[A field trial for evaluating the safety of recombinant human interferon alpha-2b for nasal spray].
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.
Chen
Qing
Q
Department of Epidemiology, Southern Medical University, Guangzhou 510515, China.
Zhang
Li-lan
LL
Yu
De-xian
DX
Yu
Zhi-ai
ZA
Liu
Yi
Y
Zhang
Li-ping
LP
Li
Zhi-feng
ZF
Duan
Zhao-jun
ZJ
Wang
Bin-hui
BH
Wei
Xue-jun
XJ
Hu
Gui-fang
GF
Liu
Yu-qing
YQ
Chu
Xin-wei
XW
Han
Yan-hong
YH
Wu
Min
M
Jiang
Xiao-ling
XL
Li
Jian-dong
JD
Dai
Ying-chun
YC
Nie
Jun
J
Long
Jun
J
Zhu
Li
L
Sun
Su-xia
SX
Rui
Yong-yu
YY
Zhang
Ding-kang
DK
Yu
Shou-yi
SY
Hou
Yun-de
YD
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
D000998:Antiviral Agents; D000077190:Interferon alpha-2; D016898:Interferon-alpha; D011994:Recombinant Proteins