Slapak I, Skoupá J, Strnad P, Horník P. Pediatric Otorhinolaryngology Clinic, Teaching Hospital Brno, Czech Republic.
OBJECTIVE: To evaluate the potential of nasal isotonic saline application to prevent reappearance of cold and flu in children during the winter.
DESIGN: Prospective, multicenter, parallel-group, open, and randomized comparison.
SETTING: Eight pediatric outpatient clinics.
PATIENTS: A total of 401 children (aged 6-10 years) with uncomplicated cold or flu.
INTERVENTIONS: We randomly assigned patients to 2 treatment groups, one with just standard medication, the other with nasal wash with isotonic saline (Physiomer) plus standard medication, and observed them for 12 weeks.
MAIN OUTCOME MEASURES: The primary efficacy end points were nasal symptoms resolution during acute illness (visits 1 and 2). We also looked for reappearance of cold or flu, consumption of medication, complications, days off school, and reported days of illness during the following weeks when preventive potential was evaluated (visits 3 and 4).
RESULTS: At visit 2, patients in the saline group achieved primary end points (measured on a 4-point numeric scale on which 1 indicated no symptoms and 4, severe symptoms) in the parameters nasal secretion and obstruction (mean scores vs nonsaline group, 1.79 vs 2.10 and 1.25 vs 1.58, respectively) (P < .05 for both)
. During the prevention phase (at visit 3, 8 weeks after study entry) patients in the saline group showed significantly lower scores in sore throat, cough, nasal obstruction, and secretion (P < .05 for all). By visit 3, significantly fewer children in the saline group were using antipyretics (9% vs 33%), nasal decongestants (5% vs 47%), mucolytics (10% vs 37%), and systemic antiinfectives (6% vs 21%) (P < .05 for all). During the same period children in the saline group also reported significantly fewer illness days (31% vs 75%), school absences (17% vs 35%), and complications (8% vs 32%) (P < .05 for all). Similar results were found at the final visit. CONCLUSION: Children in the saline group showed faster resolution of some nasal symptoms during acute illness and less frequent reappearance of rhinitis subsequently.
在干预期间，（随访组3，研究开始后第8周），在盐水组的病人在因喉咙痛、咳嗽、鼻塞和鼻分泌物等症状而得分明显较低，（全部P﹤.05）。在随访组3，盐水洗鼻的孩子使用退热剂（9% vs 33%）,鼻塞解除药（5% vs 47%），粘液溶解剂（10% vs 37%），全身抗菌素（6% vs21%）等明显减少（P值﹤0.5）；同时，盐水组的孩子们：生病天数（31%vs75%），缺课天数（17%vs35%），以及各种并发症（8%vs32%）也明显下降（P﹤.05）。随访的最终结果也与此相似。结论：盐水洗鼻组的儿童，在急性发作期鼻腔症状缓解得更快，随后的复发率也较低。
Arch Otolaryngol Head Neck Surg. 2008 Jan;134(1):67-74