国产奥司他韦颗粒治疗儿童流行性感冒A型的疗效与安全性

Efficacy and safety of domestic Oseltamivir granules in treating influenza A in children

目的评价国产奥司他韦颗粒治疗儿童流行性感冒（流感）A型的有效性及安全性。方法将2014年1月至3月广州市妇女儿童医疗中心感染科住院治疗的流感A型患儿采用随机数字法分为2组：治疗组采用国产磷酸奥司他韦颗粒治疗，对照组采用进口磷酸奥司他韦胶囊治疗，评价2组治疗前、后疗效。2组基线及不良反应比较采用，检验，疗效差异性比较采用t检验。结果治疗组44例，其中男27例（61．36％），女17例（38．64％）；年龄（2．40±1．97）岁。对照组40例，其中男28例（70．00％），女12例（30．00％）；年龄（2．99±3．19）岁，2组患儿年龄、性别比较差异均无统计学意义（P均〉0．05）。治疗组与对照组患儿发热缓解时间分别为（14．67±9．37）h和（11．80±9．98）力h，2组比较差异无统计学意义（t=2．020，P=0．52）。2组流感症状完全缓解时间分别为（62．50±25．03）h和（65．40±36．74）h，2组比较差异无统计学意义（t=2．030，P=0．71）。治疗组未观察到不良反应发生，对照组有1例出现咳嗽加重的不良反应，未予特殊处理随疾病过程逐渐缓解。2组患儿密切接触人群均未观察到第2代流感。结论与进口奥司他韦比较，国产奥司他韦治疗流感A型同样安全、有效，且国产奥司他韦因其剂型为颗粒剂，更适合儿童使用。

Objective To investigate the efficacy and safety of domestic Osehamivir granules in the treatment of influenza A in children. Methods The research subjects were the hospitalized patients with influenza A coming from the Department of Infectious Disease in Guangzhou Women and Children＇s Medical Center. from January and March, 2014 They were divided into 2 groups randomly. Patients in the treatment group received domestic Osehamivir granules, while the patients in the control group received foreign Osehamivir. Chi square test was performed to compare baseline characteristics and the difference in side effects. Paired t test was used to compare baseline characteristics and the difference in side effects. Results There were 44 cases in the study group,27 cases were male（61.36% ） , 17 cases were female（ 38.64% ）, and the average age was （2.40 ± 1.97 ） years old. There were 40 cases in the control group ,28 cases were male （70.00%） , 12 cases were female（ 30.00% ） , and the average age was （2.99 ±3.19） years old. The maximum age was 6 years old. The age and gender were not significant （ P 〉 0.05 ） between 2 groups. The fever remission time was （ 14.67 ± 9.37 ） h and （ 11.80 ± 9.98） h in the treatment group and the control group, and there was no significant difference between 2 groups （P 〉 0. 05 ） ; the flu symptoms completely remission time was （62. 50± 25.03） h and （65.40 ± 36.74） h in the treatment group and the control group, and there was no significant difference between 2 groups （P 〉 0.05 ） ;the adverse reaction was not observed in the treatment group, but 1 case in the control group had cough, and without special treatment cough alleviated gradually ; the close contacts in 2 groups did not develop influenza A. Conclusions The domestic Osehamivir granules are as effective and safe as the foreign Oseltamivir. And the domestic Osehamivir granules are the granular type, and therefore more suitable for children