Oncotarget

Research Papers:

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

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Oncotarget. 2017; 8:55176-55186. https://doi.org/10.18632/oncotarget.19220

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Abstract

Yu Liu1,2, Wei Mu2, Wei Xiao3, Bao-Lin Wei2, Lan Wang4, Xin-Qiao Liu5, Xu-Dong Xiong6, Xiao-Min Huang7, Ye-Qing Zhang8, Hai-Ming Chen9, Feng-Jie Yan10, Yu-Ping Tan11 and Yu-Hong Huang2

1Shenzhen Traditional Chinese Medicine Hospital Affiliated to Guangzhou University of Traditional Chinese Medicine, Shenzhen 518033, China

2The Second Affiliated Hospital of Tianjin University of Traditional Chinese Medicine, Tianjin 300150, China

3State Key Laboratory of New-tech for Chinese Medicine Pharmaceutical Process, Jiangsu 222001, China

4Dongzhimen Hospital Affiliated to Beijing University of Traditional Chinese Medicine, Beijing 100007, China

5The First Affiliated Hospital of Tianjin University of Traditional Chinese Medicine, Tianjin 300193, China

6Shanghai ShuGuang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine, Shanghai 201203, China

7Zhejiang Hospital of Traditional Chinese Medicine, Hangzhou 310006, China

8Jiangsu Hospital of Integrated Traditional Chinese and Western Medicine, Nanjing 210028, China

9Affiliated Hospital of Liaoning University of Traditional Chinese Medicine, Shenyang 110032, China

10Affiliated Hospital of Changchun University of Traditional Chinese Medicine, Changchun 130021, China

11Ruikang Hospital Affiliated to Guangxi University of Chinese Medicine, Nanning 530011, China

Correspondence to:

Yu-Hong Huang, email: [email protected]

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

Received: March 29, 2017     Accepted: June 24, 2017     Published: July 13, 2017

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.


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