[The efficacy and safety of intra-articular application of a combination of sodium hyaluronate and chondroitin sulfate for osteoarthritis of the knee: a multicenter prospective study].

in 3 mL on patients with knee osteoarthritis (OA) in a multicenter prospective study. MATERIALS AND METHODS: 79 outpatients (predominantly females 81.0%) from 5 RF constituent territories with primary tibiofemoral KellgrenLawrence score grade II or III knee OA, 40 mm pain intensity during walking on visual analogue scale (VAS), requiring NSAIDs intake (for at least 30 days during 3 months prior to enrollment) were included into the study after signing the informed consent form. Mean age was 60.38.7 years, mean BMI 29.24.7 kg/m2, disease duration 6 (310) years. Grade II OA was documented in 68.4% of patients, Grade III in 31.6%. The study lasted for 6 months. Efficacy and safety evaluations were made based on VAS pain assessment, Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) [WOMAC pain (0500), WOMAC function (01700), WOMAC stiffness (0200)], VAS patients health status, EQ-5D-based assessment of patients quality of life, global physicians and patients efficacy assessment, and daily NSAIDs requirements. RESULTS: Obtained results demonstrate statistically significant VAS pain reduction during walking already in 1 week after intra-articular injection of the combination [respectively, 62 (5572) and 41 (3251) mm, р0.0001]. Moreover, pain continued to subside during all 3 months of follow up [in 1 month 28 (2042), in 3 month 22 (1437) mm]. A significant pan reduction achieved at Mo 3 persisted until Mo 6 20 (1442) mm, without documented pain increase. Similar trends were observed with total WOMAC score [1125 (8991540) at baseline, and 552 (309837) mm by the end of the study, p0.0001], and all WOMAC sub-scores [268 (189312) baseline WOMAC pain, 91 (48171) mm by the end of the study p0.0001; stiffness 101 (59130) and 40 (2061) mm, p0.0001; function 802 (6471095) and 402 (191638) mm, p0.0001, respectively]. Median time to the onset of therapeutic effect was 7 (518) days. Statistically significant improvement of patients quality of life by EQ-5D and general health status was observed during all follow up period [respectively, 0.52 (-0.020.59) and 0.69 (0.590.80), р0.0001; 48 (3060) and 72 (6080) mm, р0.0001]. One injection of the drug resulted in dose reduction or discontinuation of NSAIDs therapy: at baseline 76 patients (96.2%) were taking NSAIDs, in one week 31 (39.2%) patients discontinued NSAIDs, in 1 month 72.2%, in 3 months 73.4%, and by the end of the study at Mo 6 54.4% were not taking NSAIDs. These data were consistent with physicians and patients global assessment of the efficacy of treatment, who stated significant improvement and improvement in the majority of cases, with only few no effect or worsening cases documented in analyzed population. Adverse events, such as worsening of pain and/or swelling of the joint, were documented in 8 patients (10.1%); they resolved spontaneously or following NSAIDs intake. CONCLUSION: These results suggest that intra-articular injections of hyaluronic acid plus chondroitin sulfate in patients with knee OA are efficient and safe. A single injection of the drug resulted in statistically significant reduction of pain and stiffness, reduction in NSAIDs intake, as well as improvement in patients quality of life and function.

[The efficiency and safety of adalimumab treatment in patients with active rheumatoid arthritis unresponsive to standard therapy: Russian national study results].

AIM: To confirm the efficacy and safety of adalimumab (ADA) added to the standard antirheumatic therapy performed in patients with rheumatoid arthritis (RA) of moderate and high activities. SUBJECTS AND METHODS: The open-labeled multicenter study enrolled 100 adult patients (11 men, 89 women; mean age 50.9 +/- 11.1 years) with active RA according to the ACR criteria (1987) despite their treatment with disease-modifying antirheumatic drugs, the average number of which in the history was 2.1 per man. At baseline, DAS28 CRP was as many as 6.2 +/- 0.84 scores; C-reactive protein (CRP) was 37.1 +/- 34.7 mg/l. In accordance with the indications officially registered in the European Union and the Russian Federation, ADA was given in a dose of 40 mg 2 weeks. Before administration of the drug, every patient underwent screening examination for tuberculosis, which used a tuberculin test and chest X-ray. The screening covered a period of the treatment up to 24 weeks and its subsequent period within 70 days after administration of the last dose of ADA in order to study its safety. RESULTS: DAS28-CRP scores decreased from 6.14 +/- 0.86 (at baseline) to 3.39 +/- 1.1 (by the end of the study). At 12 weeks, 22% of the patients achieved a low RA activity (DAS28-CRP < or = 3.2 scores); 14% achieved clinical remission (DAS28-CRP < or = 2.6 scores); at 24 weeks, these were 37 and 25% of the patients, respectively. There were differences in effectiveness in terms of the baseline disease activity. At 24 weeks, ACR20, ACR50, and ACR 70 responses were achieved in 88, 67, and 26% of the patients, respectively. The HAQ functional index reduced from 1.9 +/- 0.6 (at baseline) to 1.081 +/- 0.64 (at 12 weeks) and 1.04 +/- 0.68 (at 24 weeks) scores. Twenty-four patients were recorded as having 40 adverse reactions (AR), including only one severe AR (septic arthritis). There were no cases of tuberculosis. CONCLUSION: The Russian multicenter study demonstrated the high clinical efficacy of ADA in patients with the moderate and high activity of RA unresponsive to standard therapy, as well as its satisfactory safety.

[Long-term efficacy and safety of chondroitin sulphate (structum, France) in patients with coxarthrosis].

AIM: To evaluate long-term therapeutic effect and safety of structum in patients with manifest coxarthrosis. MATERIAL AND METHODS: Twenty patients with manifest coxarthrosis of degree I-III were given a 6 month structum course. Criteria of efficacy were Leken index, pain in the affected joints, nonsteroid anti-inflammatory drugs requirement, assessment of the efficacy by the patient and the doctor. Structum effects were studied with x-ray examination, CT, INC index. The assessment was made at baseline, after 3 and 6 month therapy and 6.12 and 18 months after the end of the study. RESULTS: All the patients achieved positive results without side effects on coagulation. CONCLUSION: Structum is highly effective in patients with manifest osteoarthrosis of hip joints. Is modifies symptoms, has a potential chondroprotective effect, long-term aftereffect, no significant negative action of coagulation, is well tolerated.

[Structum therapy of patients with rheumatoid arthritis]. / Opyt primeneniia struktuma u bol'nykh revmatoidnym artritom.

AIM: To study efficacy of the chondroprotector chondroitin sulphate (structum, Pier Fabr Medicament Production, France) in patients with rheumatoid arthritis (RA) and secondary osteoarthrosis of the knee joints. MATERIAL AND METHODS: 15 women with a long history of RA (mean duration 11.9 years) entered an open non-randomized trial of structum. The patients had a severe progressive highly active RA with a definite x-ray stage of the disease. 13 patients had a positive rheumatoid factor (1:80 to 1:1280) and involved knee joints which had been affected for 1 to 10 years (mean 5.3 years). The second x-ray stage was in 8 patients, the third stage of knee joints arthrosis was in 7 ones. A marked pain syndrome in the knee joints upon movement (mean 64.7 mm by VAS) was observed in all the examinees and at rest (mean 28 mm by VAS) in 13 of 15 patients. Structum was given according to a standard scheme: 500 mg 3 times a day for 3 weeks than 500 mg 2 times a day for up to 6 months. Basic drugs for RA were the same for all the observation period. RESULTS: Structum noticeably improved knee joint function (mean Leken's index 12.8, 11.3 and 9.4 scores before the treatment, on treatment month 3 and 6. Movement pain syndrome VAS reduced from 64.7 mm at the start to 51 mm 3 months and 37.5 mm 6 months later, rest VAS--from 19 to 10.3 and 6.4 mm, respectively. The demand in intraarticular glucocorticoids went down from 52 injections at the start of therapy to 6 after 6 months. Side effects for 6 months were absent. Overall efficacy was good (73.3% and 80%) as judged by the doctors and patients, respectively. After 6 months of therapy control x-rays found no progression of destructive changes in the knee joints (by MRI--in 4 patients). CONCLUSION: Structum has a marked positive therapeutic effect in patients with severe and long-term course of RA with associated pronounced secondary joint arthrosis.

[Results of the multicenter clinical trial of structum preparation in Russia]. / Itogi mnogotsentrovogo klinicheskogo issledovaniia preparata struktuma v Rossii.

AIM: To study clinical effectiveness and tolerance of structum in patients with osteoarthrosis (OA) of the knee joints (KJ) and hip joints (HJ) in a multicenter open randomised trial. MATERIAL AND METHODS: A 6-month trial of effectiveness and tolerance of structum has been performed in 9 medical centers and included outpatients (males and females) with KJ OA or HJ OA satisfying the OA diagnostic criteria of the American Rheumatology College, having x-ray stage I-III according to Kellgren-Lawrence with manifest pain, a total functional Leken index from 4 to 11, regular intake of non-steroid antiinflammatory drugs (NAID) for 30 days in the last 3 months. Consent was obtained from each patient. 192 patients received structum, 363 matched patients served control. Structum was given per os for 3 weeks in a dose of 1.5 g/day then in a dose 1.0 g/day up to 6 months. The patients continued on NAID. The patients' examination was performed in the beginning of the study, at its months 3 and 6. RESULTS: Leken index in HJ and KJ OA significantly fell after 3 months of structum treatment. Up to month 6 it fell still further (p < 0.05). After 6 months of treatment pain syndrome relieved both at rest and movement, pain at rest disappeared fully in 57% of NJ OA patients and 46% of HJ OA patients, for movement pain it was 17 and 13%, respectively. During the treatment NAID intake was less required in both groups (p < 0.05) while 55% of patients in both groups could discontinue NAID after 6 months of the treatment. Tolerance of the drug was rather good, side effects were mild. CONCLUSION: Structum (chondroitin sulphate) is an effective drug for treatment of KJ and HJ OA: it relieves pain, preserves and improves articular function, allows to reduce or discontinue NAID, is well tolerated.

[Experience with movalis administration against osteoarthritis in Moscow clinics]. / Opyt primeneniia movalisa u bol'nykh osteoartritom v klinikakh Moskvy.

AIM: To test effectiveness of a new nonsteroid antiinflammatory drug movalis in osteoarthritis. MATERIALS AND METHODS: 113 patients aged 30-85 years from 8 Moscow clinics were treated with movalis. All the patients had long-standing osteoarthritis, 26 patients had concomitant gastric or duodenal ulcers. Movalis was given in daily dose from 7.5 to 15 mg for 1-4 weeks. RESULTS: None case of ulcer onset or recurrence was observed. The response was rated as good in 44.2, satisfactory in 47.0% and bad in 8.8% of the cases. Tolerance was good in 99.1% of patients and bad in 0.9%. CONCLUSION: Movalis has a definite antiinflammatory and analgetic activity in patients with osteoarthritis and spondylarthrosis.

[The secretory and systemic humoral immune response to polysaccharide A in patients with rheumatism]. / Issledovanie sekretornogo i sistemnogo gumoral'nogo immunnogo otveta na polisakharid A u bol'nykh revmatizmom.

The level of sIgA saliva antibodies and Ig(M + G + A) serum antibodies to group polysaccharide A of streptococcus was studied in healthy donors and patients with streptococcal angina and rheumatic fever. It was shown that an elevated level of secretory and serum antibodies to polysaccharide A was registered in patients with angina and rheumatic fever reliably more frequently than in healthy donors. Independence of local and systemic humoral immune response to polysaccharide A was established.

[Use of immunoenzyme analysis for determining the persistence and biodegradation of antigens in the cell wall of group A streptococci in patients with rheumatism]. / Primenenie immunofermentnogo analiza dlia otsenki persistentsii i biodegradatsii antigenov kletochnoi stenki streptokokka gruppy A u bol'nykh revmatizmom.

A sandwich ELISA system was used for the study of the identification of antigenic group A polysaccharide determinants by antibodies in a suspension of streptococcus cells with varying degrees of lysis. Antibodies were able to identify less than 0.01% of antigenic A polysaccharides determinants in intact streptococcal cells. It is concluded that A polysaccharide is a marker of the destroyed group A streptococcus cells. The circulation of group A polysaccharide was examined in the sera of patients with rheumatism and acute streptococcal tonsillitis. Group A polysaccharide was detectable more frequently in rheumatic patients, as compared to those with tonsillitis, and circulated for long periods of time in the vascular network. Avidity and titres of antibodies to group A polysaccharide were determined in rheumatic patients with different degrees of antigenemia. In cases of marked antigenemia, correlation was disrupted between the titre and avidity of antibodies to group A polysaccharides.