芪景防感合剂预防感冒及流感的随机对照研究

A Randomized Controlled Study ofQijing FangganFangan Mixture in the Prevention of Cold and Influenza

目的:进一步研究我院在新冠病毒肺炎预防中使用的芪景防感合剂与其改进剂型芪景防感胶囊对感冒及流感的预防作用。方法:将400例受试者随机分为四组,每组各100人,并选用玉屏风口服液作为阳性对照药物,分别为芪景防感合剂组(合剂组)、芪景防感胶囊组(胶囊组)、玉屏风口服液组(玉屏风组)以及药用糊精组(安慰剂组);各组受试者间断服药3个月,随访一年,比较各组受试者服药后发生感冒及流感的次数,服药前后症状的差异,血清谷丙转氨酶、谷草转氨酶及肌酐的变化,以及不良反应的发生情况。结果:四组受试者共264例完成随访,合剂组69例,胶囊组65例,玉屏风组67例,安慰剂组63例;合剂组、胶囊组、玉屏风组受试者感冒次数与安慰剂组比相比明显减少(P<0.05),且合剂组、胶囊组较玉屏风组减少更加明显(P<0.05),而合剂组与胶囊组之间并无明显差异(P>0.05);合剂组与安慰剂组在流感次数上比较也存在明显差异(P<0.05);合剂组用药后发生感冒咳嗽及咽痛的症状减轻(P<0.05),胶囊组用药后发生感冒咳嗽的症状减轻(P<0.05);各组谷丙转氨酶、谷草转氨酶及肌酐的变化比较无明显差异(P>0.05);各组不良反应发生率也相似(P>0.05)。结论:芪景防感合剂能够有效降低感染感冒及流感的风险以及减轻感冒后的症状,预防效果优于玉屏风口服液,并且具有良好的安全性;通过剂型改进的芪景防感胶囊也具有相似的效果,但在预防流感的效果上可能略差。

Objective:To study the preventive effects of Qijing Fanggan Mixture and its improved formulation Qijing Fanggan capsule on colds and influenza.Metholds:400 subjects were randomly divided into four groups with 100 people in each group,and Yupingfeng oral liquid was selected as the positive control drug,namely,Qijing Fanggan mixture group(mixture group),Qijing Fanggan capsule group(capsule group),Yupingfeng oral liquid group(Yupingfeng group)and placebo group;Subjects in each group took medicine intermittently for 3 months,followed up for one year,and compared the frequency of influenza after taking medicine,the frequency of colds and Symptoms severity before and after taking medicine,the changes of serum ALT,AST and Cr,and the occurrence of adverse reactions;Result:A total of 264 subjects in the four groups completed the follow-up,69 in the mixture group,65 in the capsule group,67 in the Yupingfeng group,and 63 in the placebo group;The frequency of colds of subjects in the mixture group,capsule group and Yupingfeng group was significantly lower than that in the placebo group(P<0.05),and the frequency of colds in the mixture group and capsule group was significantly lower than that in the Yupingfeng group(P<0.05),while there was no significant difference between the mixture group and the capsule group(P>0.05);There was also a significant difference in the frequency of influenza between the mixture group and the placebo group(P<0.05);The symptoms of cough and pharyngalgia in the mixture group were significantly relieved after taking the medicine(P<0.05),and the cough symptoms in capsule group was also significantly relieved(P<0.05);There was no significant difference in the changes of ALT,ASTand Cr in each group(P>0.05),and the incidence of adverse reactions was similar(P>0.05).Conclusion:Qijing Fanggan Mixture can effectively reduce the risk of infection with cold and flu and reduce the symptoms after cold,its prevention effect is better than Yupingfeng oral liquid,and has good safety;The improved formulation Qijing Fanggan capsule has similar effect,but its effect on preventing influenza may be slightly worse.