Bettzuege-Pfaff Barbara I, Melzer Antje
Bonn, Germany.
Curr Med Res Opin. 2005 Nov;21(11):1735-9. doi: 10.1185/030079905X62963.
The efficacy and safety of a bath oil containing soya oil and anti-pruritic lauromacrogols have been demonstrated in experimental and clinical studies. In order to generate more efficacy and safety-related data on the day-to-day use in paediatric practice, a post-marketing surveillance study has been conducted. More than 3500 patients--the vast majority (61.4%) aged 0-4 years--were included in this investigation. Atopic eczema was diagnosed in 86.4% of the cases. The average duration of treatment was 42 days. The results confirm that the anti-pruritic bath oil is both well-tolerated and effective in treating dry and itchy skin diseases. The sum score of symptoms decreased during the treatment period from 7.21 to 2.71 mean score points. The physicians assessed the global efficacy in 89.4% of the cases as 'very good' or 'good'. Anti-pruritic properties of the combination were rated 'very good' or 'good' in 84.3%. The local tolerability was stated to be 'good' or 'very good' in 96.8% of the patients. In total, only 10 out of the 3566 patients, 0.28% respectively, experienced discomfort.Moreover, the physicians estimated that the bath oil therapy helped to reduce therapeutics like steroids in nearly 60% of patients. The potential to reduce use of external steroids and other specific therapeutics is also of particular relevance from a pharmacoeconomic point of view.
一项包含大豆油和止痒月桂醇聚醚的沐浴油的疗效和安全性已在实验和临床研究中得到证实。为了获取更多关于其在儿科日常使用中的疗效和安全性数据，开展了一项上市后监测研究。超过3500名患者——绝大多数（61.4%）年龄在0至4岁——被纳入此项调查。86.4%的病例被诊断为特应性皮炎。平均治疗时长为42天。结果证实，这款止痒沐浴油在治疗干性和瘙痒性皮肤病方面耐受性良好且有效。治疗期间症状总分从平均7.21分降至2.71分。医生在89.4%的病例中将总体疗效评估为“非常好”或“好”。该组合的止痒特性在84.3%的病例中被评为“非常好”或“好”。96.8%的患者表示局部耐受性“好”或“非常好”。在3566名患者中，总共只有10名，即0.28%，出现了不适。此外，医生估计沐浴油疗法在近60%的患者中有助于减少类固醇等治疗药物的使用。从药物经济学角度来看，减少外用类固醇和其他特定治疗药物使用的潜力也尤为重要。
