[Multi-center open comparative randomized study of efficacy and safety of Akatinol Memantine 20 mg (single-doses) vs Akatinol Memantine 10 mg (double-doses) in patients with vascular dementia]. / Mnogotsentrovoe otkrytoe sravnitel'noe randomizirovannoe issledovanie effektivnosti i bezopasnosti primeneniya preparata Akatinol Memantin, 20 mg (odnokratnyi priem) v sravnenii s preparatom Akatinol Memantin, 10 mg (dvukratnyi priem) u patsientov s sosudistoi dementsiei.

OBJECTIVE: Evaluation of the efficacy and safety of the drug Acatinol Memantine, 20 mg (once daily) in comparison with the drug Acatinol Memantine, 10 mg (twice daily) in patients with moderate to moderate severe vascular dementia. MATERIAL AND METHODS: The study included 130 patients aged 50-85 years of both sexes with instrumentally and clinically confirmed vascular dementia. The patients were randomized into 2 groups. Group I consisted of 65 patients receiving Akatinol Memantine, 20 mg once daily, group II - 65 patients receiving Akatinol Memantine, 10 mg twice daily for 24 weeks. Clinical, parametric and statistical research methods were used. The Alzheimer's disease assessment scale, the cognitive subscale (ADAS-cog), the short mental Status Assessment Scale (MMSE) and the general clinical impression scale for patients condition and illness severity (CGI-C and CGI-S) and the Hamilton Depression Rating scale (HAM-D) were used. Adverse events were collected and analyzed. RESULTS: At week 24, both groups showed statistically significant positive change in ADAS-cog total score: in group I the total score was 27.2±8.76 points (absolute difference from baseline 3.5 points; p<0.01), and in group II - 26.1±7.86 points (absolute difference from baseline 2.5 points; p<0.01) with no statistically significant differences between groups. Evaluation of secondary efficacy criteria (change in ADAS-cog total score at week 12 and MMSE at weeks 4, 12, and 24) also revealed statistically significant benefit in both groups compared to baseline with no significant differences between groups. Statistically significant improvement was noticed on CGI-S and CGI-C scales in both groups. Akatinol Memantine was safe and well tolerated in both groups. CONCLUSION: The study showed no lesser efficacy and safety of Akatinol Memantine, 20 mg (once daily) compared to Akatinol Memantine, 10 mg (twice daily) in patients with moderate and moderately severe vascular dementia.

Anaferon (pediatric formulation) in prophylactics of acute respiratory viral infection in children.

Prophylactic treatment with anaferon (pediatric formulation) in children groups reduced total morbidity and incidence of acute respiratory viral infections and shortened the duration of fever, intoxication, and catarrhal syndromes. No allergic and other reactions caused by administration of the preparation were noted.

Evaluation of the efficiency and safety of anaferon (pediatric formulation) in the treatment of chickenpox in children.

Addition of anaferon (pediatric formulation) to the therapy of chickenpox patients led to more rapid disappearance of the main symptoms and alleviated the course of the disease. The safety of the preparation is confirmed by the absence of undesirable events and stability of laboratory indexes against the background of therapy.

Application of ultralow doses of antibodies to interferon-gamma in complex therapy of bacterial infections and prophylaxis of bacterial complications.

Comparative placebo-controlled clinical trials on the efficiency and safety of ultralow doses of antibodies to human IFN-gamma (anaferon pediatric formulation and anaferon) and prophylaxis of bacterial complication showed that administration of these preparations in complex therapy of bacterial infection reduced the incidence of bacterial complications of viral infections and considerably decreased the duration of the main clinical symptoms of the disease.

Clinical study of the efficiency and safety of afala in patients with benign prostatic hyperplasia.

The use of afala in patients with benign prostatic hyperplasia and moderate urination disturbances reduced the symptoms of the disease, improved urodynamic parameters, and increased quality of life. Clinical efficiency of afala was comparable with the efficiency of Serenoa repens extract (reference preparation).

Evaluation of the efficiency and safety of combined treatment with impaza and nitrates in CHD patients with erectile dysfunction.

The safety of combined administration of ultralow doses of antigens to endothelial NO synthase (impaza) and nitrates for the treatment of erectile dysfunction in CHD patients was evaluated in an open non-comparative clinical trial. The efficiency and safety of impaza and the possibility of its administration to patients receiving nitrates were demonstrated.

The use of ultralow doses of antibodies to C-terminal fragment of angiotensin II AT1 receptor (kardos) in the therapy of arterial hypertension.

Kardos monotherapy allows attaining the target levels of systolic and diastolic blood pressure in patients with high-risk and very-high-risk hypertension. We demonstrated excellent tolerability of the preparation in combination with reliable blood pressure decrease over 24 h, during day and night hours.

Pharmacodynamics of kardos administered as monotherapy and in combination with hypothiazide and enalapril in grade I-II arterial hypertension.

Therapy with kardos produced an antiihypertensve effect in patients with grade I-II arterial hypertension. This antiihypertensve effect was considerably potentiated, when kardos was administered in combination with enalapril.

The use of tenoten (pediatric formulation) in the therapy of chronic tension-type headaches in children.

Tension-type headaches are the most common type of headaches in children. No effective treatment for this disease is developed yet. After treatment with tenoten, the number of days with headache in 9-17-years-old children decreased by 40.9%, the mean headache intensity score decreased to 1.

Efficiency and safety of long-term artrofoon treatment in rheumatoid arthritis.

In patients with rheumatoid arthritis, prolongation of artrofoon therapy to 2 years led to maintenance of the positive clinical effect attained after 6-month treatment. Moreover, significant improvement was observed by some parameters (integral pain intensity, swelling index, Ritchie articular index, morning stiffness, and articular score). No side effects related to artrofoon treatment were observed throughout the treatment period in the main group. The results indicate high efficiency and good tolerability of the preparation and attest to advisability of its long-term use.

Effect of combination of anticytokine preparations anaferon and artrofoon on immune inflammation in rheumatoid arthritis.

Treatment with a combination of artrofoon and anaferon significantly reduced clinical and laboratory parameters of rheumatoid inflammation and significantly decreased the content of antiinflammatory cytokines in the blood. These findings attest to antiinflammatory and immunomodulating effects of these preparations.

Effect of impaza on cardiovascular system.

Experiment on ISIAH rats showed that antibodies to endothelial NO synthase in ultralow doses (impaza) produced a mild and progressive antihypertensive effect slightly inferior to that of losartan. The use of impaza is perspective in patients with erectile dysfunction and cardiovascular pathology.

Experimental study of hypotensive effect of kardos in rats with inherited hypertension.

Kardos, a preparation containing ultralow doses of antibodies to C-terminal fragment of type 1 receptor of angiotensin II, intragastrically administered to SHR rats with hereditary hypertension for 28 days reduced blood pressure by 14.8%. Kardos was not inferior to losartan and, in contrast to the latter reduced HR by 9.4%.

Effect of ultralow doses of antibodies to histamine on the development of chronic ulcerative process in the stomach of experimental animals.

Antiulcer activity of ultralow doses of antibodies to histamine was demonstrated on the model of chronic acetate-induced gastric ulcer in rats. Course therapy with the preparation accelerated healing of chronic experimental ulcer by correcting hemodynamic disturbances and stimulating mucus formation in the gastric wall.

Experimental and clinical study of the effect of artrofoon on proinflammatory cytokine production.

The effect of Artrofoon on the production of proinflammatory cytokines was evaluated in experiments on mice with collagen-induced arthritis and in a clinical study on patients with rheumatoid arthritis. Artrofoon produced an antiinflammatory effect on animals with collagen-induced arthritis and reduced clinical signs of inflammation in patients with rheumatoid arthritis. These changes were accompanied by a significant decrease in the production of tumor necrosis factor-alpha and interleukin-1beta.

[Use of ultralow doses of antibodies to gamma-interferon in the treatment and prophylaxis of viral infections].

Viral infections are at present the leading cause of morbidity in the world. The clinical trials of gamma-anaferon (pediatric formulation) in the treatment and prophylaxis of a great number of viral infections (more than 20 nosological forms) due to the RNA- and DNA-containing viruses demonstrated its efficacy and safety. Gamma-anaferon is an immunomodulator with antiviral activity containing ultralow doses of antibodies to interferon. The high efficacy of anaferon and no adverse effects allowed to consider it as the drug of choice in the treatment of various viral infections including those in children under 1 year.