西维来司他钠治疗伴有SIRS的ARDS患者的多中心双盲随机对照临床试验
摘要信息:研究目的: 明确西维来司他钠治疗伴有SIRS的轻中度ARDS的有效性及安全性。 研究内容 本研究通过计算机随机,将伴有SIRS的轻中度ARDS患者随机分为安慰剂组和西维来司他钠组, 观察两组患者入组时(D0), 第1(D1),3(D3),5(D5)天氧合指数(PaO2/FiO2),呼吸频率,28天内有创机械通气率、无机械通气时间、住ICU时间、住院时间、ICU获得性感染发生率、28天全因病死率、ICU病死率等,以评价西维来司他钠治疗伴有SIRS的轻中度ARDS患者肺损伤的效果,以期改善轻中度ARDS患者氧合、增加无机械通气时间、降低ARDS病死率。 纳入标准: (1)18岁≤年龄≤75岁成年病人,其种族、国籍、性别不限; (2)研究符合赫尔辛基宣言及中国临床试验研究法规,病人或其家属知情并同意参加试验; (3)入住ICU依据2012柏林标准诊断ARDS 72 h以内,且氧合指数介于150-300mmHg, 并伴有全身炎症反应综合征(SIRS)患者 (ARDS柏林标准和SIRS诊断标准见附录); 排除标准: (1)慢性呼吸疾病的病史; (2)单纯的心源性肺水肿; (3)APACH2评分≥21分; (4)合并终末期疾病,或者临床主管医生判断近期患者预后不良; (5)ARDS病程>3天; (6)粒细胞缺乏或者接收免疫抑制剂或大剂量激素(甲强龙>40 mg)患者; (7)怀孕或哺乳; (8)曾经参与过本项研究; (9)不同意参加本试验; 主要观察指标: 1) 72 h氧合改善率[(D3氧合指数-D0氧合指数)/D0氧合指数]; 2) 28天无机械通气时间; 次要观察指标: 1) 28天有创机械通气率; 2) 28天住ICU时间; 3) 28天住院时间; 4) 28天全因病死率; 5) ICU病死率; 6)28天获得性感染发生率(定义为:实验室核酸或培养确诊的继发感染); 7)血浆中NE及炎症因子IL-6、IL-10、CRP水平变化; 8)28天严重不良事件频率; 9) D1和D5氧合改善率;
西维来司他钠在重症急性胰腺炎合并肺损伤中的应用
摘要信息:目的 观察西维来司他钠在重症急性胰腺炎(SAP)合并肺损伤患者中的应用效果。方法 按随机数字表法将 2021年1月至 2023 年12月进行治疗的 84例SAP合并肺损伤患者分为对照组和观察组,各 42例。对照组采用鸟司他丁治疗,观察组于对照组的基础上加用注射用西维来司他钠治疗。比较两组炎症介质水平、肺郚超声评分([US)、血清淀粉酶(AMY)、尿淀粉酶(AMY),呼吸功能、肺损伤程度、病情严重程度、脏器功能、症状消失时间及不良反应发生情况。结果 观察组治疗后白细胞介素 -6(Ⅱ-6)、降钙素原(PCT)及C反应蛋白(CRP)水平均低于对照组,LUS 评分、AMY 和 UAMY 水平均低于对照组,氧合指数(PaO,Fi0,)与动脉血氧分压(PaO,)均高于对照组Muray 肺损伤量表(MLIS)评分、急性生理学和慢性健康状况Ⅱ(APACHEII)评分及序贯器官衰竭评分系统(SOFA)评分均低于对照组,呼吸困难、恶心呕吐及腹痛消失时间均短于对照组,差异有统计学意义(P<0.05):两组不良反应总发生率比较,差异无统计学意义(P>0.05)。结论 SAP合并肺损伤患者采用注射用西维来司他钠与鸟司他丁联合治疗可减轻炎症反应,改善呼吸功能,保护脏器功能,减轻肺损伤,控制患者病情,且不良反应并未增加。
注射用西维来司他钠治疗急性胰腺炎引发的全身炎症反应综合征及急性肺损伤的效果
摘要信息:目的 探讨注射用西维来司他钠治疗急性胰腺炎引发的全身炎症反应综合征(SIRS)及急性肺损伤的疗效。方法,对一例急性胰腺炎引发SIRS及急性肺损伤的患者采取注射用西维来司他钠治疗,通过动态监测血淀粉酶、血脂肪酶、白细胞计数、血小板计数、总胆红素、肌酐、转氨酶、氧合指数、胸部CT变化等,对患者进行效果评价。结果,在常规治疗的基础上采取注射用西维来司他钠治疗7d后,患者SIRS表现得到改善,血淀粉酶、脂肪酶及白细胞计数较入院时下降:与初入重症医学科相比,患者氧合指数明显改善,双肺弥漫性浸润改变及双侧胸腔积液好转;用药期间患者未出现肝肾功能损伤、血小板减少等不良反应。结论,注射用西维来司他钠治疗急性胰腺炎引发的SIRS及急性肺损伤是安全有效的。
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.
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.