1. 中国中医科学院中医临床基础医学研究所
2. 广东省中医院
3. 辽宁省中医药研究院
4. 中国人民大学医院
5. 北京航空航天大学校医院
6. 中国中医科学院望京医院
7. 北京高碑店社区卫生服务中心
8. 中国中医科学院数据中心
纸质出版:2020
移动端阅览
[1]何丽云,李凌香,艾艳珂,温泽淮,李国信,王红玉,贾绍燕,高峰,姜岳,刘保延.抗病毒口服液治疗成人感冒适宜人群与剂量研究[J].中医杂志,2020,61(13):1156-1162.
HE Liyun, LI Lingxiang, AI Yanke, et al. Research on the Adapted Crowd and Dosage of Antivirus Oral Liquid (抗病毒口服液) in Treating Adult Common Cold[J]. Journal of Traditional Chinese Medicine2020, 61(13): 1156-1162.
[1]何丽云,李凌香,艾艳珂,温泽淮,李国信,王红玉,贾绍燕,高峰,姜岳,刘保延.抗病毒口服液治疗成人感冒适宜人群与剂量研究[J].中医杂志,2020,61(13):1156-1162. DOI: 10.13288/j.11-2166/r.2020.13.011.
HE Liyun, LI Lingxiang, AI Yanke, et al. Research on the Adapted Crowd and Dosage of Antivirus Oral Liquid (抗病毒口服液) in Treating Adult Common Cold[J]. Journal of Traditional Chinese Medicine2020, 61(13): 1156-1162. DOI: 10.13288/j.11-2166/r.2020.13.011.
目的探索抗病毒口服液治疗成人感冒的适宜人群特征、最佳剂量及疗程。方法采用多中心、随机、双盲、安慰剂平行对照临床研究设计
先随机分为试验组1986例和对照组661例
再以10ml、20ml、30ml 3种剂量作为分层因素
将试验组分为试验10ml组671例、试验20ml组667例、试验30ml组648例
将对照组分为对照10ml组220例、对照20ml组222例、对照30ml组219例;试验组各剂量组分别服用相应剂量抗病毒口服液
对照组各剂量组分别服用相应剂量的抗病毒口服液模拟剂
每日3次
疗程均为5天。观察单项症状消失率及消失时间、临床症状消失率、痊愈时间
选取治疗有效的试验组病例进行症状聚类
并进行安全性评价。结果单项症状消失率:试验10ml、20ml组的恶寒、发热、咳嗽、鼻塞、流涕、咽喉痛、肢体酸痛、身倦乏力症状消失率均高于同剂量对照组(P<0.05);试验30ml组除汗出症状外
其他所有单项症状消失率均高于对照30ml组(P<0.05)。临床症状消失率:试验10ml组与对照10ml组分别为62.0%、44.5%
试验20ml组与对照20ml组分别为63.0%、42.3%
试验30ml组与对照30ml组分别为64.8%、39.7%
组间比较差异均有统计学意义(P<0.01);试验10ml、20ml、30ml组组间比较
单项症状消失率和临床症状消失率差异均无统计学意义(P>0.05)。单项症状中位消失时间:试验10ml、20ml、30ml组均为3或4天。聚类分析显示
感冒症状群中最适宜的症状为流涕、咽喉痛、咳嗽。不良事件发生率试验组与对照组分别为0.46%和0.15%
组间比较差异无统计学意义(P>0.05)。结论抗病毒口服液10ml、20ml、30ml剂量均可改善感冒临床症状、缩短感冒痊愈时间
最佳剂量推荐10ml
症状较重时推荐30ml
服用方法为每日3次
疗程为4天
适宜具有流涕、咽喉痛、咳嗽症状特征人群。
Objective To explore the commended users
the dosage and treatment course of Antivirus Oral Liquid(抗病毒口服液) in the treatment of common cold in adult population. Methods A multicenter
randomized
double-blind
placebo-controlled clinical trial was adopted and patients were randomly divided into 1986 cases in the test group and 661 cases in the control group. Doses of 10 ml
20 ml and 30 ml were used as the stratification factor
and the test group were divided into 671 cases in the 10 ml test group
667 cases in the 20 ml test group and 648 in the 30 ml test group. The control group was divided into 220 cases in the 10 ml control group
222 cases in the 20 ml control group and 219 cases in the 30 ml control group. Each dose group of the test group took the corresponding dose of Antivirus Oral Liquid
and control groups took the corresponding dose of Antivirus Oral Liquid simulant
3 times a day for 5 days. Disappearance rate and disappearance time of individual symptoms
clinical symptom disappearance rate and recovery time
effective cases in the treatment group for symptom clustering
and safety were observed. Results The disappearance rate of single symptom including cold
fever
cough
stuffy nose
runny nose
sore throat
aching limbs and fatigue) in the 10 ml and 20 ml test groups was significantly higher than that in the corresponding control group(P<0.05); in addition to sweating symptoms
the disappearance rate of single symptoms in the 30 ml test group was higher than that in the 30 ml control group(P<0.05). Clinical symptom disappearance rate was 62.0% and 44.5% respectively for the 10 ml test group and the 10 ml control group
and that was 63.0% and 42.3% respectively for the 20 ml test group and the 20 ml control group
64.8% and 39.7% for the 30 ml test group and the 30 ml control group
respectively. Differences between groups were statistically significant(P<0.01). There was no statistical significant difference in the disappearance rate of single symptom and clinical symptom among the 10 ml
20 ml and 30 ml test groups(P>0.05). The median disappearance time of single symptom in the 10 ml
20 ml and 30 ml test group were all within 3-4 days. Cluster analysis showed that the most suitable symptoms in the common cold symptoms were runny nose
sore throat
and cough. The incidence of adverse events was 0.46% and 0.15% in the test groups and the control groups
respectively
and there was no statistically significant difference between the groups(P>0.05). Conclusion Antivirus Oral Liquid 10 ml
20 ml
30 ml dosage can improve the clinical symptoms of common cold
shortening the recovery time
and the recommended dosage is 10 ml
and 30 ml when the symptoms are more severe
with the method of taking 3 times a day
and the course of treatment for 4 days. It is suitable for people with runny nose
sore throat and cough symptoms.
0
浏览量
207
下载量
0
CSCD
关联资源
相关文章
相关作者
相关机构
京公网安备11010102007558号