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阿柏他毒素A注射治疗变应性鼻炎的最小有效剂量:一项剂量递增随机对照试验。

The minimum effective dose of abobotulinum toxin A injection for allergic rhinitis: A dose-escalation randomized controlled trial.

作者信息

Piromchai Patorn, Pornumnouy Worakit, Saeseow Patchareeporn, Chainansamit Seksun

机构信息

Department of Otorhinolaryngology, Faculty of Medicine Khon Kaen University Khon Kaen Thailand.

出版信息

Laryngoscope Investig Otolaryngol. 2020 Dec 8;6(1):6-12. doi: 10.1002/lio2.499. eCollection 2021 Feb.

Abstract

OBJECTIVE

To find the lowest effective injection dose of abobotulinum toxin A (Dysport) for allergic rhinitis.

STUDY DESIGN

Dose-escalation randomized controlled trial.

METHODS

We included all patients aged 18 years or older who had persistent allergic rhinitis and positive allergy skin prick test. The patients were randomly allocated to receive 40, 30, or 20 U of abobotulinum toxin A by injection at the inferior turbinate. We followed up on patients for 12 weeks to evaluate nasal symptoms, ocular symptoms, minimum nasal cross-sectional area as measured using acoustic rhinometry, and complications.

RESULTS

Seventeen patients were included in this study, with 7 receiving 20 U of abobotulinum toxin A and 5 each receiving 30 U and 40 U. Abobotulinum toxin A significantly improved nasal congestion, rhinorrhea, sneezing, and loss of smell at 40 U ( < .05) and nasal congestion, sneezing, and loss of smell at 30 U ( < .05). However, at a dose of 20 U, only nasal congestion and loss of smell improved ( < .05). Nasal patency had also significantly improved two weeks after treatment at doses of 40 and 30 U ( < .05). Complications included epistaxis (11.8%) and nasal dryness (23.5%).

CONCLUSION

Abobotulinum toxin A at a dose of at least 30 U effectively reduced most nasal symptoms.

LEVEL OF EVIDENCE

TRIAL REGISTRATION

Clinicaltrials.in.th/ TCTR20200526014.

摘要

目的

寻找用于过敏性鼻炎的阿柏他毒素A(保妥适)的最低有效注射剂量。

研究设计

剂量递增随机对照试验。

方法

纳入所有年龄在18岁及以上、患有持续性过敏性鼻炎且皮肤点刺试验呈阳性的患者。患者被随机分配接受在下鼻甲注射40、30或20单位的阿柏他毒素A。我们对患者进行了12周的随访,以评估鼻部症状、眼部症状、使用鼻声反射仪测量的最小鼻腔横截面积以及并发症。

结果

本研究纳入了17名患者,其中7名接受20单位的阿柏他毒素A,5名各接受30单位和40单位。40单位的阿柏他毒素A显著改善了鼻塞、流涕、打喷嚏和嗅觉减退(P<0.05),30单位改善了鼻塞、打喷嚏和嗅觉减退(P<0.05)。然而,20单位剂量时,仅鼻塞和嗅觉减退有所改善(P<0.05)。在40单位和30单位剂量治疗两周后,鼻腔通畅度也有显著改善(P<0.05)。并发症包括鼻出血(11.8%)和鼻干燥(23.5%)。

结论

至少30单位剂量的阿柏他毒素A能有效减轻大多数鼻部症状。

证据级别

2级。

试验注册

Clinicaltrials.in.th/TCTR20200526014。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/cd5d/7883613/3b2c803b06fb/LIO2-6-6-g001.jpg

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