[Quality of life in patients with lower extremity atherosclerosis during standard treatment and therapeutic angiogenesis]. / Kachestvo zhizni u patsientov s aterosklerozom nizhnikh konechnostei pri ispol'zovanii standartnogo lecheniia i terapevticheskogo angiogeneza.

AIM: To compare the impact of standard conservative treatment (SCT) and its combination with therapeutic angiogenesis for 3 to 5 years on quality of life in patients with Stage II (according to the classification developed by A.V. Pokrovsky-Fontaine) lower extremity atherosclerosis. SUBJECTS AND METHODS: 92 patients (69 men and 23 women) (mean age 65.2±7.7 years) were examined and divided into 2 groups of 46 people each. Only SCT (statins at an individually adjusted dose, antiaggregants, and graded exercise walking 3 to 5 km daily were used in Group 1; while Group 2 received SCT in combination with double injection of a plasmid-based VEGF165 gene drug (1.2 mg) into the ischemic limb muscles. The Russian version of the standard SF-36 questionnaire was applied; pain-free walking distances were measured before treatment and then every year; limb preservation and survival rates were determined in the patients. RESULTS: It was determined that standard treatment did not significantly affect patients' quality of life throughout the follow-up period. Addition of gene therapy leads to a significant improvement in both physical (p=0.00001) and psychological (p=0.00002) health components just in the first year of the follow-up. This is achieved through a significant (500%) increase in the average leg pain-free walking distance; p=0.007). CONCLUSION: The obtained result is consistently high throughout the subsequent period. There was no statistically significant difference in survival rates between the groups; limb preservation remained comparable.

[Five-year results of treating patients with chronic lower limb ischaemia by means of gene engineering]. / Pyatiletnie rezul'taty lecheniya bol'nykh khronicheskoi ishemiei nizhnikh konechnostei s ispol'zovaniem gennoi terapii.

The authors share their experience in comprehensive conservative treatment of patients presenting with chronic lower limb ischaemia (CLLI) associated with atherosclerosis of peripheral arteries by means of the first Russian registered gene therapeutic agent "Neovasculgen" (plasmid with the vegf165 gene), analysing the long-term outcomes of treating a total of 45 patients with stage II and III CLLI according to the classification of Pokrovsky-Fontain. The patients were followed up for 5 years. Efficacy of treatment was assessed by registering the dynamics of the pain-free walking distance (PFWD), linear blood velocity (LBV), ankle-brachial index (ABI), as well as the limb salvage rate and survival of patients. All patients showed good tolerance of treatment, with neither side effects nor complications noted. Clinical improvement in stage IIB CLLI was observed in 91% of patients with complete stabilization of the clinical course during 5 years. The limb salvage rate in this group amounted to 95%, with the survival rate equalling 82%. In patients with stage III CLLI, improvement was noted in 78% of cases, manifesting itself by a decrease of its degree to stage IIB (44.4%) and to stage IIA (33.3%). Progression of CLLI followed by amputation was registered in 22% of cases, with the survival rate of 78%. Hence, the use of a single course of combined treatment including the gene therapeutic agent "Neovasculgen" in patients with stage II and III CLLI resulted in a persistent positive effect in a considerable majority of patients in the remote period of not less than 5 years.

[Remote results of treatment of patients with chronic lower-limb ischaemia by means of indirect revascularization and gene therapy].

Presented herein are comparative remote results of combined surgical treatment of 121 patients with stage IIB-III lower limb chronic ischaemia (LLCI) by means of indirect revascularization (lumbar sympathectomy--LSE and revascularizing osteotrepanation of the tibial bone--ROT) and gene therapy using the first registered Russian gene therapeutic agent Neovasculgen®. Depending on the LLCI degree and the method of treatment, during 3 years we assessed such parameters as the limb salvage rate, pain-free walk distance (PFWD), ankle-brachial index (ABI) and linear blood velocity (LBV). An increase in the PFWD in patients with initial stage IIB LLCI in the group of gene therapy was considerably higher than in other types of treatment (p=0.0001-0.0004). Using indirect methods of revascularization was accompanied and followed by less positive alterations in the PFWD values which by the end of the third year of follow up were observed to decrease. The values of PFWD after ROT at 2 and 3 years were higher than after LSE (p=0.006). During the first year of follow up the highest increment of the ABI was observed after ROT. At two years, the ABI values after ROT and gene therapy became equal. The worst result during 3 years as compared with other methods of treatment was demonstrated by LSE (p=0.006). Changes in ABI after gene therapy were statistically significant at all terms of follow up (p=0.008-0.02). There were no limb amputations in the remote period of follow up in patients with the initial stage IIB of the disease. Patients with initial stage III LLCI also showed a considerably better result by the increment of increased PFWD after gene-therapeutic treatment (p=0.001-0.0005). A small increment of the PFWD after LSE maintained during 1 year and after LSE during 2 years. The ABI values in all periods of follow up were higher after gene therapy (p=0.01-0.003). During the 2- and 3-year period the increment of this parameter after ROT was more significant than after LSE (p=0.046-0.05). Changes in the ABI after gene therapy at all terms also turned out to be more substantial (p=0.03-0.008). An increase in the LBV during the first and second years after ROT turned out more significant as compared to LSE (p=0.05). The limb salvage rate in patients with initial stage III LLCI during the whole period after gene therapy amounted to 78%, after ROT being 54% and after LSE equalling 45%.

[REMOTE 3-YEAR RESULTS OF APPLICATION OF <> WAYS OF REVASCULARIZATION IN PATIENTS WITH CHRONIC ISCHEMIA OF LOWER EXTREMITIES].

There are several ways of <> revascularization such as revascularizated osteotrepanation of shinbone and lumbar sympathectomy (LS) for treatment of patients with chronic ischemia of lower extremities. They appeared to be sufficiently effective for the patients with II stage of the disease. Patients with critical ischemia (III stage) had persistent positive results after lumbar sympathectomy during 3-year period only in 33% of cases and using revacularized osteotrepnation - 46%. The difference in efficacy of treatment using LS and standard conservative therapy is statistically low significant, so that isn't allowed.recommending the sympathectomy for treatment of III stage ischemia. The method of revascularizated osteotrepanation of shinbone showed a reliably better result, therefore this way is reasonable to apply in surgery in case of III stage ischemia.