中国临床药理学杂志

乌司他丁联合胸腺法新治疗脓毒症患者的临床研究

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赵璟 ^1a^,^1b , 冯丽霞 ^1a^,^1b , 史晶心 ^1a^,^1b , 范风江 ^1a^,^1b

中国临床药理学杂志 | 临床与基础桥接研究 2025,41(4): 467-471

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中国临床药理学杂志 |临床与基础桥接研究 2025 , 41 (4) : 467 -471

乌司他丁联合胸腺法新治疗脓毒症患者的临床研究

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赵璟^1a^,^1b, 冯丽霞^1a^,^1b, 史晶心^1a^,^1b, 范风江^1a^,^1b

作者信息

^1a.南阳市第一人民医院，综合重症监护室，河南南阳 473000

^1b.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

通讯作者:

冯丽霞，主任医师 Tel: （0377）62208307 E-mail: sunhx2005@163.com

作者简介:

赵璟（1979-），女，副主任医师，主要从事重症医学诊疗方面的工作

Clinical trial of ulinastatin combined with thymalfasin α1 in the treatment of patients with sepsis

Jing ZHAO^1a^,^1b, Li-xia FENG^1a^,^1b, Jing-xin SHI^1a^,^1b, Feng-jiang FAN^1a^,^1b

Affiliations

^1a.Comprehensive Intensive Care Unit, Nanyang First People’s Hospital, Nanyang 473000, Henan Province, China

^1b.Key Laboratory of Translational Medicine for Sepsis, Nanyang First People’s Hospital, Nanyang 473000, Henan Province, China

出版时间: 2025-02-28 doi: 10.13699/j.cnki.1001-6821.2025.04.004

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摘要

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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2.0×10⁵ U，bid，治疗4 d，改为静脉泵注，剂量1.0×10⁵ 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，APACHE Ⅱ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。

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

Abstract

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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, 2.0×10⁵ U bid for 4 days, followed by intravenous pump infusion, 1.0×10⁵ 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) Ⅱ score, 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 APACHE Ⅱ scores 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 mortality rates in the treatment group and the control group were 18.92% (7 cases/37 cases) and 23.26% (10 cases/43 cases), respectively, with no significant difference statistically (P>0.05). No drug-related adverse reactions were observed in either group.

Conclusion

The clinical efficacy of thymalfasin for injection in the treatment of sepsis is more ideal than that of ulinastatin alone, as it can better reduce the levels of peripheral PCT, Lac, and D-D, regulate T lymphocyte subsets, demonstrating definite efficacy and safety.

Key words

thymalfasin for injection / ulinastatin injection / sepsis / procalcitonin / lactic acid / D-dimer / T lymphocyte subsets

引用本文

赵璟, 冯丽霞, 史晶心, 范风江. 乌司他丁联合胸腺法新治疗脓毒症患者的临床研究. 中国临床药理学杂志, 2025 , 41 (4) : 467 -471 . DOI: 10.13699/j.cnki.1001-6821.2025.04.004

Jing ZHAO, Li-xia FENG, Jing-xin SHI, Feng-jiang FAN. Clinical trial of ulinastatin combined with thymalfasin α1 in the treatment of patients with sepsis[J]. Chinese Journal of Clinical Pharmacology, 2025 , 41 (4) : 467 -471 . DOI: 10.13699/j.cnki.1001-6821.2025.04.004

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2025年第41卷第4期

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doi: 10.13699/j.cnki.1001-6821.2025.04.004

接收时间：2024-08-30
首发时间：2026-08-04
出版时间：2025-02-28

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收稿日期：2024-08-30

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作者信息

^1a.南阳市第一人民医院，综合重症监护室，河南南阳 473000

^1b.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

通讯作者:

冯丽霞，主任医师 Tel: （0377）62208307 E-mail: sunhx2005@163.com

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https://castjournals.cast.org.cn/joweb/zglcylxzz/CN/10.13699/j.cnki.1001-6821.2025.04.004

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2种不同金属材料的力学参数

科 Family	属数 Number of genus	种数 Number of species	占总种数比例 Percentage of total species (%)	属 Genus	种数 Number of species	占总种数比例 Percentage of total species (%)
鹅膏菌科Amanitaceae	2	11	5.26	鹅膏菌属 Amanita	10	4.78
小菇科 Mycenaceae	2	12	5.74	丝盖伞属 Inocybe	5	2.39
多孔菌科 Polyporaceae	8	14	6.70	蜡蘑属 Laccaria	5	2.39
红菇科 Russulaceae	3	23	11.00	小皮伞属 Marasmius	6	2.87
				小菇属 Mycena	11	5.26
				光柄菇属 Pluteus	5	2.39
				红菇属 Russula	17	8.13
				栓菌属 Trametes	5	2.39

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