Abstract
Objective – the study of the safety and efficacy of the gene drug "Neovasculgen" for the treatment of the chronic lower limb ischemia in patients with the II and III degree.
Material and methods. In the Department of Surgery of Arterial Pathology, Bakoulev Center from January 2017 to July 2018, 20 patients with inoperable chronic lower limb ischemia of atherosclerotic genesis with a II degree of ischemia in 13 (65%) and III – in 7 (35%) patients; concomitant diabetes mellitus of varying severity exacerbated the course of the disease in 6 (30%) patients.
Results. No side effects and adverse events, both directly during the administration of the drug and in the delayed period associated with gene therapy, were noted. Clinical improvement of the limb condition after 3 months was registered in all patients (at 45% "minimal," at 55% – "moderate"); after 6 months, a "moderate" improvement was registered already in 70%, after a year – in 84% of cases, as evidenced by the results of questionnaires on quality of life. Average TkPO2 increase was 8.5 mmHg (27%), ABI – 0.16/0.22 (39%/52%), walking distance increased by 2–3 times. In all patients examined, increased density of the collateral network in the treated limb was recorded according to CT-AG data after 6 months with its stability during a control examination after 12 months.
Conclusion. The use of the gene drug "Neovasculgen" in the treatment of patients with atherosclerotic chronic ischemia of the lower limb II and III degrees is safe and effective. The effect achieved by the 6th month is stable throughout the year in 80% of patients. The presence of diabetes mellitus and the multilevel involvement of the arteries of the lower extremities negatively affects the outcome of treatment.
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About the authors
- Ol’ga A. Demidova, Cand. Med. Sci., Senior Researcher; ORCID
- Elena Z. Golukhova, Dr. Med. Sci., Professor, Academician of the Russian Academy of Sciences, Director; ORCID
- Leo A. Bockeria, Dr. Med. Sci., Professor, Academician of the Russian Academy of Sciences, President; ORCID
- Valeriy S. Arakelyan, Dr. Med. Sci., Professor, Head of Department of Surgery Arterial Pathology; ORCID
