乌司他丁联合胸腺法新治疗脓毒症患者的临床研究  

Clinical trial of ulinastatin combined with thymalfasinα1 in the treatment of patients with sepsis

作　　者：赵璟[1,2] 冯丽霞[1,2] 史晶心 范风江[1,2] ZHAO Jing;FENG Li-xia;SHI Jing-xin;FAN Feng-jiang(Comprehensive Intensive Care Unit,Nanyang First People's Hospital,Nanyang 473000,Henan Province,China;Key Laboratory of Translational Medicine for Sepsis,Nanyang First People's Hospital,Nanyang 473000,Henan Province,China)

机构地区：[1]南阳市第一人民医院综合重症监护室,河南南阳473000 [2]南阳市第一人民医院脓毒症转化医学重点实验室,河南南阳473000

出　　处：《中国临床药理学杂志》2025年第4期467-471,共5页The Chinese Journal of Clinical Pharmacology

摘　　要：目的观察乌司他丁注射液联合注射用胸腺法新治疗脓毒症患者的临床疗效及其对患者外周血T淋巴细胞亚群的影响。方法将脓毒症患者按照队列法分为对照组和试验组。对照组在初始复苏、血液净化、抗感染等基础治疗的基础上联合乌司他丁注射液治疗,静脉滴注,剂量2.0×10^(5)U,bid,治疗4 d,改为静脉泵注,剂量1.0×10^(5)U,bid,治疗6 d。试验组在对照组治疗的基础上,给予注射用胸腺法新治疗,皮下注射,剂量1.6 mg,每周2次。2组患者均治疗2周。比较2组患者的临床疗效、序贯器官衰竭评估(SOFA)评分、急性生理与慢性健康评估(APACHE)Ⅱ评分、外周血降钙素原(PCT)、乳酸(Lac)、D-二聚体(D-D)、T淋巴细胞亚群水平,以及28 d病死率并评价安全性。结果对照组入组43例患者,试验组入组37例患者。治疗后,试验组和对照组的总有效率分别为94.59%(35例/37例)和86.05%(37例/43例),在统计学上差异无统计学意义(P>0.05)。治疗后,试验组和对照组的SOFA评分分别为(5.46±1.20)和(6.71±1.33)分,APACHEⅡ评分分别为(16.17±3.49)和(18.63±3.82)分,外周血PCT水平分别为(1.51±0.33)和(1.88±0.42)μg·L^(-1),Lac分别为(2.73±0.52)和(5.06±1.19)nmol·L^(-1),D-D分别为(0.85±0.27)和(1.02±0.33)mg·L^(-1),CD3^(+)分别为(38.98±4.36)%和(34.42±4.14)%,CD4^(+)分别为(18.66±2.47)%和(13.17±1.96)%,CD8^(+)分别为(12.35±1.42)%和(13.01±1.39)%,CD4^(+)/CD8^(+)分别为1.49±0.24和1.04±0.22,在统计学上差异均有统计学意义(均P<0.05)。试验组和对照组的28 d病死率分别为18.92%(7例/37例)和23.26%(10例/43例),在统计学上差异无统计学意义(P>0.05)。2组患者均未出现药物不良反应。结论乌司他丁注射液联合注射用胸腺法新治疗脓毒症患者的临床疗效较单用乌司他丁注射液更理想,能够更好地降低外周PCT、Lac、D-D水平,调节T淋巴细胞亚群,其疗效确切,安全可靠。Objective To observe the clinical efficacy of ulinastatin injection and thymalfasin for injection in the treatment of sepsis patients and their effects on peripheral blood T lymphocyte subsets.Methods Sepsis patients were divided into control group and treatment group according to the cohort method.The control group was treated with ulinastatin injection in addition to initial resuscitation,hemoperfusion,and antimicrobial therapy.The treatment regimen was intravenous infusion,2.0×10^(5)U bid for 4 days,followed by intravenous pump infusion,1.0×10^(5)U bid for 6 days.The treatment group received thymalfasin for injection on base of the control group’s treatment,subcutaneous injection,1.6 mg twice a week,for 2 weeks.The clinical efficacy,Sequential Organ Failure Assessment(SOFA)score,Acute Physiology and Chronic Health Evaluation(APACHE)Ⅱscore,peripheral blood procalcitonin(PCT),lactate(Lac),D-dimer(D-D),and levels of T lymphocyte subsets were compared between the two groups,as well as 28-day mortality rate and safety were evaluated.Results A total of 43 patients were enrolled in the control group and 37 patients in the treatment group.After treatment,the total effective rates in the treatment group and the control group were 94.59%(35 cases/37 cases)and 86.05%(37 cases/43 cases),respectively,with no significant difference statistically(P>0.05).After treatment,the SOFA scores in the treatment group and the control group were(5.46±1.20)and(6.71±1.33)points;the APACHEⅡscores were(16.17±3.49)and(18.63±3.82)points;the peripheral blood PCT levels were(1.51±0.33)and(1.88±0.42)μg·L^(-1);the Lac levels were(2.73±0.52)and(5.06±1.19)nmol·L^(-1);the D-D levels were(0.85±0.27)and(1.02±0.33)mg·L^(-1);the CD3^(+)levels were(38.98±4.36)%and(34.42±4.14)%;the CD4^(+)levels were(18.66±2.47)%and(13.17±1.96)%;the CD8^(+)levels were(12.35±1.42)%and(13.01±1.39)%;and the CD4^(+)/CD8^(+)ratio were 1.49±0.24 and 1.04±0.22,respectively,all showing statistically significant differences(all P<0.05).The 28-day mor

关 键 词：注射用胸腺法新 乌司他丁注射液 脓毒症 降钙素原 乳酸 D-二聚体 T淋巴细胞亚群 

分 类 号：R971[医药卫生—药品]