Abstract：
OBJECTIVE: The aim of the study was to evaluate the clinical and interferon-modulating efficacy of a combination of rectal and topical dosage forms of IFN-α2b with antioxidants in the treatment of acute respiratory infections (ARIs) in comparison with other variants of antiviral therapy.
METHODS: A total of 90 servicemen aged 19.2±0.9 years with uncomplicated forms of ARI were hospitalized not later than 48 hours after the onset of the disease. Patients were randomized into 3 groups of 30 people each. In the first group, patients received rectal suppositories containing IFN-α2b (1 million IU) and antioxidants (alpha-tocopherol acetate and ascorbic acid) twice a day for 5 days. In the second group, patients received intranasally a gel formulation containing IFN-α2b (36 000 IU/1 g) and antioxidants 3 times a day in addition to the above suppositories. In the third group, patients were prescribed umifenovir (reference drug) at dose of 200 mg 4 times a day for 5 days. The dynamics of regression of clinical manifestations of ARI in different groups, changes in concentrations of IFN-α and IFN-γ in blood plasma, as well as spontaneous and induced production of these cytokines by blood cells ex vivo were evaluated. After that, the patients were observed for another 3 months to register repeated cases of hospitalization for ARI.
RESULTS: Marked tendency to accelerate the regression of symptoms of intoxication and fever was observed when intranasal dosage form of IFN-α2b was administered to patients receiving the rectal form of this cytokine. The combination of rectal and topical dosage forms of IFN-α2b with antioxidants was more effective than monotherapy with the rectal suppositories in preventing repeated hospitalization for ARI. The above combination caused the most complete correction of induced production of IFN-α by blood cells ex vivo at its initial deviation from the norm.
CONCLUSIONS: The obtained data indicate the expediency of using the combination of rectal and topical dosage forms of IFN-α2b with antioxidants for treatment of ARI.
METHODS: A total of 90 servicemen aged 19.2±0.9 years with uncomplicated forms of ARI were hospitalized not later than 48 hours after the onset of the disease. Patients were randomized into 3 groups of 30 people each. In the first group, patients received rectal suppositories containing IFN-α2b (1 million IU) and antioxidants (alpha-tocopherol acetate and ascorbic acid) twice a day for 5 days. In the second group, patients received intranasally a gel formulation containing IFN-α2b (36 000 IU/1 g) and antioxidants 3 times a day in addition to the above suppositories. In the third group, patients were prescribed umifenovir (reference drug) at dose of 200 mg 4 times a day for 5 days. The dynamics of regression of clinical manifestations of ARI in different groups, changes in concentrations of IFN-α and IFN-γ in blood plasma, as well as spontaneous and induced production of these cytokines by blood cells ex vivo were evaluated. After that, the patients were observed for another 3 months to register repeated cases of hospitalization for ARI.
RESULTS: Marked tendency to accelerate the regression of symptoms of intoxication and fever was observed when intranasal dosage form of IFN-α2b was administered to patients receiving the rectal form of this cytokine. The combination of rectal and topical dosage forms of IFN-α2b with antioxidants was more effective than monotherapy with the rectal suppositories in preventing repeated hospitalization for ARI. The above combination caused the most complete correction of induced production of IFN-α by blood cells ex vivo at its initial deviation from the norm.
CONCLUSIONS: The obtained data indicate the expediency of using the combination of rectal and topical dosage forms of IFN-α2b with antioxidants for treatment of ARI.
摘要：
目的：本研究的目的是评估IFN-α2b直肠和局部剂型与抗氧化剂联合治疗急性呼吸道感染（ARIs）的临床和干扰素调节功效。
方法：在发病后48小时内，共90名年龄为19.2±0.9岁的无复杂ARI军人住院。患者被随机分为3组，每组30人。在第一组中,患者接受含有IFN-α2b(1百万IU)和抗氧化剂(α-生育酚乙酸酯和抗坏血酸)的直肠栓剂,每日2次,共5天.在第二组中,除上述栓剂外,患者每天3次鼻内接受含有IFN-α2b(36000IU/1g)和抗氧化剂的凝胶制剂.在第三组中,患者接受200mg剂量的抗美非诺韦(参比药物),每日4次,共5天.不同组ARI临床表现消退的动态变化,血浆中IFN-α和IFN-γ浓度的变化，以及通过血细胞离体评价这些细胞因子的自发和诱导产生。之后,对患者再观察3个月,登记ARI住院的重复病例.
结果:当鼻内剂型的IFN-α2b给予接受该细胞因子的直肠形式的患者时,观察到明显的加速中毒和发热症状消退的趋势。IFN-α2b的直肠和局部剂型与抗氧化剂的组合在预防ARI重复住院方面比直肠栓剂的单一疗法更有效。上述组合在其最初偏离标准时引起对离体血细胞诱导的IFN-α产生的最完全校正。
结论：获得的数据表明使用IFN-α2b的直肠和局部剂型与抗氧化剂的组合治疗ARI的权宜之计。
方法：在发病后48小时内，共90名年龄为19.2±0.9岁的无复杂ARI军人住院。患者被随机分为3组，每组30人。在第一组中,患者接受含有IFN-α2b(1百万IU)和抗氧化剂(α-生育酚乙酸酯和抗坏血酸)的直肠栓剂,每日2次,共5天.在第二组中,除上述栓剂外,患者每天3次鼻内接受含有IFN-α2b(36000IU/1g)和抗氧化剂的凝胶制剂.在第三组中,患者接受200mg剂量的抗美非诺韦(参比药物),每日4次,共5天.不同组ARI临床表现消退的动态变化,血浆中IFN-α和IFN-γ浓度的变化，以及通过血细胞离体评价这些细胞因子的自发和诱导产生。之后,对患者再观察3个月,登记ARI住院的重复病例.
结果:当鼻内剂型的IFN-α2b给予接受该细胞因子的直肠形式的患者时,观察到明显的加速中毒和发热症状消退的趋势。IFN-α2b的直肠和局部剂型与抗氧化剂的组合在预防ARI重复住院方面比直肠栓剂的单一疗法更有效。上述组合在其最初偏离标准时引起对离体血细胞诱导的IFN-α产生的最完全校正。
结论：获得的数据表明使用IFN-α2b的直肠和局部剂型与抗氧化剂的组合治疗ARI的权宜之计。
