馥感啉口服液治疗小儿急性上呼吸道感染上市后再评价
发布时间：2018-11-05 12:52
【摘要】：目的观察馥感啉口服液治疗小儿急性上呼吸道感染在广泛应用条件下的有效性和安全性。方法采用多中心、观察性研究的方法,收集2 124例急性上呼吸道感染的患儿,服用馥感啉口服液,疗程为1周。分别从不同剂量、年龄段、辨证/辨病以及治疗手段方面,观察各组的痊愈率、继发下呼吸道感染/呼吸道并发症的情况,并对其安全性进行评价。结果馥感啉口服液治疗感冒总痊愈率为95.12%;倍增剂量与标准剂量、辨证(气虚风热证、风热证)与辨病的痊愈率比较,差异无统计学意义;不同年龄段和不同治疗方式的痊愈率比较,差异有统计学意义,其中以1岁年龄段患者及单独服用馥感啉的患者痊愈率较高。并发症总发生率为0.24%;倍增剂量与标准剂量、不同年龄段、辨证(气虚风热证、风热证)与辨病的并发症发生率比较,差异均无统计学意义;单独用药的并发症发生率低于联合用药。整体总临床不良事件及不良反应发生率分别为1.37%、1.04%。;临床不良事件及不良反应发生率比较,除不同剂量组外,差异均有统计学意义。结论馥感啉口服液治疗小儿急性上呼吸道感染具有较高的临床痊愈率和较低的并发症发生率,疗效较好;对于气虚风热证、风热证,甚至辨病治疗,有着较好而接近的疗效;年龄越小治疗痊愈率稍高。临床不良事件/不良反应的总发生率较低,倍增剂量未显示出较标准剂量更高的安全风险。提示该品种有着较好的临床应用前景。
[Abstract]:Objective to observe the efficacy and safety of Fuganlin oral liquid in the treatment of acute upper respiratory tract infection in children. Methods A multicenter, observational study was used to collect 2 124 children with acute upper respiratory tract infection. The recovery rate, secondary lower respiratory tract infection and respiratory complications were observed from different dosage, age, syndrome differentiation / disease differentiation and treatment methods, and their safety was evaluated. Results the total cure rate of Fuganlin oral liquid in treating cold was 95.12.The difference between double dose and standard dose, syndrome differentiation (qi deficiency wind heat syndrome, wind heat syndrome) and disease differentiation was not statistically significant. There was significant difference in the cure rate between different age groups and different treatment methods, among which the cure rate was higher in the patients aged 1 years old and those who took fulminate alone. The total incidence of complications was 0.24. There was no significant difference in the incidence of complications between double dose and standard dose, different age groups, syndrome differentiation (qi deficiency, wind heat syndrome, wind heat syndrome) and disease differentiation. The incidence of complications of single medication was lower than that of combined medication. The overall incidence of clinical adverse events and adverse reactions were 1.37 and 1.044.There were significant differences in the incidence of clinical adverse events and adverse reactions except for different dosage groups. Conclusion Fuganlin oral liquid has higher clinical cure rate and lower incidence of complications in the treatment of acute upper respiratory tract infection in children, and has good curative effect on qi deficiency, wind-heat syndrome and even disease differentiation. The younger the age, the higher the cure rate. The overall incidence of clinical adverse events / adverse reactions was low, and the multiplying dose did not show a higher safety risk than the standard dose. It is suggested that this variety has a good clinical application prospect.
【作者单位】： 天津中医药大学第一附属医院;天津中医药大学;
【分类号】：R272
本文编号：2312143
[Abstract]:Objective to observe the efficacy and safety of Fuganlin oral liquid in the treatment of acute upper respiratory tract infection in children. Methods A multicenter, observational study was used to collect 2 124 children with acute upper respiratory tract infection. The recovery rate, secondary lower respiratory tract infection and respiratory complications were observed from different dosage, age, syndrome differentiation / disease differentiation and treatment methods, and their safety was evaluated. Results the total cure rate of Fuganlin oral liquid in treating cold was 95.12.The difference between double dose and standard dose, syndrome differentiation (qi deficiency wind heat syndrome, wind heat syndrome) and disease differentiation was not statistically significant. There was significant difference in the cure rate between different age groups and different treatment methods, among which the cure rate was higher in the patients aged 1 years old and those who took fulminate alone. The total incidence of complications was 0.24. There was no significant difference in the incidence of complications between double dose and standard dose, different age groups, syndrome differentiation (qi deficiency, wind heat syndrome, wind heat syndrome) and disease differentiation. The incidence of complications of single medication was lower than that of combined medication. The overall incidence of clinical adverse events and adverse reactions were 1.37 and 1.044.There were significant differences in the incidence of clinical adverse events and adverse reactions except for different dosage groups. Conclusion Fuganlin oral liquid has higher clinical cure rate and lower incidence of complications in the treatment of acute upper respiratory tract infection in children, and has good curative effect on qi deficiency, wind-heat syndrome and even disease differentiation. The younger the age, the higher the cure rate. The overall incidence of clinical adverse events / adverse reactions was low, and the multiplying dose did not show a higher safety risk than the standard dose. It is suggested that this variety has a good clinical application prospect.
【作者单位】： 天津中医药大学第一附属医院;天津中医药大学;
【分类号】：R272
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