Ragab Ahmed, Farahat Taghreed, Al-Hendawy Ghada, Samaka Rehab, Ragab Seham, El-Ghobashy Amira
Department of Otorhinolaryngology, Menoufia University Hospital, Gamal Abd El-Nasir, Shebeen El-Kom, Menoufia Governorate, Egypt.
Department of Pathology, Menoufia University Hospital, Gamal Abd El-Nasir, Shebeen El-Kom, Menoufia Governorate, Egypt.
Int J Pediatr Otorhinolaryngol. 2015 Dec;79(12):2178-86. doi: 10.1016/j.ijporl.2015.09.045. Epub 2015 Oct 22.
Acute rhinosinusitis (ARS) is a common pediatric problem. Our aim was to determine the efficacy of normal nasal saline irrigation (NSI) with or without amoxicillin in treatment of acute rhinosinusitis (ARS) in children.
It is a prospective randomized, blind placebo-controlled trial. Children with uncomplicated ARS were recruited. One group received (amoxacillin 100mg/kg/day) and 0.9% NSI. The second group received placebo and 0.9% NSI. The primary outcome was the effect of treatment on clinical response. Secondary outcomes included: Rating of Pediatric Rhinoconjunctivitis Quality of Life Questionnaire (PRQLQ), middle meatus (MM) bacteriological and cytological cellular responses and adverse effects.
Sixty two patients with ARS were eligible for the study. In amoxicillin group (31 patients); clinical cure was observed in 26 (83.9%) in comparison to 22 (71%) patients in NSI without antibiotics group (31 patients) (p=0.22). No differences between both groups in the reported nasal symptom scores and total symptoms scores improvements at day 7 (p=0.09 and 0.65) and day 14 (p=0.29 and 0.14), respectively. The mean total PRQLQ values had no differences between both groups after the 2 weeks of treatment (p=0.06). At day 7, MM neutrophils reduced significantly in amoxicillin group in comparison to placebo group (p=0.004). At day 14, the MM cytological content had no differences between both groups (p=0.07). Normal NSI with placebo has less reported adverse effects than amoxicillin and nasal saline irrigations (p=0.005).
NSI can be used alone with the same clinical, bacteriological and cytological cellular changes efficacy and with higher safety profile than amoxicillin after 14 days of treatment in uncomplicated clinically diagnosed ARS in children.
急性鼻-鼻窦炎（ARS）是常见的儿科疾病。我们的目的是确定使用或不使用阿莫西林的生理盐水鼻腔冲洗（NSI）治疗儿童急性鼻-鼻窦炎（ARS）的疗效。
这是一项前瞻性随机、双盲安慰剂对照试验。招募了患有单纯性ARS的儿童。一组接受（阿莫西林100mg/kg/天）和0.9%生理盐水鼻腔冲洗。第二组接受安慰剂和0.9%生理盐水鼻腔冲洗。主要结局是治疗对临床反应的影响。次要结局包括：儿童鼻结膜炎生活质量问卷（PRQLQ）评分、中鼻道（MM）细菌学和细胞学细胞反应以及不良反应。
62例ARS患者符合研究条件。在阿莫西林组（31例患者）中，26例（83.9%）观察到临床治愈，而在无抗生素的生理盐水鼻腔冲洗组（31例患者）中为22例（71%）（p=0.22）。两组在第7天（p=0.09和0.65）和第14天（p=0.29和0.14）报告的鼻部症状评分和总症状评分改善方面无差异。治疗2周后，两组的平均PRQLQ总值无差异（p=0.06）。在第7天，与安慰剂组相比，阿莫西林组中鼻道中性粒细胞显著减少（p=0.004）。在第14天，两组的中鼻道细胞学内容无差异（p=0.07）。使用安慰剂的生理盐水鼻腔冲洗报告的不良反应比阿莫西林和生理盐水鼻腔冲洗少（p=0.005）。
在儿童单纯性临床诊断的ARS中，治疗14天后，生理盐水鼻腔冲洗可单独使用，具有相同的临床、细菌学和细胞学细胞变化疗效，且安全性高于阿莫西林。
