Clinical trial: controlled, open, randomized multicentre study comparing the effects of treatment on quality of life, safety and efficacy of budesonide or mesalazine enemas in active left-sided ulcerative colitis.

BACKGROUND: Therapy for active left-sided ulcerative colitis usually involves topical application of mesalazine (mesalamine) or budesonide. AIM: To compare the efficacy and safety of budesonide enema and mesalazine enema in the treatment of active left-sided ulcerative colitis. METHODS: A total of 237 patients with mild-moderate ulcerative colitis were randomized open 1:1 to receive either budesonide (n = 118) or mesalazine enemas (n = 119) for 8 weeks. Efficacy variables were clinical activity index, endoscopic, histological index and IBDQ scores after 4 and 8 weeks. RESULTS: Clinical remission (intention-to-treat analysis) at week 4 was 63.5% for budesonide enemas and 77.2% for mesalazine enemas (P < 0.05). The respective values for the per protocol population (PP) were 59.9% examined in the budesonide group and 77.5% in the mesalazine group (P < 0.02). At the final visit (W8), clinical remission was diagnosed in the ITT analysis for 64.4% of the budesonide group and 77.4% of the mesalazine group (P < 0.05). The respective values for the PP analysis were 59.5% in the budesonide group and 75.3% in the mesalazine group (P < 0.02). CONCLUSIONS: Compared with budesonide, mesalazine enema was associated with a significantly higher remission rate; this was supported by favourable trends in endoscopic, histological remission rates and the IBDQ score.

[Pathophysiological-based diagnosis and therapy of iron-deficient anaemia in inflammatory bowel disease]. / Pathophysiologisch-orientierte Diagnostik und Therapie der Eisenmangelanämie bei chronisch entzündlichen Darmerkrankungen.

Anaemia is the most frequent extraenteric complication of inflammatory bowel disease (IBD, Crohn's disease and ulcerative colitis). A disabling complication of IBD, anaemia worsens the patient's general condition and quality of life, and increases hospitalization rates. The main types of anemia in IBD are iron deficiency anemia and anemia of chronic disease. The combination of the serum transferrin receptor with ferritin concentrations and inflammatory markers allows a reliable assessment of the iron status. Iron deficiency is usually treated with oral iron supplements. However, it is less effective in IBD and may lead to an increased inflammatory activity through the generation of reactive oxygen species. A systematic review of anemia in IBD, its pathogenetic features, epidemiology, diagnosis and therapy based on the evidence from recent studies will be the focus of this article.

[Integrated health care at Lübeck]. / Das "Lübecker Modell".

This paper reports on a project of Integrated Health Care in cardiology at Lübeck, Germany. Information on the structure of the contract, the participants, the agreed claiming of benefits and provision of services are provided as well as relevant figures and contact data.

High-dose cytarabine and mitoxantrone in consolidation therapy for acute promyelocytic leukemia.

The objective of our study was to evaluate high-dose cytarabine in consolidation therapy in patients with newly diagnosed acute promyelocytic leukemia (APL). Patients (age 16-60 years) received induction therapy according to the AIDA protocol (all-trans retinoic acid, idarubicin) followed by one cycle of ICE (idarubicin, cytarabine, etoposide) and two cycles of HAM (cytarabine 3 g/m(2) q12h, days 1-3; mitoxantrone 10 mg/m(2), days 2 and 3). From 1995 to 2003, 82 patients were enrolled. In total, 72 patients (88%) achieved a complete remission, and 10 patients (12%) died from early/hypoplastic death (ED/HD). A total of 71 patients received at least one cycle of HAM. Relapse-free survival (RFS) and overall survival (OS) after 46 months were 83 and 82%, respectively. White blood cell count above 10.0 x 10(9)/l at diagnosis and additional chromosomal aberrations were unfavorable prognostic markers for OS, whereas no prognostic markers for RFS were identified including FLT3 mutations. In conclusion, high-dose cytarabine in consolidation therapy for patients with newly diagnosed APL is an effective treatment approach.