1. Efficacy and safety of Re-Du-Ning injection in the treatment of seasonal influenza: results from a randomized, double-blinded, multicenter, oseltamivir-controlled trial
- Author
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Feng-Jie Yan, Yu Liu, Wei Xiao, Hai-Ming Chen, Wei Mu, Yu-Ping Tan, Bao-Lin Wei, Yuhong Huang, Xu-Dong Xiong, Ye-Qing Zhang, Lan Wang, Xiao-Min Huang, and Xin-Qiao Liu
- Subjects
0301 basic medicine ,Oseltamivir ,medicine.medical_specialty ,oseltamivir ,030106 microbiology ,Traditional Chinese medicine ,law.invention ,03 medical and health sciences ,chemistry.chemical_compound ,0302 clinical medicine ,Randomized controlled trial ,Beijing ,law ,Internal medicine ,Sore throat ,Medicine ,030212 general & internal medicine ,Re-Du-Ning injection ,China ,Adverse effect ,Traditional medicine ,business.industry ,virus diseases ,clinical trial ,Clinical trial ,Oncology ,chemistry ,seasonal influenza ,medicine.symptom ,business ,Research Paper - Abstract
// 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 and Yu-Hong Huang 2 1 Shenzhen Traditional Chinese Medicine Hospital Affiliated to Guangzhou University of Traditional Chinese Medicine, Shenzhen 518033, China 2 The Second Affiliated Hospital of Tianjin University of Traditional Chinese Medicine, Tianjin 300150, China 3 State Key Laboratory of New-tech for Chinese Medicine Pharmaceutical Process, Jiangsu 222001, China 4 Dongzhimen Hospital Affiliated to Beijing University of Traditional Chinese Medicine, Beijing 100007, China 5 The First Affiliated Hospital of Tianjin University of Traditional Chinese Medicine, Tianjin 300193, China 6 Shanghai ShuGuang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine, Shanghai 201203, China 7 Zhejiang Hospital of Traditional Chinese Medicine, Hangzhou 310006, China 8 Jiangsu Hospital of Integrated Traditional Chinese and Western Medicine, Nanjing 210028, China 9 Affiliated Hospital of Liaoning University of Traditional Chinese Medicine, Shenyang 110032, China 10 Affiliated Hospital of Changchun University of Traditional Chinese Medicine, Changchun 130021, China 11 Ruikang Hospital Affiliated to Guangxi University of Chinese Medicine, Nanning 530011, China Correspondence to: Yu-Hong Huang, email: hyh101@126.com 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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- 2017