[Efficacy and safety of oseltamivir in children with suspected influenza: a multicenter randomized open-label trial]

Objective: To evaluate the efficacy and safety of oseltamivir in the treatment of suspected influenza in children. Method: A multicenter, randomized and open-label trial was conducted among 229 individuals with suspected influenza which were collected from the clinic of 5 hospitals in Guangdong province (Guangzhou Women and Children's Medical Center, Shenzhen Baoan District Maternity and Child Care Service Center, the Second Affiliated Hospital of Shantou University Medical College, Dongguan Maternity and Child Care Service Centre, Yuexiu District Children's Hospital of Guangzhou) from April to July 2015. They were randomized either to oseltamivir group (oseltamivir 30-75 mg, twice daily for 5 days) or control group who were given symptom relief medicines for 5 days. Result: No significant difference was found between two groups in influenza symptoms of the patients before the treatment(P>0.05). Altogether 229 individuals (114 in oseltamivir group, 115 in control group) were analyzed for efficacy, in which 73 individuals (42 oseltamivir, 31 control), 31.9%, were identified as influenza-infected through laboratory test. No significant difference was found between the two groups in the duration of fever although shortened. In the 229 individuals , the cumulative alleviation proportion between oseltamivir and control group was not significantly different (P>0.05): the median duration of illness was 69.9 hours (95% CI 65.3-91.5) in oseltamivir group and 75.4 hours (95%CI 63.9-91. 7) in control group; the median duration of fever was 40.4 hours (95%CI 31.5-53.4) in oseltamivir group and 44.0 hours (95%CI 33.2-50.0) in control group. In the 73 individuals, the cumulative alleviation proportion between oseltamivir and control group was significantly different (P<0.05). The median duration of illness was 61.2 hours (95%CI 48.0-121. 0) in oseltamivir group, being significantly shorter than that of 116.0 hours (95%CI 91.5-175.0) in control group. But it was not significantly different that the median duration of fever was 32.8 hours (95%CI 24.0-47.0 ) in oseltamivir group and 55.8 hours (95%CI 43.6-78.3 ) in control group (P>0.05). And the median duration of fever in 60 individuals (38 oseltamivir, 22 control) was significantly different between two groups(P<0.05), who had finished a course of taking oseltamivir in the 73 individuals, 34.8 hours (95%CI 24.0-48.5 ) in oseltamivir group being significantly shorter than that of 53.3 hours (95%CI 43.6-104.0 ) in control group. There was certain difference in side effects rate between the two groups (oseltamivir 10%, control 2%, P<0.05). The main side-effects were gastrointestinal symptoms (stomachache, diarrhea, poor appetite, vomiting). Conclusion: The duration of illness and fever in suspected influenza patients treated with oseltamivir was shorter than those in the patients treated with no oseltamivir, the difference was not statistically significant, when 31.9% was confirmed with positive result of virus test in suspected influenza in children. But in these patients with positive result of virus test, the duration of illness was significantly shortened with treatment with oseltamivir as compared with no treatment with oseltamivir, and it would be better if full oseltamivir course was completed for reducing the duration of fever. Oseltamivir treatment was safe with mild side effects.