Background: Enisamium iodide (EI) is a Russian drug whose molecule was developed in the Institute of Pharmacology and Toxicology of Ukraine as an anti-inflammatory and antipyretic agent. Later, other properties of EI were found: inhibition of the influenza virus hemagglutinin, increasing the production of interferon-γ, level of Th1, blood antioxidant activity, inhibition TNF-α and other pro-inflammatory cytokines, activation of macrophages and lysozyme activity. The aim of study was to evaluate the efficacy of antiviral therapy with EI in out-patient patients with influenza and influenza-like illnesses (ILI) without risk factors for severe course of disease. Methods and materials: 124 patients aged 18–55 years with influenza and ILI within 6–48 h of symptoms onset were randomized into 2 groups. 1st group (n = 66) was treated with EI 500 mg tid 5 days, 2nd group (n = 63) received placebo according to the same scheme. In the 1nd group the proportion between influenza and other respiratory viruses was 32.2%: 67.8%, in the 2nd group 31.7%: 68.3%, accordingly. Duration of disease and main clinical symptoms, frequency of complications and speed of the virus elimination from the nasopharynx were estimated. Results: The number of cases with complete recovery within 96 h was 56 (84.8% ± 4.2%) in 1st group and 44 (69.8% ± 5.8%) in 2nd group (p = 0.047). The duration of fever was 68.0 ± 2.8 h in 1th group and 77.1 ± 2.9 h in 2nd group (p = 0.044), muscle pain – 52.3 ± 2.3 and 60.6 ± 2.6 h (p = 0.041), headache-52.1 ± 2.6 and 65.1 ± 2.5 h (p = 0.032), weakness – 75.5 ± 2.3 and 90.4 ± 2.5 h (p = 0.001), accordingly. On the 4th day of treatment the viruses were isolated in 37.8 ± 5.9% of cases in the 1st group and 57.1 ± 6.2% in 2nd group; p = 0.048. Bacterial complications were observed in 3.0 ± 2.1% and 12.6 ± 4.2% accordingly, p = 0.048. Conclusion: The study is demonstrated the effectiveness of EI in the treatment of influenza and ILI in adult outpatient patients. The antiviral and anti-inflammatory effects of the drug, which was administered within 48 h of the symptoms onset were demonstrated by a more rapid reduction of clinical symptoms, frequency of bacterial complications and reduction in the time of virus elimination. Continuation of EI clinical trials are necessary for more full evaluation of its effectiveness.
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