Riley David S, Lizogub Viktor G, Heger Marianne, Funk Petra, Mueller Heiko, Lehmacher Walter
University of New Mexico Medical School, Santa Fe, New Mexico, USA.
Faculty Therapy No. 2, National Medical University, Kiev, Ukraine.
Integr Med (Encinitas). 2019 Feb;18(1):42-51.
EPs 7630 was shown to be effective and safe in the treatment of acute respiratory tract infections such as acute bronchitis, acute rhinosinusitis, and acute tonsillopharyngitis. A clinical trial was conducted to investigate its efficacy and safety in the common cold.
In this multicenter, randomized, double-blind phase 3 clinical trial, 105 adults suffering from common cold symptoms were randomized to a thrice-daily administration of either 1 film-coated tablet containing 40 mg EPs 7630 or matched placebo for a treatment period of 10 days. The primary outcome measure was the sum of differences in the cold intensity score (CIS) from day 1 to day 5, defined as the Sum of the Symptom Intensity Differences (SSID), indicating the degree of symptom improvement in the course of 5 days of treatment. Among the secondary outcomes were clinical cure defined as (a) complete resolution of all cold symptoms (CIS = 0 points) or (b) complete resolution of all or all but one cold symptom, treatment outcome, satisfaction with treatment, and safety parameters.
On day 5, the mean (±SD) SSID was significantly higher in the EPs 7630 group compared with the placebo group (12.5 ± 4.4 points versus 8.8 ± 6.8 points). Moreover, 55% of patients in the EPs 7630 group rated the treatment outcome as at least "major improvement" compared with 15% of patients in the placebo group. On day 10, 45% of patients of the EPs 7630 group and 12% of patients of the placebo group had reached 0 points on the CIS (=clinical cure, definition a), whereas all or all but one symptom (clinical cure, definition b) had completely resolved in 74% (EPs 7630) and 25% of patients (placebo), respectively. Satisfaction with treatment was higher in the EPs 7630 than in the placebo group (75% vs 37%) ( values ≤ .0002). During the clinical trial, adverse events occurred in 5 patients (9.4%) in the EPs 7630 and in 7 (13.5%) in the placebo group. All adverse events were of mild intensity, with the exception of 3 events in the placebo group, which were classified as moderate.
Treatment with EPs 7630 was shown to be superior to placebo in patients with the common cold indicating faster reduction of symptom intensity and distinctly more pronounced effects achieved by administration of the investigational drug in patients suffering from the common cold. Results extend previous findings on efficacy, safety, and tolerability of this active substance.
EP7630已被证明在治疗急性呼吸道感染（如急性支气管炎、急性鼻-鼻窦炎和急性扁桃体咽炎）方面有效且安全。开展了一项临床试验以研究其在普通感冒治疗中的疗效和安全性。
在这项多中心、随机、双盲3期临床试验中，105名有普通感冒症状的成年人被随机分为每日三次服用1片含40mg EP7630的薄膜包衣片或匹配的安慰剂，治疗期为10天。主要结局指标是第1天至第5天感冒严重程度评分（CIS）的差异总和，定义为症状严重程度差异总和（SSID），表明治疗5天期间症状改善的程度。次要结局包括定义为（a）所有感冒症状完全缓解（CIS = 0分）或（b）所有或除一种外的所有感冒症状完全缓解的临床治愈、治疗结局、对治疗的满意度以及安全性参数。
在第5天，EP7630组的平均（±标准差）SSID显著高于安慰剂组（12.5±4.4分对8.8±6.8分）。此外，EP7630组55%的患者将治疗结局评为至少“显著改善”，而安慰剂组为15%。在第10天，EP7630组45%的患者和安慰剂组12%的患者CIS达到0分（=临床治愈，定义a），而所有或除一种外的所有症状（临床治愈，定义b）在EP7630组和安慰剂组中分别有74%和25%的患者完全缓解。EP7630组对治疗的满意度高于安慰剂组（75%对37%）（P值≤0.0002）。在临床试验期间，EP7630组有5名患者（9.4%）发生不良事件，安慰剂组有7名患者（13.5%）发生不良事件。所有不良事件均为轻度，安慰剂组有3起事件被分类为中度除外。
在普通感冒患者中，EP7630治疗优于安慰剂，表明症状严重程度减轻更快，且该研究药物在普通感冒患者中产生的效果明显更显著。结果扩展了关于这种活性物质疗效、安全性和耐受性的先前发现。
