抗病毒口服液治疗成人感冒适宜人群与剂量研究  

Research on the Adapted Crowd and Dosage of Antivirus Oral Liquid (抗病毒口服液) in Treating Adult Common Cold

作　　者：何丽云[1] 李凌香 艾艳珂[1] 温泽淮[2] 李国信[3] 王红玉[4] 贾绍燕[5] 高峰[6] 姜岳 刘保延[8] HE Liyun;LI Lingxiang;AI Yanke;WEN Zehuai;LI Guoxin;WANG Hongyu;JIA Shaoyan;GAO Feng;JIANG Yue;LIU Baoyan(Institute of Basic Research in Clinical Medicine,China Academy of Chinese Medical Sciences,Beijing,100700;Guangdong Provincial Hospital of Chinese Medicine;Liaoning Academy of Traditional Chinese Medicine;Hospital of Renmin University of China;Campus Hospital,Beihang University;Wangjing Hospital,China Academy of Chinese Medical Sciences;Beijing Gaobeidian Community Health Service Center;Data Center,China Academy of Chinese Medical Sciences)

机构地区：[1]中国中医科学院中医临床基础医学研究所,北京市100700 [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

出　　处：《中医杂志》2020年第13期1156-1162,共7页Journal of Traditional Chinese Medicine

基　　金：广东省中药(香雪)工程技术研究中心项目(2015S-P095);广州市科技计划(201604016057)。

摘　　要：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 1

关 键 词：成人感冒 抗病毒口服液 适宜人群 最佳剂量 随机对照试验 

分 类 号：R285.6[医药卫生—中药学]