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A型肉毒杆菌毒素对变应性鼻炎患者鼻部症状的影响:一项双盲、安慰剂对照临床试验。

Effect of botulinum toxin type A on nasal symptoms in patients with allergic rhinitis: a double-blind, placebo-controlled clinical trial.

作者信息

Unal Murat, Sevim Serhan, Doğu Okan, Vayisoğlu Yusuf, Kanik Arzu

机构信息

Department of Otorhinolaryngology, Mersin University School of Medicine, Mersin, Turkey.

出版信息

Acta Otolaryngol. 2003 Dec;123(9):1060-3. doi: 10.1080/00016480310000755.

Abstract

OBJECTIVE

To investigate the possible beneficial effects of botulinum toxin type A (BTX-A) on nasal symptoms in patients with allergic rhinitis (AR).

MATERIAL AND METHODS

Thirty-four patients (21 females, 13 males; mean age 28 years) were included in the study. AR was diagnosed by means of history, clinical examination and skin prick test. Patients were randomly divided into 3 subgroups a follows: in Group A, 20 units of BTX-A was injected into each nasal cavity (total 40 units); in Group B, 30 units of BTX-A was injected into each nasal cavity (total 60 units); and in Group C, 2 ml of isotonic saline was injected as placebo. The symptoms of AR (rhinorrhea, nasal obstruction, sneezing, itching) were scored by the patient on a six-point scale (from 0 to 5). All of the patients were followed up at Weeks 1, 2, 4, 6 and 8; at each visit an anterior rhinoscopic examination was done and symptom scores were recorded.

RESULTS

There was no statistically significant difference between Groups A and B in terms of average symptom scores. Rhinorrhea, nasal obstruction and sneezing scores in Groups A and B were significantly better than those in Group C at all time points. Although itching scores were significantly lower at Weeks 1 and 2, there was no difference in the Week 4, 6 and 8 scores in Groups A and B. When total symptom scores were evaluated, the results for Groups A and B were similar but significantly better than those for Group C.

CONCLUSION

In selected cases, injection of 40 units of BTX-A into the turbinates, as a single agent, may help the symptomatic control of AR for up to 8 weeks.

摘要

目的

探讨A型肉毒毒素(BTX-A)对变应性鼻炎(AR)患者鼻部症状可能的有益作用。

材料与方法

34例患者(21例女性,13例男性;平均年龄28岁)纳入本研究。通过病史、临床检查和皮肤点刺试验诊断AR。患者随机分为3个亚组如下:A组,每侧鼻腔注射20单位BTX-A(共40单位);B组,每侧鼻腔注射30单位BTX-A(共60单位);C组,注射2 ml等渗盐水作为安慰剂。AR症状(鼻流涕、鼻塞、打喷嚏、瘙痒)由患者采用六点量表(从0至5)评分。所有患者在第1、2、4、6和8周进行随访;每次随访时进行前鼻镜检查并记录症状评分。

结果

A组和B组的平均症状评分在统计学上无显著差异。A组和B组在所有时间点的鼻流涕、鼻塞和打喷嚏评分均显著优于C组。虽然在第1周和第2周瘙痒评分显著较低,但A组和B组在第4、6和8周的评分无差异。评估总症状评分时,A组和B组的结果相似,但显著优于C组。

结论

在选定病例中,作为单一药物向鼻甲注射40单位BTX-A可有助于AR症状控制长达8周。

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