A Randomized Controlled Trial Of Recombinant Human Interferon α-2b Nasal Spray To Prevent Respiratory Virus Infections In Recruits

Objective:This randomized controlled trial try to evaluate the effectiveness and safety ofrecombinant human interferonα-2b nasal spray for the prevention of respiratory viralinfections in recruits, and to analyse potential economic value bypharmacoeconomics methods.Methods:(1) The parallel double blind randomized controlled design was adopted, and1500 recruits from three districts (Guangzhou and Foshan in Guangdong, Liuzhouin Guangxi) included 721 qualified recruits were assigned randomly to theexperimental group, which take recombinant human interferonα-2b nasal spray lastedfor 5days. The other 728 qualified recruits were in the control group which takeplacebo instead lasted for 5 days as well. Blood was collected before the trial and 15days after taking recombinant human interferonα-2b nasal spray or placebo. Theantibody level against five common respiratory viruses was detected by ELISA. Fromthe comparison of infection positive rate between experimental group and controlgroup, we come to the conclusion of effectiveness and safety of recombinant humaninterferonα-2b nasal spray for preventing infection.(2) All adverse reactions were recorded five days during and after trial,including abnormal body temperature, cough, dry throat and so on, which werestatistically described and analyzed. The relevance between adverse reactions andrecombinant human interferonα-2b nasal spray was concluded by observation andanalysis during the trial, and the effectiveness of adverse reactions was classified tofive degrees to judge the relevance.(3) According to the result of randomized controlled trial, Cost-effectivenessanalysis and Cost-benefit analysis of recombinant human interferonα-2b wereevaluated.Results(1) After randomization, 721 recruits entered into experimental group, and 728recruits enter into control group. During the trial, 7 cases in experimental group and12 cases in control group were excluded. There were no differences in age, nativeplace,education between two groups. Moreover, the levels of respiratory virus IgMantibodies before trial are also comparable well.Comparison of respiratory virus IgM positive rate in two groups of recruits whoare respiratory virus IgM negative before the trial showed that the positive rate of allfive respiratory viruses IgM of experimental group were lower than those in thecontrol group, including adenovirus (ADV), respiratory syncytialvirus (RSV),influenza A(IFV-A), influenza B (IFV-B), parainfluenza viruses (PIV). Among five viruses, the positive rate of four of them has statistical significance(P＜0.05). Theanalytic results of per protocol (PP) and intention to treat (ITT) are coherent. Theprotective rates of four common respiratory viruses ADV,IFV-A, IFV-B, PIV are57.6%,71.7%,72.8%,74.2%, which means that 24, 6, 9, and 8 persons should betreated in order to prevent one infection case. The prevention to two viruses of PIV,IFV-B was most efficient.(2) During the trial, no severe adverse reactions was observed. All adversereactions were insignificant influenza-like syndrome. One case in the experimentalgroup and 6 cases in the control group required out of trial for fear of secondary effect.All adverse reactions were reversible, only lasted for a few days, and recovered afterstopping trial without treatment. The comparison of average occurrence of eachsymptom between two groups during five days treatment showed that there wasstatistic significance in throat dry and bloody nasal mucus, the experimental groupwere 1.699 and 1.783 times than control group respectively. The adverse reactionsoccurrences each day during trial had statistical significance in throat dry, runningnose, bloody nasal mucus, and pharyngodynia, and 9, 29, 50, and 94 persons shouldbe treated if one case of respective adverse reactions happened.(3) Cost-benefit analysis show that to prevent one case of ADV,IFV-A,IFV-Band PIV need to spend 72, 18, 24, and 24 Yuan respectively. From Cost-benefitanalysis, one percent decrease of four common respiratory viruses infectionprevalence needs to cost 527.26, 133.52, 180.25, and 183.31 Yuan. When the cost ofdirect treatment considered only, one yuan cost can have 1.53 yuan return incost-benefit analysis, and when direct treatment and indirect cost considered, oneyuan can have 3.12 yuan return. Conclusions(1) Recombinant human interferonα-2b nasal spray is effective to preventcommon respiratory viruses infection in recruits and have protective efficiency.(2) No severe adverse reactions was observed during the treatment ofrecombinant human interferonα-2b nasal spray, only some insignificantinfluenza-like syndrome, such as throat dry, nasal mucus. Recombinant humaninterferonα-2b nasal spray is safe when using in the recruits.(3) Recombinant human interferonα-2b nasal spray have optimistic economicpotential, and is feasible to popularize.