A Non-inferiority Randomized Controlled Trial of Topical <italic style="font-style: italic">Bisaitong </italic>（鼻塞通） in Treatment of Moderate to Severe Allergic Rhinitis

PANG Jintao; FAN Feiting; XIAO Jingmin; HE Bing; WU Lei; XU Yisheng; XU Fuping; WANG Zhongwen; CHEN Yuanbin

doi:10.13288/j.11-2166/r.2023.19.010

您当前的位置：

首页 >

文章列表页 >

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

更新时间：2023-09-26

- A Non-inferiority Randomized Controlled Trial of Topical Bisaitong （鼻塞通） in Treatment of Moderate to Severe Allergic Rhinitis
- Journal of Traditional Chinese Medicine Vol. 64, Issue 19, Pages: 1995-2002(2023)
- 作者机构：
  
  1.广州中医药大学第二临床医学院，广东省广州市白云区机场路12号，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
- 作者简介：
- 基金信息：
  
  HUAN Luyao1,2, WENG Jiajun2,3,4, SHENG Song2, WANG Haiyun2, ZHANG Yanhong2(粤科智字［2022］6号)
- DOI：10.13288/j.11-2166/r.2023.19.010
  CLC：
- Received：22 April 2023，
  
  Revised：2023-07-15，
  
  Published：02 October 2023
- 稿件说明：
移动端阅览
庞金桃,范斐婷,肖晶旻等.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[J].中医杂志,2023,64(19):1995-2002.

PANG Jintao,FAN Feiting,XIAO Jingmin,et al.A Non-inferiority Randomized Controlled Trial of Topical Bisaitong （鼻塞通） in Treatment of Moderate to Severe Allergic Rhinitis[J].Journal of Traditional Chinese Medicine,2023,64(19):1995-2002.
庞金桃,范斐婷,肖晶旻等.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[J].中医杂志,2023,64(19):1995-2002. DOI： 10.13288/j.11-2166/r.2023.19.010.

PANG Jintao,FAN Feiting,XIAO Jingmin,et al.A Non-inferiority Randomized Controlled Trial of Topical Bisaitong （鼻塞通） in Treatment of Moderate to Severe Allergic Rhinitis[J].Journal of Traditional Chinese Medicine,2023,64(19):1995-2002. DOI： 10.13288/j.11-2166/r.2023.19.010.

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100 μg，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（

＞0.05），但两组各指标随时间变化差异均有统计学意义（

＜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（

＞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（

＞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。

Abstract

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 100 μg 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 （

＞0.05）， but each outcome changed significantly over time in both groups （

＜0.01）. The differences between groups in EOS count， EOS%， ECP levels， serum dust mite， dermatophagoides farinae， cockroach sIgE levels， and drug overuse rate were not statistically significant at enrollment and after 4-week treatment （

＞0.05）. Adverse events occurred in eight cases （15.10%） in the

Bisaitong

group and five cases （9.30%） in the mometasone furoate group， showing no significant difference between groups （

＞0.05）.

Conclusion

Topical

Bisaitong

is non-inferior to mometasone furoate nasal spray in the treatment of moderate to severe AR in terms of clinical symptom relief，reduction in the episodes， improvement of quality of life， and sound safety.

关键词

Keywords

references

BOUSQUET J ， ANTO JM ， BACHERT C ， et al . Allergic rhinitis ［J］. Nat Rev Dis Primers ， 2020 ， 6 （ 1 ）： 95 .

MELTZER EO . Allergic rhinitis： burden of illness， quality of life， comorbidities， and control ［J］. Immunol Allergy Clin North Am ， 2016 ， 36 （ 2 ）： 235 - 248 .

毛得宏，厍红红 . 变应性鼻炎内外兼顾辨治思路［J］. 中医杂志， 2016 ， 57 （ 19 ）： 1697 - 1699 .

王忠文 . 子午流注方药［M］. 天津：天津科学技术出版社， 2013 .

何冰，陈远彬，胡振宇，等 . 鼻塞通治疗持续性变应性鼻炎32例［J］. 广东医学， 2020 ， 41 （ 20 ）： 2091 - 2095 .

SOE KK ， KRIKEERATI T ， PHEERAPANYAWARANUN C ， et al . Comparative efficacy and acceptability of licensed dose intranasal corticosteroids for moderate-to-severe allergic rhinitis： a systematic review and network meta-analysis ［J］. Front Pharmacol ， 2023 ， 14 ： 1184552 . doi： 10.3389/fphar.2023.1184552 http://dx.doi.org/10.3389/fphar.2023.1184552 .

SEIDMAN MD ， GURGEL RK ， LIN SY ， et al . Clinical practice guideline： allergic rhinitis ［J］. Otolaryngol Head Neck Surg ， 2015 ， 152 （ 1 Suppl ）： S1 - S43 .

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 . 变应性鼻炎诊断和治疗指南（2015年，天津）［J］. 中华耳鼻咽喉头颈外科杂志， 2016 ， 51 （ 1 ）： 6 - 24 .

何霞，冯彦，王斌全，等 . 变应性鼻炎健康相关生存质量测定常用量表简析［J］. 临床耳鼻咽喉头颈外科杂志， 2017 ， 31 （ 1 ）： 23 - 26 .

张罗，许庚，王向东，等 . 鼻用糠酸莫米松治疗中-重度变应性鼻炎的多中心临床研究［J］. 中华耳鼻咽喉头颈外科杂志， 2009 ， 44 （ 6 ）： 455 - 459 .

PFAAR O ， DEMOLY P ， GERTH VAN WIJK R ， et al . Recommendations for the standardization of clinical outcomes used in allergen immunotherapy trials for allergic rhinoconjunctivitis： an EAACI position paper ［J］. Allergy ， 2014 ， 69 （ 7 ）： 854 - 867 .

BOUSQUET PJ ， COMBESCURE C ， NEUKIRCH F ， et al . Visual analog scales can assess the severity of rhinitis graded according to ARIA guidelines ［J］. Allergy ， 2007 ， 62 （ 4 ）： 367 - 372 .

US Department of Health and Human Services ， National Institutes of Health ， National Cancer Institute . Common Terminology Criteria for Adverse Events （CTCAE） Version 5.0 ［EB/OL］.（ 2017-11-27 ）［ 2023-04-22 ］. https：//ctep.cancer.gov/protocolDevelopment/electronic_applications/ctc.htm#ctc_archive https://ctep.cancer.gov/protocolDevelopment/electronic_applications/ctc.htm#ctc_archive .

北京医学会过敏变态反应学分会 . 过敏性疾病诊治和预防专家共识（Ⅰ）［J］. 中华预防医学杂志， 2022 ， 56 （ 10 ）： 1387 - 1394 .

刘蓬 . 中医耳鼻咽喉科学［M］. 北京：中国中医药出版社， 2016 ： 214 - 219 .

王美雅，王旭 . 变应性鼻炎中医外治研究进展［J］. 实用中医药杂志， 2023 ， 39 （ 1 ）： 206 - 208 .

李叶，王道光，王忠文 . 从子午流注针药角度谈中医疗法标准化［J］. 医学争鸣， 2019 ， 10 （ 6 ）： 55 - 57 .

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 .

孟娟，徐睿，叶菁，等 . 变应性鼻炎的分类和诊断专家共识（2022，成都）［J］. 中国眼耳鼻喉科杂志， 2022 ， 22 （ 3 ）： 215 - 224 .

HAAHTELA T ， BURBACH GJ ， BACHERT C ， et al . Clinical relevance is associated with allergen-specific wheal size in skin prick testing ［J］. Clin Exp Allergy ， 2014 ， 44 （ 3 ）： 407 - 416 .

WISE SK ， LIN SY ， TOSKALA E ， et al . International consensus statement on allergy and rhinology： allergic rhinitis ［J］. Int Forum Allergy Rhinol ， 2018 ， 8 （ 2 ）： 108 - 352 .

查看原文

Views

下载量

CSCD

Alert me when the article has been cited

提交

Tools

Publicity Resources

Methodological Issues in the Design，Evaluation，and Reporting of Randomized Controlled Trials with "Pattern Dominating Disease"

Effect of Electroacupuncture on Metabolism-Inflammation Network in Patients with Simple Obesity：A Randomized Controlled Trial

Acupuncture Treatment for Severe Bell's Palsy and Its Impact on Serum GDNF and NGF：A Randomized Controlled Trial

Effect of Heat-sensitive Moxibustion on Quality of Life and Immune Function in Non-Small Cell Lung Cancer Patients with Qi Deficiency and Phlegm Stasis Syndrome Undergoing Chemotherapy：A Randomized Controlled Trial

Effect of Xiaoqinglong Decoction （小青龙汤） on Th2 Immune Responses and Nasal Mucosal TSLP/OX40L Pathway in Allergic Rhinitis Model Rats

Related Author

WANG Lu

WANG Jiajia

ZHANG Yingying

LUO Xufei

CHEN Yaolong

LI Jiansheng

SHU Qi

PENG Qiumei

Related Institution

Lung Disease Diagnosis and Treatment，The First Affiliated Hospital of Henan University of Chinese Medicine

Collaborative Innovation Center for Chinese Medicine and Respiratory Diseases Co-constructed by Henan Province Education Ministry of P.R.China/Henan Key Laboratory of Chinese Medicine for Respiratory Diseases，Henan University of Chinese Medicine

School of Chinese Medicine，Hong Kong Baptist University

Research Unit of Evidence-Based Evaluation and Guidelines，Chinese Academy of Medical Sciences，School of Basic Medical Sciences，Lanzhou University

Key Laboratory of Evidence Based Medicine of Gansu Province

Address：No.16, Nanxiao street, Dongzhimen, Dongcheng District, Beijing Postal code：100700
Tel：010-64035632 Email：jtcmcn@188.com
Technical support is provided by Beijing Founder electronics co., LTD 京ICP备09064830号-19 京公网安备11010102007558号
It is recommended to read the content of this site in Chrome&IE9+. Please switch to extreme mode in browser 360.
Cookies We use cookies to help provide and enhance our service and tailor content. By continuing, you agree to the use of cookies.

⁰

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

DOI：10.13288/j.11-2166/r.2023.19.010

摘要

Abstract

关键词

Keywords

references