Abstract

Objective. To evaluate the efficacy and safety of CHDI in the treatment of influenza infection. Method. A randomized double-blind, double dummy trial was conducted. Influenza patients with a positive influenza A rapid test diagnosis were randomized to receive CHDI or oseltamivir. Primary outcome was assessed by the median fever alleviation time and clearance time, and secondary outcome was total scores of influenza symptoms. Results. One hundred thirty-nine participants were screened and 34 had a RT-PCR laboratory confirmation of influenza virus infection. Fever alleviation time was 2.5 and 5 hours in CHDI and oseltamivir, respectively, and fever clearance time was 32.5 and 49 hours. The HR of fever alleviation and clearance time shows no significant difference between two groups. Total scores of influenza symptoms descended significantly in both groups after treatment and descended more in CHDI than oseltamivir on day 2. Similar to total symptoms severity score, fever severity score descend more significantly in CHDI than oseltamivir on day 2, and there were no differences on other symptoms. Conclusions. CHDI have a similar effect to oseltamivir in reducing the duration of influenza illness. CHDI was well tolerated, with no serious adverse events noted during the study period.

Highlights

  • The influenza virus is an orthomyxovirus and causes an acute respiratory tract disease

  • Traditional Chinese medicine injection is a kind of new TCM preparations, which was mainly used for treatment of acute and severe disease

  • A research pharmacist at Nanjing Medical University received the study medication from the producer of CHDI, Jiangsu Kangyuan pharmaceutical co., LTD., prepared the study medication according to the randomization schedule and shipped study medication to the clinical site, which distributed the numbered container of study medication to research nurses sequentially, when eligible participants were enrolled

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Summary

Objective

To evaluate the efficacy and safety of CHDI in the treatment of influenza infection. Influenza patients with a positive influenza A rapid test diagnosis were randomized to receive CHDI or oseltamivir. Primary outcome was assessed by the median fever alleviation time and clearance time, and secondary outcome was total scores of influenza symptoms. Fever alleviation time was 2.5 and 5 hours in CHDI and oseltamivir, respectively, and fever clearance time was 32.5 and 49 hours. The HR of fever alleviation and clearance time shows no significant difference between two groups. Total scores of influenza symptoms descended significantly in both groups after treatment and descended more in CHDI than oseltamivir on day 2. Similar to total symptoms severity score, fever severity score descend more significantly in CHDI than oseltamivir on day 2, and there were no differences on other symptoms. CHDI was well tolerated, with no serious adverse events noted during the study period

Introduction
Method
Results
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