Effect of gene therapy for quality of life and change of objective indexes blood supply of the lower limbs in patients with peripheral atherosclerosis

The purpose of the study To evaluate the results of gene therapy in patients with HODLLA stage II and III within the period up to 3 years. Materials and methods We have experience of using the first registered domestic genetic drug based on gene vegf 165 in treatment of patients with chronic obliterating diseases of lower limb arteries (HODLLA) for stages II and III of A.V. Pokrovsky - Fontaine in the amount of 65 observations. Of these, traced long-term outcomes in terms of over 3 years, 45 people (II stage - 27 patients, III st. N = 18). The average age of patients was 63,3 ± 5,8. Evaluation results performed depending on the initial stage of the disease. The efficacy of treatment was evaluated by the following methods: 1. Determination of the quality of life (physical and psychological components of health) was made in using Russian version of the standard questionnaire SF 36; 2. pain-free walking distance was determined during the treadmill-test (walking speed of 1 km/h, the angle of 0°); 3. save the leg; 4. the survival rate of patients. Results and their discussion Significantly improved quality of life at 1 year follow-up, and then save a positive result for 3 years for all patients with stage II disease. The average value of the physical health component for inclusion in the clinical trial was 29,0 ± 6 points. During the first year PH had increased to 42,2 ± 8. In the future, marked by a further increase to the level of 47,6 ± 9 to the end of the observation period. The mental component of health initially 34,2 ± 4,0 points, in the first year of observation MH increased to 52,9 ± 5, and 2 and 3 years was stabilized and reached 54,8 ± 6. The average value of pain-free walking distance was 159 ± 123 m, to the end of 1 year - 676 ± 542 m, to the end of 2 year it was 704 ± 475 m, 3 years - 654 ± 415m. A safety limb throughout the observation period was 100%, survival rate - 88.9%. Patients with stage III HODLLA original value PH was 22,3 ± 1,3 points. During the first year had increased to 31,4 ± 9,3 and further noted its gradual increase to 37,5 ± 9,0 at the end of 3 years. MH changes were more significant. When included in the CI it was 25,2 ± 4,3 points, for the first year of follow-up increase in 36,2 ± 11. For 2 and 3 years, he continued to grow and reached 51,1 ± 8,3 points. Initially, the average value of pain-free walking distance was 31,5 ± 25m, to the end of 1 year - 200 ± 107m, after 2 years - 274 ± 72m, after 3 years - 271 ± 63m. Save the limb for the entire observation period - 78%. Three observations in the first year and one in the second year of lower limb amputations performed at the level of the thigh on the progression of chronic ischemia. The survival rate in this group was 100%. Conclusion The use of a single course of treatment based on gene vegf 165 in patients with stage II and III of HODLLA A.V. Pokrovsky-Fontaine classification leads to a stable positive effect in the large majority of patients in long-term period of three years and does not require repeated courses of gene therapy. In 82% of patients showed improvement, both physical and, to a greater extent, the psychological component of quality of life; It showed a significant increase in pain-free walking distance, increased their daily activity. All patients showed good tolerability and lack of side effects; fixed stabilization of the results. The survival rate was 93.3%. Keywords. Atherosclerosis, chronic lower limb ischemia, gene treatment, quality of life

Atherosclerosis, chronic lower limb ischemia, gene treatment, quality of life.