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外用5-氟尿嘧啶治疗颗粒性鼓膜炎:一项双盲研究。

Topical 5-fluorouracil for granular myringitis: a double-blinded study.

作者信息

Atef A M, Hamouda M M, Mohamed A H A, Fattah A F A

机构信息

Department of Otorhinolaryngology, Faculty of Medicine, Cairo University, Egypt.

出版信息

J Laryngol Otol. 2010 Mar;124(3):279-84. doi: 10.1017/S0022215109992179. Epub 2009 Dec 11.

DOI:10.1017/S0022215109992179
PMID:20003585
Abstract

BACKGROUND

Granular myringitis is a poorly understood disease which causes considerable discomfort and concern to affected individuals. Some cases may progress to inflammatory obliteration of the deep ear canal. Treatment options are diverse, and no single accepted treatment modality exists. Local application of 5-fluorouracil has recently been trialled in the treatment of chronic otitis media, with promising results.

AIM

To investigate the efficacy and safety of topical 5-fluorouracil in cases of granular myringitis.

METHODS

Sixty patients with granular myringitis were enrolled in this controlled, double-blinded study. Patients were divided randomly into two equal groups. Patients in the study group (n = 30) received three successive applications of topical 5-fluorouracil 5 per cent cream, with two-week intervals between treatments. Patients in the control group (n = 30) received only local petroleum jelly cream packing at the same intervals. Follow-up appointments were scheduled every two weeks for the first three months; patients were then seen again after two years for evaluation of any persistent disease. Outcome measures were: (1) after three months, symptomatic response to treatment (i.e. quantity of aural discharge as reported by patient) and change in the amount of granulation tissue (as assessed by the physician via endoscopic examination); and (2) persistent disease after two years.

RESULTS

There was a highly statistically significant difference in the studied outcomes, comparing the study and control groups.

CONCLUSION

Local application of 5-fluorouracil is a new treatment method for granular myringitis. In this study, it proved safe and efficacious, with no serious local reactions or complications.

摘要

背景

颗粒性鼓膜炎是一种了解甚少的疾病,给患病个体带来极大不适与困扰。部分病例可能进展为深部耳道的炎性闭塞。治疗方案多样,尚无一种被广泛认可的治疗方式。5-氟尿嘧啶局部应用近期已用于慢性中耳炎的治疗试验,结果颇具前景。

目的

探讨局部应用5-氟尿嘧啶治疗颗粒性鼓膜炎的疗效及安全性。

方法

60例颗粒性鼓膜炎患者纳入这项对照双盲研究。患者随机分为两组,每组30例。研究组患者接受连续3次局部应用5% 5-氟尿嘧啶乳膏治疗,每次治疗间隔2周。对照组患者仅在相同间隔时间接受局部凡士林乳膏填塞。前3个月每2周安排一次随访;2年后再次对患者进行检查,评估是否存在持续性疾病。观察指标为:(1)3个月后,治疗的症状反应(即患者报告的耳漏量)以及肉芽组织量的变化(由医生通过内镜检查评估);(2)2年后的持续性疾病情况。

结果

研究组与对照组在研究结果方面存在高度统计学显著差异。

结论

局部应用5-氟尿嘧啶是治疗颗粒性鼓膜炎的一种新方法。在本研究中,该方法被证明安全有效,未出现严重局部反应或并发症。

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