荆防颗粒治疗普通感冒(风寒证)的随机双盲安慰剂对照试验  

Randomized double-blind placebo-controlled trial of Jingfang Granules in treatment of common cold(wind-cold syndrome)

作　　者：杨道文[1] 屈毓敏 祝庆华[3] 赵家亮 庞建国 韩杰 颜振刚 麻晓 裴天源 张柏刚 李晓鹏 张洪春[1] YANG Dao-wen;QU Yu-min;ZHU Qing-hua;ZHAO Jia-liang;PANG Jian-guo;HAN Jie;YAN Zhen-gang;MA Xiao;PEI Tian-yuan;ZHANG Bo-gang;LI Xiao-peng;ZHANG Hong-chun(China-Japan Friendship Hospital,Beijing 100029,China;Beijing Xuanwu District Traditional Chinese Medicine Hospital,Beijing 100050,China;Shenzhen Traditional Chinese Medicine Hospital,Shenzhen 518021,China;Jingzhou Hospital of Traditional Chinese Medicine,Jingzhou 434000,China;Nanyang Traditional Chinese Medicine Hospital,Nanyang 473000,China;the People′s Hospital of Linqing,Linqing 252600,China;the First People′s Hospital of Tancheng,Linyi 276100,China;Luohe Hospital of Traditional Chinese Medicine,Luohe 462000,China;Beijing Chuangli Kechuang Medicine Technology Development Co.,Ltd.,Beijing 100013,China;Chengdu Simplion Data Analytics Co.,Ltd.,Chengdu 610095,China)

机构地区：[1]中日友好医院,北京100029 [2]北京市宣武中医医院,北京100050 [3]深圳市中医院,广东深圳518021 [4]荆州市中医院,湖北荆州434000 [5]南阳市中医院,河南南阳473000 [6]临清市人民医院,山东临清252600 [7]郯城县第一人民医院,山东临沂276100 [8]漯河市中医院,河南漯河462000 [9]北京创立科创医药技术开发有限公司,北京100013 [10]成都兴普莱数据分析有限责任公司,四川成都610095

出　　处：《中国中药杂志》2022年第10期2819-2824,共6页China Journal of Chinese Materia Medica

基　　金：国家重点研发计划项目(2019YFC1711200)。

摘　　要：荆防颗粒具有发汗解表、散风祛湿的功效,现代研究表明亦有解热、抗病毒的药理作用。因此,为评价荆防颗粒治疗普通感冒(风寒证)的有效性和安全性,选取符合纳入与排除标准的138例普通感冒(风寒证)患者,按2∶1随机分为试验组(92例)和安慰剂组(46例),试验组服用荆防颗粒,安慰剂组服用荆防颗粒模拟剂,疗程5 d,随访时间8 d,主要疗效指标为疾病痊愈时间。结果显示,试验组患者感冒的中位数痊愈时间为3.33 d,少于安慰剂组的7.00 d,经统计学检验,试验组疗效优于安慰剂组(P<0.0001);试验组主症严重程度评分-时间曲线下面积(AUC)为489.90±206.95,小于安慰剂组的763.50±339.53;试验组痊愈率和显效率均高于安慰剂组,2组比较差异均具有统计学意义(P<0.05)。同时单项症状恶寒、鼻塞、流清涕、咳嗽、头痛、咽痒/咽痛、白痰、身痛消失时间,消失率2组比较差异均有统计学意义(P<0.05),说明荆防颗粒在改善上述症状上具有优势。研究过程试验组发现1例不良反应(血肌酐轻度增高),复查时已恢复至正常水平,不良反应发生率为1.10%,未发现严重不良反应,2组不良反应发生率比较差异无统计学意义。结果表明,荆防颗粒可显著缩短普通感冒(风寒证)的病程,并能改善普通感冒引起的临床症状,安全性良好,具备临床优势。Jingfang Granules have the effects of inducing sweating to releasing exterior,dispersing wind and dispelling dampness.Modern studies have demonstrated that it has antipyretic and antiviral activities.Therefore,this trial was conducted to evaluate the efficacy and safety of Jingfang Granules in the treatment of common cold(wind-cold syndrome).A total of 138 common cold(wind-cold syndrome)patients meeting the inclusion and exclusion criteria were randomly assigned into the experimental group(n=92)and the placebo group(n=46)at a ratio of 2∶1 and respectively received Jingfang Granules and Jingfang Granules simulation agent.The treatment lasted for 5 d,and the follow-up time was 8 d.Recovery time was employed as the main indicator of efficacy.The median reco-very time of the experimental group was 3.33 d,shorter than that 7.00 d of the placebo group.The efficacy of the experimental group was better than that of the placebo group(P<0.0001).The major symptom severity score-time AUC of the experimental group was 489.90±206.95,which was smaller than that of the placebo group(763.50±339.53).The recovery rate and marked effective rate of the experimental group were higher than those of the placebo group,The above outcomes were statistically significant between the two groups(P<0.05).The disappearance time and rate of single symptoms including aversion to cold,nasal congestion,runny nose,cough,headache,pharyngeal itching/pain,white sputum,and somatalgia also had significant differences between the two groups(P<0.05),indicating that Jingfang Granules had good performance in alleviating the above symptoms.During the study period,one case of the experimental group had a slight increase in serum creatinine,which returned to the normal level after re-examination.The incidence of adverse reactions was 1.10%,and no serious adverse reaction was found.The two groups had no significant difference in the incidence of adverse reactions.In conclusion,Jingfang Granules can significantly shorten the course of common cold(wind-cold syn

关 键 词：荆防颗粒 感冒 风寒证 随机对照试验 

分 类 号：R254.9[医药卫生—中医内科学]