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学科主题: 临床医学
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An uncontrolled open-label, multicenter study to monitor the antiviral activity and safety of inhaled zanamivir (as Rotadisk via Diskhaler device) among Chinese adolescents and adults with influenza-like illness
作者: Cao Bin; Wang Da-yan2; Yu Xiao-min; Wei Lu-qing3; Pu Zeng-hui4; Gao Yan5; Wang Jing6; Dong Jian-ping7; Li Xiao-ling8; Xu Qian9; Hu Ke10; Chen Bai-yi11; Yu Yun-song12; Song Shu-fan; Shu Yue-long2; Wang Chen1,13
关键词: influenza ; zanamivir ; safety ; susceptibility
刊名: CHINESE MEDICAL JOURNAL
发表日期: 2012-09-05
DOI: 10.3760/cma.j.issn.0366-6999.2012.17.007
卷: 125, 期:17, 页:3002-3007
收录类别: SCI
文章类型: Article
WOS标题词: Science & Technology
类目[WOS]: Medicine, General & Internal
研究领域[WOS]: General & Internal Medicine
关键词[WOS]: NEURAMINIDASE INHIBITOR ZANAMIVIR ; B VIRUS-INFECTIONS ; CLINICAL-EFFICACY ; BURDEN
英文摘要:

Background It is the first multicenter clinical study in China to investigate zanamivir use among Chinese adolescents and adults with influenza-like illness (ILI) since 2009, when inhaled zanamivir (RELENZA (R)) was marketed in China.

Methods An uncontrolled open-label, multicentre study to evaluate the antiviral activity, and safety of inhaled zanamivir (as Rotadisk via Diskhaler device); 10 mg administered twice daily for 5 days in subjects >= 12 years old with ILI. Patients were enrolled within 48 hours of onset and followed for eight days. Patients were defined as being influenza-positive if the real-time reverse transcriptase-polymerase chain reaction (rRT-PCR) test had positive results.

Results A total of 400 patients >= 12 years old were screened from 11 centers in seven provinces from March 2010 to January 2011. Three hundred and ninety-two patients who took at least one dose of zanamivir were entered into the safety analysis. The mean age was 33.8 years and 50% were male. Cardiovascular diseases and diabetes were the most common comorbidities. All the reported adverse events, such as rash, nasal ache, muscle ache, nausea, diarrhea, headache, occurred in less than 1% of subjects. Mild sinus bradycadia or arrhythmia occurred in four subjects (1%). Most of the adverse events were mild and did not require any change of treatment. No severe adverse events (SAE) or fatal cases were reported. Bronchospasm was found in a 38 years old woman whose symptoms disappeared after stopping zanamivir and without additional treatment. All the 61 influenza virus isolates (43 before enrollment, 18 during treatment) proved to be sensitive to zanamivir.

Conclusions Zanamivir is well tolerated by Chinese adolescents and adults with ILIs. There is no evidence for the emergence of drug-resistant isolates during treatment with zanamivir. (ChiCTR-TNRC-10000938) Chin Med J 2012;125(17):3002-3007

语种: 英语
所属项目编号: 810 30032/H19 ; 81070005/H0104 ; D101100049810002
项目资助者: National Natural Science Foundation of China ; Beijing Science and Technology Key Projects Foundation ; GlaxoSmithkline (China) Investment Co. Ltd.
WOS记录号: WOS:000309378100007
Citation statistics:
内容类型: 期刊论文
URI标识: http://ir.bjmu.edu.cn/handle/400002259/65048
Appears in Collections:北京大学第二临床医学院_期刊论文

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作者单位: 1.Yantai Yuhuangding Hosp, Yantai 264000, Shandong, Peoples R China
2.Capital Med Univ, Beijing ChaoYang Hosp,Beijing Inst Resp Med, Beijing Engn Res Ctr Diag & Treatment Pulm & Crit, Dept Resp Med,Beijing Key Lab Resp & Pulm Circula, Beijing 100020, Peoples R China
3.China CDC, Chinese Natl Influenza Ctr, Natl Inst Viral Dis Control & Prevent, Beijing 102206, Peoples R China
4.Chinese Peoples Armed Police Forces, Pingjing Hosp, Logist Coll, Tianjin 300162, Peoples R China
5.Capital Med Univ, Beijing Xuanwu Hosp, Beijing 100053, Peoples R China
6.China Japan Friendship Hosp, Beijing 100029, Peoples R China
7.China Med Univ, Hosp 1, Shenyang 110001, Liaoning, Peoples R China
8.Sir Run Run Shaw Hosp, Hangzhou 310020, Zhejiang, Peoples R China
9.China Minist Hlth, Beijing Hosp, Beijing 100730, Peoples R China
10.Peking Univ, Peoples Hosp, Beijing 100044, Peoples R China
11.Beiing Hai Dian Hosp, Beijing 100080, Peoples R China
12.Chengdu Infect Dis Hosp, Chengdu 610061, Sichuan, Peoples R China
13.Wuhan Univ, Renmin Hosp, Wuhan 430060, Hubei, Peoples R China

Recommended Citation:
Cao Bin,Wang Da-yan,Yu Xiao-min,et al. An uncontrolled open-label, multicenter study to monitor the antiviral activity and safety of inhaled zanamivir (as Rotadisk via Diskhaler device) among Chinese adolescents and adults with influenza-like illness[J]. CHINESE MEDICAL JOURNAL,2012,125(17):3002-3007.
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