Efficacy and safety of Re-Du-Ning injection in the treatment of seasonal influenza: results from a randomized, double-blinded, multicenter, oseltamivir-controlled trial.

Yu Liu,Wei Xiao,Bao-Lin Wei,Yu-Hong Huang,Xiao-Min Huang,Xu-Dong Xiong,Yu-Ping Tan,Ye-Qing Zhang,Feng-Jie Yan,Xin-Qiao Liu,Wei Mu,Hai-Ming Chen,Lan Wang

doi:10.18632/oncotarget.19220

Abstract

ObjectiveTo assess the efficacy and safety of RDNI in the treatment of seasonal influenza.Results1575 participants were screened and 229 completed the study and had a RT-PCR laboratory confirmation of influenza virus infection. Fever alleviation time was 2 and 6 hours, and fever clearance time was 27 and 47 in RDNI and oseltamivir, with significant difference between two groups. Total scores of influenza symptoms descended more in RDNI than oseltamivir on day 2 and day 3. Single symptom such as fever, aversion to cold, sore throat and nasal obstruction score descended more in RDNI than oseltamivir on different days. 20 subjects used aspirin during the trial, and there was no significant difference between two groups.Materials and MethodsWe conducted a randomized, double-blind, double-dummy, oseltamivir controlled clinical trial. Patients with a positive influenza rapid test diagnosis were enrolled and randomized to receive RDNI or oseltamivir. Primary outcome was the median fever alleviation and clearance time. Secondary outcomes were total 8 influenza symptom scores, the single influenza symptom score, and the frequency of aspirin usage.ConclusionsThe effect of RDNI was not worse than oseltamivir on the alleviation of influenza symptoms. RDNI was well tolerated, with no serious adverse events noted during the study period.

Highlights

The influenza epidemicAccording to WHO reports, Influenza is an acute respiratory infections disease which can result in annual infection of 5–15% of the population, leading to 250,000 and 500,000 deaths [1]
Total scores of influenza symptoms descended more in Re-DuNing injection (RDNI) than oseltamivir on day 2 and day 3
Single symptom such as fever, aversion to cold, sore throat and nasal obstruction score descended more in RDNI than oseltamivir on different days. 20 subjects used aspirin during the trial, and there was no significant difference between two groups

Summary

Introduction

According to WHO reports, Influenza is an acute respiratory infections disease which can result in annual infection of 5–15% of the population, leading to 250,000 and 500,000 deaths [1]. Numerous outbreaks of influenza/ Influenza-like (ILI) illness are reported every year throughout China. From April 1, 2005 to November 30, 2013, there were 2.768 influenza/ILI outbreaks recorded in the Emergency Public Reporting System. Influenza is caused by type A, including H1N1, H3N2, H5N1, H7N9, and type B influenza viruses. Such respiratory disease is characterized by sudden onset of high fever, aversion of cold, headache, myalgia, sore throat, fatigue and cough [2]

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Conclusion