Gene-mediated induction of angiogenesis in inoperable patients with atherosclerosis and diabetes mellitus

Kalinin R.E., Suchkov I.A., Deev R.V., Mzhavanadze N.D., Krylov A.A.

Ryazan State Medical University named after Academician I.P. Pavlov under the RF Ministry of Public Health, Ryazan, Russia

Analysed in the article are the results of a comprehensive approach to treatment of patients presenting with lower limb critical ischaemia and diabetes mellitus by means of gene-induced angiogenesis. The study comprised a total of 65 patients found to have an ill-suited for surgical reconstruction peripheral arterial bed and undergoing conservative therapy. The patients were divided into two groups. The Study Group patients additionally to the conventional conservative therapy received 2 intramuscular injections of therapeutic agent Neovasculgen at a course dose of 2.4 mg. The active period of follow up amounted to 6 months followed by evaluating limb salvage and lethal outcomes at a further 6 months thereafter. Efficacy of treatment was determined both by primary criteria (lethality rate, amputations, dynamics of necrosis healing, clinical relief of critical ischaemia) and secondary criteria (pain-free walking distance, ankle-brachial index, transcutaneous oxygen tension, linear velocity of blood flow, the Michigan Neuropathy Screening Instrument (MNSI) and Neurological Symptom Score (NSS) scale).

After 6 months of follow up, the statistical significance in the intragroup and intergroup comparisons was reached for the pain-free walking distance (increment up to 72.9±9.2 m, p=0.032), transcutaneous oxygen tension (increment by 34.4%, p=0.028), linear velocity of blood flow (increment by 65.3%, p=0.047). Induction of angiogenesis also made it possible to statistically significantly decrease the manifestations of diabetic neuropathy, as was evidenced by the data of the MSNI (p=0.009) and the NSS scale (p=0.044). The findings of the study also demonstrated the best value of the limb salvage rate (p=0.049) and a lower number of lethal complications at 1 year of follow up.

KEY WORDS: atherosclerosis, diabetes mellitus, lower limb critical ischaemia, therapeutic angiogenesis, gene therapy.

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