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. 2017 Jul 13;8(33):55176-55186.
doi: 10.18632/oncotarget.19220. eCollection 2017 Aug 15.

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  1   2 , Wei Mu  2 , Wei Xiao  3 , Bao-Lin Wei  2 , Lan Wang  4 , Xin-Qiao Liu  5 , Xu-Dong Xiong  6 , Xiao-Min Huang  7 , Ye-Qing Zhang  8 , Hai-Ming Chen  9 , Feng-Jie Yan  10 , Yu-Ping Tan  11 , Yu-Hong Huang  2
Affiliations

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 et al. Oncotarget. .

Abstract

Objective: To assess the efficacy and safety of RDNI in the treatment of seasonal influenza.

Results: 1575 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 methods: We 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.

Conclusions: The 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.

Keywords: Re-Du-Ning injection; clinical trial; oseltamivir; seasonal influenza.

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Conflict of interest statement

CONFLICTS OF INTEREST This trial was approved by CFDA and it is under the supervision of CFDA. The aim of the trial was to expand clinical indication of drug already on the market. Everyone has no financial and personal relationships with other people or organizations that can inappropriately influence our work.

Figures

Figure 1
Figure 1. Liquid quantitative fingerprint of Re-Du-Ning injection
Figure 2
Figure 2. Participant flowchart
Figure 3
Figure 3. Decline of single symptom severity score
T, treatment group (RDNI); C, control group (oseltamivir); #between two groups, comparing with control group, fever score and aversion to cold score of RDNI descended significantly on day 2 and day 3 (P < 0.01); sore throat score of RDNI descended significantly on day 3 and day 4 (P < 0.05); nasal obstruction score of RDNI descended significantly on day 2 and day 4 (P < 0.05). Within the group itself, comparing with prior treatment score, post treatment score descended significantly on day 2, day 3, day 4 and day 6 (P < 0.0001).
Figure 4
Figure 4. Participants with a rapid diagnosis of influenza will be recruited and randomized into two different treatment groups
After 5 days of treatment and follow-up, efficacy and safety of the treatment were evaluated.
See this image and copyright information in PMC

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