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CHEST:吸入甘露醇或可减少非囊性纤维化支气管扩张患者抗生素使用量

2013-3-22 作者:sd3212   来源:丁香园 我要评论2

已知给非囊性纤维化支气管扩张患者吸入为期两周的干粉甘露醇(DPM)可增强患者气道的黏液清除能力,并改善其生活质量。而当此类患者吸入DPM的疗程超过12周时,其治疗的有效性和安全性目前仍尚不清楚。为加深对这一问题的了解,来自英国伦敦市皇家布朗普顿医院呼吸内科的Diana Bilton博士及其同事进行了一项研究,研究结果在线发表于2013年2月21日的《CHEST》杂志上。研究结果显示:受试者痰量的差异似乎与安慰剂组患者抗生素的使用增加相关。因此,研究者认为,目前需要一个更大的对照研究来评估长期吸入甘露醇治疗对肺部疾病急性加重及其抗生素使用方面的影响。
该研究是一项随机、安慰剂对照、双盲研究。其研究对象主要为:年龄15-80岁、FEV1≥FEV150%预计值,且FEV1≥1L的支气管扩张症患者。所有患者的诊断均经高分辨率CT(HRCT)所证实。在甘露醇激发试验阴性后,受试者被随机分为2组,并分别吸入甘露醇320mg(n=231例)或安慰剂(n=112例),均每日两次,连用12周。为进一步评估甘露醇吸入疗法的安全性,研究者还使用同样剂量和用药频率的甘露醇,对一个亚组患者进行了为期52周以上的开放标签延长(OLE)试验。研究的主要终点为:在基线及治疗12周时,患者24小时痰量和圣乔治呼吸问卷(SGRQ)得分的变化。
该研究的主要结果为:经12周治疗后,甘露醇组和安慰剂组患者与基线时24小时痰重量的变化有统计学上的显著性差异(4.3克,95%可信区间:1.64~7.00;P=0.002)。然而这种差异在很大程度上是由于安慰剂组患者痰量的减少所致,这也使得安慰剂与患者更多的抗生素应用之间产生了相关性。研究显示,安慰剂组患者抗生素的使用率为45%(50/112例),而甘露醇吸入组患者抗生素的使用率为37%(85/231例)。此外,在SGRQ评分的变化方面,甘露醇组患者的总分差值为-3.4分(95%可信区间:-4.81~-1.94);而安慰剂组患者的差值为-2.1分(95%可信区间:-4.12~-0.09),两组比较无统计学上的显著性差异(p=0.304)。在亚组研究中(n=82例),甘露醇组患者经12周治疗后,其HRCT检查时的小气道黏液堵塞发生率较安慰剂组患者明显减少(P=0.048)。研究还发现,甘露醇组患者对治疗的依从性高、耐受性好;其不良事件发生率也与安慰剂组相似(P=0.304)。
该研究结果显示:患者痰量的差异似乎与安慰剂组患者抗生素的使用增加相关。因此,研究者认为,目前需要一个更大的对照研究来评估长期吸入甘露醇对肺部疾病急性加重及其抗生素使用方面的影响
甘露醇相关的拓展阅读:

Background
Inhaled dry powder mannitol (DPM) enhanced mucus clearance and improved quality of life over two weeks in non-cystic fibrosis bronchiectasis. This study’s objective was to investigate efficacy and safety of DPM over 12 weeks.
Methods
Subjects with bronchiectasis, confirmed by high resolution computer tomography (HRCT), aged 15-80 years, with FEV1 ≥ 50% predicted and ≥ 1L, participated in a randomised, placebo-controlled, double-blind study. Subjects with a negative mannitol provocation test were randomised to inhale 320mg mannitol (n=231) or placebo (n=112) twice daily for 12 weeks. To further assess safety, the same mannitol dose/frequency was administered to a patient subset in an open-label extension (OLE) over 52 weeks. Primary endpoints: changes at 12 weeks from baseline in 24-hour sputum weight and St George’s Respiratory Questionnaire (SGRQ) score.
Results
There was a significant difference between mannitol and placebo in terms of change in sputum weight over 12 weeks 4.3g (95% CI: 1.64, 7.00; p=0.002) however this was largely driven by a decrease in sputum weight in the placebo group. This was in turn associated with more antibiotic use in the placebo group (50/112 (45%) vs. inhaled mannitol 85/231 (37%)).There was no statistical difference between the groups (p = 0.304) for total SGRQ score (Mannitol -3.4 points (95% CI: -4.81, -1.94) versus placebo -2.1 points (95% CI: -4.12,-0.09)). In a subgroup study (n=82) Mannitol subjects showed less small airway mucus plugging on HRCT at 12 weeks compared to placebo (p=0.048). Compliance rates were high and mannitol was well tolerated with similar adverse events to placebo.
Conclusion
As the difference in sputum weights appears to be associated with increased antibiotic use in the placebo group, a larger controlled study is now required to investigate the long-term mannitol effect on pulmonary exacerbations and antibiotic use.



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1883512****(暂无匿称)

是一篇不错的文章

(来自:梅斯医学APP)

2016-1-26 17:18:00 回复

1883512****(暂无匿称)

这篇文章有一定深度

(来自:梅斯医学APP)

2016-1-26 17:18:00 回复

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