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一项评估 5 种植物提取物 BNO 1012 在儿童急性病毒性和病毒性后鼻-鼻窦炎延迟抗生素处方方法中疗效、安全性和耐受性的开放性、多中心、随机对照研究。

An open-label, multicentre, randomized comparative study of efficacy, safety and tolerability of the 5 plant - extract BNO 1012 in the Delayed Antibiotic Prescription Method in children, aged 6 to 11 years with acute viral and post-viral rhinosinusitis.

机构信息

ENT - Department of Ivano-Frankivsk National Medical University, Halytska Street, 2, Ivano-Frankivsk, Ivano-Frankivsk Region 76000, Ukraine.

Department of Children and Adolescent Diseases of the National Academy of Postgraduate Education, 9, Dorogozhytska Street, Kyiv 04112, Ukraine.

出版信息

Am J Otolaryngol. 2020 Sep-Oct;41(5):102564. doi: 10.1016/j.amjoto.2020.102564. Epub 2020 Jun 1.

DOI:10.1016/j.amjoto.2020.102564
PMID:32593046
Abstract

UNLABELLED

Acute rhinosinusitis (ARS) can be characterized as bacterial (ABRS) and require antibiotic therapy only in 0.5-5% of cases. In most cases, the disease is in a viral and post-viral form, which requires pathogenetic and symptomatic treatment. The study objective was to determine the efficacy of BNO 1012 extract in the technology of delayed antibiotic prescribing in children with acute rhinosinusitis.

METHODS

292 children aged 6 to 11 years with ARS were randomized in the multicenter, comparative study. They received an extract of five medicinal plants in addition to standard symptomatic therapy or standard therapy only. EVALUATION CRITERIA: reduction of the sinusitis severity according to a 4-point medical assessment scale (nasal congestion, severity of anterior and posterior rhinorrhea) at each visit, dynamics of self-scoring of rhinorrhea and headache (according to a 10-point visual analogue scale), "therapeutic benefit" in days, frequency of antibiotic prescriptions due to the use of an extract of five plants.

RESULTS

The use of the 5-plant extract BNO 1012 in addition to the standard symptomatic treatment of acute rhinosinusitis provides a clinically significant, adequate reduction in the severity of rhinorrhea, nasal congestion and post-nasal drip, assessed by a physician at V2 (p < 0.005). Significant differences are noted in the patient's self-scoring of rhinorrhea on the second or third day in viral RS, and from the fourth to the eighth day in post-viral RS. Symptoms of similar intensity in control group were observed at V3. Thus, in the first week of treatment, the treatment group compared to the control one showed a "therapeutic benefit" of three days. The use of BNO 1012 in patients with acute rhinosinusitis can 1.81-fold reduce the prescription of antibacterial drugs.

CONCLUSION

The combination of five medicinal plants is effective for the treatment of acute rhinosinusitis in children aged 6 to 11 years. Its use provides a significant "therapeutic benefit" when administered in addition to standard symptomatic therapy, reducing the need for antibiotic use.

摘要

目的

确定 BN012 提取物在延迟开具抗生素处方治疗儿童急性鼻-鼻窦炎技术中的疗效。

方法

在这项多中心、对照研究中,将 292 名 6 至 11 岁的急性鼻-鼻窦炎患儿随机分组。除标准对症治疗外,他们还接受了五种药用植物提取物的治疗或仅接受标准治疗。

评估标准

每次就诊时根据四点医学评估量表(鼻塞、前鼻漏和后鼻漏严重程度)评估鼻窦炎严重程度的降低,根据 10 分视觉模拟量表评估鼻漏和头痛的自我评分变化,以天数表示“治疗效益”,由于使用五植物提取物而开具抗生素的频率。

结果

除标准对症治疗急性鼻-鼻窦炎外,使用 BN012 的五植物提取物可显著、充分地降低医师评估的鼻漏、鼻塞和后鼻漏严重程度(V2 时,p<0.005)。在病毒性 RS 中,患者在第 2 或第 3 天自我评估鼻漏,在病毒性 RS 中从第 4 天到第 8 天,差异具有统计学意义。在对照组中,第 3 天观察到相似强度的症状。因此,在治疗的第一周,治疗组与对照组相比,“治疗效益”为三天。在急性鼻-鼻窦炎患者中使用 BN012 可使抗菌药物的处方减少 1.81 倍。

结论

五种药用植物的组合对 6 至 11 岁儿童急性鼻-鼻窦炎的治疗有效。与标准对症治疗联合使用时,可显著提供“治疗效益”,减少抗生素的使用。

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