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《Chinese Journal of Experimental and Clinical Virology》 2005-03
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A field trial for evaluating the safety of recombinant human interferon α-2b for nasal spray

CHEN Qing *, ZHANG Li-lan, YU De-xian, YU Zhi-ai, LIU Yi, ZHANG Li-ping, LI Zhi-feng, DUAN Zhao-jun, WANG Bin-hui, WEI Xue-jun, HU Gui-fang, LIU Yu-qing , CHU Xin-wei, HAN Yan-hong, WU Min, JIANG Xiao-ling, LI Jian-dong,DAI Ying-chun, NIE Jun, LONG Jun, ZHU Li, SUN Su-xia, RUI Yong-yu,ZHANG Ding-kang ,YU Shou-yi, HOU Yun-de. * Department of Epidemiology, Southern Medical University, Guangzhou 510515, China  
Objective To evaluate the safety of recombinant human interferon α-2b for nasal spray for the prevention of SARS and other upper respiratory viral infections. Methods Field epidemiologic evaluation was conducted, the design was randomized and had a synchronously parallel control group. In the study, the drugs were given for five days and all subjects were followed up for ten days. Results During the period of using interferon, body temperature of the experimental group was normal compared to the control group. Experimental group had more influenza-like symptoms than the control group (P0.05), such as headache (4.83%-7.09%), dizziness (7.17%-11.63%), lassitude (8.55%-15.06%), muscular soreness (4.43%-7.09%), pharynx dryness (12.10%-17.85%), angina (6.25%-8.72%), abdominal pain (2.30%-5.50%) and diarrhea (2.45%-5.66%). Most of side effects reached their peak with in the first 3 days. Except for pharynx dryness, the incidences of all other side effects declined after completion of the use of the trial drug, and incidences of some symptoms in experimental group were lower than those of the control group. There were no significant differences in the symptoms of cough and expectoration between the experimental group and the control group. The incidence of exanthem in the control group was significantly higher than that in the experimental group. The side effect of bloody nasal mucus was not observed in experimental group, which had been reported by other authors in several volunteer studies. Conclusions Using recombinant human interferon α-2b for nasal spray could lead to some influenza-like symptoms, however, all those symptoms were mild , reversible, and relieved after completion of the use of the trial drug. No serious side effects were found during the period of following up. The authors conclude that the drug is safe.
【Fund】: 国家863计划资助(2003AA208206;2003AA208209)
【CateGory Index】: R96
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