊断价值有所提高(AUCROC = 0.80 与 AUCROC = 0.722 相比,p ROC = 0.804 与 AUCROC = 0.550 相比,p ROC = 0.804 与 AUCROC = 0.571 相比,p 结论:PSPWI 68.75% 对非酸性 GERC 的诊断价值有所提高:PSPWI 68.75%。
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引用次数: 0
Basic assessment of chronic cough in primary care and referral pathways of patients to different specialists: plain language summary of publication. 基层医疗机构对慢性咳嗽的基本评估以及将患者转诊至不同专科医生的途径:纯文字出版物摘要。
IF 3.3 3区 医学 Q2 RESPIRATORY SYSTEM Pub Date : 2024-01-01 DOI: 10.1177/17534666241257166
Christian Domingo, Jaime Gonzálvez-Rey, Ignacio Dávila, Alfonso Del Cuvillo, Marta Sánchez-Jareño, Luis Cea-Calvo, Karlos Naberan

People with chronic cough (a cough lasting more than 8 weeks) are often referred to different specialists and undergo numerous diagnostic tests, but clear guidance is lacking. This work summarizes a consensus (an agreement) among medical specialists who are involved in managing people with chronic cough: primary care physicians (family doctors), pulmonologists (doctors who specialize in lung conditions), allergists (medical professionals specializing in allergies) and ear, nose and throat (ENT) specialists. They discussed how to perform a basic assessment of people with chronic cough in primary care (day-to-day healthcare given by a general practitioner or family doctor) and how to refer them to different specialists based on clinical findings or test results.

慢性咳嗽患者(咳嗽持续时间超过 8 周)通常会被转诊至不同的专科医生,并接受大量的诊断测试,但却缺乏明确的指导。本著作总结了参与管理慢性咳嗽患者的医学专家们达成的共识(协议):初级保健医生(家庭医生)、肺病专家(肺部疾病专科医生)、过敏症专家(过敏症专科医生)和耳鼻喉科专家。他们讨论了如何在初级保健(全科医生或家庭医生提供的日常医疗服务)中对慢性咳嗽患者进行基本评估,以及如何根据临床发现或检查结果将患者转诊给不同的专科医生。
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引用次数: 0
Early experience of endobronchial ultrasound-guided transbronchial nodal cryobiopsy: a case series from Sabah, Malaysia. 支气管内超声引导下经支气管结节冷冻生物切片检查的早期经验:马来西亚沙巴州的病例系列。
IF 4.3 3区 医学 Q2 RESPIRATORY SYSTEM Pub Date : 2024-01-01 DOI: 10.1177/17534666241231122
Hema Yamini Ramarmuty, Nai-Chien Huan, Larry Ellee Nyanti, Teng Shin Khoo, Tamilarasi Renganathan, Ahmad Zaki Manoh, Nusaibah Azman, Kunji Kannan Sivaraman Kannan

Endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) is an established minimally invasive method for the diagnosis of benign and malignant conditions. Continuous efforts are underway to improve the material adequacy of EBUS-TBNA, including the introduction of a new technique called EBUS-guided transbronchial nodal cryobiopsy (EBUS-TBNC). This method allows for the retrieval of larger and well-preserved histologic samples from the mediastinum. We present a case series of four patients who underwent combined EBUS-TBNA and EBUS-TBNC procedures in our centre. All procedures were performed under general anaesthesia using a convex probe EBUS scope (Pentax EB-1970UK). Two patients were diagnosed with malignancy and two with benign disorders (silicosis and tuberculosis). In the malignant cases, both EBUS-TBNA/cell block and cryobiopsy provided a diagnosis but cryobiopsy yielded more material for ancillary tests in one patient. However, in the benign cases, there was discordance between EBUS-TBNA/cell block and cryobiopsy. Only cryobiopsy detected granuloma in the patient with TB (tuberculosis), and in the patient with silicosis, TBNC provided a better overall histological evaluation, leading to a definitive diagnosis. No complications were observed. This case series supports the potential diagnostic value of combining EBUS-TBNA and EBUS-TBNC, particularly in benign mediastinal lesions (granulomatous diseases), and in cases requiring additional molecular tests in cancer diagnosis.

支气管内超声引导下经支气管针吸术(EBUS-TBNA)是一种成熟的诊断良性和恶性疾病的微创方法。目前正在不断努力提高 EBUS-TBNA 的材料充分性,包括引入一种称为 EBUS 引导下经支气管结节冷冻活检(EBUS-TBNC)的新技术。这种方法可以从纵隔取出较大且保存完好的组织学样本。我们介绍了在本中心接受 EBUS-TBNA 和 EBUS-TBNC 联合手术的四名患者的病例系列。所有手术均在全身麻醉下使用凸探头 EBUS 镜(Pentax EB-1970UK)进行。两名患者被诊断为恶性肿瘤,两名患者被诊断为良性疾病(矽肺和肺结核)。在恶性病例中,EBUS-TBNA/细胞阻断术和冷冻活组织检查都能提供诊断结果,但冷冻活组织检查为一名患者提供了更多的辅助检查材料。然而,在良性病例中,EBUS-TBNA/细胞阻断术和冷冻活组织切片检查结果不一致。在肺结核(肺结核)患者中,只有冷冻活检发现了肉芽肿,而在矽肺患者中,TBNC提供了更好的整体组织学评估,从而得出了明确诊断。没有发现并发症。这组病例证明了 EBUS-TBNA 和 EBUS-TBNC 联合应用的潜在诊断价值,尤其是在纵隔良性病变(肉芽肿性疾病)和癌症诊断中需要额外分子检测的病例中。
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引用次数: 0
The prevalence of asthma and its predictor among patients presetting in Ethiopian public hospitals: systematic review and meta-analysis, 2024. 埃塞俄比亚公立医院预设患者的哮喘发病率及其预测因素:系统回顾和荟萃分析》,2024 年。
IF 3.3 3区 医学 Q2 RESPIRATORY SYSTEM Pub Date : 2024-01-01 DOI: 10.1177/17534666241275336
Ousman Adal, Sosina Tamire Mamo, Alamirew Eneyew Belay, Yeshimebet Tamir Tsehay, Henok Biresaw Netsere, Sileshi Mulatu, Gebrehiwot Berie Mekonnen, Mengistu Abebe Messelu, Gebremeskel Kibret Abebe, Wubet Tazeb Wondie, Chernet Tafere, Asnake Gashaw Belayneh

Background: Asthma is a leading cause of emergency hospital visits and a significant factor in lost productive hours. The lack of a synthesized body of knowledge on bronchial asthma has notable public health implications.

Objective: This systematic review and meta-analysis aim to investigate the prevalence of asthma and its predictors among patients presenting in Ethiopian public hospitals.

Design: Duplicate studies were removed using EndNote version X9. The Newcastle-Ottawa Scale guided the quality assessment, and data extraction followed the Joanna Briggs Institute format.

Data source and methods: The authors used advanced search methods, including databases such as PubMed, Scopus, Embase, Africa Index Medicus, Science Direct, HINARI, Google Scholar, and manual searches. Data presentation adhered to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) checklist. Publication bias was assessed using Egger's regression test and a funnel plot. Sensitivity analysis was also conducted.

Results: The search yielded 352 original articles, with 22 meeting the criteria for inclusion. Using the random-effects DerSimonian-Laird model, the prevalence of bronchial asthma was found to be 9.02% (95% CI: 7.50, 10.53). Several factors were associated with the prevalence of bronchial asthma, including the spring season (AOR 3.7; 95% CI: 2.11, 6.49), childhood age (AOR 4.2; 95% CI: 1.84, 9.55), and urban residence (AOR 1.7; 95% CI: 1.29, 2.31). Other significant factors include family history of asthma (AOR 2.89; 95% CI: 2.22, 3.75), insecticide exposure (AOR 3.3; 95% CI: 2.23, 4.91), and the presence of household insects like cockroaches (AOR 3.33; 95% CI: 2.15, 5.15). Smoking (AOR 3.64; 95% CI: 2.66, 4.98), obstructive sleep apnea (AOR 4.29; 95% CI: 2.37, 7.76), and recurrent upper respiratory tract infections (AOR 4.31; 95% CI: 2.24, 8.32) were also significant.

Conclusion: The pooled prevalence of bronchial asthma is notably high in Ethiopia. Key predictors include childhood age, spring season, urban living, family history of asthma, exposure to insecticides, presence of cockroaches, smoking, obstructive sleep apnea, and recurrent upper respiratory infections. Targeted interventions are crucial and should focus on lifestyle improvements, allergen identification, cockroach control, smoking cessation, reducing insecticide exposure, and promoting a safe environment.

Trial registration: This review's protocol was pre-registered with the International Prospective Register of Systematic Reviews (PROSPERO registration number CRD42023491222).

背景:哮喘是医院急诊的主要病因,也是造成生产时间损失的一个重要因素。缺乏有关支气管哮喘的综合知识对公共卫生有着显著的影响:本系统综述和荟萃分析旨在调查埃塞俄比亚公立医院就诊患者的哮喘发病率及其预测因素:设计:使用 EndNote X9 版本删除重复研究。采用纽卡斯尔-渥太华量表进行质量评估,数据提取采用乔安娜-布里格斯研究所的格式:作者采用了先进的检索方法,包括 PubMed、Scopus、Embase、Africa Index Medicus、Science Direct、HINARI、Google Scholar 等数据库以及人工检索。数据展示遵循系统综述和元分析首选报告项目(PRISMA)清单。采用 Egger 回归检验和漏斗图评估了发表偏倚。此外还进行了敏感性分析:搜索结果显示,共有 352 篇原创文章,其中 22 篇符合纳入标准。采用随机效应 DerSimonian-Laird 模型,发现支气管哮喘的患病率为 9.02%(95% CI:7.50, 10.53)。有几个因素与支气管哮喘的发病率有关,包括春季(AOR 3.7;95% CI:2.11,6.49)、儿童年龄(AOR 4.2;95% CI:1.84,9.55)和城市居住地(AOR 1.7;95% CI:1.29,2.31)。其他重要因素包括哮喘家族史(AOR 2.89;95% CI:2.22,3.75)、杀虫剂接触(AOR 3.3;95% CI:2.23,4.91)和家中有蟑螂等昆虫(AOR 3.33;95% CI:2.15,5.15)。吸烟(AOR 3.64;95% CI:2.66,4.98)、阻塞性睡眠呼吸暂停(AOR 4.29;95% CI:2.37,7.76)和反复上呼吸道感染(AOR 4.31;95% CI:2.24,8.32)也有显著影响:结论:埃塞俄比亚支气管哮喘的总体发病率很高。主要预测因素包括儿童年龄、春季、城市生活、哮喘家族史、接触杀虫剂、蟑螂、吸烟、阻塞性睡眠呼吸暂停和反复上呼吸道感染。有针对性的干预措施至关重要,应侧重于改善生活方式、识别过敏原、控制蟑螂、戒烟、减少杀虫剂接触和促进安全环境:本综述方案已在国际系统综述前瞻性登记处进行了预先登记(PROSPERO 登记号为 CRD42023491222)。
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引用次数: 0
Liver injury due to endothelin receptor antagonists: a real-world study based on post-marketing drug monitoring data. 内皮素受体拮抗剂导致的肝损伤:基于上市后药物监测数据的真实世界研究。
IF 4.3 3区 医学 Q2 RESPIRATORY SYSTEM Pub Date : 2024-01-01 DOI: 10.1177/17534666231223606
Shichao Dong, Xiaofei Guo, Huayu Wang, Chuan Sun
<p><strong>Background: </strong>Liver injury is the hallmark adverse reaction of endothelin receptor antagonist (ERA). Since the first drug, bosentan has been widely used in clinical practice, hepatotoxicity has been accompanied by the history of ERA. The new ERA has been proven to have a lower liver risk but the current research findings are inconsistent. ERA-based targeted drug combinations are commonly used in the treatment of pulmonary arterial hypertension, where the risk of liver injury is difficult to estimate.</p><p><strong>Objectives: </strong>This study aimed to compare the correlation between ERA and different ERA combination regimens with liver injury in the real world.</p><p><strong>Design: </strong>This is a retrospective study using data from the Adverse Event Reporting System (Food and Drug Administration AERS, FAERS).</p><p><strong>Methods: </strong>The study used proportional imbalance and Bayesian analysis to mine FAERS data from January 2004 to December 2022 to determine the association of three ERAs with liver injury and to further mine the risk of liver injury due to the combination of ERAs with other targeted drugs. In addition, we analyzed the onset time, mortality, and hospitalization rate of liver injury caused by different ERA combination regimens.</p><p><strong>Results: </strong>We screened out 3581 ERA-related liver injury events, of which bosentan (59.82%) had the largest number of cases. The patients with liver injury were mainly female (60.63%), and the age was concentrated between 61 and 75 years (26.75%). According to different signal mining methods, reporting odds ratio (ROR; 3.38, 95% confidence interval = 3.23-3.53), proportional reporting ratio (PRR; 3.22, <i>χ</i><sup>2</sup> = 37.84), Bayesian confidence propagation neural network (BCPNN; 1.68, 95% confidence interval = 1.61), multi-item gamma Poisson shrinker (MGPS; 3.21, 95% confidence interval = 3.09), bosentan had the strongest association with liver injury compared to ambrisentan and macitentan. Furthermore, bosentan + sildenafil [ROR (2.52, 95% confidence interval = 2.23-2.84), PRR (2.44, <i>χ</i><sup>2</sup> = 15.92), BCPNN (1.29, 95% confidence interval = 1.14), MGPS (2.44, 95% confidence interval = 2.21)], bosentan + epoprostenol [ROR (5.39, 95% confidence interval = 4.29-6.77), PRR (4.94, <i>χ</i><sup>2</sup> = 65.18), BCPNN (2.30, 95% confidence interval = 1.83), MGPS (4.94, 95% confidence interval = 4.08)], bosentan + iloprost [ROR (2.70, 95% confidence interval = 2.11-3.45), PRR (2.61, <i>χ</i><sup>2</sup> = 31.03), BCPNN (1.38, 95% confidence interval = 1.08), MGPS (2.61, 95% confidence interval = 2.12)] had a higher risk of liver injury caused by the three ERA combination regimens. The median time to onset of hepatotoxicity associated with all ERA combination regimens was 259 days (interquartile range: 58-716.5 days). Finally, the hospitalization rate for patients experiencing hepatotoxicity with ERA combination regimens was 47.86% and the mo
背景:肝损伤是内皮素受体拮抗剂(ERA)的标志性不良反应。自第一种药物波生坦被广泛应用于临床以来,肝毒性一直伴随着ERA的历史。新的ERA已被证实具有较低的肝脏风险,但目前的研究结果并不一致。基于ERA的靶向药物组合常用于肺动脉高压的治疗,其肝脏损伤风险难以估计:本研究旨在比较ERA和不同ERA联合用药方案在现实世界中与肝损伤的相关性:这是一项回顾性研究,使用的数据来自不良事件报告系统(食品药品管理局 AERS,FAERS):本研究采用比例失衡和贝叶斯分析法挖掘2004年1月至2022年12月的FAERS数据,以确定三种ERA与肝损伤的相关性,并进一步挖掘ERA与其他靶向药物联用导致肝损伤的风险。此外,我们还分析了不同ERA联合用药方案导致肝损伤的发病时间、死亡率和住院率:结果:我们筛选出 3581 例 ERA 相关肝损伤事件,其中波生坦(59.82%)的病例数最多。肝损伤患者以女性为主(60.63%),年龄集中在61-75岁之间(26.75%)。根据不同的信号挖掘方法,报告几率比(ROR;3.38,95% 置信区间 = 3.23-3.53)、比例报告比(PRR;3.22,χ2 = 37.84)、贝叶斯置信传播神经网络(BCPN;1.68,95% 置信区间 = 1.61)、多项目伽马泊松收缩器(MGPS;3.21,95% 置信区间 = 3.09),与安立生坦和马西替坦相比,波生坦与肝损伤的相关性最强。此外,波生坦+西地那非[ROR(2.52,95% 置信区间 = 2.23-2.84)、PRR(2.44,χ2 = 15.92)、BCPNN(1.29,95% 置信区间 = 1.14)、MGPS(2.44,95% 置信区间 = 2.21)]、波生坦 + 依前列醇[ROR(5.39,95% 置信区间 = 4.29-6.77)、PRR(4.94,χ2 = 65.18)、BCPNN(2.30,95%置信区间=1.83),MGPS(4.94,95%置信区间=4.08)]、波生坦+伊洛前列素[ROR(2.70,95%置信区间=2.11-3.45),PRR(2.61,χ2=31.03),BCPNN(1.38,95%置信区间=1.08),MGPS(2.61,95%置信区间=2.12)]三种ERA联合方案引起肝损伤的风险较高。所有ERA联合疗法引起肝毒性的中位时间为259天(四分位距:58-716.5天)。最后,ERA联合疗法肝毒性患者的住院率为47.86%,死亡率为12.67%:通过使用 FAERS,我们分析比较了不同ERA和ERA联合用药方案的肝损伤风险,以及所有ERA联合用药方案的发病时间和不良反应结果。研究结果显示,波生坦的肝损伤风险最高,波生坦+西地那非、波生坦+表前列醇、波生坦+伊洛前列素等联合方案的肝损伤风险较高。从治疗早期开始,我们就需要定期监测患者的肝功能,尤其是女性和老年人,一旦出现肝损伤,应立即停用可疑药物。
{"title":"Liver injury due to endothelin receptor antagonists: a real-world study based on post-marketing drug monitoring data.","authors":"Shichao Dong, Xiaofei Guo, Huayu Wang, Chuan Sun","doi":"10.1177/17534666231223606","DOIUrl":"10.1177/17534666231223606","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Background: &lt;/strong&gt;Liver injury is the hallmark adverse reaction of endothelin receptor antagonist (ERA). Since the first drug, bosentan has been widely used in clinical practice, hepatotoxicity has been accompanied by the history of ERA. The new ERA has been proven to have a lower liver risk but the current research findings are inconsistent. ERA-based targeted drug combinations are commonly used in the treatment of pulmonary arterial hypertension, where the risk of liver injury is difficult to estimate.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Objectives: &lt;/strong&gt;This study aimed to compare the correlation between ERA and different ERA combination regimens with liver injury in the real world.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Design: &lt;/strong&gt;This is a retrospective study using data from the Adverse Event Reporting System (Food and Drug Administration AERS, FAERS).&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Methods: &lt;/strong&gt;The study used proportional imbalance and Bayesian analysis to mine FAERS data from January 2004 to December 2022 to determine the association of three ERAs with liver injury and to further mine the risk of liver injury due to the combination of ERAs with other targeted drugs. In addition, we analyzed the onset time, mortality, and hospitalization rate of liver injury caused by different ERA combination regimens.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Results: &lt;/strong&gt;We screened out 3581 ERA-related liver injury events, of which bosentan (59.82%) had the largest number of cases. The patients with liver injury were mainly female (60.63%), and the age was concentrated between 61 and 75 years (26.75%). According to different signal mining methods, reporting odds ratio (ROR; 3.38, 95% confidence interval = 3.23-3.53), proportional reporting ratio (PRR; 3.22, &lt;i&gt;χ&lt;/i&gt;&lt;sup&gt;2&lt;/sup&gt; = 37.84), Bayesian confidence propagation neural network (BCPNN; 1.68, 95% confidence interval = 1.61), multi-item gamma Poisson shrinker (MGPS; 3.21, 95% confidence interval = 3.09), bosentan had the strongest association with liver injury compared to ambrisentan and macitentan. Furthermore, bosentan + sildenafil [ROR (2.52, 95% confidence interval = 2.23-2.84), PRR (2.44, &lt;i&gt;χ&lt;/i&gt;&lt;sup&gt;2&lt;/sup&gt; = 15.92), BCPNN (1.29, 95% confidence interval = 1.14), MGPS (2.44, 95% confidence interval = 2.21)], bosentan + epoprostenol [ROR (5.39, 95% confidence interval = 4.29-6.77), PRR (4.94, &lt;i&gt;χ&lt;/i&gt;&lt;sup&gt;2&lt;/sup&gt; = 65.18), BCPNN (2.30, 95% confidence interval = 1.83), MGPS (4.94, 95% confidence interval = 4.08)], bosentan + iloprost [ROR (2.70, 95% confidence interval = 2.11-3.45), PRR (2.61, &lt;i&gt;χ&lt;/i&gt;&lt;sup&gt;2&lt;/sup&gt; = 31.03), BCPNN (1.38, 95% confidence interval = 1.08), MGPS (2.61, 95% confidence interval = 2.12)] had a higher risk of liver injury caused by the three ERA combination regimens. The median time to onset of hepatotoxicity associated with all ERA combination regimens was 259 days (interquartile range: 58-716.5 days). Finally, the hospitalization rate for patients experiencing hepatotoxicity with ERA combination regimens was 47.86% and the mo","PeriodicalId":22884,"journal":{"name":"Therapeutic Advances in Respiratory Disease","volume":"18 ","pages":"17534666231223606"},"PeriodicalIF":4.3,"publicationDate":"2024-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10771067/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139098657","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Referral rates and barriers to lung transplantation based on pulmonary function criteria in interstitial lung diseases: a retrospective cohort study. 基于肺功能标准的间质性肺病肺移植转诊率和障碍:一项回顾性队列研究。
IF 4.3 3区 医学 Q2 RESPIRATORY SYSTEM Pub Date : 2024-01-01 DOI: 10.1177/17534666231221750
Ofir Deri, David Ovadia, Ella Huszti, Michael Peled, Milton Saute, Tammy Hod, Amir Onn, Lior Seluk, Nadav Furie, Inbal Shafran, Ronen Mass, Sumit Chatterji, Liran Levy

Background: Interstitial lung diseases (ILD) unresponsive to medical therapy often require lung transplantation (LTx), which prolongs quality of life and survival. Ideal timing for referral for LTx remains challenging, with late referral associated with significant morbidity and mortality. Among other criteria, patients with ILD should be considered for LTx if forced vital capacity (FVC) is less than 80% or diffusion capacity for carbon monoxide (DLCO) is less than 40%. However, data on referral rates are lacking.

Objectives: To evaluate referral rates for LTx based on pulmonary function tests (PFTs) and identify barriers associated with non-referral.

Design: A single-center retrospective cohort study.

Methods: The study consisted of ILD patients who performed PFT between 2014 and 2020. Patients with FVC < 80% or a DLCO < 40% were included in the study. Patients with absolute contraindications to LTx were excluded. Referral rates were computed, and a comparison was made between referred and non-referred subjects.

Results: Out of 114 ILD patients meeting criteria for referral to LTx, 35 were referred (30.7%), and 7 proceeded to undergo LTx. Median time from PFT to referral for assessment was 255 days [interquartile range (IQR) 35-1077]. Median time from referral to LTx was 89 days (IQR 59-143). Referred patients were younger (p = 0.003), had lower FVC (p < 0.001), DLCO (p < 0.001), and a higher rate of pulmonary hypertension (p = 0.04). Relatively better PFT, and older age, were significantly associated with non-referral of patients.

Conclusion: There is under-referral of ILD patients who are eligible for LTx, which is associated with severe disease and missed opportunities for LTx. Further research is required to validate these findings.

背景:对药物治疗无效的间质性肺病(ILD)通常需要进行肺移植(LTx),以延长患者的生活质量和生存期。转诊进行肺移植的理想时机仍具有挑战性,转诊过晚与严重的发病率和死亡率有关。除其他标准外,如果强迫生命容量(FVC)小于 80%,或一氧化碳弥散容量(DLCO)小于 40%,ILD 患者应考虑接受 LTx。然而,目前还缺乏有关转诊率的数据:评估基于肺功能检测(PFT)的LTx转诊率,并确定与不转诊相关的障碍:设计:单中心回顾性队列研究:研究对象为 2014 年至 2020 年期间进行过 PFT 检查的 ILD 患者。患者的 FVC 结果:在符合LTx转诊标准的114例ILD患者中,35例(30.7%)被转诊,7例接受了LTx治疗。从PFT到转诊评估的中位时间为255天[四分位距(IQR)35-1077]。从转诊到LTx的中位时间为89天(IQR为59-143)。转诊患者更年轻(P = 0.003),FVC 更低(P = 0.04)。PFT相对较好和年龄较大与未转诊患者明显相关:结论:符合长期治疗条件的 ILD 患者转诊不足,这与病情严重和错过长期治疗机会有关。需要进一步研究来验证这些发现。
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引用次数: 0
A comparison between a gastroesophageal reflux disease questionnaire-based algorithm and multichannel intraluminal impedance-pH monitoring for the treatment of gastroesophageal reflux-induced chronic cough. 基于胃食管反流病调查问卷的算法与多通道腔内阻抗-pH 监测在治疗胃食管反流引起的慢性咳嗽方面的比较。
IF 4.3 3区 医学 Q2 RESPIRATORY SYSTEM Pub Date : 2024-01-01 DOI: 10.1177/17534666231220817
Wanzhen Li, Tongyangzi Zhang, Wenhua Gu, Wenbo Shi, Shengyuan Wang, Yiqing Zhu, Cuiqin Shi, Li Yu, Xianghuai Xu

Background: Empiric therapy with multichannel intraluminal impedance-pH monitoring (MII-pH) has been used for the initial treatment of gastroesophageal reflux-induced chronic cough (GERC). However, an algorithm based on the gastroesophageal reflux disease questionnaire (GerdQ) has the potential to achieve a simple, structured, and effective treatment approach for patients with GERC.

Objectives: This study compared the efficacy of anti-reflux therapy based on GerdQ (new structured pathway, NSP) with medical treatment after MII-pH examination (ordinary clinical pathway, OCP) in the management of GERC.

Design: For the NSP, we adapted the GerdQ score to establish the basis for a treatment algorithm. For the OCP, treatment was determined using the MII-pH examination results.

Methods: The non-inferiority (NI) hypothesis was used to evaluate NSP versus OCP.

Results: Overall, the NSP and OCP-based therapeutic algorithms have similar efficacy for GERC [NI analysis: 95% confidence interval (CI), -4.97 to 17.73, p = 0.009; superiority analysis: p = 0.420]. Moreover, the cough symptom scores and cough threshold improved faster in the NSP group than in the OCP group at week 8 (p < 0.05). In the subgroup analyses using the GerdQ and GerdQ impact scale (GIS) scores, patients with low-likelihood GERC (GerdQ < 8) were more likely to benefit from OCP (NI analysis: 95% CI, -19.73 to 18.02, p = 0.213). On the other hand, in patients with high-likelihood and low-reflux impact GERC patients (GerdQ > 8 and GIS < 4), the NSP arm was not inferior to the standard treatment of OCP (NI analysis: 95% CI, -8.85 to 28.21%, p = 0.04; superiority analysis: p = 0.339), indicating that GerdQ- and GIS-guided diagnosis and management of patients with GERC could be an alternative to MII-pH management, especially in settings with reduced medical resources.

Conclusions: The use of the GerdQ algorithm should be considered when handling patients with GERC in the primary care setting.

Trial registration: This research was registered in the Chinese Clinical Trials Registry (ChiCTR-ODT-12001899).

背景:多通道腔内阻抗-pH 监测(MII-pH)经验疗法一直被用于胃食管反流引起的慢性咳嗽(GERC)的初始治疗。然而,基于胃食管反流病问卷(GerdQ)的算法有可能为 GERC 患者提供一种简单、结构化且有效的治疗方法:本研究比较了基于 GerdQ 的抗反流治疗(新结构化路径,NSP)与 MII-pH 检查后的药物治疗(普通临床路径,OCP)在 GERC 治疗中的疗效:对于 NSP,我们对 GerdQ 评分进行了调整,为治疗算法奠定了基础。对于 OCP,我们根据 MII-pH 检查结果决定治疗方法:方法:采用非劣效性(NI)假设对 NSP 和 OCP 进行评估:总体而言,基于 NSP 和 OCP 的治疗算法对 GERC 具有相似的疗效[NI 分析:95% 置信区间 (CI),-4.97 至 17.73,p = 0.009;优越性分析:p = 0.420]。此外,在第 8 周时,NSP 组的咳嗽症状评分和咳嗽阈值的改善速度快于 OCP 组(P = 0.213)。另一方面,在高可能性和低反流影响的 GERC 患者中(GerdQ > 8 和 GIS p = 0.04;优越性分析:p = 0.339),这表明在 GerdQ 和 GIS 指导下对 GERC 患者进行诊断和管理可以替代 MII-pH 管理,尤其是在医疗资源减少的情况下:结论:在基层医疗机构处理 GERC 患者时,应考虑使用 GerdQ 算法:本研究已在中国临床试验注册中心注册(ChiCTR-ODT-12001899)。
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引用次数: 0
Effects of omalizumab on lung function in patients with moderate-to-severe allergic asthma: a systematic review and meta-analysis. 奥马珠单抗对中重度过敏性哮喘患者肺功能的影响:系统综述和荟萃分析。
IF 4.3 3区 医学 Q2 RESPIRATORY SYSTEM Pub Date : 2024-01-01 DOI: 10.1177/17534666231221771
Junyi Liao, Jia Tang, Yuanping Jiang, Youwen Wang, Jiali Ding, Yong He

Background: With the rise of targeted treatments for asthma, treatment with omalizumab is a new option.

Objectives: To assess the improvement of pulmonary function with additional omalizumab treatment in patients (⩾6 years old) with moderate-to-severe allergic asthma.

Data sources and methods: Observational studies of randomized controlled trials of add-on omalizumab for the treatment of patients with moderate-to-severe allergic asthma, published from the establishment till August 2022, were retrieved from WAN FANG DATA, PubMed, CNKI, Embase, Cochrane, and Web of Science databases. Data extraction and quality evaluation were performed on the literature that met the inclusion criteria, using RevMan 5.3 to analyze the data.

Results: A total of 11 randomized controlled clinical trials were included, involving a total of 3578 patients with asthma, 1856 patients in the omalizumab group, and 1722 patients in the control group. The improvement in Forced expiratory volume in 1 s as a percentage of predicted normal and Forced expiratory volume in 1 s was more pronounced in the omalizumab-treated group [MD = 3.91, 95% confidence interval (CI): 1.89-5.94, p = 0.0002; MD = 0.09, 95% CI: 0.05-0.13, p < 0.0001], while the improvement in Morning Peak expiratory flow rate was not statistically different between the two groups (MD = 3.64, 95% CI: -22.17-29.45, p = 0.78).

Conclusion: Additional omalizumab treatment showed some improvement in lung function in patients with moderate-to-severe asthma.

Trial registration: PROSPERO ID:CRD42022378498.

背景随着哮喘靶向治疗的兴起,使用奥马珠单抗治疗是一种新的选择:评估中重度过敏性哮喘患者(⩾6岁)接受奥马珠单抗附加治疗后肺功能的改善情况:从万方数据(WAN FANG DATA)、PubMed、CNKI、Embase、Cochrane和Web of Science等数据库中检索了自建立至2022年8月期间发表的关于加用奥马珠单抗治疗中重度过敏性哮喘患者的随机对照试验的观察性研究。对符合纳入标准的文献进行了数据提取和质量评估,并使用RevMan 5.3对数据进行分析:结果:共纳入了 11 项随机对照临床试验,涉及 3578 名哮喘患者,其中奥马珠单抗组有 1856 名患者,对照组有 1722 名患者。奥马珠单抗治疗组患者1 s内用力呼气量占预测正常值的百分比和1 s内用力呼气量的改善更为明显[MD = 3.91,95% 置信区间(CI):1.89-5.94,P = 0.0002;MD = 0.09,95% CI:0.05-0.13,P = 0.78]:结论:追加奥马珠单抗治疗可在一定程度上改善中重度哮喘患者的肺功能:试验注册:PREMCO ID:CRD42022378498。
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Therapeutic Advances in Respiratory Disease
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