| ObjectiveTo study the preventive effect of zinc gluconate nasal spray on the common cold during the popular season of upper respiratory tract infection.MethodsA randomized controlled trial was conducted in the popular season of upper respiratory tract infection, from November 5,2007 to December 5,2007 and from March 15,2008 to April 14 2008. Altogether 2000 subjects ware recruited. The subjects were healthy students in Langfang Health School without the following diseases, such as nasal endoscopy nasal obstruction, nasal bleeding, nasal polyps, nasal tumors, and chronic rhinitis, bronchitis or abnormal liver function and also without a cold in the last month. Informed consent was conducted. All the subjects were randomly divided into test group and control group, and zinc gluconate nasal spray drugs and placebo with same packaging was used respectively. the sprays were used twice a day on the double nostril for a month. When there were any symptoms of upper respiratory tract infection or after a bottle of drugs was finished with the original bottle and receive a refund original numbers to continue to use. A uniformed questionnaire about the symptoms and days they lasted was filled and collected every week. EPIinfo software was used for statistical analysis. Statistical methods included descriptive analysis, t test andχ2 test.ResultsA total of 2000 students in the two stage were collected in this study, in which 1945 students eligibly completed the questionnaire, and 55 not due to trauma, acute and chronic disease. The rates of losing-up were both less than 10% in the two groups, and no statistically significant difference between them, which indicated no losing-up bias existed.(χ2=2.36, P>0.05)The subjects were from 76 classes in the school. The distribution of classes between two groups was not significantly different (χ2=1.03, P>0.05), so was the age and sex distribution.The incidence density of upper respiratory tract infection among the test group was significant lower than that of the control group. The incidence of man-months of upper respiratory tract infection in test group was 14.393%, The incidence of man-months of upper respiratory tract infection in control group was 31.258%, Protection rate is 53.954%.The proportion of a variety of symptoms of upper respiratory tract infection symptoms in test group is lower than the control group, especially runny nose, stuffy nose, sneezing, headache, fatigue, muscle aches, and fever were statistically significant. (P<0.05).The proportion of a variety of symptoms of upper respiratory tract infection symptoms in First-year test group is lower than control group students, especially nasal congestion, muscle aches, headache and fever was statistically significant (P< 0.05). The proportion of a variety of symptoms of upper respiratory tract infection symptoms in Second-year test group is lower than the control group, especially headache, muscle painand and weakness were statistically significant (P<0.05). The proportion of a variety of symptoms of upper respiratory tract infection symptoms in Third-year test group is lower than control group. especially nasal congestion, fatigue, muscle pain and fever were statistically significant (P<0.05).In the spring, The proportion of a variety of symptoms of upper respiratory tract infection symptoms in test group is lower than control group. especially muscle soreness, fatigue, sore throat, and hoarseness were statistically significant between the two groups (P<0.05).20 days ago, the incidence of respiratory tract infection is lower than the control group, and differences was statistically significant between the two groups (P<0.05).In winter, The proportion of a variety of symptoms of upper respiratory tract infection symptoms in test group is lower than control group, especially runny nose, fever, fatigue, nasal congestion and headache were statistically significant (P< 0.05).In 1-5 days,10 to 15 days,15 to 20 days and 25-30 days,the incidence of upper respiratory tract infection in test group is lower than the control group, and the difference was statistically significant between the two groups (P<0.05).75 students (7.7%) in the test group and 30students (3.1%) in the control group had some uncomfortable feeling after treatment, such as nasal itching, burning sensation, feel sad, and runny nose symptoms which belonged to the normal reaction after treatment. No serious adverse reactions occured.in both groups.ConclusionThe treatment group students had the lower risk of the upper respiratory tract infection than the control group, which indicated that zinc gluconate nasal spray may be effective in prevention of upper respiratory tract infection and in alleviating a variety of symptoms of the disease.No serious adverse events occurred after the use of zinc gluconate nasal spray. |