A multi-center observation of the therapeutic efficacy of Bencycloquidium bromide in the treatment of seasonal allergic rhinitis with predominant symptoms of rhinorrhea
-
摘要: 目的 多中心观察M受体拮抗剂苯环喹溴铵鼻喷雾剂治疗以流涕为主要症状的季节性变应性鼻炎(SAR)患者的疗效及安全性。方法 纳入2021年8月-2021年9月北京大学第三医院、吉林中日联谊医院、哈尔滨医科大学附属第一医院耳鼻喉科门诊以流涕为主的SAR患者134例，其中男71例，女63例，中位年龄38岁。用苯环喹溴铵鼻喷雾剂治疗，4次/d，每次2喷90 μg，用药14 d后，观察疗效及安全性。结果 受试者鼻部症状TNSS评分由第0天的(8.89±3.31)分下降至(3.71±2.51)分(P < 0.001)，鼻部总症状VAS评分由第0天的(24.86±7.40)分下降至用药第14天的(6.84±5.94)分(P < 0.001)，流涕症状VAS评分由第0天的(6.88±2.06)分下降至用药第14天的(1.91±1.81)分(P < 0.001)，鼻结膜炎生存质量调查问卷评分由第0天的(94.63±33.35)分下降至用药第14天的(44.95±32.28)分(P < 0.001)，整个试验过程中无严重不良事件发生。结论 M受体拮抗剂苯环喹溴铵鼻喷雾剂对季节性变应性鼻炎具有显著的疗效和良好的安全性。Abstract: Objective To observe the efficacy and safety of the M receptor antagonist Bencycloquidium bromide nasal spray in treatment of seasonal allergic rhinitis with runny nose as the main symptom.Methods From August 2021 to September 2021, 134 patients with seasonal allergic rhinitis were enrolled in the otolaryngology Outpatient Department of Peking University Third Hospital, First Affiliated Hospital of Harbin Medical University and China-Japanese Friendship Hospital of Jilin University, including 71 males and 63 females, with a median age of 38 years. TNSS score and visual analogue scale(VAS) of total nasal symptoms were observed during 2 weeks of treatment with Bencycloquidium bromide nasal spray.Results TNSS score decreased from (8.89±3.31) on day 0 to (3.71±2.51) on day 14(P < 0.001), VAS score of nasal symptoms decreased from (24.86±7.40) on day 0 to (6.84±5.94) on day 14(P < 0.001), VAS score of rhinorrhoea decreased from (6.88±2.06) on day 0 to (1.91±1.81) on day 14(P < 0.001). Rhinoconjunctivitis quality of life questionnaire(RQLQ) score decreased from (94.63±33.35) on day 0 to (44.95±32.28) on day 14(P < 0.001). The incidence of adverse reaction was low and no serious adverse events occurred during the whole experiment.Conclusion Bencycloquidium bromide nasal spray has significant efficacy and good safety in the treatment of seasonal allergic rhinitis.
-
Key words:
- allergic rhinitis /
- cholinergic antagonists /
- nasal sprays
-
-
表 1 患者用药前与用药后第14天鼻部各项症状评分及TNSS评分
变量 X±S 95%CI 配对t检验 治疗前1 d(D0) D14 t P 流涕 2.48±1.00 1.06±0.84 0.12(1.19，1.65) 12.13 < 0.001 鼻痒 2.09±1.05 0.88±0.76 0.11(1.00，1.44) 10.78 < 0.001 鼻塞 2.23±0.93 0.95±0.82 0.10(1.09，1.47) 13.53 < 0.001 喷嚏 2.09±0.91 0.88±0.77 0.10(1.01，1.40) 12.03 < 0.001 TNSS评分 8.89±3.31 3.71±2.51 0.37(4.45，5.91) 14.00 < 0.001 
下载: 导出CSV
表 2 患者治疗前1 d和第14天RQLQ评分
变量名称 X±S 95%CI 独立样本t检验 治疗前1d 第14天 t P 活动 11.52±4.08 5.68±4.13 0.51(4.83，6.85) 11.38 < 0.001 睡眠 10.63±4.83 5.09±4.11 0.56(4.44，6.64) 9.88 < 0.001 非鼻眼症状 20.13±10.16 9.66±8.37 1.16(8.18，12.76) 9.00 < 0.001 实际问题 12.65±4.14 6.30±4.78 0.56(5.24，7.44) 11.36 < 0.001 鼻部症状 15.25±5.15 7.07±4.94 0.63(6.94，9.42) 12.97 < 0.001 眼部症状 12.33±6.47 5.41±4.94 0.72(5.51，8.34) 9.62 < 0.001 情感 12.12±5.55 5.73±5.01 0.66(5.09，7.69) 9.67 < 0.001 总分 94.63±33.35 44.95±32.28 4.10(41.60，57.76) 12.11 < 0.001
下载: 导出CSV
-
[1] Zhang X, Zhang M, Sui H, et al. Prevalence and risk factors of allergic rhinitis among Chinese adults: A nationwide representative cross-sectional study[J]. World Allergy Organ J, 2023, 16(3): 100744. doi: 10.1016/j.waojou.2023.100744
[2] 中华耳鼻咽喉头颈外科杂志编辑委员会鼻科组, 中华医学会耳鼻咽喉头颈外科学分会鼻科学组. 中国变应性鼻炎诊断和治疗指南(2022年, 修订版)[J]. 中华耳鼻咽喉头颈外科杂志, 2022, 57(2): 106-129. doi: 10.3760/cma.j.cn115330-20211228-00828
[3] 庄严, 马婷婷, 康振祥, 等. 内蒙古锡林郭勒盟草原地区变应性鼻炎流行病调查[J]. 临床耳鼻咽喉头颈外科杂志, 2021, 35(11): 1004-1008. https://lceh.whuhzzs.com/article/doi/10.13201/j.issn.2096-7993.2021.11.009
[4] 王云梦, 方宏艳, 刘敩, 等. 长春及周边地区秋季变应性鼻炎变应原分布特点及临床特征分析[J]. 临床耳鼻咽喉头颈外科杂志, 2021, 35(12): 1124-1129. doi: 10.13201/j.issn.2096-7993.2021.12.014 https://lceh.whuhzzs.com/article/doi/10.13201/j.issn.2096-7993.2021.12.014
[5] 白铭宇, 朱丽, 安凤杨, 等. 变应性鼻炎患者用药行为分析[J]. 临床耳鼻咽喉头颈外科杂志, 2017, 31(17): 1330-1333. doi: 10.13201/j.issn.1001-1781.2017.17.008
[6] Dockhorn R, Aaronson D, Bronsky E, et al. Ipratropium bromide nasal spray 0.03% and beclomethasone nasal spray alone and in combination for the treatment of rhinorrhea in perennial rhinitis[J]. Ann Allergy Asthma Immunol, 1999, 82(4): 349-359. doi: 10.1016/S1081-1206(10)63284-X
[7] Lötvall J, Ekerljung L, Lundbäck B. Multi-symptom asthma is closely related to nasal blockage, rhinorrhea and symptoms of chronic rhinosinusitis-evidence from the West Sweden Asthma Study[J]. Respir Res, 2010, 11(1): 163. doi: 10.1186/1465-9921-11-163
[8] Bousquet J, Schünemann HJ, Togias A, et al. Next-generation Allergic Rhinitis and Its Impact on Asthma(ARIA)guidelines for allergic rhinitis based on Grading of Recommendations Assessment, Development and Evaluation(GRADE)and real-world evidence[J]. J Allergy Clin Immunol, 2020, 145(1): 70-80. doi: 10.1016/j.jaci.2019.06.049
[9] Jiang Z, Xiao H, Liu S, et al. Bencycloquidium bromide nasal spray is effective and safe for persistent allergic rhinitis: a phase Ⅲ, multicenter, randomized, double-blinded, placebo-controlled clinical trial[J]. Eur Arch Otorhinolaryngol, 2020, 277(11): 3067-3077. doi: 10.1007/s00405-020-06183-5
[10] Van Gerven L, Steelant B, Hellings PW. Nasal hyperreactivity in rhinitis: A diagnostic and therapeutic challenge[J]. Allergy, 2018, 73(9): 1784-1791. doi: 10.1111/all.13453
[11] 李新, 宋波. M受体的研究进展[J]. 国际药学研究杂志, 2001, 28(1): 26-28. https://www.cnki.com.cn/Article/CJFDTOTAL-XCYJ201603015.htm
[12] 黄玉, 邱峰, 龙锐. 毒蕈碱样胆碱能受体与变应性鼻炎关系研究进展[J]. 中国临床药理学杂志, 2019(17): 4-4. https://www.cnki.com.cn/Article/CJFDTOTAL-GLYZ201917031.htm
[13] 臧健, 姜学钧. 季节性和常年性中重度持续性变应性鼻炎患者生活质量对比研究[J]. 中国耳鼻咽喉头颈外科, 2017, 24(1): 4-4. https://www.cnki.com.cn/Article/CJFDTOTAL-EBYT201701008.htm
[14] Li J, Huang Y, Lin X, et al. China Alliance of Research on Respiratory Allergic Disease(CARRAD). Influence of degree of specific allergic sensitivity on severity of rhinitis and asthma in Chinese allergic patients[J]. Respir Res, 2011, 12(1): 95. doi: 10.1186/1465-9921-12-95
[15] Emeryk A, Emeryk-Maksymiuk J, Janeczek K. New guidelines for the treatment of seasonal allergic rhinitis[J]. Postepy Dermatol Alergol, . 2019, 36(3): 255-260.
[16] 李娟, 何海霞, 周远大, 等. 苯环喹溴铵的毒蕈碱样乙酰胆碱受体亚型选择性研究[J]. 中国新药与临床杂志, 2010, 29(1): 45-49. https://www.cnki.com.cn/Article/CJFDTOTAL-XYYL201001012.htm
[17] 李娟, 周远大, 陈小平. 苯环喹溴铵对大鼠变应性鼻炎的治疗作用[J]. 中国新药与临床杂志, 2008, 27(3): 191-194. https://www.cnki.com.cn/Article/CJFDTOTAL-XYYL200803011.htm
[18] Sun L, Ding L, Wang Y, et al. Pharmacokinetics, safety and tolerability of Bencycloquidium bromide, a novel selective muscarinic M1/M3 receptor antagonist, after single and multiple intranasal doses in healthy chinese subjects: an open-label, single-center, first-in-human study[J]. Drugs R D, 2012, 12(1): 17-28.
[19] Li J, He H, Zhou Y, et al. Subchronic toxicity and toxicokinetics of long-term intranasal administration of bencycloquidium bromide: a 91-day study in dogs[J]. Regul Toxicol Pharmacol, 2011, 59(2): 343-352.
-
图(4)
表(2)
计量
- 文章访问数: 1022
- PDF下载数: 141
- 施引文献: 0