| l.Objective:Recombinant Human Interferon a-2b for Spray was a sort of new medicament producing by Yuance company, and had been already approved to do clinical study by State food and drug administration on April, 2003. In order to evaluate the safety of Recombinant Human Interferon a-2b for Spray and its preventive role to respiratory virus infections, a large scale field trial study was finished.2.Methods:The study was finished with methods of experiment epidemiology and seroepidemiology.(1) Evaluation of safety:All subjects came from three populations: military students at Guangzhou city, recruits at Zhuhai city, recruits at Guangzhou city. Field trial was conducted in military students; experimental group had 1272 people, and control group had 2857 people. A randomized, placebo-controlled, double-blind field trial study was conducted in recruits at Guangzhou city and Zhuhai city. All recruits at Zhuhai city were divided into experimental group and placebo-controlled group by the method of cluster sampling (a squad as a cluster); experimental group had 234 people, and placebo-controlled group had 236 people. Recruits at Guangzhou city, experimental group and placebo-controlled group were divided according to the serial number that was gave for check-up; experimental group had 110 people, and placebo-controlled group had 110 people, too.In this study, the drugs were given for five days(0.9 X106 IU at 12:30 and 19:30) and all subjects were followed up for ten days. Control group use placebo or nothing(military students). Otherwise, questionnaires of side effects were provided to every people of experimental group and control group, and they were needed to fill in the questionnaires every night during the period of following up. After field trial was finished, we collected questionnaires and analyse them.After 15 days of the beginning of field trial study, we got blood 3~5ml from every subject, segregated serum and freeze them at -20 ℃, then purchase test kit to detect IgM antibody of respiratory viruses in the serum.(2) Evaluation of preventive effect to Respiratory Virus InfectionsWe sampled randomly serum of 584 shares from military students and 220 shares from the recruits at Guangzhou city, then detected IgM antibody of respiratory viruses in the serum by test kits. Five sorts of respiratory viruses need to detect, they were PIV1.2.3 (parainfluenza virus), Flu A (influenza A ), Flu B (influenza B), ADV (adenovirus), and RSV (respiratory syncytial virus).3. Results:(1) Safety: Using Recombinant Human lnterferon 0.05).The results of recruits group (Zhuhai city): During the period of using interferon, no one appeared the symptoms of fever. Experimental group had higherInfluenza-like symptoms than the control group (P<0.05), such as cough (2.62%~7.86%), expectoration (2.62%~8.30%), muscular ache (8.30%~16.16%), snuffle (11.35%~17.03%), sneeze (3.06%~7.42%), angina (4.80%~7.86%), pharynx dryness (6.99%~16.16%) and diarrhea (3.93%~4.37%), and the incidence of snuffle was highest in all symptoms (the average of experimental group was 14.06%, and placebo-controlled group was 6.96%); but headache and lassitude had lower incidence in experimental group than in placebo-controlled group; There were no significant differences in the symptoms of dizziness, abdominal pain and exanthem between experimental group and placebo-controlled group (P>0.05). Most of side effects came to their peak in the first day, then dropped gradually, and to mild after the period of using interferon.The results of recruits group (Guangzhou city): During the period of following up, no one appeared the symptoms of fever. The incidence of side effects in experimental group had the same trend with control group: most incidence of symptoms came to their peak in the first 3 days, then dropped gradually, and changed mild in the second 5 days of following up. There were no significant differences in everyday incidence of most symptoms between experimental group and placebo-controlled group (P>0.05).(2) Preventive effect to respiratory viruses: After using interferon, all five sorts of respiratory viruses (PTV 1.2.3, Flu A, Flu B, ADV and RSV) in experimental group had lower IgM antibody positive rates than the control group. In recruits, the antibody positive rates of PIV1.2.3, Flu B and ADV in experimental group were 4.55%, 3.64% and 17.27%, respectively, and control group were 16.36%, 13.64% and 31.82%, there were significant differences between the two groups (P<0.05). In military college students, the antibody positive rates of PIV1.2.3 and Flu B in experimental group were 4.66%, 6.74%, and control group were 11.86%, 14.89%, there were significant differences between the two groups (P<0.05). Protective efficacy of interferon to five sorts of respiratory viruses were different, from high to low, werePIV1.2.3(65.22%), FluB(59.65%), RSV(42.11%), ADV3.7(38.60%) and Flu A (36.35%) .The average protective rate was 50.75%.4. Conclusions:Using Recombinant Human Interferon |
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