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

被引：5

作者：

Cao Bin

Wang Da-yan ^{[2
]}

Yu Xiao-min

Wei Lu-qing ^{[3
]}

Pu Zeng-hui ^{[4
]}

Gao Yan ^{[5
]}

Wang Jing ^{[6
]}

Dong Jian-ping ^{[7
]}

Li Xiao-ling ^{[8
]}

Xu Qian ^{[9
]}

Hu Ke ^{[10
]}

Chen Bai-yi ^{[11
]}

Yu Yun-song ^{[12
]}

Song Shu-fan

Shu Yue-long ^{[2
]}

Wang Chen ^{[1
,13
]}

机构：

[1] 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

[2] China CDC, Chinese Natl Influenza Ctr, Natl Inst Viral Dis Control & Prevent, Beijing 102206, Peoples R China

[3] Chinese Peoples Armed Police Forces, Pingjing Hosp, Logist Coll, Tianjin 300162, Peoples R China

[4] Yantai Yuhuangding Hosp, Yantai 264000, Shandong, Peoples R China

[5] Peking Univ, Peoples Hosp, Beijing 100044, Peoples R China

[6] Capital Med Univ, Beijing Xuanwu Hosp, Beijing 100053, Peoples R China

[7] Beiing Hai Dian Hosp, Beijing 100080, Peoples R China

[8] Chengdu Infect Dis Hosp, Chengdu 610061, Sichuan, Peoples R China

[9] China Japan Friendship Hosp, Beijing 100029, Peoples R China

[10] Wuhan Univ, Renmin Hosp, Wuhan 430060, Hubei, Peoples R China

[11] China Med Univ, Hosp 1, Shenyang 110001, Liaoning, Peoples R China

[12] Sir Run Run Shaw Hosp, Hangzhou 310020, Zhejiang, Peoples R China

[13] China Minist Hlth, Beijing Hosp, Beijing 100730, Peoples R China

来源：

CHINESE MEDICAL JOURNAL | 2012年 / 125卷 / 17期

基金：

中国国家自然科学基金;

关键词：

influenza; zanamivir; safety; susceptibility; NEURAMINIDASE INHIBITOR ZANAMIVIR; B VIRUS-INFECTIONS; CLINICAL-EFFICACY; BURDEN;

D O I：

10.3760/cma.j.issn.0366-6999.2012.17.007

中图分类号：

R5 [内科学];

学科分类号：

1002 ; 100201 ;

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

引用

页码：3002 / 3007

页数：6

共 17 条

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