A型肉毒素对季节性过敏性鼻炎疗效的临床研究  

Effects of Botulinum Toxin A on Patients with Seasonal Allergic Rhinitis:A Pilot Randomized Controlled Trial

作　　者：韩晋博 张怡[2] 王宏艳[3] 何帅 刘方[2] HAN Jinbo;ZHANG Yi;WANG Hongyan;HE Shuai;LIU Fang(Department of Otolaryngology and Head and Neck Surgery,Beijing Chaoyang Hospital,Capital Medical University,Beijing 100020,China;Department of Dermatology and Medical Cosmetology,Beijing Chaoyang Hospital,Capital Medical University,Beijing 100020,China;Department of Nursing,Beijing Chaoyang Hospital,Capital Medical University,Beijing 100020,China)

机构地区：[1]首都医科大学附属北京朝阳医院耳鼻咽喉头颈外科,北京100020 [2]首都医科大学附属北京朝阳医院皮肤性病与医学美容科,北京100020 [3]首都医科大学附属北京朝阳医院护理部,北京100020

出　　处：《皮肤科学通报》2024年第4期424-429,435,共7页Dermatology Bulletin

基　　金：北京市医院管理中心青年人才培养“青苗”计划(QML20210308)。

摘　　要：目的探讨A型肉毒素(botulinum toxin A,BTX-A)对秋季花粉诱导的SAR的临床疗效,并比较不同剂量BTX-A的疗效差异。方法本研究为随机、双盲探索性临床试验。纳入患者分为BTX-A高剂量组(25 U/侧)、BTX-A低剂量组(12.5 U/侧)和盐水对照组(0.9%生理盐水)。采用鼻症状总评分(TNSS)、眼症状总评分(TOSS)、视觉模拟评分(VAS)和鼻结膜炎生活质量问卷(RQLQ),在第2、4、8周对患者鼻眼部症状及生活质量进行评估。结果29例患者被最终纳入本研究。BTX-A高剂量组患者治疗后4、8周的TNSS,以及治疗后2、4、8周的TOSS显著低于治疗前及对照组,同时RQLQ也有降低趋势。BTX-A高剂量组患者治疗后4周的TNSS显著低于低剂量组,治疗后第4、8周的TOSS显著低于低剂量组,提示高剂量BTX-A对SAR鼻、眼部症状的改善更加明显。BTX-A自治疗后4周起可显著降低SAR患者鼻塞、流涕、鼻痒VAS,并可持续到第8周。同时,BTX-A自治疗后2周起可显著降低SAR患者眼痒、眼肿、流泪、眼痛VAS,并可持续到第8周。结论BTX-A可有效缓解SAR临床症状,安全性高、副作用少,值得在临床推广。Objective To investigate the clinical efficacy of botulinum toxin A(BTX-A)on autumn pollen-induced SAR and compare the difference of different doses of BTX-A.Methods This study was a randomized,double-blind exploratory clinical trial.The included patients were divided into a high-dose BTX-A group(25 U/side),a low-dose BTX-A group(12.5 U/side)and a saline control group(0.9%normal saline).The total nasal symptom score(TNSS),total ocular symptom score(TOSS),visual analogue scale(VAS)and rhinoconjunctivitis quality of life questionnaire(RQLQ)were used to evaluate the nasal and ocular symptoms and quality of life of the patients at week 2,4 and 8.Results Totally,29 patients were finally included in this study.The TNSS of the high-dose BTX-A group at week 4 and 8 after treatment,and the TOSS of the high-dose BTX-A group at week 2,4,8 after treatment were significantly lower than those before treatment and the control group.The RQLQ also showed a downward trend.The TNSS of the high-dose BTX-A group at week 4 after treatment was significantly lower than that of the low-dose group,and the TOSS of the high-dose BTX-A group at week 4 after treatment was significantly lower than that of the low-dose group,indicating that high-dose BTX-A had a more obvious improvement on the nasal and eye symptoms of SAR.BTX-A can significantly reduce the VAS of nasal congestion,runny nose and nasal itching in SAR patients at week 4 after treatment,and can last until the week 8.At the same time,BTX-A can significantly reduce the VAS of eye itching,eye swelling,tearing and eye pain in SAR patients at week 2 after treatment,and can last until the week 8.Conclusion BTX-A can effectively relieve the clinical symptoms of SAR,with high safety and few side effects,and is worthy of clinical promotion.

关 键 词：过敏性鼻炎 A型肉毒素 随机对照实验 

分 类 号：R765.21[医药卫生—耳鼻咽喉科] R751[医药卫生—临床医学]