Kamin Wolfgang, Behre Ulrich, Helm Klaus, Reling Birgit, Funk Petra, Malek Fathi Abdul
Children's Hospital, Evangelic Hospital, Hamm, Germany.
Faculty of Medicine, Pomeranian Medical University, Szczecin, Poland.
Front Pediatr. 2023 Feb 14;11:1107984. doi: 10.3389/fped.2023.1107984. eCollection 2023.
The efficacy and tolerability of DC. root extract EPs 7630 in children with acute bronchitis (AB) have been widely demonstrated. We investigated the safety and tolerability of a syrup formulation and an oral solution in pre-school children.
In an open-label, randomized clinical trial (EudraCT number 2011-002652-14), children aged 1-5 years suffering from AB received EPs 7630 syrup or solution for 7 days. Safety was assessed by frequency, severity, and nature of adverse events (AE), vital signs, and laboratory values. Outcome measures for evaluating the health status were the intensity of coughing, pulmonary rales, and dyspnea, measured by the short version of the Bronchitis Severity Scale (BSS-ped), further symptoms of the respiratory infection, general health status according to the Integrative Medicine Outcomes Scale (IMOS), and satisfaction with treatment according to the Integrative Medicine Patient Satisfaction Scale (IMPSS).
591 children were randomized and treated with syrup ( = 403) or solution ( = 188) for 7 days. In both treatment groups, the number of adverse events was similarly low and revealed no safety concerns. The most frequently observed events were infections (syrup: 7.2%; solution: 7.4%) or gastrointestinal disorders (syrup: 2.7%; solution: 3.2%). After one week's treatment, more than 90% of the children experienced an improvement or remission of the symptoms of the BSS-ped. Further respiratory symptoms decreased similarly in both groups. At Day 7, more than 80% of the whole study population had completely recovered or showed a major improvement as assessed by the investigator and the proxy, respectively. Parents were "very satisfied" or "satisfied" with the treatment in 86.1% of patients in the combined syrup and solution group.
Both pharmaceutical forms, EPs 7630 syrup and oral solution, were shown to be equally safe and well tolerated in pre-school children suffering from AB. Improvement of health status and of complaints were similar in both groups.
紫锥菊根提取物EPs 7630治疗急性支气管炎（AB）患儿的疗效和耐受性已得到广泛证实。我们研究了糖浆制剂和口服液在学龄前儿童中的安全性和耐受性。
在一项开放标签的随机临床试验（欧洲临床试验注册号2011-002652-14）中，1-5岁的AB患儿接受EPs 7630糖浆或口服液治疗7天。通过不良事件（AE）的频率、严重程度和性质、生命体征及实验室检查值评估安全性。评估健康状况的指标包括咳嗽强度、肺部啰音和呼吸困难，采用支气管炎严重程度量表简版（BSS-ped）进行测量，还包括呼吸道感染的其他症状、根据综合医学结局量表（IMOS）评估的总体健康状况以及根据综合医学患者满意度量表（IMPSS）评估的治疗满意度。
591名儿童被随机分组，分别接受糖浆（n = 403）或口服液（n = 188）治疗7天。两个治疗组的不良事件数量均同样较少，未显示出安全问题。最常观察到的事件为感染（糖浆组：7.2%；口服液组：7.4%）或胃肠道疾病（糖浆组：2.7%；口服液组：3.2%）。经过一周治疗后，超过90%的儿童BSS-ped症状得到改善或缓解。两组的其他呼吸道症状也有类似程度的减轻。在第7天，分别由研究者和监护人评估，超过80%的全部研究对象已完全康复或有显著改善。糖浆和口服液联合治疗组中86.1%的患者家长对治疗“非常满意”或“满意”。
对于患有AB的学龄前儿童，EPs 7630糖浆和口服液这两种剂型均显示出同样的安全性和良好耐受性。两组的健康状况改善及症状缓解情况相似。
