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一项关于元素锌附加疗法对鼻息肉慢性鼻窦炎(CRSwNP)患者临床结局影响的随机临床试验。

A Randomized Clinical Trial of Elemental Zinc Add-on Therapy on Clinical Outcomes of Patients with Chronic Rhinosinusitis with Nasal Polyposis (CRSwNP).

作者信息

Akbari Dilmaghani Nader, Alani Nadereh, Fazeli Sepideh

机构信息

Department of Otolaryngology, Head and Neck Surgery, Loghman Hakim Educational Hospital, School of Medicine, Shahid Beheshti University of Medical Sciences, Tehran, Iran.

Hearing Disorders Research Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran.

出版信息

Iran J Pharm Res. 2019 Summer;18(3):1595-1601. doi: 10.22037/ijpr.2019.1100767.

Abstract

Recent studies suggest a relationship between zinc deficiency and inflammation. In the present study, we studied the effect of oral zinc supplementation on clinical improvement of chronic rhinosinusitis with nasal polyposis. In this single-blind randomized controlled trial, 44 patients with chronic rhinosinusitis with polyposis referring to ENT clinic of the Loghman Hakim hospital during 2013-2014 were randomly allocated in two groups. The treatment group (n = 28) was treated with a four-drug fixed-dose regimen (FD_FDR) consisting of oral dexamethasone (0.02 mg/kg), fluticasone nasal spray, fexophenadine 60 mg daily, montelukast 10 mg daily plus 220mg zinc sulfate capsules containing 55 mg elemental zinc, b.d., and the control group (n = 16) received the FD_FDR without supplemental zinc, for six weeks. After sixth week, two groups were compared regarding clinical outcomes based on theSNOT20 (Sinonasal outcome test) questionnaire, the general health questionnaire (SF12), the Lund-Mackay, and the Lund-Kennedy scoring systems. In the treatment group, serum zinc levels were significantly increased compared to those at the baseline (1.33 fold-increase; = 0.0002). Within groups analysis revealed a significant reduction ( < 0.01) in LM and LK in both treatment (55% LM; 50% LK) and control groups (45% LM; 53% LK). Incontrast, between groups analysis revealed no significant differences in the LM and LK. The treatment group showed a mild superiority in general health improvement compared to that of the control group. Add-on therapy with supplemental zinc sulfate was not associated with significant improvement in patients with chronic rhinosinusitis with nasal polyposis (CRSwNP). The advantage of zinc supplementation on the general health improvement of the patients with CRSwNP requires further assessments.

摘要

近期研究表明锌缺乏与炎症之间存在关联。在本研究中,我们探讨了口服补充锌对伴有鼻息肉的慢性鼻窦炎临床改善情况的影响。在这项单盲随机对照试验中,2013年至2014年期间转诊至洛格曼·哈基姆医院耳鼻喉科门诊的44例伴有鼻息肉的慢性鼻窦炎患者被随机分为两组。治疗组(n = 28)采用四药固定剂量方案(FD_FDR)进行治疗,该方案包括口服地塞米松(0.02 mg/kg)、氟替卡松鼻喷雾剂、每日60 mg非索非那定、每日10 mg孟鲁司特以及含55 mg元素锌的220 mg硫酸锌胶囊,每日两次;对照组(n = 16)接受不含补充锌的FD_FDR治疗,为期六周。六周后,根据鼻窦结局测试(SNOT20)问卷、一般健康问卷(SF12)、Lund - Mackay和Lund - Kennedy评分系统对两组的临床结局进行比较。治疗组血清锌水平较基线时显著升高(增加了1.33倍;P = 0.0002)。组内分析显示,治疗组(Lund - Mackay评分降低55%;Lund - Kennedy评分降低50%)和对照组(Lund - Mackay评分降低45%;Lund - Kennedy评分降低53%)的Lund - Mackay和Lund - Kennedy评分均显著降低(P < 0.01)。相比之下,组间分析显示Lund - Mackay和Lund - Kennedy评分无显著差异。与对照组相比,治疗组在总体健康改善方面显示出轻微优势。补充硫酸锌的附加疗法与伴有鼻息肉的慢性鼻窦炎(CRSwNP)患者的显著改善无关。补充锌对CRSwNP患者总体健康改善的益处需要进一步评估。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/3436/6934942/8ed267716f63/ijpr-18-1595-g001.jpg

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