鼻炎宁颗粒辅助治疗变应性鼻炎的临床观察

Clinical trial of Biyanning Granule as Complementary Treatment of Allergic Rhinitis

目的:观察鼻炎宁颗粒用于治疗中重度持续性变应性鼻炎的疗效、对生活质量影响及其安全性。方法:入选的中重度持续性变应性鼻炎患者177例,按就诊的先后次序随机分为A组、B组和C组。A组治疗采用布地奈德鼻喷雾剂喷鼻。B组为布地奈德鼻喷雾剂喷鼻,同时冲服鼻炎宁颗粒。C组为布地奈德鼻喷雾剂喷鼻,同时口服盐酸西替利嗪片。治疗结束后对3组疗效、治疗前后生活质量改善情况及不良反应进行分析比较。结果:治疗1周后A、B、C组有效率分别为47%、67%、74%,A组有效率分别与B、C组比较,差异有统计学意义(P<0.05),B组有效率与C组比较差异无统计学意义(P>0.05)。治疗2周后A组、B组、C组有效率分别为60%、79%、82%,A组有效率分别与B、C组比较,差异有统计学意义(P<0.05),B组有效率与C组比较差异无统计学意义(P>0.05)。3组患者治疗前后总体生活质量评分差异均有统计学意义(P<0.05);治疗后总体生活质量评分比较,A组与B、C组差异有统计学意义(P<0.05),B组与C组差异无统计学意义(P>0.05)。所有患者治疗过程中均未出现严重不良事件。A、B、C组不良反应发生率分别为13.3%、15.3%、22.4%,未见鼻炎宁颗粒相关不良反应发生。结论:鼻炎宁颗粒治疗中重度持续性变应性鼻炎有一定的疗效,与布地奈德鼻喷剂联合应用时其作用与盐酸西替利嗪片相当,且不良反应少。

Objective： To evaluate the efficacy and safety of Biyanning Granule on moderate to severe persistent allergic rhinitis. Methods： To compare efficacy, quality of life, safety of Biyanning and Cetirizine hydrochloride tablet on top of Budesonide nasal spray in 177 patients. Group A was treated with Budesonide nasal spray, group B with Budesonide plus Biyanning Granule, group C with Budesonide plus Cetirizine hydrochloride tablet. Results：After one week, the effective rates of group A, B and C was 47% ,67% and 74% ,and there was significant difference between group A and B or A and C（P 〈0.05）, but not significant between group B and C（P 〉0. 05）~ After two weeks, the effective rates of group A, B and C was 60%, 79% and 82% ,there was significant difference between group A and B or A and C （ P 〈 0. 05 ）, but not significant between group B and C （ P 〉 0. 05 ）. There was significant improvement of qual- ity of life after treatment for all groups （ P 〈 0. 05 ）. Quality of life of Group A was significantly better than that of group B or C, but not significant between group B and C. Without severe adverse reaction, the AE occurence rates were 13.3 %, 15.3 % and 22.4 % Conclusion：Biyanning Granule has corrective efficacy for moderate to severe persistent allergic rhinitis. The combined effect with Budesonide nasal spray is as good as Cetirizine Hydrochloride with less adverse drug reactions.