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    Low-dose natural human interferon-? lozenges in the treatment of Behcet's syndrome
    (Oxford Univ Press, 2009) Kilic, Hasan; Zeytin, Hasan E.; Korkmaz, Cengiz; Mat, Cem; Gul, Ahmet; Cosan, Fulya; Dinc, Ayhan
    Objectives. There had been evidence that low-dose local IFN could be beneficial in the management of recurrent oral ulcers (OUs). We investigated the efficacy and collected initial data on the safety of low-dose natural human IFN-alpha administered by the oral mucosal route in Behcet's syndrome (BS) in a placebo controlled, double blind study. Methods. Eighty-four (59 males and 25 females) patients with BS with mainly skin mucosa disease and a history of recurrent OU for >= 1 year were studied. When they had at least two OUs with a total diameter of >= 4mm, they were randomly allocated to (i) 2000 IFN-alpha IU/day, (ii) 1000 IFN-alpha IU/day and (iii) placebo groups. Subjects were monitored weekly over an initial 4 weeks and bi-weekly for an additional 8 weeks of treatment. OU were counted and measured at each study visit. The primary efficacy end point was the difference in the total ulcer burden at Week 0 compared with that at Week 12. Results. Out of the 84 patients enrolled, 72 completed the trial. There were no statistically significant differences between the treatment arms in terms of the primary endpoint. Conclusions. Low-dose natural human IFN-alpha did not have beneficial effects on reducing the total ulcer burden among BS patients from Turkey. The study also showed that counting the number of ulcers rather than measuring the size would be adequate in future studies.
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    Prognosis of Behcet's syndrome among men with mucocutaneous involvement at disease onset: long-term outcome of patients enrolled in a controlled trial
    (Oxford Univ Press, 2010) Hamuryudan, Vedat; Hatemi, Gulen; Tascilar, Koray; Sut, Necdet; Ozyazgan, Yilmaz; Seyahi, Emire; Mat, Cem
    Objective. To assess the influence of being free of major organ involvement during the early years of the disease on the prognosis of men with Behcet's syndrome (BS). Methods. Ninety-six men with BS, who had only active mucocutaneous manifestations when entering a controlled trial of thalidomide mean (S. D.) 11.7 (0.8) years ago, were re-evaluated for the use of immunosuppressives as an indication of major organ involvement during the post-trial period. Results. Outcome information was obtained in 91 (95%) patients. Thirty-nine (43%) patients had to use immunosuppressives during the post-trial period. Immunosuppressive use was significantly more frequent among patients developing BS at younger age (76%; 424 years) than older age (30%; 525 years). Developing BS at young age (OR 6.3; 95% CI 2.09, 19.04) and not using colchicine during the post-trial period (OR = 3.860; 95% CI 1.484, 10.034) were risk factors for immunosuppressive use. However, 82% of the patients using colchicine had onset during old age. Colchicine showed a significant effect in decreasing the use of immunosuppressives only among patients of old age at onset (Fisher's exact test = 5.026; P = 0.031) in the subgroup analysis. Eye disease (18 patients) and vascular involvement (14 patients) were the most frequent indications for immunosuppressive use. Conclusions. Being free of major organ involvement during the early years of BS does not indicate a mild prognosis for men developing BS at young age. Whether colchicine will reduce the need for immunosuppressive use among men developing BS at old age awaits formal studies.