A multi-center observation of the therapeutic efficacy of Bencycloquidium bromide in the treatment of seasonal allergic rhinitis with predominant symptoms of rhinorrhea
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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.
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Key words:
- allergic rhinitis /
- cholinergic antagonists /
- nasal sprays
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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 
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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
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