帕拉米韦治疗儿童疑似流感的疗效与安全性

Abstract

目的 评价帕拉米韦治疗儿童临床诊断疑似流行性感冒(流感)病例的有效性及安全性.方法 将2016年6月至2017年1月北京儿童医院收治的临床诊断疑似流感儿童,采用前瞻性研究,患者或其监护人接受新药帕拉米韦输液治疗者纳入治疗组(n=180),不接受者给予口服布洛芬混悬滴剂等对症治疗药物进行常规治疗者纳入对照组(n=180).评价两组间平均发热缓解时间、平均症状缓解时间、不良反应等.结果 两组间性别、年龄差异均无统计学意义(均 P>0.05);两组间治疗前出现症状到给药平均时间、平均体温差异均无统计学意义(均 P>0.05).治疗后,治疗组和对照组平均发热缓解时间分别为16.38 ± 7.34小时和60.20 ± 32.52小时,治疗组和对照组平均症状缓解时间分别为45.77 ± 27.58小时和65.43 ± 33.44小时,治疗组平均发热缓解时间、平均症状缓解时间,以及咳嗽、咽喉痛、鼻卡他/鼻塞主要症状缓解时间均显著少于对照组(t值分别为 -17.988、-7.301、-8.488、-11.080、-10.641,均 P<0.05).治疗组出现6例腹泻恶心等胃肠道反应,对照组出现5例恶心呕吐等胃肠道反应,两组间差异无统计学意义(P>0.05),所有不良反应未进行特殊处理且随病情好转逐渐缓解并消失.抗菌药物使用率治疗组和对照组分别为12.78% 和41.11%,两组比较差异有统计学意义(χ2=36.704,P<0.05).结论 帕拉米韦治疗临床诊断疑似流感儿童可以显著快速缓解症状,减少抗菌药物的使用,安全性及耐受性良好.

Objective To evaluate the curative effect and safety of Peramivir in treatment of children suspected with influenza(flu). Methods The children suspected with influenza in Beijing Children's Hospital during June 2016 to January 2017 were selected. Prospective study method was adopted in this study.And the children and their guardians who agreed to accept the intravenous injection of Peramivir,a new medicine for treatment,were divided into treatment group(n=180),while the children and their guardian who refused intravenous injection of Peramivir were treated with conventional therapy by oral administration of Ibuprofen suspensions and other symptomatic drugs and were divided into control group(n=180).The average fever relief time,average symptom relief time and adverse reactions of children in two groups were evaluated.Results There was no significant difference in gender and age of children between two groups(both P>0.05).And the differences in the average time during symptom appearing to drug administration before treatment and mean body temperature between two groups were not statistically significant(both P>0.05).After treatment,the average fever relief time of the treatment group and the control group were 16.38 ± 7.34 hours and 60.20 ± 32.52 hours,respectively,and the average symptom relief time of the treatment group and the control group were 45.77 ± 27.58 hours and 65.43 ± 33.44 hours,respectively.The average fever relief time,average symptom relief time,the relief time of main symptoms such as cough,sore throat,nasal catarrh/rhinobyon of children in the treatment group were significantly less than those of children in the control group(t value was -17.988,-7.301, -8.488,-11.080 and -10.641,respectively,all P<0.05).In the treatment group,there were 6 children presenting nausea,diarrhea and other gastrointestinal reactions,while in the control group,there were 5 children presenting nausea,vomiting and other gastrointestinal reactions.The difference between two groups was not statistically significant(P>0.05).All the adverse reactions were not treated with special treatment and gradually relieved and disappeared with the improvement of disease.The usage rate of antibiotics in the treatment group and the control group were 12.78% and 41.11%,respectively.The difference between two groups was statistically significant(χ2=36.704,P<0.05).Conclusion In treatment of children suspected with influenza,Peramivir can significantly and rapidly relieve the symptoms and reduce the usage of antimicrobials with good safety and tolerability.