感冒消炎片治疗儿童甲型H_1N_1流感临床试验评价

Clinical Trial of Ganmaoxiaoyan Tablets in the Treatment of Influenza A(H_1N_1)Infection in Children

目的评价《感冒消炎片》治疗儿童甲型H1N1流感的效果和安全性,为儿童甲型H1N1流感提供新的中药治疗方法.方法按照病例纳入标准,收集儿童甲型H1N1流感疑似病例,将病例对象完全随机地分配为治疗组与对照组,分别给予治疗药物(感冒消炎片)和对照药物(银翘解毒片)治疗.详细记录病例的临床信息并进行连续随访观察;采集治疗前后的鼻咽拭子,用实时荧光定量RT-PCR方法对所采集的鼻咽拭子进行病原学定性和定量检测.结果治疗组与对照组患儿用药后热退时间(h)分别为(13.09±7.02)h和(22.13±15.55)h(P<0.05);咽痛缓解时间为(20.36±7.91)h和(27.20±12.30)h(P<0.05);咳嗽缓解时间为51.20±13.81 h和53.25±16.50 h(P>0.05).两组患儿治疗前后甲型H1N1流感病毒荧光定量RT-PCR检测结果比较和两组治疗后病毒转阴率比较,均显示出显著的差异(P>0.05).结论以云南特色中药臭灵丹为主要成份的感冒消炎片对于儿童甲型H1N1流感,显示出很好的治疗效果和安全性,能够迅速缓解流感所致的发热、咽痛等症状,并能够有效降低呼吸道分泌物中甲型H1N1流感病毒载量,加快病毒转阴.

Objective To observe efficacy and safety of traditional Chinese medicine in Yunnan-GanMaoXiaoYan tablets in treatment of children with influenza A（H1N1）infection.Methods According to the case inclusion criteria,we collected influenza A（H1N1）suspected cases and randomly divided them into treatment group and control group.Patients in treatment group and control group were given treatment drug and control drug,respectively.We detailedly recorded the clinical information,collected nasal swabs before and after treatment and continuously followed up with real-time RT-PCR on nasal swabs for pathogen detection.Results The thermal annealing time（h）of patients in treatment group and control group was 13.09±7.02,and 22.13± 15.55（P〈0.05）,respectively.The sore throat relief time（h）was 20.36±7.91 and 27.20±12.30（P〈0.05）,respectively.The cough relief time（h）was 51.20±13.81 and 53.25±16.50（P〉0.05）,respectively.There was significant difference in the H1N1 quantitative PCR results and positive to negative rate between treatment group and control group（P〈0.05）.Conclusions GanMao XiaoYan tablets with the main characteristics of Chinese medicine in Yunnan Province is safe and efficient in the treatment of influenza A（H1N1）infection,able to quickly alleviate the influenza-induced fever,sore throat and other symptoms.It can reduce the viral load in respiratory secretions quickly,and speed up the virus turn to negative.