鼻塞通溶液外用治疗中重度变应性鼻炎的非劣效性随机对照试验  

A Non-inferiority Randomized Controlled Trial of Topical Bisaitong(鼻塞通)in Treatment of Moderate to Severe Allergic Rhinitis

作　　者：庞金桃 范斐婷 肖晶旻 何冰 吴蕾[1,2] 徐逸生[1,2] 徐福平[1,2] 王忠文 陈远彬[1,2] PANG Jintao;FAN Feiting;XIAO Jingmin;HE Bing;WU Lei;XU Yisheng;XU Fuping;WANG Zhongwen;CHEN Yuanbin(The Second Clinical Medical College of Guangzhou University of Chinese Medicine,Guangzhou,510405;The Second Affiliated Hospital of Guangzhou University of Chinese Medicine/Guangdong Provincial Hospital of Chinese Medicine;South China Normal University Hospital)

机构地区：[1]广州中医药大学第二临床医学院,广东省广州市510405 [2]广州中医药大学第二附属医院/广东省中医院 [3]华南师范大学医院

出　　处：《中医杂志》2023年第19期1995-2002,共8页Journal of Traditional Chinese Medicine

基　　金：广东省科学技术厅海外名师项目(粤科智字[2022]6号);广东省中医院中医药科学技术研究专项(YN2019QL04);广东省中医院治未病和护理专项(YN2019ZWB03);广东省中医院名中医药专家学术经验传承工作室建设项目(中医二院[2018]7号)。

摘　　要：目的评价鼻塞通溶液外用治疗中重度变应性鼻炎(AR)的有效性与安全性。方法采用随机、阳性对照、非劣效性试验设计,将纳入的108例中重度AR患者随机分为鼻塞通组和糠酸莫米松组各54例。鼻塞通组予鼻塞通溶液涂抹鼻腔治疗(每日2次),糠酸莫米松组予鼻腔吸入糠酸莫米松鼻喷雾剂(每侧鼻孔100μg,每日1次),均连续治疗4周。治疗结束后4周进行随访。比较两组患者入组时、治疗2周、治疗4周及随访时的鼻结膜炎生存质量量表(RQLQ)总均分,鼻眼症状总体(RTSS)评分,喷嚏、流涕、鼻痒、鼻塞严重程度视觉模拟(VAS)评分以及AR发作天数;比较入组时、治疗4周后外周血嗜酸性粒细胞(EOS)计数及其百分比(EOS%)、血清嗜酸性粒细胞阳离子蛋白(ECP),血清户尘螨、粉尘螨、蟑螂过敏原特异性IgE(sIgE)水平;计算超量用药率并进行安全性评价。所有疗效指标均进行全分析集(FAS)和符合方案集(PPS)分析。结果FAS和PPS分析结果均显示,治疗2周、治疗4周及随访时分别与入组时比较,两组患者的RQLQ总均分差值的95%可信区间下限均大于-0.6,提示鼻塞通组非劣效于糠酸莫米松组;两组在各时间点的RTSS评分,喷嚏、流涕、鼻痒、鼻塞严重程度VAS评分以及AR发作天数,组间比较差异均无统计学意义(P>0.05),但两组各指标随时间变化差异均有统计学意义(P<0.01);两组入组时与治疗4周后EOS计数、EOS%、ECP水平及血清户尘螨、粉尘螨、蟑螂sIgE水平,超量用药率,组间比较差异均无统计学意义(P>0.05)。鼻塞通组发生8例(15.10%)不良事件,糠酸莫米松组发生5例(9.30%)不良事件,两组比较差异无统计学意义(P>0.05)。结论鼻塞通溶液外用治疗中重度AR疗效非劣效于糠酸莫米松鼻喷雾剂,可以有效缓解AR临床症状,减少AR发作天数,提高患者生存质量,且安全性较好。Objective To evaluate the efficacy and safety of topical Bisaitong(鼻塞通)in treating moderate-to-severe allergic rhinitis(AR).Methods A randomized,positive-controlled,non-inferiority clinical trial design was adopted.Totally,108 cases of moderate-to-severe AR were randomly divided into Bisaitong group and mometasone furoate group,with 54 cases in each group.The Bisaitong group was treated with Bisaitong smeared at the nasal cavity twice a day,and the mometasone furoate group received inhalation of mometasone furoate nasal spray 100μg in each nostril,once a day.Both groups were treated for 4 weeks and followed up after additional 4 weeks.Both groups were compared on the rhinoconjunctivitis quality of life questionnaire(RQLQ),rhinoconjunctivitis total symptom score(RTSS),visual analogue score(VAS)of sneezing,runny nose,nasal itching,nasal congestion degree,days of AR episodes at enrollment,after 2-and 4-week,and at follow-up.The peripheral blood eosinophil(EOS)count and percentage(EOS%),serum eosinophil cationic protein(ECP),serum dust mite,dermatophagoides farinae,and cockroach allergen-specific IgE(sIgE)levels were compared between groups at enrollment and after 4-week treatment.Drug overuse rate was calculated,and the safety was evaluated.The analysis of all efficacy outcomes was based on both full analysis set(FAS)and per-protocol set(PPS).Results The lower limit of the 95%confidence interval for the differences in RQLQ scores were greater than-0.6 measured after 2-and 4-week treatment and at follow-up compared to that measured at the enrollment in both groups,indicating of the Bisaitong group being non-inferior to the mometasone furoate group.There was no statistically significant difference between groups on RTSS score,VAS scores of sneezing,runny nose,nasal itching,nasal congestion degree and days of episodes at all timepoints(P>0.05),but each outcome changed significantly over time in both groups(P<0.01).The differences between groups in EOS count,EOS%,ECP levels,serum dust mite,dermatophagoides farina

关 键 词：变应性鼻炎 鼻塞通溶液 非劣效性试验 随机对照试验 

分 类 号：R276.1[医药卫生—中医五官科学]