[Preliminary results of an open-label observational study evaluating the efficacy and safety of Prolia used in women with postmenopausal osteoporosis].

AIM: To evaluate the efficacy and safety of Denosumab (Prolia), a first-line osteoporosis (OP) medication that is a fully human monoclonal antibody to the receptor activator of nuclear factor xB ligand (RANKL), within an open-label observational study. SUBJECTS AND METHODS: Patients aged 50 years or older with postmenopausal OP, who were treated with Prolia in clinical practice, were examined. The concentrations of the bone resorption (BR) marker of C-terminal telopeptide and other laboratory indicators (total serum calcium, total alkaline phosphatase, and creatinine) were measured following 3 months. Adverse drug reactions were recorded. RESULTS: Three months after initiation of the investigation, there was a significant decrease in the BR marker C-terminal telopeptide (by 89%; p<0.0001). There were rare adverse reactions: hypocalcemia in 3 (5.9%) patients, arthralgias in 2 (3.9%), and eczema in 1 (1.9%). There were neither serious adverse events nor study withdrawal cases. CONCLUSION: The preliminary results of the open-label study of Prolia in postmenopausal OP suggest that the significantly lower BR activity determines the efficacy of this drug and its high safety.

[Prevalence of rheumatoid arthritis in Russia (according to epidemiological findings)].

AIM: To define the prevalence of rheumatoid arthritis (RA) from the data of an epidemiological study. SUBJECTS AND METHODS: During a questionnaire survey of 37057 adults of Russia, patients with complaints of articular swelling (n = 4975) were selected; of the latter a group (n = 3420) was randomly formed to be clinically examined by rheumatologists in order to detect RA. The 1987 ACR criteria were used for its diagnosis. RESULTS: According to the data of the questionnaire survey, RA was diagnosed in 159 (4.6%) of the 3420 patients with complaints of articular swelling. The prevalence of RA in Russia averaged 0.61%. Among the respondents who complained about articular swelling during the questionnaire survey, 258 (7.5%) respondents considered to have RA before rheumatological examination. While comparing the diagnoses reported by the respondents during the survey and the final diagnosis established by a specialist, RA was confirmed only in 61 (24%) patients. Out of all the identified patients with RA (n = 159), only 61 (38%) were aware of their diagnosis. In RA patients with less than one-year articular complaints (n = 24), 17% were familiar with their diagnosis; the diagnosis was first made in the others (n = 20). Among the patients with long-term articular complaints (n = 135), 42% were aware of their diagnosis. CONCLUSION: The epidemiological survey indicated that the number of patients with RA were twice higher than those given in the official statistics of the Russian Federation (671,000 versus 300,000, respectively). In outpatient practice, RA is correctly diagnosed only in 38% of cases. There is a significant hyperdiagnosis of this disease. The duration of articular complaints affects the establishment of the diagnosis of RA.

[Association of polymorphisms and haplotypes in the 5' region of COLIA1 gene with the risk of osteoporotic fractures in Russian women from Volga-Ural region].

The analysis of -1997G/T, -1663indelT, and +1245G/T polymorphic loci of the 5'region of COLIA1 gene in 124 females aged from 50 to 70 years old with low numbers of traumatic fractures as well as 150 healthy individuals from Volga-Ural region has been conducted. The association of -1663indelT and +1245G/T loci with the risk of osteoporotic fractures has been discovered. It has been shown that -1997*G*G/-1663*I*D/+1245*G*T genotype combination and -1997*G/-1663*D/+1245*T haplotype can be considered as markers for fracture development.

[The prevalence of chronic generalized pain and its relationship to demographic characteristics and mental status]. / Rasprostranennost' khronicheskoi generalizovannoi boli i ee sviaz' s demograficheskimi kharakteristikami i psikhicheskim statusom.

Chronic generalized pain (CGP) as one of the diagnostic criteria of fibromyalgia is a common condition amongst the populations of Western Europe and the USA. The prevalence of CGP in these countries is 10.7-13.2%. The etiology of CGP is unclear; however, several findings suggest that this is a process of somatization that masks affective disorders. There have been no studies of the epidemiology of CGP in Russia. The study was undertaken to determine the prevalence of CGP in the Yekaterinburg adult population and to examine the relationship of CGP to its demographic characteristics and affective disorders. A ostal cross-sectional population survey was conducted. This covered 159 persons (54 males and 105 females) aged 27 to 75 years who had been randomly selected from the election lists of Yekaterinburg residents. A questionnaire was posted to each participant in order to reveal whether a respondent had experienced pain a month before, to define its location, duration, severity, and to evaluate psychoemotional disorders. The response rate was 75.5% (120 replies). The prevalence of CGP was 13.3%. There was no relationship of the sex of a respondent to CGP. The latter was shown to be associated with age. There was also its significant association with psychoemotional disorders. CGP is a common condition in the Yekateringburg population, which occurs in every 8 adult residents, more frequently in those aged above 43 years. The individuals who suffer from CGP exhibit a high level of psychological distress.

[Vitrum osteomag in prevention of osteoporosis in postmenopausal women: results of the comparative open multicenter trial]. / Vitrum osteomag v profilaktike osteoporoza u zhenshchin v postmenopauze: rezul'taty sravnitel'nogo otkrytogo mnogotsentrovogo issledovaniia.

AIM: To investigate efficacy, tolerance and safety of the drug vitrum osteomag one tablet of which contains 600 mg calcium (1500 mg calcium carbonate), 200 IU of cholecalcepherol, 40 mg of magnesium, zinc (7.5 mg), copper (1 mg), manganese (1.8 mg) and boron (250 mcg) in women with osteopenia for prevention of osteoporosis. MATERIAL AND METHODS: A multicenter comparative open trial of vitrum osteomag influence on mineral bone density (MBD), change of pain syndrome in bones, index of calcium-phosphorous metabolism covered 334 postmenopausal women with osteopenia. MBD was measured in low-back spine and proximal part of the hip with DEXA method. All the patients were divided into 3 groups: 125 women taking 2 tablets of vitrum osteomag daily for 12 months (group 1); 111 women taking 1500 mg calcium carbonate (group 2); 96 women--control group (only observation). RESULTS: Vitrum osteomag relieved pain in the back and joints, had a positive effect on bone density (+1.5%) and proximal parts of the hip (0.6-0.93%) exceeding the effect of calcium carbonate only which preserves the initial MBD in low back spine but does not prevent bone loss in the hip. MBD dynamics in patients given vitrum osteomag differs essentially from one in the control group (from -1.9 to -2.91%) which demonstrates a reliable preventive anti-osteoporotic effect of this medication. The drug increases the level of general and ionized calcium in blood but does not cause hypercalcemia lowering the level of parathormone in blood. The rate of side effects in group 1 was 14.4% and did not differ much from that in group 2 (16.2%). CONCLUSION: The results of the study allow to recommend vitrum osteomag for prophylaxis of a rapid loss of bone tissue mineral density.

[Osteoporotic fracture of the vertebral body in patients with steroid dependent bronchial asthma]. / Osteoporoticheskie perelomy tel pozvonkov u bol'nykh steoidzavisimoi bronkhial'noi astmoi.

The aim of the study was an analysis of the frequency of oral steroids prescription to patients with bronchial asthma treated in hospital and of vertebral fractures and deformations as the result of GCS-induced osteoporosis in patients with bronchial asthma taking prednisolone tablets for at least 6 months. The incidence of steroid-dependent bronchial asthma (SDBA) was 12.9%. Roentgenomorphometric analysis of the thoracic and lumbar spine performed in 52 patients with SDBA revealed vertebral fractures in 11(21.1%) patients, deformations of the first and second degree in 25(48.0%) patients. Depressed fractures of the vertebra were the most numerous--14.6%. Males and females had vertebral fractures with similar frequency (21.4 and 20%, respectively). A correlation was found between the number of the affected vertebra and prednisolone treatment duration, total dose.

[Clinical characteristics and risk factors of hepatic damage in lyme borrheliosis]. / Klinicheskaia kharakteristika i faktory riska porazheniia pecheni pri laim-borrelioze.

The study is based on the study of data on 33 patients with Lyme Borrelia infection in the presence of typical erythema migrans in whom elevated levels of serum bilirubin or transaminases were detected simultaneously with erythema or just shortly. The obligatory criterion was no history evidence of hepatitis and abnormal hepatic functional tests. Higher levels of serum aminotransferases were a major manifestation of Lyme hepatitis in the Sverdlovsk region. In 32 patients, ALT was increased, on the average, up to 176 U/l, and AST activity was up to 113 U/l within the first 2 weeks of the disease in the absence of clinical manifestations of hepatic and biliary diseases. There were changes in the levels of serum transaminases and bilirubin following 3- and 8-month antibiotic therapy. The presence of viruses A and C in moderate chronic hepatitis induced long-term increases in the activity of transaminases in 3 cases, as evidenced by histological studies of hepatic biopsy specimens.

[Clinical characteristics of tick-borne encephalitis complicated by Lyme borreliosis]. / Klinicheskaia kharakteristika kleshchevogo éntsefalita pri ego sochetanii s Laim-borreliozom.

Clinical characteristics of mixed tick borne encephalitis (TBE) + Lyme borrelliosis (LB) infection and monoinfections are compared. Eighty-five patients with TBE + LB mixed infection serologically verified by EIA and 87 with isolated TBE, who fell ill in 1996, were examined. Among patients with mixed infection, cases with blurred TBE predominated; severe forms (meningeal and focal) were almost two times less incident than in TBE monoinfection. Typical clinical symptoms of LB were observed in 63.5% patients, while in the rest 36.5% LB manifested only by circulation of antibodies to B. burgdorferi. Comparative analysis of patients with mixed TBE + LB infection and TBE monoinfection confirmed a more benign course of TBE during the acute period in patients with mixed infection. Mixed infection should be ruled out or confirmed by thorough clinical examinations with obligatory detection of antibodies to agents of both diseases.

[Antiphospholipid syndrome in females with recurrent fetal losses]. / Antifosfolipidnyi sindrom u zhenshchin s privychnym preryvaniem beremennosti.

Antiphospholipid antibodies (APA) were studied in 30 women with a history of recurrent fetal losses. An increased level of anticardiolipin antibodies was found in 7(23.3%) of them, being high and moderate in 4 women. Lupus anticoagulant was present in 9(30.0%) examinees. None cases of SLE were diagnosed. Diagnostically significant APA levels were associated with moderate symptomless thrombocytopenia. 12 of 13 women with antiphospholipid syndrome markers had definite (livedo reticularis, damage of cardiac valves, recurrent thrombophlebitis, leg ulcers, stroke, migraine) and possible (moderate arterial hypertension, proteinuria, retina angiopathy) extragenital features of this disorder. The most serious vascular complications took place in the group with high and moderate levels of anticardiolipin antibodies IgG.

[Comparative study of results of serological diagnosis of Lyme borreliosis by indirect immunofluorescence and immunoenzyme analysis]. / Sravnitel'noe izuchenie rezul'tatov serologicheskoi diagnostiki Laim-Borrelioza v reaktsii nepriamoi immunofliuorestsentsii i immunofermentnom analize.

A total of 176 sera from 73 patients with verified Lyme borreliosis at different stages of the disease are examined. Serological diagnosis was carried out by 2 methods: indirect immunofluorescence (IIF) with corpuscular B. burgdorferi antigen and enzyme immunoassay (EIA) with purified flagellar B. burgdorferi antigen (Dako). EIA with Dako antigen is more sensitive for the diagnosis of Lyme borreliosis at any period of the disease than IIF. Analysis of correlations between the results of IIF and EIA showed correlation in the levels of IgG but not IgM antibodies. The findings confirmed a previous hypothesis that inadequate antibacterial therapy before investigation decreases the level of antibodies to Borrelia. In patients with a history of Lyme borreliosis, antibodies to B. burgdorferi are detected less frequently by both IIF and EIA. Patients with persistent levels of antibodies to B. burgdorferi, even without clinical signs of infection, are in need of regular check-ups, because the prognostic significance of antibodies to B. burgdorferi is unknown and relapses may occur after months and years.

[The laboratory diagnosis of spring-summer infections in Yekaterinburg in the epidemic season for tick-borne encephalitis]. / Laboratornaia diagnostika vesenne-letnikh infektsii v Ekaterinburge v épidemicheskii sezon kleshchevogo éntsefalita.

The authors propose a comprehensive approach to laboratory diagnosis of seasonal transmissible infections, based on modern methods permitting etiological deciphering of disease. A universal diagnostic algorithm notably accelerated the laboratory diagnosis due to cutting the period between collection of material from a patient and consecutive screening for antibodies to agents of tick-borne encephalitis, Lyme disease, and California encephalitis.

[The comparative clinico-laboratory characteristics of Lyme arthritis and reactive arthritis]. / Sravnitel'naia kliniko-laboratornaia kharakteristika Laim-artrita i reaktivnogo artrita.

The paper presents comparative clinical and laboratory characteristics of 17 cases of Lyme-arthritis (LA) and 28 cases of reactive arthritis (RA). LA and RA patients differed by age and sex. LA arose after the tick bite followed by erythema migrans or infection symptoms. In RA patients the above symptoms were absent. In LA patients arthritis was associated with typical symptoms of neuroborreliosis. The articular syndrome manifested similarly in LA and RA: arthritis was preceded by arthralgias, low limb joints and periarticular tissues were involved most frequently. The differences were: monoarthritis, elbow and shoulder joints, muscles lesions occurred more frequently in LA; polyarthritis, arthritis of hand and foot joints, talalgia were more common in RA. RA ran more actively, joint syndrome more frequently gave rise to fever. Prevalence of chlamydial infection in LA was close to that in RA. LA may run as RA, is frequently combined with Chlamydia trachomatis infection.

[The characteristics of peripheral nervous system involvement in Lyme borreliosis in an endemic region of Russia]. / Osobennosti porazheniia perifericheskoi nervnoi sistemy pri Laim-borrelioze v éndemichnom raione Rossii.

Clinical and laboratory data are available on affection of the peripheral nervous system (PNS) in 27 patients with Lyme-borreliosis (LB) in the endemic region of Russia. PNS disorders arose early, 88.9% of the patients had them within one month of the disease. 9 (37.5%) patients had meningoradiculoneuropathy (MRN) which emerged in the acute period in 77.8% of the patients. Inflammation in the cerebrospinal fluid was registered only in patients with clinical signs of meningitis. MRN developed more frequently in facial nerve neuritis (FNN) than in radiculopathy (RP)-80.0% and 14.3%, respectively, p = 0.01. Intrathecal synthesis of antibodies to B. burgdorferi in combination with pleocytosis was found only in FNN patients (16.7%). In 6 (37.5%) of 16 patients with neuroborreliosis concentrations of C-reactive protein were elevated. Its high level occurred significantly more frequently in RP (83%) than in FNN (17%) (p = 0.05). 5 out of 14 LB patients exhibited high level of Willebrand factor antigen. No clear clinical relations between this value and PNS lesions in LB were found.

[Frequency of lyme borreliosis and diagnostic titers of antibodies to borrelia burgdorferi in patients with neurological diseases in endemic region of Russia]. / Chastota Laim-borrelioza i diagnosticheskikh titrov antitel k Borrelia burgdorferi u bol'nykh s nevrologicheskimi zabolevaniiami v endemicheskom raione Rossii.

The frequency of diagnostic titers of antibodies to Borrelia burgdorferi in 289 examinees suffering from neurological diseases made up 10.4%, while in the population this figure was under 1.9%. Lyme-borreliosis was detected in 11 (3.8%) patients, 2 of them had mixed infection with tick-borne viral encephalitis. In 10 patients (3.5%) the diagnosis of neuroborreliosis required verification with other techniques. It is thought valid to perform serological screening for neuroborreliosis only in patients with tick-born encephalitis to identify mixed infection.

[A multicenter evaluation of efficacy and tolerance in the local treatment with dolgit cream of patients with osteoarthrosis]. / Mnogotsentrovaia otsena éffektivnosti i perenosimosti lokal'noi terapii kremom dolgit u bol'nykh osteoartrozom.

A 2-week clinical trial of cream dolgit efficacy and tolerance in 76 patients with primary osteoarthritis in 8 rheumatological centers showed this preparation to reduce local pain syndrome in 70.1%, palpation pain sensitivity in 79.2%, joint swelling in 75.5% of patients. Unwanted reactions in the form of skin itch at the site of application were reported in 7.8% of cases.