| To explore the clinical effect,mechanism and safety of Qishen Buqi Capsule in the treatment of adult recurrent respiratory tract infection.Methods:A total of 360 adult patients with recurrent respiratory tract infection,treated in the outpatient clinic in Chengdu First People's Hospital from October 2017 to September 2018，were randomly divided into 2 groups,180 cases in each group,followed up to 12 months after the treatment.The control group was given pidomode capsule,0.8 g(2 capsules)at a time,once a day,2 months as a course of treatment,2 courses interval of a month,3 courses of treatment; the observation group was given Qishen Buqi Capsule 0.9 g(3 capsules)at a time,3 times a day,1 month as a course of treatment,2 courses interval of a month,3 courses of treatment.The main outcome measure was the number of respiratory tract infections per year.The secondary outcome measures included blood WBC,N(%),IgA,IgG,C3,CD4,CD8,CD4/CD8,TNF-α,IL-6,IL-8,and the occurrence of adverse events in the 2 groups.Results:There was no statistical difference between the 2 groups(P>0.05)in the rate of falling off and the rate of losing visit.There was no statistical difference between the 2 groups in the baseline situation(P>0.05),which was comparable.The number of respiratory tract infections decreased significantly in both 2 groups(P<0.05).Among them,the number of annual respiratory tract infection in the observation group was significantly lower(P<0.05),and for the patients with smoking history,chronic pharyngitis and chronic sinusitis,the effect of the observation group was significantly more significant(P<0.05).The CD4/CD8 ratio was significantly increased in both 2 groups(P<0.05).However,the levels of IgA,IgG and C3 were significantly increased in the observation group(P<0.05),but the control group(P>0.05).The levels of TNF-α,IL-6 and IL-8 were significantly decreased in both 2 groups(P<0.05),and there was no significant difference between the 2 groups(P>0.05).No serious adverse events were found in the 2 groups,and the incidence of adverse events was similar(P>0.05).Conclusion:Qishen Buqi Capsule is effective and safe in the treatment of adult recurrent respiratory tract infection.Its mechanism may be related to the improvement of cellular immunity,humoral immunity and complement system activity at the same time. |
