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Báo cáo y học: "Treatment of active lupus nephritis with the novel immunosuppressant 15-deoxyspergualin: an open-label dose escalation study"

Tuyển tập các báo cáo nghiên cứu về y học được đăng trên tạp chí y học General Psychiatry cung cấp cho các bạn kiến thức về ngành y đề tài: Treatment of active lupus nephritis with the novel immunosuppressant 15-deoxyspergualin: an open-label dose escalation study. | Lorenz et al. Arthritis Research Therapy 2011 13 R36 http arthritis-research.eom content 13 2 R36 RESEARCH ARTICLE Open Access Treatment of active lupus nephritis with the novel immunosuppressant 15-deoxyspergualin an open-label dose escalation study I_I s n nf A I s I I r r nvn 71 A ilh l KỲ I_I c z In m I F 2 ỉ n Z l I I r I zsr I r3 I I I T k II Ini I n Z l m r V4 I z fs I M n V V4 I r fs m I_I n I I Z V5 Hanns-Martin Lorenz Wilhelm H Schmitt Vladimir Tesar Ulf Miuller-Ladner Ingo Idiner Ingeborg A Hauser Falk Hiepe6 Tobias Alexander6 Heike Woehling7 Kyuichi Nemoto8 and Peter A Heinzel8 Abstract Introduction As the immunosuppressive potency of 15-deoxyspergualin DSG has been shown in the therapy of renal transplant rejection and Wegener s granulomatosis the intention of this study was to evaluate the safety of DSG in the therapy of lupus nephritis LN . Methods Patients with histologically proven active LN after prior treatment with at least one immunosuppressant were treated with 0.5 mg kg normal body weight day DSG injected subcutaneously for 14 days followed by a break of one week. These cycles were repeated to a maximum of nine times. Doses of oral corticosteroids were gradually reduced to 7.5 mg day or lower by cycle 4. Response was measured according to a predefined decision pattern. The dose of DSG was adjusted depending on the efficacy and side effects. Results A total of 21 patients were included in this phase-I II study. After the first DSG injection one patient was excluded from the study due to renal failure. Five patients dropped out due to adverse events or serious adverse events including fever leukopenia oral candidiasis herpes zoster or pneumonia. Eleven out of 20 patients achieved partial 4 or complete responses 7 8 were judged as treatment failures and 1 patient was not assessable. Twelve patients completed all nine cycles in those patients proteinuria decreased from 5.88 g day to 3.37 g day P 0.028 Selena-SLEDAI Safety of Estrogens in Lupus .