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Clinical trial of ulinastatin combined with thymalfasin α1 in the treatment of patients with sepsis
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Jing ZHAO1a, 1b, Li-xia FENG1a, 1b, Jing-xin SHI1a, 1b, Feng-jiang FAN1a, 1b
Chinese Journal of Clinical Pharmacology | 2025, 41(4) : 467 - 471
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Chinese Journal of Clinical Pharmacology | 2025, 41(4): 467-471
Clinical and Basic Bridging Research
Clinical trial of ulinastatin combined with thymalfasin α1 in the treatment of patients with sepsis
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Jing ZHAO1a, 1b, Li-xia FENG1a, 1b, Jing-xin SHI1a, 1b, Feng-jiang FAN1a, 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
Published: 2025-02-28 doi: 10.13699/j.cnki.1001-6821.2025.04.004
Outline
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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.

thymalfasin for injection  /  ulinastatin injection  /  sepsis  /  procalcitonin  /  lactic acid  /  D-dimer  /  T lymphocyte subsets
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
Year 2025 volume 41 Issue 4
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doi: 10.13699/j.cnki.1001-6821.2025.04.004
  • Receive Date:2024-08-30
  • Online Date:2026-08-04
  • Published:2025-02-28
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  • Received:2024-08-30
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
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表12种不同金属材料的力学参数

Family
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Number of
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Number of
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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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