A pilot, open labelled, randomised controlled trial of hypertonic saline nasal irrigation and gargling for the common cold

A pilot, open labelled, randomised controlled trial of hypertonic saline nasal irrigation and gargling for the common cold
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DOI:
10.1038/s41598-018-37703-3
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发表时间:
2019-01-31
期刊:
影响因子:
4.6
通讯作者:
Sheikh, Aziz
Sheikh, Aziz
中科院分区:
综合性期刊3区
文献类型:
--
作者:
Ramalingam, Sandeep;Graham, Catriona;Sheikh, Aziz

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没有抗病毒药物可以治疗病毒性上呼吸道感染 (URTI)。由于许多病毒会引起 URTI,因此抗病毒治疗是不切实际的。由于我们有上皮细胞中氯离子依赖性先天抗病毒反应的证据,因此我们在 URTI 发病 48 小时内对健康成人进行了一项非盲式随机对照试验,比较高渗盐水鼻腔冲洗和漱口 (HSNIG) 与标准护理,以评估招募(主要结果)。可接受性、症状持续时间和病毒排出是次要结果。参与者记录症状日记直至康复两天或最多 14 天,并连续收集 5 个中鼻甲拭子以测量病毒脱落情况。干预组准备高渗盐水并进行HSNIG。我们招募了 68 名参与者(2.6 名参与者/周;2014 年 11 月至 2015 年 3 月)。随机分组后,一名参与者拒绝了。另一个因服用抗生素而被移除(干预:32,对照:34)。随访数据来自 61 名患者(干预组:30 名,对照组:31 名)。 87% 的人认为 HSNIG 可以接受,93% 的人认为 HSNIG 对他们的症状有影响。在干预组中,病程缩短了 1.9 天 (p = 0.01),非处方药 (OTCM) 使用减少了 36% (p = 0.004),家庭接触者内的传播减少了 35% (p = 0.006),病毒传播量减少了 >= 0.5 log(10)/天 (p = 0.04)。因此,我们需要进行更大规模的试验来证实我们的发现。
There are no antivirals to treat viral upper respiratory tract infection (URTI). Since numerous viruses cause URTI, antiviral therapy is impractical. As we have evidence of chloride-ion dependent innate antiviral response in epithelial cells, we conducted a pilot, non-blinded, randomised controlled trial of hypertonic saline nasal irrigation and gargling (HSNIG) vs standard care on healthy adults within 48 hours of URTI onset to assess recruitment (primary outcome). Acceptability, symptom duration and viral shedding were secondary outcomes. Participants maintained a symptom diary until well for two days or a maximum of 14 days and collected 5 sequential mid-turbinate swabs to measure viral shedding. The intervention arm prepared hypertonic saline and performed HSNIG. We recruited 68 participants (2.6 participants/week; November 2014-March 2015). A participant declined after randomisation. Another was on antibiotics and hence removed (Intervention: 32, Control: 34). Follow up data was available from 61 (Intervention: 30, Control: 31). 87% found HSNIG acceptable, 93% thought HSNIG made a difference to their symptoms. In the intervention arm, duration of illness was lower by 1.9 days (p = 0.01), over-the-counter medications (OTCM) use by 36% (p = 0.004), transmission within household contacts by 35% (p = 0.006) and viral shedding by >= 0.5 log(10)/day (p = 0.04). We hence need a larger trial to confirm our findings.