Charité - Universitätsmedizin Berlin, Clinic for Paediatrics, Augustenburger Platz 1, 13353, Berlin, Germany.
Clinical Research Department, Dr. Willmar Schwabe GmbH & Co. KG, Karlsruhe, Germany.
BMC Pediatr. 2019 Apr 23;19(1):119. doi: 10.1186/s12887-019-1473-z.
Fever is a very common adaptive immune response in acute respiratory tract disorders during infancy. Antipyretic / analgesic drugs such as paracetamol (acetaminophen) are widely used to improve the comfort of the child but may cause medically unneeded antipyresis and rare but potentially serious side effects. We assess whether treatment with Pelargonium sidoides extract EPs 7630 reduces the administration of paracetamol in children with acute tonsillopharyngitis (ATP) or acute bronchitis (AB).
Meta-analysis of randomised, placebo-controlled clinical trials.
We searched clinical trial registries (ISRCTN, ClinicalTrials.gov ) and medical literature (MEDLINE, EMBASE), for randomised, placebo-controlled trials investigating the administration of EPs 7630 to children with ATP or AB and reporting the co-administration of paracetamol. Based on the individual participant data of the eligible trials, study populations were characterized according to sex and age, and meta-analyses were performed for cumulative paracetamol use and ability to attend school at treatment end.
Six trials including a total of 523 children aged 6-10 years (EPs 7630: 265; placebo: 258) and suffering from non-β-hemolytic streptococcal ATP (3 trials) or from AB (3 trials) were identified and eligible. Children received EPs 7630 or placebo for 6 (ATP) or 7 days (AB). Compared to placebo, EPs 7630 reduced the cumulative dose of paracetamol in 5 out of the 6 trials, by an average of 244 mg (Hedges' g; - 0.28; 95% confidence interval: [- 0.53; - 0.02]; p < 0.03). At treatment end, 30.2% (EPs 7630) and 74.4% (placebo) of the children were still unable to attend school (risk ratio: 0.43; 95% confidence interval: [0.29; 0.65]; p < 0.001).
In children aged 6-10 years with AB or ATP, EPs 7630 alleviated the symptom burden and accelerated recovery. Although EPs 7630 has no known antipyretic effect, concomitant use of paracetamol was reduced.
发热是婴儿急性呼吸道疾病中非常常见的适应性免疫反应。扑热息痛（对乙酰氨基酚）等解热/镇痛药被广泛用于改善儿童的舒适度，但可能导致不必要的解热作用，以及罕见但潜在严重的副作用。我们评估 Pelargonium sidoides 提取物 EPs 7630 治疗急性扁桃体咽炎（ATP）或急性支气管炎（AB）儿童是否减少扑热息痛的使用。
随机对照临床试验的荟萃分析。
我们检索了临床试验注册处（ISRCTN、ClinicalTrials.gov）和医学文献（MEDLINE、EMBASE），以寻找调查 EPs 7630 给药治疗 ATP 或 AB 儿童并报告同时使用扑热息痛的随机、安慰剂对照试验。根据合格试验的个体参与者数据，根据性别和年龄对研究人群进行特征描述，并对累积扑热息痛使用和治疗结束时上学能力进行荟萃分析。
共纳入 6 项试验，共 523 名 6-10 岁儿童（EPs 7630：265 名；安慰剂：258 名），患有非乙型溶血性链球菌 ATP（3 项试验）或 AB（3 项试验）。儿童接受 EPs 7630 或安慰剂治疗 6（ATP）或 7 天（AB）。与安慰剂相比，EPs 7630 在 6 项试验中的 5 项中减少了扑热息痛的累积剂量，平均减少 244mg（Hedges' g；-0.28；95%置信区间：[-0.53；-0.02]；p<0.03）。治疗结束时，30.2%（EPs 7630）和 74.4%（安慰剂）的儿童仍无法上学（风险比：0.43；95%置信区间：[0.29；0.65]；p<0.001）。
在 6-10 岁患有 AB 或 ATP 的儿童中，EPs 7630 减轻了症状负担并加速了康复。尽管 EPs 7630 没有已知的解热作用，但同时使用扑热息痛减少了。
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