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磷酸奥司他韦治疗高危人群流行性感冒患者多中心临床随机对照研究 被引量:25

A multicenter randomized controlled study of the efficacy and safety of oseltamivir in the treatment of influenza in a high risk population
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摘要 目的 观察磷酸奥司他韦在患有慢性呼吸系统疾病和慢性心脏疾病的流行性感冒 (流感 )患者中的临床疗效及安全性。方法 采用随机、对照、开放性的多中心临床试验设计。患有慢性支气管炎、支气管哮喘、支气管扩张、阻塞性肺疾病等慢性呼吸系统疾病或慢性心脏疾病的人群 ,在流感流行季节内有发热≥ 37 8℃并至少有 2项流感样症状 ,在出现症状后 4 8h内 ,合格的受试者随机接受磷酸奥司他韦 75mg ,每天 2次 ,共 5d(试验组 )或只给予对症治疗 (对照组 )。结果  10 8例受试者中被证实为流感患者 (即感染总体 ,ITTI)共 5 6例 ,其中 (试验组 ) 2 7例 ,对照组 2 9例。试验组和对照组流感症状平均缓解时间分别为 (110± 12 6 )h和 (174± 93)h ,差异有显著性 ,试验组比对照组缩短6 4h(36 7% ) ;症状总评分以曲线下面积 (AUC)表示 ,分别为 (817± 4 6 7)分和 (14 35± 6 4 7)分 ,两组差异有非常显著性 ,试验组比对照组减少 6 18分 (4 3 1% )。两组流感平均发热持续时间分别为 (5 7±4 5 )h和 (10 4± 77)h ,两组差异有显著性 (F =7 19,P =0 0 0 98) ,试验组比对照组平均发热持续时间缩短达 4 6 8h(4 5 0 % )。试验组恢复到感染流感前基础状态所需时间平均为 6d ,对照组平均为 11d。并发症的发生率两组分别为 Objective To evaluate the efficacy and safety of oseltamivir in the treatment of influenza in a high risk population. Methods A randomized,open,control trial was conducted from Nov. 2002 to Feb. 2003. Patiensts with chronic respiratory disease,such as chronic bronchitis,obstructive emphysema,bronchial asthma,bronchiectasis or chronic cardiac disease,and with symptoms of influenza were enrolled. They should satisfy the following criteria:Fever≥37.8℃ plus at least two of the following influenza symptoms:coryza/nasal congestion,sore throat,cough,myalgia/ muscle aches and pain,fatigue,headache and chills/sweats. Within 48 h after the onset of the symptoms,the patients were randomly assigned to oseltamivir group(oseltamivir 75 mg,twice daily for 5 days) or control group(symptom relief medicine only). Results Fifty-six of the 108 recruited patients were identified as influenza-infected through laboratory test. They were defined as intent-to-treat infected population(ITTI)(27 oseltamivir,29 control). The duration of influenza symptom was 64 h shorter(36.7%) and AUC score of the influenza symptom was decreased by 618(43.1%) in the oseltamivir group as compared with those in the control group. The fever duration was 46.8 h(45.0%) less in the oseltamivir group than that in the control group. It took 6 d for the oseltamivir group and 11 days for the control group to recover to the basic health status. Secondary complications such as bronchitis,sinusitis and pneumonia occurred 11%(3/27) in the oseltamivir group and 45%(13/29) in the control group. The treatment expense for influenza and its complication was 587.4 RMB in the oseltamivir group and 786.5 RMB in the control group,which showed no significant difference(P=0.246). Conclusions It is suggested that oseltamivir is effective and well tolerated in patients with chronic respiratory or cardiac diseases. It can reduce the fever duration and severity of influenza symptom,and decrease the incidence of secondary complications and antibiotic use,while does not increase the total medical cost.
出处 《中华结核和呼吸杂志》 CAS CSCD 北大核心 2004年第7期455-459,共5页 Chinese Journal of Tuberculosis and Respiratory Diseases
关键词 流行性感冒 磷酸奥司他韦 高危人群 随机对照试验 Influenza Oseltamivir High risk population Randomized controlled trials
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