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A randomized, open-label, multicentre, comparative study of therapeutic efficacy, preventive potential and tolerability of BNO 1030 extract, containing Althea root, Chamomile flowers, horsetail herb, walnut leaves, yarrow herb, oak bark, dandelion herb in the treatment of acute non-bacterial tonsillitis in children aged 6 to 18 years
Clinical Phytoscience Pub Date : 2021-01-28 , DOI: 10.1186/s40816-020-00240-6
Vasyl Popovych , Ivana Koshel , Oleksandr Malofiichuk , Lubov Pyletska , Oleksandr Semenyuk , Oksana Martynnyk , Ruslana Orlovska

Acute tonsillitis tends to recur. In cases where patients do not meet the Paradise criteria, the possibilities of non-surgical treatment are more often considered. The objective of this study was to evaluate the therapeutic efficacy during the long-term follow-up and the effect on the recurrence of the phytoneering extract BNO 1030 (Imupret®) in patients with acute non-bacterial tonsillitis. In this Randomized, Open-Label, Multicentre, Comparative Study, 238 outpatients aged 6–18 years were randomized to receive either BNO 1030 (Imupret®) for 4 weeks in addition to standard symptomatic treatment, or to receive standard treatment. Evaluation criteria: reduction in the symptom severity less than 1 point, the number of tonsillitis recurrences at each control point after 3, 6 and 12 months during the one-year follow-up. A significant reduction in the severity of local symptoms and the general condition at each control point within the year of follow-up and a significant decrease (by 66.56%) in the recurrence rate of tonsillitis were noted. The anti-recurrent action was manifested during within the year of follow-up. All patients tolerated phytotherapy well; no adverse reactions were noted. BNO 1030 (Imupret®) is a safe and effective medicinal product for acute non-bacterial tonsillitis in children aged 6–18 years. In addition to the main symptomatic treatment, it leads to a significant reduction in the clinical manifestations and the number of recurrences of tonsillitis within the year of follow-up. This trial was registered in German Clinical Trials Register retrospectively on June 27, 2018. Trial Acronym: ATi-1 DRKS-ID: DRKS00015020

中文翻译:

随机,开放标签,多中心,BNO 1030提取物的治疗功效,预防潜力和耐受性的比较研究,其中含有木槿根,洋甘菊花,马尾草,核桃叶,草,橡树皮,蒲公英草,用于治疗急性6至18岁儿童的非细菌性扁桃体炎

急性扁桃体炎倾向于复发。如果患者不符合“天堂”标准,则通常会考虑采用非手术治疗的可能性。这项研究的目的是评估长期随访期间的治疗效果以及对急性非细菌性扁桃体炎患者中的植物提取物BNO 1030(Imupret®)复发的影响。在这项随机,开放标签,多中心比较研究中,将238名6-18岁的门诊患者随机接受BNO 1030(Imupret®)治疗4周,同时接受标准对症治疗或接受标准治疗。评估标准:在一年的随访中,症状严重程度的降低少于1分,在3、6和12个月后每个控制点的扁桃体炎复发次数。在随访的一年内,每个控制点的局部症状和一般状况的严重性显着降低,扁桃体炎的复发率显着降低(66.56%)。在随访的一年之内表现出了抗复发作用。所有患者对植物疗法的耐受性良好;没有发现不良反应。BNO 1030(Imupret®)是用于6至18岁儿童的急性非细菌性扁桃体炎的安全有效药物。除了主要的对症治疗外,它还导致随访期间一年内扁桃体炎的临床表现和复发次数大大减少。该试验已于2018年6月27日在德国临床试验注册中心进行回顾性注册。试验首字母缩写词:ATi-1 DRKS-ID:DRKS00015020 扁桃体炎的复发率达到56%)。在随访的一年之内表现出了抗复发作用。所有患者对植物疗法的耐受性良好;没有发现不良反应。BNO 1030(Imupret®)是用于6至18岁儿童的急性非细菌性扁桃体炎的安全有效药物。除了主要的对症治疗外,它还导致随访期间一年内扁桃体炎的临床表现和复发次数大大减少。该试验已于2018年6月27日在德国临床试验注册中心进行回顾性注册。试验首字母缩写词:ATi-1 DRKS-ID:DRKS00015020 扁桃体炎的复发率达到56%)。在随访的一年之内表现出了抗复发作用。所有患者对植物疗法的耐受性良好;没有发现不良反应。BNO 1030(Imupret®)是用于6至18岁儿童的急性非细菌性扁桃体炎的安全有效药物。除了主要的对症治疗外,它还导致随访期间一年内扁桃体炎的临床表现和复发次数大大减少。该试验已于2018年6月27日在德国临床试验注册中心进行回顾性注册。试验首字母缩写词:ATi-1 DRKS-ID:DRKS00015020 BNO 1030(Imupret®)是用于6至18岁儿童的急性非细菌性扁桃体炎的安全有效药物。除了主要的对症治疗外,它还导致随访期间一年内扁桃体炎的临床表现和复发次数大大减少。该试验已于2018年6月27日在德国临床试验注册中心进行回顾性注册。试验首字母缩写词:ATi-1 DRKS-ID:DRKS00015020 BNO 1030(Imupret®)是用于6至18岁儿童的急性非细菌性扁桃体炎的安全有效药物。除了主要的对症治疗外,它还导致随访期间一年内扁桃体炎的临床表现和复发次数大大减少。该试验已于2018年6月27日在德国临床试验注册中心进行回顾性注册。试验首字母缩写词:ATi-1 DRKS-ID:DRKS00015020
更新日期:2021-01-28
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