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急性A型主动脉夹层术前低氧血症患者围术期应用西维来司他钠缩短术后有创机械通气时间的临床预试验
急性A型主动脉夹层术前低氧血症患者围术期应用西维来司他钠缩短术后有创机械通气时间的临床预试验

摘要信息:研究目标: 评价急性A型主动脉夹层术前低氧血症(PaO2/FiO2≤300mmHg)患者术中应用西维来司他钠缩短术后有创机械通气的有效性和安全性。 研究设计类型、原则与实施方法 总体设计 单中心、安慰剂、双盲、随机平行对照研究。 本研究计划纳入30例急性A型主动脉夹层术前低氧血症(PaO2/FiO2≤300mmHg)患者,受试者按照1:1的比例随机分配至试验组或对照组,分别接受西维来司他钠组与安慰剂组,评价西维来司他钠缩短术后有创机械通气时间。 评价指标 主要终点指标 有创机械通气时间(小时):从有创机械通气开始至第一次成功拔除气管插管的持续时间。第一次成功拔除气管插管定义为拔除气管插管后患者能够自主呼吸超过48小时。 次要终点指标 全部有创机械通气情况(模式和时间)、全部无创机械通气情况(模式和时间)、全部高流量吸氧情况(流量和时间)。 氧合指数及其曲线下面积、PaO2/FiO2≤300mmHg持续时间(小时)、急性肺损伤、呼吸机相关肺炎、Murray肺损伤评分。 术后ICU滞留时间(天)、术后住院时间(天)、APACHE II评分、SOFA评分。 围术期死亡、脑卒中、截瘫、暂时性神经系统功能不全、癫痫、急性肾损伤、感染、心律失常、心脏骤停、急性胰腺炎、消化道出血、术中、术后输注血制品的情况(种类和数量)。 血流动力学指标、实验室检查指标、影像学指标、卫生经济学指标。 28天无呼吸机时间(天)、术后28天的全因死亡、28天内氧疗、无创机械通气、有创机械通气、俯卧位通气、吸入一氧化碳治疗。 安全性指标 急性肝功能损伤、黄疸、白细胞减少、中性粒细胞减少、血小板减少等不良事件发生情况。 实验室检查(血常规、血生化)

汇伦医药 邹文成 2024-09-05 214 0 公开
A neutrophil elastase inhibitor, sivelestat, improved respiratory and cardiac function in pediatric cardiovascular surgery with cardiopulmonary bypass
A neutrophil elastase inhibitor, sivelestat, improved respiratory and cardiac function in pediatric cardiovascular surgery with cardiopulmonary bypass

摘要信息:Purpose:Several reports indicate that a neutrophil elastase inhibitor, sivelestat, may have prophylactic efficacy against a systemic inflammatory response after cardiovascular surgery with cardiopulmonary bypass (CPB). We evaluated the clinical pulmonary and cardiac effects of sivelestat. Methods:We performed a retrospective study of 25 pediatric patients who underwent elective cardiovascular surgery with CPB for ventricular septal defect with pulmonary hypertension. Ten patients received 0.2 mg x kg(-1) x h(-1) sivelestat; the other is patients were the control group. There were no significant differences in demographic characteristics between the two groups. The P(a)O(2)/fractional inspired oxygen (F(I)O(2); P/F) ratio, the respiratory index (RI), and the fractional area change (FAC) of the left ventricle (LV) in the postoperative course were measured. Results:The P/F ratio was higher in the sivelestat group compared with the control group and there were significant differences between the two groups immediately after weaning form CPB, and at 12 h after weaning from CPB (P < 0.05). The RI was lower in the sivelestat group compared with the control group and there were significant differences between the two groups at immediately after weaning from CPB, and at 6 h and 12 h after CPB (P < 0.05). The FAC of the LV was significantly better in the sivelestat group and there was a significant difference between the two groups on postoperative day (POD) 3 (P < 0.05). Conclusion:We have shown that pediatric patients who underwent cardiovascular surgery with CPB who received sivelestat had a higher P/F ratio, a lower RI, and better FAC of the LV in the postoperative course.

汇伦医药 邹文成 2024-09-05 181 0 公开
Effect of additional preoperative administration of the neutrophil elastase inhibitor sivelestat on perioperative inflammatory response after pediatric heart surgery with cardiopulmonary bypass
Effect of additional preoperative administration of the neutrophil elastase inhibitor sivelestat on perioperative inflammatory response after pediatric heart surgery with cardiopulmonary bypass

摘要信息:Cardiopulmonary bypass (CPB) elicits a systemic inflammatory response. Our previous reports revealed that prophylactic sivelestat administration at CPB initiation suppresses the postoperative acute inflammatory response due to CPB in pediatric cardiac surgery. The purpose of this study was to compare the effects of sivelestat administration before CPB and at CPB initiation in patients undergoing pediatric open-heart surgery. Twenty consecutive patients weighing 5-10 kg and undergoing ventricular septal defect closure with CPB were divided into pre-CPB (n = 10) and control (n = 10) groups. Patients in the pre-CPB group received a 24 h continuous intravenous infusion of 0.2 mg/kg/h sivelestat starting at the induction of anesthesia and an additional 0.1 mg/100 mL during CPB priming. Patients in the control group received a 24-h continuous intravenous infusion of 0.2 mg/kg/h sivelestat starting at the commencement of CPB. Blood samples were tested. Clinical variables including blood loss, water balance, systemic vascular resistance index, and the ratio between partial pressure of oxygen and fraction of inspired oxygen (P/F ratio) were assessed. White blood cell count and neutrophil count as well as C-reactive protein levels were significantly lower in the pre-CPB group according to repeated two-way analysis of variance, whereas platelet count was significantly higher. During CPB, mixed venous oxygen saturation remained significantly higher and lactate levels lower in the pre-CPB group. Postoperative alanine aminotransferase and blood urea nitrogen levels were significantly lower in the pre-CPB group than in the control group. The P/F ratio was significantly higher in the pre-CPB group than in the control group. Fluid load requirement was significantly lower in the pre-CPB group.Administration of sivelestat before CPB initiation is more effective than administration at initiation for the suppression of inflammatory responses due to CPB in pediatric open-heart surgery, with this effect being confirmed by clinical evidence.

汇伦医药 邹文成 2024-09-05 191 0 公开
Neutrophil elastase inhibitor sivelestat attenuates perioperative inflammatory response in pediatric heart surgery with cardiopulmonary bypass
Neutrophil elastase inhibitor sivelestat attenuates perioperative inflammatory response in pediatric heart surgery with cardiopulmonary bypass

摘要信息:Cardiopulmonary bypass (CPB) evokes activation of a systemic inflammatory response. Sivelestat has been used clinically to treat acute lung injury associated with systemic inflammatory response syndrome. This prospective, doubleblind, randomized study was designed to evaluate the effects of sivelestat in the perioperative period of elective pediatric open-heart surgery with CPB. Twenty-six consecutive pediatric patients weighing between 5 and 10 kg and undergoing open-heart surgery with CPB were divided into a sivelestat group (n = 13) and a control group (n = 13). The patients in the sivelestat group were administered a continuous intravenous infusion of 0.2 mg/kg/hour of sivelestat, and the patients in the control group were administered the same volume of 0.9% saline from the initiation of CPB to 24 hours after surgery. Blood samples were drawn for the measurement of cytokines, polymorphonuclear elastase (PMN-E), white blood cell count (WBC), neutrophil count (NC), and C-reactive protein (CRP). There were no significant differences in cytokine data between the two groups. The peak PMN-E and WBC levels were significantly increased in the control group (P = 0.049, P = 0.039). The WBC and NC levels immediately after surgery in the control group were significantly greater than those in the sivelestat group (P = 0.049, P = 0.044). The peak CRP level in the control group was significantly greater than the sivelestat group (P = 0.04), and the CRP level on postoperative day 4 in the control group was significantly greater than in the sivelestat group (P = 0.014). This study showed that sivelestat attenuates the perioperative inflammatory response in pediatric heart surgery with CPB.

汇伦医药 邹文成 2024-09-05 195 0 公开
Effect of the neutrophil elastase inhibitor sivelestat on perioperative inflammatory response after pediatric heart surgery with cardiopulmonary bypass: a prospective randomized study
Effect of the neutrophil elastase inhibitor sivelestat on perioperative inflammatory response after pediatric heart surgery with cardiopulmonary bypass: a prospective randomized study

摘要信息:Cardiopulmonary bypass (CPB) elicits a systemic inflammatory response. The neutrophil elastase inhibitor sivelestat is known to suppress this systemic inflammatory response, which can eventually result in acute organ failure. The prophylactic effect of sivelestat on acute lung injury, especially in pediatric cardiac surgery, remains unclear. This prospective double-blind, randomized study evaluated the perioperative prophylactic effect of sivelestat in patients undergoing elective pediatric open heart surgery with CPB. Thirty consecutive patients, weighing 5-10 kg and undergoing open heart surgery with CPB, were assigned to sivelestat (n = 15) or control (n = 15) groups. From CPB initiation to 24 h after surgery, patients in the sivelestat group received a continuous intravenous infusion of 0.2 mg/kg/h sivelestat, whereas patients in the control group received the same volume of 0.9% saline. Blood samples were collected, and levels of interleukin (IL)-6, IL-8, tumor necrosis factor alpha, polymorphonuclear elastase (PMN-E), C-reactive protein (CRP), as well as the white blood cell (WBC) count, platelet count, and neutrophil count (NC) were measured. PMN-E levels, IL-8 levels, WBC count, NC, and CRP levels were significantly lower, and platelet count was significantly higher in the sivelestat group, according to repeated two-way analysis of variance. The activated coagulation time was significantly shorter in the sivelestat group, similarly, blood loss was significantly less in the sivelestat group. In conclusion, Sivelestat attenuates perioperative inflammatory response and clinical outcomes in patients undergoing pediatric heart surgery with CPB.

汇伦医药 邹文成 2024-09-05 188 0 公开
不同剂量西维来司他钠对急性Stanford A型主动脉夹层手术患者围术期急性肺损伤的影响
不同剂量西维来司他钠对急性Stanford A型主动脉夹层手术患者围术期急性肺损伤的影响

摘要信息:[摘要] 目的 探讨西维来司他钠对急性 Stanford A型主动脉夹层(AAAD)手术患者围术期急性肺损伤(ALI)的影响。方法招募2021年12月至2022年6月期间于河南省胸科医院手术室急诊行手术治疗的AAAD 患者 72 例,采用随机数字表法将其分为西维来司他钠组(S 组)和乌司他丁组(U 组),每组36 例。S组患者于麻醉前 10 min 经静脉以 0.2 mg/(kg·h)的速率泵注西维来司他钠注射液直至机械通气脱机。U 组患者于麻醉前 10 min 以2万 U/kg的剂量经静脉泵注乌司他丁直至机械通气结束脱机。于麻醉诱导后切皮前(T)术毕即刻(T,)、术后 24 h(T;)及48 h(T)时采集桡动脉血行血气分析,计算肺泡-动脉血氧分压差(PDO,)肺泡氧合指数(0D)和呼吸指数(RI) 。于T~T 时抽取中心静脉血测定肿瘤坏死因子(TNF-)、白细胞介素6(Ⅱ6)和白细胞介素8(Ⅱ8)水平。于术前1d及术后1d、3 d时抽取外周静脉血并测定白细胞计数(WBC)中性粒细胞计数(NEUT)和中性粒细胞百分比(NEUT%)及C反应蛋白(CRP)水平。记录患者术后肺部并发症(PPC)发生率及不良反应发生率。结果与U组比较,S组患者术后机械通气时间及 ICU 入住时间更短差异有统计学意义(P<0.05)。在T,~T 时间点,S组PDO,和 RI水平显著低于U组(P<0.05),0I水平显著高于U组(P<0.05);血清 TNF-、ⅡL6、Ⅱ8水平均显著低于U组(P<0.05)。与术前1d相比,两组术后1 d3 d的 WBC、NEUT、NEUT%及 CRP 水平均显著增高(P<0.05),S 组水平低于U组(P<0.05)。S 组术后高碳酸血症、低氧血症、新出现肺部啰音和支气管痉挛发生率均低于U组,差异有统计学意义(P<0.05)。结论西维来司他钠可抑制 AAAD 手术患者炎性反应,减轻围术期 ALI,降低 PPCs 发生率,改善患者早期预后。

汇伦医药 邹文成 2024-09-04 167 1 公开
Thoracic trauma a descriptive review of 4168 consecutive cases in East China
Thoracic trauma a descriptive review of 4168 consecutive cases in East China

摘要信息:Thoracic trauma in China was scarcely reported. This study aimed to summarize the clinical profiles and to analyze the management approaches of patients with traumatic thoracic injury.Data for consecutive patients with thoracic trauma from January 2003 to January 2018 were retrospectively collected and analyzed. Patients' profiles and clinical outcomes were compared between those patients treated with a dedicated thoracic trauma team and those without.The study included 4168 patients with mean age of 49.0 years, of whom 82.1% were male. Traffic accident accounted for 42.7% of the injuries. Most of the patients (66.8%) had rib fractures. Associated injuries were present in 48.3% of the patients; of them 86.0% were extremity fractures. Majority of the patients were managed without surgical procedures other than tube thoracostomy (33.2%). ICU service was needed in 12.0% of the patients. Patients treated with thoracic trauma team were older (53.59 ± 16.8 year vs 45.1 ± 18.0 year, P < .001), less male (78.3% vs 85.2%, P < .001), with higher injury severity scores (17.5 ± 10.1 vs 13.7 ± 8.2, P < .001), required more ventilator support (48.3% vs 25.3%, P < .001) and underwent more tube thoracostomy and other surgeries (43.8% vs 24.2%, and 34.4% vs 14.1%, respectively, all P < .001), yet with a shorter hospital stay (11.7 ± 9.0 days vs 12.7 ± 8.8 days, P < .001), and numerically lower ICU usage and mortality when compared to those without.Thoracic trauma in China usually affects mid-age males. Traffic accident is the top one etiology. The most common type of thoracic injuries is rib fracture. Associated injuries occur frequently. Nonoperative treatment and tube thoracostomy are effective for majority of the patients. A multidisciplinary approach with a dedicated thoracic trauma team could improve the treatment for these patients.

汇伦医药 邹文成 2024-09-04 155 0 公开
Ten-year retrospective analysis of multiple trauma complicated by pulmonary contusion
Ten-year retrospective analysis of multiple trauma complicated by pulmonary contusion

摘要信息:Background:This study reports a 10-year retrospective analysis of multiple trauma complicated by pulmonary contusion. The purpose of this study is to ascertain the risk factors for mortality due to trauma in patients with pulmonary contusion, the impact of various treatment options for prognosis, and the risk factors for concurrent Acute Respiratory Distress Syndrome (ARDS). Methods:We retrospectively analyzed 252 trauma patients with lung contusion admitted to the General Hospital of Guangzhou Command from January 2000 to June 2011 by using the statistical processing system SPSS 17.0 for Windows. Results:We included 252 patients in our study, including 214 males and 38 females. The average age was 37.1 ± 14.9 years. There were 110 cases admitted to the ICU, of which 26 cases with ARDS. Nine of the 252 patients died. We compared those who survived with those who died by gender and age, the difference was not statistically significant (P = 0.199, P = 0.200). Separate univariate analysis of those who died and those who survived found that shock on admission (P = 0.000), coagulation disorders (P = 0.000), gastrointestinal bleeding (P = 0.02), the need for emergency surgery on admission (P = 0.000), pre-hospital intubation (P = 0.000), blood transfusion within 24 hours (P = 0.006), the use of mechanical ventilation (P = 0.000), and concurrent ARDS (P = 0.000) are poor prognosis risk factors. Further logistic analysis, including the admission GCS score (OR = 0.708, 95% CI 0.516-0.971, P = 0.032), ISS score (OR 1.135, 95% CI 1.006-1.280, P = 0.039), and concurrent ARDS (OR = 15.814, 95% CI 1.819-137.480, P = 0.012), identified the GCS score, ISS score and concurrent ARDS as independent risk factors of poor prognosis. Shock (OR = 9.121, 95% CI 0.857-97.060, P = 0.067) was also related to poor prognosis. Patients with injury factors such as road accident, falling injury, blunt injury and crush injury, et al.(P = 0.039), infection (P = 0.005), shock (P = 0.004), coagulation disorders (P = 0.006), emergency surgery (P = 0.01), pre-hospital intubation (P = 0.000), chest tube insertion (P = 0.004), blood transfusion (P = 0.000), usage of hormones (P = 0.002), phlegm (P = 0.000), ventilation (P = 0.000) were at a significantly increased risk for ARDS complications. Conclusions:Those patients with multiple trauma and pulmonary contusion admitted to the hospital with shock, coagulopathy, a need for emergency surgery, pre-hospital intubation, and a need for mechanical ventilation could have a significantly increased risk of mortality and ARDS incidence. A risk for poor prognosis was associated with gastrointestinal bleeding. A high ISS score, high APACHE2, and low GCS score were independent risk factors for poor prognosis. If patients developed an infection or were given drainage, hormones, and phlegm treatment, they were at higher risk of ARDS. Pre-hospital intubation and drainage were independent risk factors for ARDS. In patients with ARDS, the ICU stay, total length of stay, and hospital costs might increase significantly. A GCS score < 5.5, APACHE 2 score > 16.5, and ISS score > 20.5 could be considered indicators of poor prognosis for patients with multiple trauma and lung contusion.

汇伦医药 邹文成 2024-09-04 221 0 公开
Sivelestat sodium for aspiration-related acute lung injury: a review and analysis of published case reports
Sivelestat sodium for aspiration-related acute lung injury: a review and analysis of published case reports

摘要信息:Background:There are conflicting views on the of sivelestat sodium (sivelestat-Na) on acute lung injury. Methods:The efficacy of sivelestat-Na on aspiration-related acute lung injury was analyzed by reviewing case reports published before or after the appearance of the drug on the clinical practice in Japan. Data were analyzed from the 23 sivelestat-treated cases and 5 non-sivelestat cases. Results:Sivelestat-Na was administered by 0.2 mg x kg(-1) x hr(-1) for 10 +/- 4 (mean +/- SD) days. PaO2/ ratio increased significantly from 124 +/- 59 mmHg of baseline to 253 +/- 79 mmHg on the third and to 361 +/- 84 mmHg on the termination of the therapy. Significantly better response was observed if the drug was administered within 24 hours after aspiration for patients with background of neurological disease, in which the increases in the P/F ratio were greater and the duration of the drug administration was shorter compared with other patients. In comparison with the non-sivelestat cases, sivelestat-Na therapy appears to be associated with shorter ventilator days or higher P/F increase, although sivelestat-Na costs higher. Conclusions:These results suggest the possibility of conducting prospective clinical trials to assess the efficacy of early sivelestat-Na therapy for aspiration-related acute lung injury.

汇伦医药 邹文成 2024-09-04 228 0 公开
西维来司他钠对急性StanfordA型主动脉夹层手术患者术后谵妄的预防作用及其机制
西维来司他钠对急性StanfordA型主动脉夹层手术患者术后谵妄的预防作用及其机制

摘要信息:摘要:目的 探讨西维来司他钠对急性: Stanford A型主动脉夹层(ATAAD)患者术后谵妄(POD)的预防作用及其机制。方法 纳入急诊行ATAAD手术患者80例,跟据随机数字表法分为西维来司他钠组及对照组各40例。西维来司他钠组于手术麻醉诱导前10 min静脉泵注西维来司他钠直至手术结束,对照组以相同的速率静脉泵注相同体积的生理盐水直至手术结束。术后3d内采用3min谵妄诊断量表(3D-CAM)对患者POD发生情况进行评估;于术后24h时采集患者外周静脉血,采用改良的Ficoll密度梯度离心法提取外周血单个核细胞(PBMCs),比色法检测PBMCs内铁离子(Fe”)浓度、丙二醛(MDA)含量及超氧化物歧化酶(SOD)活性,Westem bloting法检测PBMCs内长链脂酰辅酶A合成酶(ACSL4)及谷胱甘肽过氧化物酶4(GPX4)蛋白。记录围手术期情况及不良反应发生情况。结果 西维来司他钠组POD发生率低于对照组(P<0.05),两组POD严重程度评分及POD持续时间比较差异均无统计学意义。西维来司他钠组PBMCS内Fe”浓度及MDA含量低于对照组,SOD活性高于对照组(P均<0.05)。西维来司他钠组 PBMCS内ACSL4蛋白表达低于对照组,GRX4蛋白表达高于对照组(P均<0.05)。西维来司他钠组ICU人住时间及术后住院时间少于对照组(P均<0.05):两组不良反应发生率差异均无统计学意义。结论,西维来司他钠可预防急性ATAAD手术患者POD的发生,其机制可能与抑制铁死亡从而减轻神经损伤有关。

汇伦医药 邹文成 2024-09-04 172 0 公开