Wolfgang Kamin

Akute Atemwegsinfektionen gehören weltweit zu den häufigsten Erkrankungen. Dabei sind rund 90% aller akuten Infektionen der oberen und unteren Atemwege viraler Ursache. Obwohl Antibiotika bei Virusinfekten keine Wirksamkeit zeigen, werden diese zur Behandlung weiterhin viel zu häufig eingesetzt. Dies könnte unter anderem damit zusammenhängen, dass der Effekt einer antibiotischen Behandlung bei Erkältungskrankheiten überschätzt wird [1]. Hier gilt jedoch: Eine Pneumonie auszuschliessen ist wichtig - bei Patienten ohne Herz- oder Lungenerkrankung, bei Patienten ohne Immunsuppression in der Vorgeschichte sowie bei Patienten, die kürzer als eine Woche krank sind, ist eine Antibiotikatherapie bei einem unkomplizierten Atemwegsinfekt jedoch von geringem Nutzen [2].

Background: Respimat ^® Soft Mist™ Inhaler (SMI) is a hand-held device that generates an aerosol with a high, fine-particle fraction, enabling efficient lung deposition. The study objective was to assess inhalation success among children using Respimat SMI, and the requirement for assistance by the parent/caregiver and/or a valved holding chamber (VHC). Methods: This open-label study enrolled patients aged n =27) and 3 to n =30), 55.6% and 30.0%, respectively, achieved success without a VHC or help; with assistance, another 29.6% and 10.0%, respectively, achieved success, and the remaining children were successful with VHC. All children aged 2 to n =20) achieved success with the Respimat SMI and VHC. Of those aged n =22), 95.5% had successful handling of the Respimat SMI with VHC and parent/caregiver help. Inhalation flow profiles generally confirmed the outcome of the handling assessment by the investigators. Most parent/caregiver and/or child respondents were satisfied with operation, instructions for use, handling, and ease of holding the Respimat SMI with or without a VHC. Conclusions: The Respimat SMI is suitable for children aged <5 years; however, children aged <5 years are advised to add a VHC to complement its use.

Background:  The aim of this trial was to investigate the efficacy and tolerability of EPs 7630, a herbal drug preparation from Pelargonium sidoides, in children and adolescents suffering from acute bronchitis, outside the strict indication for antibiotics.Methods:  A total of 220 patients with acute bronchitis were randomized and given either verum containing EPs 7630 (1–6 years/>6–12 years/>12–18 years: 3 × 10/3 × 20/3 × 30 drops/day) or matching placebo for 7 days. The main outcome measure was the change in the total score of bronchitis‐specific symptoms (BSS) from day 0 to day 7.Results:  The decrease in the BSS total score was significantly higher for EPs 7630 compared to placebo (change day 0–day 7: 4.4 ± 1.6 vs 2.9 ± 1.4 points; P < 0.0001). Improvements were most pronounced for ‘coughing’ and ‘rales at auscultation’. Tolerability was similarly good in both groups.Conclusions:  EPs 7630 proved to be an efficacious and well‐tolerated option for the treatment of acute bronchitis in children and adolescents outside the strict indication for antibiotics.

Mucopolysaccharidosis type II (MPS II) is a rare, life-limiting, X-linked recessive disease characterised by deficiency of the lysosomal enzyme iduronate-2-sulfatase. Consequent accumulation of glycosaminoglycans leads to pathological changes in multiple body systems. Age at onset, signs and symptoms, and disease progression are heterogeneous, and patients may present with many different manifestations to a wide range of specialists. Expertise in diagnosing and managing MPS II varies widely between countries, and substantial delays between disease onset and diagnosis can occur. In recent years, disease-specific treatments such as enzyme replacement therapy and stem cell transplantation have helped to address the underlying enzyme deficiency in patients with MPS II. However, the multisystem nature of this disorder and the irreversibility of some manifestations mean that most patients require substantial medical support from many different specialists, even if they are receiving treatment. This article presents an overview of how to recognise, diagnose, and care for patients with MPS II. Particular focus is given to the multidisciplinary nature of patient management, which requires input from paediatricians, specialist nurses, otorhinolaryngologists, orthopaedic surgeons, ophthalmologists, cardiologists, pneumologists, anaesthesiologists, neurologists, physiotherapists, occupational therapists, speech therapists, psychologists, social workers, homecare companies and patient societies. Take-home message Expertise in recognising and treating patients with MPS II varies widely between countries. This article presents pan-European recommendations for the diagnosis and management of this life-limiting disease.

The study aim was to demonstrate the efficacy and to investigate the tolerability of EPs 7630, a herbal drug preparation from Pelargonium sidoides roots, in the treatment of patients (1 - 18 years) with acute bronchitis outside the strict indication for antibiotics. A total of 200 patients were randomized to receive either active drug containing EPs 7630 (1 - 6 years: 3 x 10 drops/d; > 6 - 12 years: 3 x 20 drops/d; > 12 - 18 years: 3 x 30 drops/d) or placebo for 7 consecutive days. change in the total score of bronchitis-specific symptoms (BSS) from Day 0 to Day 7. Main secondary outcome measures: treatment outcome, patients' satisfaction with treatment, onset of effect, bed rest. From baseline to Day 7, the mean BSS score improved significantly more for EPs 7630 compared with placebo (3.4 +/- 1.8 vs. 1.2 +/- 1.8 points, p < 0.0001). On Day 7, treatment outcome was significantly better (p < 0.0001), satisfaction with treatment more pronounced (77.6% vs. 25.8%, p < 0.0001), onset of effect faster, and time of bed rest shorter as compared with placebo. Tolerability was similarly good in both groups. All adverse events were assessed as non-serious. EPs 7630 was shown to be efficacious and safe in the treatment of acute bronchitis in children and adolescents outside the strict indication for antibiotics with patients treated with EPs 7630 perceiving a more favorable course of the disease and a good tolerability as compared with placebo.

Aim:  For EPs‐7630, a herbal drug preparation from Pelargonium sidoides roots, therapeutic effects in respiratory tract infections outside the strict indication for antibiotics have already been demonstrated in adults. Now, a dose‐finding study for EPs‐7630 was performed in children and adolescents.Methods:  A total of 400 patients (aged 6–18 years) were randomized to receive either 30 mg, 60 mg or 90 mg EPs‐7630 or placebo daily. Primary outcome criterion was the change in the Bronchitis Severity Score (BSS) from day 0 to day 7.Results:  After 7 days of treatment, the change in the BSS total score was significantly better in the 60 mg and 90 mg groups compared with placebo that of the without relevant differences between these two dosages. Especially ‘coughing’, ‘sputum’ and ‘rales at auscultation’ improved under EPs‐7630. Onset of effect was faster, time of bed rest shorter and treatment outcome and satisfaction with treatment were rated better. Tolerability was comparable with placebo in all treatment groups.Conclusion:  EPs‐7630 is effective in acute bronchitis outside the strict indication for antibiotics in 6–18 years old patients, with a dose of 60 mg or 90 mg daily offering the best benefit/risk ratio. EPs‐7630 significantly reduces the severity of symptoms, leads to a more favourable course of the disease and a faster recovery from acute bronchitis compared with the placebo, and is well tolerated.

Seasonal allergic rhinitis (SAR) affects at least 10-25% of the Caucasian race and about 40% of patients are children. Standard treatment of SAR is specific immunotherapy (SIT), but anti-allergic drugs can significantly enhance efficacy of SIT. One candidate is the humanized monoclonal anti-IgE antibody omalizumab. Randomized, double-blind, placebo-controlled, multi-centre trial in Germany. A total of 221 children were randomly assigned to four different groups and treated with SIT (either grass or birch pollen), starting at least 14 wk before the local birch pollen season. After the 12-wk SIT titration phase, either anti-IgE (omalizumab) or placebo (NaCl 0.9%) therapy was added. This combination therapy with SIT and anti-IgE or placebo lasted 24 wk. To record local reactions and adverse events (AE), the injection site was examined by a clinician 20 min after application of study medication. Further, patients stated any AE and the use of rescue medication by means of a diary 3 days after every injection. Finally, any AE or serious adverse event (SAE) reported by the patients was specified on a standard form by clinicians. Overall tolerance was judged by the doctors according to the patient's diaries. To test differences between the groups, we used either the two-sided Wilcoxon rank-sum test or the two-sided chi-square test. Tolerability of SIT and omalizumab treatment was good (82% of patients). Only some AE with possible causal relationship to treatment occurred slightly more often in the verum groups, i.e. local reactions (16.8 vs. 12.3%) and gastrointestinal (2.7 vs. 0.9%) and ear symptoms (1.8 vs. 0%). Most AE (93.4% in omalizumab and 87.2% in placebo group) were judged by the patients as mild to moderate. SAE were restricted to four patients with asthma in the placebo group, two subjects with headache in the verum group and three patients with infections (two in verum and one in placebo group). Only the cases of asthma were judged to be possibly related to study medication. Further, redness and swelling at the SIT injection site appeared significantly more often in the placebo group which suggests a positive effect of omalizumab on local reaction induced by SIT. Omalizumab represents an important clinical advance in the management of allergic diseases and can be considered to be safe in children.

Zur Erweiterung der Erfahrungen hinsichtlich der Unbedenklichkeit von Pinimenthol® Erkältungssalbe* bei Patienten ab 12 Jahren mit Erkältungskrankheiten der oberen Luftwege wurde eine Kohortenstudie durchgeführt. Es wurden Verträglichkeitsdaten für 3060 Patienten erfasst (64,9% prospektiv über einen individuellen Zeitraum von 5–14 Tagen, 35,1% retrospektiv). Die prospektive Erfassung beinhaltete zudem Daten zum Behandlungseffekt. Der Stichprobenumfang war so berechnet, dass für UAWs mit einer Auftretenshäufigkeit von 1:1000 eine Wahrscheinlichkeit von 95% besteht, dass diese im Rahmen der Kohortenstudie mindestens einmal auftreten. Umgekehrt kann für UAWs, die im Rahmen der Kohortenstudie nicht auftreten, die Auftretenswahrscheinlichkeit bei dieser Fallzahl mit 5%iger Irrtumswahrscheinlichkeit nach oben mit (1:1000) abgeschätzt werden. Die meisten Patienten litten an Schnupfen, akuter oder chronischer Bronchitis, Bronchialkatarrh oder Heiserkeit. Pinimenthol® Erkältungssalbe wurde zur Einreibung (29,6%), zur Inhalation (17,3%) bzw. zur Einreibung und Inhalation (52,9%) verordnet. Die mittlere Therapiedauer betrug 8,0±3,4 Tage. Die Verträglichkeit wurde von 97,7% der Ärzte bzw. 97,0% der Patienten mit ausgezeichnet oder gut angegeben. Bei 22 Patienten (0,7%) traten unerwünschte Arzneimittelwirkungen (UAW) auf, die meist die Haut und Schleimhäute betrafen und somit dem erwarteten Nebenwirkungsprofil des Präparates entsprachen. Der Behandlungseffekt wurde überwiegend als sehr gut oder gut beurteilt (Prüfärzte: 89,2%; Patienten: 89,3%). Insgesamt bestätigt die Studie Pinimenthol® Erkältungssalbe als gut verträgliche Therapieoption bei Erkältungskrankheiten der oberen Luftwege, dies auch bei Jugendlichen. *arzneilich wirksame Bestandteile: Eucalyptusöl, Kiefernnadelöl, Menthol; Spitzner Arzneimittel, Ettlingen.