摘要
目的评价葡萄糖酸锌喷鼻剂对上呼吸道感染(上感)的预防效果及安全性。方法随机、双盲、安慰剂对照试验。纳入健康男性新兵营战士901人,用随机数字表法将其分为试验组(447人,给予葡萄糖酸锌喷鼻剂)和对照组(454人,给予安慰剂),持续用药1个月,患者和实施者均不知道分组情况。试验中途剔除试验组61人、对照组67人。1个月后计算两组上感、流感样病例的月发病率及各种症状的月发生率,并观察不良反应。结果773人(试验组386人,对照组387人)完成试验。试验组的上感和流感样发病率[分别为26.94%(104/386)和0.26%(1/386)]均低于对照组[34.37%(133/387)和2.06%(8/387);上感=5.010,P<0.05;流感=4.047,P<0.05)]。试验组在用药期间各种上感症状的发生率均低于对照组,其中4项症状(咳嗽、咽痛、鼻塞、流涕)的差别有统计学意义(P<0.05)。两组均无严重不良反应。结论葡萄糖酸锌喷鼻剂对上感有预防作用且安全性好。
Objective To evaluate the clinical efficacy and safety of zinc gluconate nasal spray in the prevention of upper respiratory infection. Methods A random, double-blind and placebo-controlled study was conducted in a total of 901 healthy male recruits, who were randomized into 2 groups, experiment group and control group, by using a random-number table The experiment group, consisted of 447 recruits, was given zinc gluconate nasal spray, and the control group, consisted of 454 recruits, with placebo for one month. During the course of the experiment, 61 in trial group and 67 in control group were eliminated. The incidence of upper respiratory infection, influenzalike illness, and the incidence of all the symptoms were documented after treatment for one month. Results Seven hundred and seventythree recruits completed the schedule finally up to standard, among them 386 recruits were in experiment group and 387 in placebo group. The incidence of upper respiratory infection and influenza-like illness were lower in experiment group （26. 94% and 0. 26%, respectively） than in control group （34. 37% and 2. 06%, respectively; χ^2 = 5. 010 for upper respiratory infection, P〈0. 05, and χ^2= 4. 047 for influenza-like illness, P〈0. 05）. The symptoms of upper respiratory infection occurred less frequently in the experiment group than in control group, and the incidence of 4 symptoms, including cough, pharyngodynia, nasal obstruction and running nose, was significantly different between the 2 groups （P〈0. 05）. No adverse reactions occurred in both groups during the course of experiment. Conclusion Zinc gluconate nasal spray is efficacious and safe in prevention of upper respiratory infection.
出处
《解放军医学杂志》
CAS
CSCD
北大核心
2009年第7期838-840,共3页
Medical Journal of Chinese People's Liberation Army
基金
全军医学科学技术研究“十一五”计划课题(06G026)
关键词
葡萄糖酸锌喷鼻剂
呼吸道感染
化学预防
随机对照试验
Zinc Gluconate Nasal Spray
respiratory tract infections
chemoprevention
randomized control trials
