title: [A field trial for evaluating the safety of recombinant human interferon alpha-2b for nasal spray].
abstract: OBJECTIVE
  To evaluate the safety of recombinant human interferon alpha-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 (P < 0.05), 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 alpha-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.
authors.affiliation: Department of Epidemiology, Southern Medical University, Guangzhou 510515, China.
authors.forename: Qing
authors.initials: Q
authors.lastname: Chen
authors.forename: Li-lan
authors.initials: LL
authors.lastname: Zhang
authors.forename: De-xian
authors.initials: DX
authors.lastname: Yu
authors.forename: Zhi-ai
authors.initials: ZA
authors.lastname: Yu
authors.forename: Yi
authors.initials: Y
authors.lastname: Liu
authors.forename: Li-ping
authors.initials: LP
authors.lastname: Zhang
authors.forename: Zhi-feng
authors.initials: ZF
authors.lastname: Li
authors.forename: Zhao-jun
authors.initials: ZJ
authors.lastname: Duan
authors.forename: Bin-hui
authors.initials: BH
authors.lastname: Wang
authors.forename: Xue-jun
authors.initials: XJ
authors.lastname: Wei
authors.forename: Gui-fang
authors.initials: GF
authors.lastname: Hu
authors.forename: Yu-qing
authors.initials: YQ
authors.lastname: Liu
authors.forename: Xin-wei
authors.initials: XW
authors.lastname: Chu
authors.forename: Yan-hong
authors.initials: YH
authors.lastname: Han
authors.forename: Min
authors.initials: M
authors.lastname: Wu
authors.forename: Xiao-ling
authors.initials: XL
authors.lastname: Jiang
authors.forename: Jian-dong
authors.initials: JD
authors.lastname: Li
authors.forename: Ying-chun
authors.initials: YC
authors.lastname: Dai
authors.forename: Jun
authors.initials: J
authors.lastname: Nie
authors.forename: Jun
authors.initials: J
authors.lastname: Long
authors.forename: Li
authors.initials: L
authors.lastname: Zhu
authors.forename: Su-xia
authors.initials: SX
authors.lastname: Sun
authors.forename: Yong-yu
authors.initials: YY
authors.lastname: Rui
authors.forename: Ding-kang
authors.initials: DK
authors.lastname: Zhang
authors.forename: Shou-yi
authors.initials: SY
authors.lastname: Yu
authors.forename: Yun-de
authors.initials: YD
authors.lastname: Hou
mesh_terms: D015746:Abdominal Pain / Q000139:chemically induced; D000293:Adolescent; D000328:Adult; D000998:Antiviral Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D004244:Dizziness / Q000139:chemically induced; D005260:Female; D005500:Follow-Up Studies; D006261:Headache / Q000139:chemically induced; D006801:Humans; D000077190:Interferon alpha-2; D016898:Interferon-alpha / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D008297:Male; D011994:Recombinant Proteins; D045473:Severe acute respiratory syndrome-related coronavirus / Q000187:drug effects; D045169:Severe Acute Respiratory Syndrome / Q000517:prevention & control* / Q000821:virology; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D000998:Antiviral Agents; D000077190:Interferon alpha-2; D016898:Interferon-alpha; D011994:Recombinant Proteins