4 . 2023

The effectiveness of Galavit® for preventing of the postoperative purulent-septic complications at surgical patients with several competing diseases, including diabetes mellitus

Vasilina S. Lesovik

Abstract

Aim. This study evaluates the efficiency of Galavit® for the prevention of postoperative purulent-septic complications in patients with diabetes and one or more competing diseases.

Material and methods. The comparative non-randomized single-center study included 60 surgical patients with diabetes and one or more competing diseases. The patients were divided into two groups: group 1 (n=30) received Galavit® intramuscularly 100 mg for 10 days, and group 2 (n=30) did not receive Galavit®.

Results. After 30 days of follow-up, one case of purulent-septic complication (forearm phlegmon in a patient of group 2) was registered. After 10 days from inclusion in the study, according to the immunogram data in both groups, there was an increase in CD3+, CD4+, CD19+, CD16+/56+, CD3+/HLA-DR+, IgG and a decrease in CIC (p<0.05 for all indicators). The analysis of the dynamics of the immunogram indicators showed a statistically significant difference in the change of CD4+, CD19+, CD16+/CD56+, CD3+/HLA-DR+ and IgG levels in patients of group 1 compared with group 2 (all p<0.05). Comparison of the duration of hospitalization between the groups showed a reduction in the number of bed days in group 1 (4.3±4.01 versus 16.37±10.55 days in group 2, p<0.05). During the observation period, no adverse events were registered in group 1.

Conclusion. Galavit® stimulates T- and B-cell immunity, increases the activity of T-lymphocytes, T-helper cells, B-lymphocytes, natural killers, activated lymphocytes and the level of immunoglobulin G in surgical patients. The drug reduces the severity of the infectious process, which was confirmed by a lower level of CIC after administration of Galavit®. The use of Galavit® in patients before surgery can reduce the time of hospitalization, with a high degree of safety.

Keywords:purulent-septic complications; diabetes; immunomodulators; Galavit®; aminodihydrophthalazinedione sodium

Funding. The study had no sponsor support.

Conflict of interest. The author declares no conflict of interest.

For citation: Lesovik V.S. The effectiveness of Galavit® for preventing of the development of postoperative purulent-septic complications at surgical patients with several competing diseases, including diabetes mellitus. Clinical and Experimental Surgery. Petrovsky Journal. 2023; 11 (4): 83–9. DOI: https://doi.org/10.33029/2308-1198-2023-11-4-83-89 (in Russian)

References

1. European Health Information Gateway. Total number of inpatient surgical procedures per year. URL: https://gateway.euro.who.int/ru/indicators/hfa_539-6031-total-number-of-inpatient-surgical-procedures-per-year/visualizations/#id=19634

2. Karchalova А.М., Beysenov B.B., Zhanaydarov Zh.S., et al. Risk factors and treatment of infection complications in spinal surgery: a literature review. Vestnik Kazakhskogo natsional’nogo meditsinskogo universiteta [Bulletin of the Kazakh National Medical University]. 2021; (4): 364–71. (in Russian)

3. Al-Qurayshi Z., Walsh J., Owen S., et al. Surgical site infection in head and neck surgery: a national perspective. Otolaryngol Head Neck Surg. 2019; 161 (1): 52–62. DOI: https://doi.org/10.1177/0194599819832858

4. Terentyev A.M. Effect of comorbidity on the nature and frequency of postsurgical complications in hip replacement. Medicine and Physical Education: Science and Practice. 2021; 12: 16–21. DOI: https://doi.org/10.20310/2658-7688-2021-3-4(12)-16-21

5. Shevchenko Yu.L., Susov R. P. Infectious and inflammatory complications after оperations in cardiothoracic surgery. Vestnik Natsional’nogo mediko-khirurgicheskogo Tsentra imeni N.I. Pirogova [Bulletin of the National Medical-Surgical Center named after N.I. Pirogov]. 2022; 17 (1): 84–9. (in Russian)

6. Stepin A.V. Modifiable risk factors and modern approaches to prevention of surgical site infection in cardiac surgery. Klinicheskaya i eksperimental’naya khirurgiya. Zhurnal imeni akademika B.V. Petrovskogo [Clinical and Experimental Surgery. The Journal named after B.V. Petrovsky]. 2022; 10 (2): 126–33. DOI: https://doi.org/10.33029/2308-1198-2022-10-2-126-133 (in Russian)

7. Diaregistr. Prevalence of type 2 diabetes in the Russian Federation on 01.01.2023. URL: https://sd.diaregistry.ru/content/o-proekte.html#content (in Russian)

8. Dedov I.I., Shestakova M.V., Vikulova O.K., et al. Epidemiological characteristics of diabetes mellitus in the Russian Federation: clinical and statistical analysis according to the Federal diabetes register data of 01.01.2021. Sakharniy diabet [Diabetes Mellitus]. 2021; 24 (3): 204–21. DOI: https://doi.org/10.14341/DM12759 (in Russian)

9. Dedov I.I., Shestakova M.V., Mayorov A.Yu. (eds). Standards of specialized diabetes care. 10th edition. Sakharniy diabet [Diabetes Mellitus]. 2022; 24 (1S): 1–148. DOI: https://doi.org/10.14341/DM12802 (in Russian)

10. Gololobov А.М., Mel’nikov V.V., Topchiev M.A., et al. Stimulation of reparative processes in treatment of purulent wounds in patients with diabetes mellitus. Tavricheskiy mediko-biologicheskiy vestnik [Taurian Medical and Biological Bulletin]. 2019; 22 (1): 22–9. (in Russian)

11. Tan D.J.H., Yaow C.Y.L., Mok H.T., et al. The influence of diabetes on postoperative complications following colorectal surgery. Tech Coloproctol. 2021; 25 (3): 267–78. DOI: https://doi.org/10.1007/s10151-020-02373-9

12. Brem H., Tomic-Canic M. Cellular and molecular basis of wound healing in diabetes. J Clin Invest. 2007; 117 (5): 1219–22. DOI: https://doi.org/10.1172/JCI32169

13. Mayorov V.M., Dundarov Z.A., Adamovich D.M. Immune status of patients operated for necrotic parapancreatitis at the stage of septic sequestration. In: Actual Problems of Hepatopancreatobiliary Surgery. 2017: 205–6. (in Russian)

14. Shumakov V.I., Suskova V.S., Emets V.I., et al. Immunodiagnostics and immunocorrection tactics at different stages of treatment of patients at cardiac operations. Vestnik transplantologii i iskusstvennykh organov [Bulletin of Transplantology and Artificial Organs]. 2006; (4): 55–62. (in Russian)

15. Dombrowski M., Murawski C. D., Yasui Y., et al. Medical comorbidities increase the rate of surgical site infection in primary Achilles tendon repair. Knee Surg Sports Traumatol Arthrosc. 2019; 27 (9): 2840–51.

16. Chernousov F.A., Vinnitskiy L.I. Prevention of postoperative complications with the use of the immunomodulator Galavit: a meta-analysis of studies. Consilium Medicum. 2012; (2): 25–31. (in Russian)

17. Cherdantsev D.V., Vinnik Yu.S., Pervova O.V. Correction of systemic inflammatory reaction syndrome with widespread purulent peritonitis. Sibirskoe meditsinskoe obozrenie [Siberian Medical Review]. 2009; 60 (6): 27–32. (in Russian)

18. Cherdantsev D.V., Pervova O.V., Miller S.V., et al. The new method of correction of immune abnormalities in case of patients with destructive pancreatitis. Vestnik khirurgicheskoy gastroenterologii [Bulletin of Surgical Gastroenterology]. 2007; (2): 55–9. (in Russian)