Natural herbal medicine Lianhuaqingwen capsule anti-influenza A (H1N1) trial: a randomized, double blind, positive controlled clinical trial

被引:83
作者
Duan Zhong-ping [2 ]
Jia Zhen-hua [1 ]
Zhang Jian [1 ]
Liu Shuang [2 ]
Chen Yu [2 ]
Liang Lian-chun [2 ]
Zhang Chang-qing [3 ]
Zhang Zong [4 ]
Sun Yan [5 ]
Zhang Shu-qin [6 ]
Wang Yong-yan [7 ]
Wu Yi-ling [1 ]
机构
[1] Yiling Pharmaceut Res Acad Hebei Prov, Key Res Ctr Collateral Dis State Adm Tradit Chine, Shijiazhuang 050035, Hebei, Peoples R China
[2] Capital Med Univ, Beijing You An Hosp, Beijing 100069, Peoples R China
[3] Kaifeng Infect Dis Hosp, Kaifeng 475001, Henan, Peoples R China
[4] Jinan Infect Dis Hosp, Jinan 250021, Shandong, Peoples R China
[5] Henan Prov Infect Dis Hosp, Zhengzhou 450005, Henan, Peoples R China
[6] Jilin Prov Hepatopathy Hosp, Changchun 130061, Jilin, Peoples R China
[7] China Acad Chinese Med Sci, Beijing 100700, Peoples R China
关键词
influenza A (H1N1); Lianhuaqingwen capsule; clinical randomized controlled trial; INFLUENZA; VIRUS; INHIBITOR; OSELTAMIVIR;
D O I
10.3760/cma.j.issn.0366-6999.2011.18.024
中图分类号
R5 [内科学];
学科分类号
1002 ; 100201 ;
摘要
Background The 2009 influenza A (H1N1) virus infection is associated with the high risk of severe complications and is spreading more rapidly throughout the world than other reported seasonal influenzas. This study aimed to evaluate the efficacy and safety of the nature herbal medicine Lianhuaqingwen capsule (LHC) in patients infected with influenza A (H1N1) virus. Methods A total of 244 patients aged 16-65 years confirmed with influenza A (H1N1) virus infection by the real time RT-PCR were randomized to one of two treatment groups of 122 patients each. Each group assigned to receive either LHC or Oseltamivir for five days and observation for seven days. The patients were enrolled within 36 hours of illness onset if they had an axillary temperature of >= 37.4 degrees C and with at least one of the following symptoms: nasal obstruction, runny nose, cough, sore throat, fatigue, headache, myalgia, chills and sweating. The primary end point was the duration of illness. Results Of 244 patients, 240 (98.36%) patients with a median age 21 years completed the study between October 24, 2009 and November 23, 2009. There were no significant overall differences between LHC treated and Oseltamivir treated patients in the median duration of illness (LHC 69 hours vs. Oseltamivir 85 hours P >0.05) or the median duration of viral shedding (LHC 103 hours vs. Oseltamivir 96 hours, P >0.05). However, it was worthwhile to note that LHC significantly reduced the severity of illness and the duration of symptoms including fever, cough, sore throat, and fatigue (P <0.05). Both study medications were well tolerated. No drug related serious adverse events occurred during the study. Conclusions Compared with Oseltamivir, LHC achieved a similar therapeutic effectiveness reduction of the duration of illness and duration of viral shedding. Therefore, LHC might be an alternative therapeutic measure for influenza A (H1N1) virus infections. (Clinical trial number: ChiCTR-TRC-00000589) Chin Med J 2011;124(18):2925-2933
引用
收藏
页码:2925 / 2933
页数:9
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