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
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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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