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[药物名称]治疗变应性鼻炎患者的疗效和安全性:一项在中国开展的单臂临床试验

Efficacy and safety of in patients with allergic rhinitis: a single-arm clinical trial in China.

作者信息

Hu Haisheng, Luo Jiaying, Ma Jing, Liang Zhiman, Dai Jinyu, Wang Wenxin, Zhong Jinglin, Tian Loushi, Sun Baoqing

机构信息

Department of Allergy and Clinical Immunology, State Key Laboratory of Respiratory Disease, National Clinical Research Center of Respiratory Disease, Guangzhou Institute of Respiratory Health, First Affiliated Hospital of Guangzhou Medical University, Guangzhou Medical University, Guangzhou, China.

出版信息

Ann Transl Med. 2022 Jun;10(12):684. doi: 10.21037/atm-22-2768.

DOI:10.21037/atm-22-2768
PMID:35845528
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC9279765/
Abstract

BACKGROUND

Traditional Chinese medicine (TCM) has a long history and its own characteristics in the treatment of allergic rhinitis. In this study, the efficacy and safety of patients with allergic rhinitis treated with were observed to support the clinical medication of patients with allergic rhinitis.

METHODS

A total of 61 patients with allergic rhinitis aged 12-70 years from the First Affiliated Hospital of Guangzhou Medical University were included in this study. All the patients were treated with for a period of 7 days. Return visits were carried out 24 hours after the first medication, the 4th day of medication, and the 7th day of medication, during which the efficacy and safety were assessed.

RESULTS

The effective rates of at 24 hours, 4 days, and 7 days were 49.2%, 60.7%, and 65.6%, respectively. Comparing the severity of various symptoms after treatment to baseline, significant differences were found in nasal secretion (2.95±0.67 2.26±1.30, P<0.001), stuffy nose (5.66±2.95 3.34±2.57, P<0.001), mucosa congestion (7.08±1.82 4.23±2.28, P<0.001), running nose (5.21±1.81 2.90±1.89, P<0.001), and sneezing (3.00±0 1.92±1.45, P<0.001). The full symptom scores showed progressive decline during treatment, measuring 20.21±5.13 at baseline and 12.02±6.47 at 7 days (P<0.001). Compared to the Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) score of 64.61±30.27 at baseline, statistical significance (P<0.001) was found at 24 hours, 4 days, and 7 days, measuring 43.11±28.01, 40.74±28.6, and 39.97±40.48, respectively. The incidence rate of adverse events (AEs) was 3.3% (2/61), with no serious AEs.

CONCLUSIONS

In this study, the use of is effective in the treatment of allergic rhinitis patients, especially in patients with severe symptoms. Although the treatment system of TCM is different from that of Western medicine, the application of TCM will provide a new direction for the treatment of chronic diseases. Follow-up studies with an increased sample size are required for verification.

摘要

背景

中医在治疗过敏性鼻炎方面历史悠久且有自身特点。本研究观察了[具体治疗方法]治疗过敏性鼻炎患者的疗效和安全性,以支持过敏性鼻炎患者的临床用药。

方法

本研究纳入了广州医科大学附属第一医院61例年龄在12 - 70岁的过敏性鼻炎患者。所有患者接受[具体治疗方法]治疗7天。在首次用药后24小时、用药第4天和用药第7天进行回访,评估疗效和安全性。

结果

在24小时、4天和7天时的有效率分别为49.2%、60.7%和65.6%。将治疗后各种症状的严重程度与基线进行比较,发现鼻分泌物(2.95±0.67对2.26±1.30,P<0.001)、鼻塞(5.66±2.95对3.34±2.57,P<0.001)、黏膜充血(7.08±1.82对4.23±2.28,P<0.001)、流涕(5.21±1.81对2.90±1.89,P<0.001)和打喷嚏(3.00±0对1.92±1.45,P<0.001)有显著差异。全症状评分在治疗期间呈逐渐下降趋势,基线时为20.21±5.13,7天时为12.02±6.47(P<0.001)。与基线时变应性鼻炎生活质量问卷(RQLQ)评分为64.61±30.27相比,在24小时、4天和7天时差异有统计学意义(P<0.001),分别为43.11±28.01、40.74±28.6和39.97±40.48。不良事件(AE)发生率为3.3%(2/61),无严重不良事件。

结论

本研究中,[具体治疗方法]治疗过敏性鼻炎患者有效,尤其是对症状严重的患者。虽然中医治疗体系与西医不同,但中医的应用将为慢性病治疗提供新方向。需要增加样本量的随访研究进行验证。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/49e0/9279765/10a133c1c3e5/atm-10-12-684-f2.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/49e0/9279765/3b6ead4c9af2/atm-10-12-684-f1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/49e0/9279765/10a133c1c3e5/atm-10-12-684-f2.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/49e0/9279765/3b6ead4c9af2/atm-10-12-684-f1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/49e0/9279765/10a133c1c3e5/atm-10-12-684-f2.jpg

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