不同剂量血必净注射液联合乌司他丁注射液治疗脓毒症合并急性肺损伤的临床观察(1)
摘 要 目的：比较不同剂量血必净注射液联合乌司他丁注射液治疗脓毒症合并急性肺损伤(ALI)的临床效果及安全性。方法：收集2015年7月-2019年11月于我院重症医学科治疗的脓毒症合并ALI患者115例，根据治疗方法的不同将其分为对照组(26例)、低剂量组(29例)、中剂量组(30例)、高剂量组(30例)。对照组患者在常规治疗的基础上静脉滴注乌司他丁注射液30万单位，q8 h，连续5 d;低剂量组患者在对照组基础上静脉滴注血必净注射液50 mL，bid，连续7 d;中剂量组患者在对照组基礎上静脉滴注血必净注射液100 mL，bid，连续7 d;高剂量组患者在对照组基础上静脉滴注血必净注射液100 mL，qid，连续7 d。比较4组患者治疗前后血清炎症因子(白细胞介素6、肿瘤坏死因子α、超敏C反应蛋白)、呼吸功能指标[血氧分压(PaO2)、氧合指数(PaO2/FiO2)、肺血管外肺水指数(ELWI)]和相关评分(急性生理和慢性健康状况评分Ⅱ和全身性感染相关性器官功能衰竭评分)，并记录机械通气时间及重症监护病房(ICU)住院时间、28 d病死率和不良反应发生情况。结果：治疗前，4组患者血清炎症因子水平、呼吸功能指标和相关评分比较，差异均无统计学意义(P>0.05)。治疗后，4组患者的血清炎症指标水平、ELWI、相关评分均较治疗前显著降低，且低、中、高剂量组均显著低于对照组，高剂量组显著低于低、中剂量组(P<0.05);4组患者的PaO2、PaO2/FiO2均较治疗前显著升高，且低、中、高剂量组均显著高于对照组，高剂量组显著高于低、中剂量组(P<0.05)。低、中、高剂量组患者的机械通气时间及ICU住院时间均显著短于对照组(P<0.05)，但各剂量组上述指标组间比较差异均无统计学意义(P>0.05)。4组患者的28 d病死率组间比较，差异均无统计学意义(P>0.05)，且未见严重的不良反应发生。结论：不同剂量血必净注射液联合乌司他丁注射液均可显著降低脓毒症合并ALI患者的血清炎症因子水平，改善其肺功能，减轻其器官衰竭程度;加用高剂量血必净注射液的效果更为明显且不影响治疗的安全性。
关键词 血必净注射液;乌司他丁;脓毒症;急性肺损伤;剂量;疗效;安全性
ABSTRACT OBJECTIVE： To compare clinical effect and safety of different doses of Xuebijing injection combined with Ulinastatin injection in the treatment of sepsis complicated with acute lung injury (ALI). METHODS： Totally 115 patients diagnosed as sepsis complicated with ALI were collected from Jul. 2015 to Nov. 2019 in intensive care unit of our hospital. According to therapy method， the patients were divided into control group (26 cases)， low-dose group (29 cases)， medium-dose group (30 cases)， high-dose group (30 cases). The control group received Ulinastatin injection 300 thousands u intravenously， q8 h， for consecutive 5 days， on the basis of routine treatment. On the basis of control group， low-dose group additionally received intravenous drip of Xuebijing injection 50 mL， bid， for consecutive 7 days; medium-dose group additionally received intravenous drip of Xuebijing injection 100 mL， bid， for consecutive 7 days; high-dose group additionally received intravenous drip of Xuebijing injection 100 mL， qid， for consecutive 7 days. The serum inflammatory factors (IL-6， TNF-α， CRP)， respiratory function indexes (PaO2， PaO2/FiO2， ELWI) and related scores (APACEⅡ score and SOFA score) were compared among 4 groups before and after treatment， and mechanical ventilation time， ICU hospitalization time， 28-day mortality rate and adverse reactions during the treatment were recorded. RESULTS： Before treatment， there was no statistical significance in serum inflammatory factors， respiratory function indexes or related scores among 4 groups (P>0.05). After treatment， serum inflammatory factors， ELWI and related scores of 4 groups were decreased significantly; the low-dose， medium-dose and high-dose groups were significantly lower than the control group; the high-dose group was significantly lower than the low-dose and medium-dose groups (P<0.05). PaO2 and PaO2/FiO2 of 4 groups were increased significantly， compared with before treatment; the low-dose， medium-dose and high-dose groups were significantly higher than the control group; the high-dose group was significantly higher than the low-dose and medium-dose groups (P<0.05). The mechanical ventilation time and ICU hospitalization time in the low-dose， medium-dose and high-dose groups were significantly shorter than control group (P<0.05)， but there was no statistical significance in above indexes among different doses groups (P>0.05). There was no statistical significance in 28-day mortality among 4 groups (P>0.05)， and no serious adverse reactions were found. CONCLUSIONS： Different doses of Xuebijing injection combined with Ulinastatin injection could effectively decrease the level of serum inflammatory factors in patients with sepsis complicated with ALI， improve lung function and relieve the degree of organ failure; after combined with high-dose Xuebijing injection， the therapeutic effect is more obvious and does not affect the treatment safety., http://www.100md.com(李乐辉 杨远征 林润 洪丽明)
关键词 血必净注射液;乌司他丁;脓毒症;急性肺损伤;剂量;疗效;安全性
ABSTRACT OBJECTIVE： To compare clinical effect and safety of different doses of Xuebijing injection combined with Ulinastatin injection in the treatment of sepsis complicated with acute lung injury (ALI). METHODS： Totally 115 patients diagnosed as sepsis complicated with ALI were collected from Jul. 2015 to Nov. 2019 in intensive care unit of our hospital. According to therapy method， the patients were divided into control group (26 cases)， low-dose group (29 cases)， medium-dose group (30 cases)， high-dose group (30 cases). The control group received Ulinastatin injection 300 thousands u intravenously， q8 h， for consecutive 5 days， on the basis of routine treatment. On the basis of control group， low-dose group additionally received intravenous drip of Xuebijing injection 50 mL， bid， for consecutive 7 days; medium-dose group additionally received intravenous drip of Xuebijing injection 100 mL， bid， for consecutive 7 days; high-dose group additionally received intravenous drip of Xuebijing injection 100 mL， qid， for consecutive 7 days. The serum inflammatory factors (IL-6， TNF-α， CRP)， respiratory function indexes (PaO2， PaO2/FiO2， ELWI) and related scores (APACEⅡ score and SOFA score) were compared among 4 groups before and after treatment， and mechanical ventilation time， ICU hospitalization time， 28-day mortality rate and adverse reactions during the treatment were recorded. RESULTS： Before treatment， there was no statistical significance in serum inflammatory factors， respiratory function indexes or related scores among 4 groups (P>0.05). After treatment， serum inflammatory factors， ELWI and related scores of 4 groups were decreased significantly; the low-dose， medium-dose and high-dose groups were significantly lower than the control group; the high-dose group was significantly lower than the low-dose and medium-dose groups (P<0.05). PaO2 and PaO2/FiO2 of 4 groups were increased significantly， compared with before treatment; the low-dose， medium-dose and high-dose groups were significantly higher than the control group; the high-dose group was significantly higher than the low-dose and medium-dose groups (P<0.05). The mechanical ventilation time and ICU hospitalization time in the low-dose， medium-dose and high-dose groups were significantly shorter than control group (P<0.05)， but there was no statistical significance in above indexes among different doses groups (P>0.05). There was no statistical significance in 28-day mortality among 4 groups (P>0.05)， and no serious adverse reactions were found. CONCLUSIONS： Different doses of Xuebijing injection combined with Ulinastatin injection could effectively decrease the level of serum inflammatory factors in patients with sepsis complicated with ALI， improve lung function and relieve the degree of organ failure; after combined with high-dose Xuebijing injection， the therapeutic effect is more obvious and does not affect the treatment safety., http://www.100md.com(李乐辉 杨远征 林润 洪丽明)