Kamin Wolfgang, Ilyenko Lidia I, Malek Fathi A, Kieser Meinhard
University Hospital Paediatrics, Mainz, Germany.
Pediatr Int. 2012 Apr;54(2):219-26. doi: 10.1111/j.1442-200X.2012.03598.x.
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.
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.
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.
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.
本试验旨在研究从香叶天竺葵中提取的草药制剂EPs 7630在患有急性支气管炎的儿童和青少年中的疗效和耐受性，这些患者不在抗生素的严格适应症范围内。
总共220例急性支气管炎患者被随机分组，给予含EPs 7630的试验药物（1 - 6岁/＞6 - 12岁/＞12 - 18岁：每日3×10/3×20/3×30滴）或匹配的安慰剂，为期7天。主要结局指标是从第0天到第7天支气管炎特异性症状（BSS）总分的变化。
与安慰剂相比，EPs 7630组BSS总分的下降显著更高（第0天至第7天的变化：4.4±1.6对2.9±1.4分；P＜0.0001）。“咳嗽”和“听诊有啰音”方面的改善最为明显。两组的耐受性同样良好。
对于不在抗生素严格适应症范围内的儿童和青少年急性支气管炎治疗，EPs 7630被证明是一种有效且耐受性良好的选择。
