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清热解毒注射液治疗流感的有效性和安全性:一项随机、双盲、安慰剂对照试验

Efficacy and safety of clearing heat and detoxifying injection in the treatment of influenza: a randomized, double-blinded, placebo-controlled trial.

作者信息

Liu Yu, Huang Yuhong, Wei Baolin, Liu Xinqiao, Zhang Yaqing, Huang Xiaomin, Tan Yuping, Sun Zengtao

机构信息

The Second Affiliated Hospital of Tianjin University of Traditional Chinese Medicine, No. 816 Zhenli Road, Hebei District, Tianjin 300150, China.

The First Affiliated Hospital of Tianjin University of Traditional Chinese Medicine, No. 314 Anshanxi Road, Naikai District, Tianjin 300193, China.

出版信息

Evid Based Complement Alternat Med. 2014;2014:151235. doi: 10.1155/2014/151235. Epub 2014 Nov 25.

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.

摘要

目的。评估CHDI治疗流感感染的疗效和安全性。方法。进行了一项随机双盲、双模拟试验。甲型流感快速检测诊断呈阳性的流感患者被随机分配接受CHDI或奥司他韦治疗。主要结局通过发热缓解时间中位数和清除时间进行评估,次要结局为流感症状总分。结果。共筛选出139名参与者,其中34人经RT-PCR实验室确诊为流感病毒感染。CHDI组和奥司他韦组的发热缓解时间分别为2.5小时和5小时,发热清除时间分别为32.5小时和49小时。两组发热缓解和清除时间的风险比无显著差异。两组治疗后流感症状总分均显著下降,且在第2天CHDI组下降幅度大于奥司他韦组。与总症状严重程度评分相似,第2天CHDI组发热严重程度评分下降幅度比奥司他韦组更显著,其他症状方面无差异。结论。CHDI在缩短流感病程方面与奥司他韦效果相似。CHDI耐受性良好,研究期间未发现严重不良事件。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/be92/4260441/22a97be0369f/ECAM2014-151235.001.jpg

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