The role of viscosupplementation with hylan G-F 20 (Synvisc) in the treatment of osteoarthritis of the knee: a Canadian multicenter trial comparing hylan G-F 20 alone, hylan G-F 20 with non-steroidal anti-inflammatory drugs (NSAIDs) and NSAIDs alone.

To determine the safety and efficacy of viscosupplementation with hylan G-F 20, a cross-linked hyaluronan preparation, used either alone or in combination with continuous non-steroidal anti-inflammatory drug (NSAID) therapy, a randomized, controlled, multicenter clinical trial, assessed by a blinded assessor, was conducted in 102 patients with osteoarthritis (OA) of the knee. All patients were on continuous NSAID therapy for at least 30 days prior to entering the study. Patients were randomized into three parallel groups: (1) NSAID continuation plus three control arthrocenteses at weekly intervals; (2) NSAID discontinuation but with three weekly intra-articular injections of hylan G-F 20; and (3) NSAID continuation plus three injections, one every week, intra-articular injections of hylan G-F 20. Outcome measures of pain and joint function were evaluated by both the patients and an evaluator at baseline and weeks 1, 2, 3, 7 and 12, with a follow-up telephone evaluation at 26 weeks. At 12 weeks all groups showed statistically significant improvements from baseline, but did not differ from each other. A statistical test for the equivalence, the q-statistic, demonstrated that viscosupplementation with hylan G-F 20 was at least as good or better than continuous NSAID therapy for all outcome measurements except activity restriction. At 26 weeks both groups receiving hylan G-F 20 were significantly better than the group receiving NSAIDs alone. A transient local reaction was observed in three patients after hylan G-F 20 injection; only one patient withdrew from the study as a result and all recovered without any sequela. Hylan G-F 20 is a safe and effective treatment for OA of the knee and can be used either as a replacement for or an adjunct to NSAID therapy.

Antineutrophil cytoplasmic autoantibodies (ANCA) associated vasculitides--immunologic and clinical aspects.

The author reviews the opinions on vasculitis pathogenesis which is based on the direct noxa impact, active immunity process against the specific components of the vascular tissue and/or passive impact of the inflammatory process upon vessels. The detection is especially based on two most important ANCA tests, i.e. indirect immunofluorescence and ELISA. The author includes also the sensitivity and specificity of these examinations and their predictive value in progressive glomerulonephritis, Wegener's granulomatosis and other diseases. (Tab. 1, Ref. 20.).

Correction of immunodeficiency in aged mice by levamisole and bestatin administration.

An attempt to correct the impaired immune functions of aged mice was made by injecting repeatedly (over a 6-month period) two chemically defined immunostimulating agents, levamisole and bestatin, into 12- to 16-month-old hybrid mice. Continuous treatment with levamisole restored T-cell-dependent functions (delayed-type hypersensitivity reaction and antibody response to T-dependent antigens) and prevented the appearance of suppressor cells induced by aging. In aged animals, this treatment led to macrophage activation and to a significant reduction of ADCC activity near the baseline value of young animals. Weekly injections of bestatin resulted in varying effects, depending on the dose administered. Small doses (10 microgram/injection) were more effective in restoring humoral response to SRBC rather than delayed-type hypersensitivity reaction, whereas large doses (100 microgram/injection) had the opposite effect. Macrophage activation was obtained only after the administration of the high dose of bestatin. Continuous treatment with bestatin did not eliminate suppressor cell activity, but decreased the ADCC normally elevated in aged animals. A significant reduction of spontaneous tumors and prolongation of median survival was observed in mice given repeated injections of levamisole and of 100 microgram bestatin, compared with untreated aged mice and with mice given low doses of bestatin.

Double-blind trial comparing flunisolide and placebo for the treatment of perennial rhinitis.

The effectiveness of a new topical steroid, flunisolide, was evaluated for the treatment of patients with perennial rhinitis. The sixty-nine patients in this 8 week double-blind parallel trial received either 300 microgram/day of flunisolide or placebo. The flunisolide group showed statistically greater improvement than the placebo group in such symptoms as the duration of sneezing, stuffy nose, runny nose and nose blowing. 63% of the flunisolide group compared with 39% of the placebo group felt the test spray had provided substantial or total control of their nasal symptoms (P = 0.0026). When those patients who were skin test-positive (allergic) were considered separately from those who were skin test-negative (non-allergic), differences in responsiveness were noted. While those patients who had negative skin tests received greater relief of their symptoms with flunisolide than with placebo, patients who had positive skin tests showed a greater responsiveness to flunisolide and reported a higher incidence of significant or total control of their symptoms. Careful monitoring of plasma cortisol levels revealed no evidence of adrenal suppression in any of the patients in this trial. This lack of suppression may be due to two factors: (a) flunisolide is rapidly metabolized into a metabolite with a low degree of activity and (b) a very low dose of corticosteroid is administered.