Klinische Pädiatrie
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Klinische Pädiatrie · Jul 2001
Randomized Controlled Trial Multicenter Study Clinical Trial[Improved treatment results in children with AML: Results of study AML-BFM 93].
In the multicenter trial AML-BFM 93 daunorubicin or idarubicin was randomly applied in all patients during induction in combination with cytarabine and etoposide. After induction all patients were stratified to the standard or high risk group. To improve outcome in high risk patients high dose cytarabine and mitoxantrone (HAM) was introduced. The placing of HAM as either the 2nd or 3rd therapy block was randomized to evaluate the efficacy and toxicity accordingly. ⋯ Compared to study AML-BFM 87 treatment results in study AML 93 improved significantly in high risk patients. This can partly be contributed to the better response on day 15 after idarubicin induction but is mainly due to the introduction of HAM.
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Klinische Pädiatrie · Jul 1998
Randomized Controlled Trial Multicenter Study Clinical TrialPrevention of CNS recurrence in childhood ALL: results with reduced radiotherapy combined with CNS-directed chemotherapy in four consecutive ALL-BFM trials.
The introduction of cranial radiotherapy (CRT) has provided efficient control of overt or subclinical meningeosis in acute lymphoblastic leukemia (ALL). Especially due to the long-term toxicity of CRT, reduction or elimination of radiotherapy appeared mandatory after cure rates of more than 70% had been achieved in ALL. The Berlin-Frankfurt-Münster (BFM) Study Group initiated several attempts in certain ALL subgroups to omit or reduce CRT while using more CNS-directed chemotherapy but without extended intrathecal treatment during maintenance therapy. This analysis summarizes the essential results that are in particular relevant because irradiation of the central nervous system (CNS) has been further reduced in the most recent trial ALL-BFM 95. ⋯ Low-risk ALL patients can be efficiently prevented from CNS relapse by intensive systemic and intrathecal chemotherapy without CRT. Patients with intermediate or medium risk ALL, including T-cell ALL, did not suffer from more CNS or systemic relapses when CRT was reduced to only 12 Gy. Patients with inadequate response to therapy are at particularly high risk for relapse with CNS involvement. Therefore, more CNS-directed systemic and intrathecal chemotherapy was applied in trial ALL-BFM 90, combined with only 12 Gy cranial irradiation, and improved the control of CNS recurrence. It seems likely that larger subsets of B-precursor ALL can be protected from CNS-related relapse by intensive chemotherapy without extended IT treatment and without CRT. This is being investigated in the ongoing trial ALL-BFM 95.
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Klinische Pädiatrie · Sep 1996
Randomized Controlled Trial Multicenter Study Comparative Study Clinical Trial[5-day therapy of bacterial pharyngitis and tonsillitis with cefixime. Comparison with 10 day treatment with penicillin V. Cefixime Study Group].
160 children aged 1 to 12 years with clinical diagnosis of bacterial pharyngitis and/or tonsillitis were treated either with cefixime ready-to-use-suspension or penicillin V in an open, controlled and randomized multicenter study. Before treatment a rapid antigen detection test was accomplished and throat swabs were taken. After randomization, the children were either treated for 5 days with 8 mg cefixime/kg bodyweight ready-to-use suspension once daily or with 20,000 I. ⋯ Both regimes were safe. Mild to moderate adverse events at least possibly related to the study medication were seen in only 4 children treated with cefixime and in 5 treated with penicillin. A 5 day treatment of bacterial pharyngitis and tonsillitis with cefixime was as effective as a ten day treatment with penicillin V.
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Klinische Pädiatrie · Nov 1995
Randomized Controlled Trial Comparative Study Clinical Trial[Analgosedation with fentanyl/midazolam after correction of congenital heart defects].
There is no standard therapy in the management of postoperative pain control following corrective cardiac surgery of congenital heart disease. Assessment in the preverbal age is difficult. ⋯ Fentanyl and midazolam are an appropriate combination for postoperative pain treatment. Continuous application is considered to be more effective concerning basic anxiety, cumulative dosage and to avoid volume overload in infants and young children, following cardiac surgery; overdosage was not observed.
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Klinische Pädiatrie · Jan 1994
Randomized Controlled Trial Multicenter Study Comparative Study Clinical Trial[Effectiveness and tolerance of cefixime in comparison with penicillin V in bacterial pharyngitis and tonsillitis in children. Cefixime Study Group].
154 children aged 2 to 12 years with clinical diagnosis of bacterial pharyngitis and/or tonsillitis and--in most of the patients--a positive enzyme immunoassay for group A beta-hemolytic streptococci before therapy were enrolled in this open controlled randomized and multicenter trial. The children received either 8 mg/kg bodyweight cefixime once daily or 20,000 I. E. pencillin V/kg bodyweight t.i.d. ⋯ Mild side effects were reported by 4 patients in the cefixime group and by 3 children treated with penicillin V (1 drop out each). These results show that cefixime once daily is at least as effective as penicillin V t.i.d. in pharyngitis and tonsillitis in children. Both compounds are well tolerated.