目的 探讨血必净注射液（简称血必净）治疗脓毒症相关急性呼吸窘迫综合征（acute respiratory distress syndrome，ARDS）肺热血瘀证患者的临床疗效。方法 选取2022年6月—2023年12月徐州医科大学附属医院收治的脓毒症相关ARDS肺热血瘀证患者140例，使用随机数字表法分为对照组与试验组，各70例，剔除、脱落与退出者13例，最终纳入127例，其中对照组65例，试验组62例。两组患者均接受常规治疗，试验组给予血必净100 mL，2次/d；对照组给予等量0.9%氯化钠注射液。两组均连续用药7 d。记录两组患者治疗前后中医证候积分、西医临床评分、呼吸功能指标、炎症指标、凝血功能、T淋巴细胞亚群、肝肾功能；并观察患者治疗7 d后的中医证候疗效；同时记录其机械通气时间、住院时间、病死率与不良反应。结果 两组患者治疗前的中医证候积分、西医临床评分、呼吸功能指标、炎症指标、凝血功能、T淋巴细胞亚群、肝肾功能无统计学差异（P＞0.05）；治疗7 d后上述指标均较治疗前得到改善，有统计学差异（P＜0.05）。治疗7 d后，试验组的总有效率（85.5%）高于对照组（67.7%），有统计学差异（P＜0.05）。治疗7 d后，与对照组比较，试验组中医证候积分、急性生理学与慢性健康状况（acute physiology and chronic health evaluation，APACHE）Ⅱ评分、序贯器官衰竭评估（sequential organ failure assessment，SOFA）评分、Murray肺损伤评分、平台压（plateau pressure，Pplat）、驱动压（ΔP）、C-反应蛋白（C-reactive protein，CRP）、降钙素原（procalcitonin，PCT）、白细胞介素-6（interleukin-6，IL-6）、肝素结合蛋白（heparin binding protein，HBP）、白细胞计数（white blood cell count，WBC）、中性粒细胞计数（neutrophil count，NEU）、中性粒细胞与淋巴细胞比值（neutrophil/lymphocyte ratio，NLR）、D-二聚体（D-dimer，D-D）降低更明显，氧分压（PaO₂）、氧合指数（PaO₂/FiO₂）、肺静态顺应性（static lung compliance，Cst）、CD3⁺、CD4⁺、CD4⁺/CD8⁺升高更明显，有统计学差异（P＜0.05）。试验组患者的机械通气时间、重症监护病房（intensive care unit，ICU）住院时间、总住院时间短于对照组，有统计学差异（P＜0.05）；两组患者的病死率无统计学差异（P＞0.05）。两组患者肝肾功能变化与不良反应发生率无统计学差异（P＞0.05）。结论 在常规治疗的基础上联合血必净治疗能有效改善脓毒症相关ARDS肺热血瘀证患者的呼吸功能，降低炎症反应，改善凝血功能，调节免疫功能，改善预后，是一种有效的治疗方法。

Objective To investigate the clinical efficacy of Xuebijing Injection (血必净注射液, XBJ) in the treatment of sepsis-associated acute respiratory distress syndrome (ARDS) patients with lung heat and blood stasis syndrome. Methods A total of 140 sepsis-associated ARDS patients with lung heat and blood stasis syndrome admitted to the Affiliated Hospital of Xuzhou Medical University from June 2022 to December 2023 were selected and randomly divided into the control group and the experimental group by random number table method, with 70 cases in each group. After excluding 13 cases that were removed, dropped out or withdrew during the study, a total of 127 cases were finally included, including 65 cases in the control group and 62 cases in the experimental group. The patients in both groups received conventional treatment. On the basis of conventional treatment, the experimental group was treated with 100 mL XBJ twice a day, and the control treatment group used the same volume of 0.9% sodium chloride injection. Both groups were treated for seven days. The traditional Chinese medicine syndrome score, western medicine clinical score, respiratory function indicators, inflammatory indicators, coagulation function, T lymphocyte subsets, liver and kidney function of the two groups were recorded before and after treatment. The traditional Chinese medicine syndrome efficacy after seven days of treatment was observeed. In addition, the duration of mechanical ventilation, length of hospital stay, mortality and adverse reactions were recorded. Results There were no significant differences in traditional Chinese medicine syndrome score, western medicine clinical score, respiratory function indicators, inflammatory indicators, coagulation function, T lymphocyte subsets, liver and kidney function between the two groups before treatment (P > 0.05). After seven days of treatment, these indicators were improved compared with those before treatment, and the differences were statistically significant (P < 0.05). After seven days of treatment, the total effective rate of experimental group (85.5%) was higher than that of cntrol group (67.7%), and the difference was statistically significant (P < 0.05). After seven days of treatment, the traditional Chinese medicine syndrome score, acute physiology and chronic health evaluation (APACHE) Ⅱ score, sequential organ failure assessment (SOFA) score, Murray lung injury score, plateau pressure (Pplat), driving pressure (ΔP), C-reactive protein (CRP), procalcitonin (PCT) and interleukin-6 (IL-6), heparin binding protein (HBP), white blood cell count (WBC), neutrophil count (NEU), neutrophil/lymphocyte ratio (NLR), and D-dimer (D-D) of the experimental group were lower than those of the control group, the partial pressure of oxygen (PaO₂), oxygenation index (PaO₂/FiO₂), static lung compliance (Cst), CD3⁺, CD4⁺, and CD4⁺/CD8⁺ were higher than those of the control group, and the differences were statistically significant (P < 0.05). The duration of mechanical ventilation, the intensive care unit (ICU) length of hospital stay and the total length of hospital stay in the experimental group were less than those of the control group, and the differences were statistically significant (P < 0.05). There was no significant difference in mortality between the two groups (P > 0.05). There were no significant differences in liver and kidney function changes and the incidence of adverse reactions between the two groups (P > 0.05). Conclusion For sepsis-associated ARDS patients with lung heat and blood stasis syndrome, on the basis of conventional treatment, XBJ treatment can effectively improve the respiratory function of patients, reduce inflammatory response, improve coagulation function, regulate immune function, and improve prognosis. Therefore, it is an effective treatment method.

R285.64

江苏省自然科学基金面上项目(BK20211136);江苏省徐州市科技计划项目(KC21215，KC22136);徐州医科大学附属医院科技发展基金项目(XYFY202232);北京协和医学基金-睿E(睿意)急诊医学研究专项基金项目(22222012001)