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
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
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一项不受控制的开放标签、多中心研究，旨在监测吸入扎那米韦（通过 Diskhaler 装置作为 Rotadisk）在患有流感样疾病的中国青少年和成人中的抗病毒活性和安全性
DOI：
10.3760/cma.j.issn.0366-6999.2012.17.007
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发表时间：
2012-09-05
影响因子：
6.1
通讯作者：
Wang Chen
中科院分区：
文献类型：
--
作者：
Cao Bin;Wang Da-yan;Wang Chen
这是自2009年吸入式扎那米韦（RELENZA (R)）在中国上市以来，中国首个调查扎那米韦在患流感样疾病（ILI）的青少年和成人中使用情况的多中心临床研究。方法采用非对照、开放标签、多中心研究，评价吸入扎那米韦（通过Diskhaler装置作为Rotadisk）的抗病毒活性和安全性；12岁ILI患者10 mg，每日2次，连用5天。患者在发病48小时内入组，随访8天。如果实时逆转录聚合酶链反应（rRT-PCR）检测结果为阳性，则将患者定义为流感阳性。结果2010年3月至2011年1月，在全国7个省11个中心共筛选出400例患者，年龄bb0 = 12岁。392名至少服用了一剂扎那米韦的患者被纳入了安全性分析。平均年龄33.8岁，男性占50%。心血管疾病和糖尿病是最常见的合并症。所有报告的不良事件，如皮疹、鼻痛、肌肉疼痛、恶心、腹泻、头痛，发生在不到1%的受试者中。轻度窦性心动过缓或心律失常发生4例（1%）。大多数不良事件是轻微的，不需要任何改变治疗。无严重不良事件（SAE）或死亡病例报告。支气管痉挛发现于一名38岁妇女，停用扎那米韦后症状消失，无需额外治疗。所有61株流感病毒分离株（入组前43株，治疗期间18株）均被证明对扎那米韦敏感。结论扎那米韦在中国青少年和成人ILIs患者中具有良好的耐受性。没有证据表明在用扎那米韦治疗期间出现耐药分离株。（ChiCTR-TNRC-10000938）中华医学杂志2012；125 (17): 3002 - 3007
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