扎那米韦吸入粉雾剂治疗流感及流感样患者的随机双盲对照多中心研究  

A multicenter,double-blind,and randomized controlled trial of zanamivir power for inhalation in influenza and influenza-like patients

作　　者：卞家蓉[1] 聂蔚[1] 叶俊[1] 方正[1] 修清玉[1] 

机构地区：[1]上海长征医院呼吸内科,上海200003

出　　处：《中国新药与临床杂志》2013年第9期696-700,共5页Chinese Journal of New Drugs and Clinical Remedies

基　　金：十二五"重大新药创制"项目(2011ZX09302-003-01)

摘　　要：目的评价扎那米韦吸入粉雾剂治疗我国流感及流感样患者的疗效及安全性。方法采用多中心、随机双盲、安慰剂平行对照临床试验设计方法,共入选286例患者。全部患者随机分为两组,扎那米韦组予扎那米韦吸入粉雾剂10 mg,安慰剂组予安慰剂,bid,疗程5 d,两组均常规给予对症、支持治疗。观察患者口温及鼻塞、咽喉痛、咳嗽、肌肉酸痛、乏力、头痛及寒战等症状,并于治疗前和治疗后6、21 d进行实验室检查,观察并记录不良反应。结果 286例患者中疑似流感患者151例,确诊流感患者135例。纳入安全性分析集(SAS)、全分析集(FAS)、符合方案数据分析集(PPS)和确诊流感病例集(PPi)的病例数扎那米韦组分别为142、141、131和69例,安慰剂组分别为144、144、143和66例。扎那米韦组患者临床症状缓解时间短于安慰剂组,有显著差异(P<0.05),治疗后60、72 h扎那米韦组疾病缓解率显著高于安慰剂组(P<0.05),扎那米韦组确诊流感患者对乙酰氨基酚片应用率低于安慰剂组(P<0.05)。扎那米韦组和安慰剂组不良反应发生率分别为12.7%和13.9%,差异无显著意义(P>0.05)。结论扎那米韦吸入粉雾剂用于治疗流感及流感样患者安全、有效。AIM To evaluate the efficacy and safety of zanamivir power for inhalation on influenza （flu） and flu-like Chinese patients. METHODS A multiceuter, double-blind, and randomized controlled trial was performed in 286 patients with flu- like symptoms. Patients were randomized to two groups received zanamivir power for inhalation 10 mg or placebo, hid, for 5 days respectively. In addition, the patients in both groups were given symptomatic and supportive treatment. Assessments included oral temperature, stuffy nose, sore throat, cough, myalgia, headache and malaise. Laboratory testing and physical examination were conducted on day 6 and day 21 and the vital signs and adverse reactions were recorded to assess the safety. RESULTS There were 151 flu-like patients and 135 laboratory-confirmed flu patients. SAS, FAS, PPS and PPi was 142, 141,131 and 69 patients in the zanamivir group, and 144, 144, 143 and 66 patients in the placebo group, respectively. The remission time in zanamivir group was significantly shorter than that in placebo group （P 〈 0.05）. The disease remission rate in zanamivir group was significantly higher than that in placebo group at 60 h and 72 h after treatment beginning （P 〈 0.05）. The usage rates of paracetamol in flu patients of zanamivir group was less than that in placebo group （P 〈 0.05）. The incidence of adverse reactions was 12.7% and 13.9% in zanamivir group and plaeebo group, respectively. There was no significant difference between the two groups （P 〉 0.05）. CONCLUSION Zanamivir power for inhalation is effective and safe for treating Chinese flu and flu-like patients.

关 键 词：流感 人 扎那米韦 随机对照试验 多中心研究 

分 类 号：R978.7[医药卫生—药品]