Beijing Chao-Yang Hospital, Beijing Institute of Respiratory Medicine, Capital Medical University, Beijing 100020, China.
Chin Med J (Engl). 2012 Sep;125(17):3002-7.
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(®)) was marketed in China.
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.
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.
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.
这是自 2009 年吸入用扎那米韦（瑞乐沙®）在中国上市以来，首次在中国开展的评估流感样病例（ILI）青少年和成年患者使用扎那米韦的多中心临床研究。
一项非对照、开放性、多中心研究，旨在评估 12 岁及以上 ILI 患者使用扎那米韦（通过 Diskhaler 装置吸入用扎那米韦）的抗病毒活性和安全性，疗程为 5 天，每日 2 次，每次 10mg。患者于发病后 48 小时内入组，并随访 8 天。如果实时逆转录-聚合酶链反应（rRT-PCR）检测结果为阳性，则患者被定义为流感阳性。
2010 年 3 月至 2011 年 1 月，从中国 7 个省的 11 个中心共筛选了 400 例 12 岁及以上的患者。共 392 例至少服用了 1 剂扎那米韦的患者被纳入安全性分析。患者的平均年龄为 33.8 岁，50%为男性。最常见的合并症为心血管疾病和糖尿病。所有报告的不良反应，如皮疹、鼻痛、肌肉痛、恶心、腹泻、头痛，发生率均低于 1%。4 例（1%）出现轻度窦性心动过缓或心律失常。大多数不良反应为轻度，无需改变治疗。未报告严重不良事件（SAE）或死亡病例。一名 38 岁女性出现支气管痉挛，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）均对扎那米韦敏感。
扎那米韦在中国 ILI 青少年和成年患者中具有良好的耐受性。在使用扎那米韦治疗期间，未发现耐药分离株出现。
