韩国现实环境中过敏性鼻炎医学登记研究（KOREA-R）：一项多中心登记研究方案。
Korean medicine registry for allergic rhinitis in real-world settings (KOREA-R): a multicenter registry protocol.
作者信息
Lee Boram, Chang Gyu Tae, Lee Hyelim, Lee Sun Haeng, Kim Tae Hwan, Ko Mi Mi, Seo Sumin, Seo Bok-Nam, Lim Su Eun, Son Mi Ju
机构信息
Korea Institute of Oriental Medicine, Daejeon, Republic of Korea.
Department of Korean Pediatrics, College of Korean Medicine, Kyung Hee University Hospital at Gangdong, Kyung Hee University, Seoul, Republic of Korea.
出版信息
BMC Complement Med Ther. 2025 Jul 22;25(1):282. doi: 10.1186/s12906-025-05030-6.
BACKGROUND
Allergic rhinitis is a prevalent immune disorder with a significant impact on quality of life and socioeconomic burden. Korean Medicine treatments such as herbal medicine and acupuncture are widely utilized for allergic rhinitis due to clinical effectiveness and patient preferences. In particular, herbal decoctions, a key component of Korean Medicine treatment for allergic rhinitis, offer personalized treatment but pose challenges for randomized controlled trials due to the difficulty of placebo development. This study aims to establish a registry utilizing real-world data (RWD) on Korean Medicine treatment for allergic rhinitis, focusing on the effectiveness, safety, and cost-effectiveness of herbal decoctions in clinical practice.
METHODS
The KOrean medicine REgistry for Allergic rhinitis in Real-world settings (KOREA-R) aims to enroll 400 patients with allergic rhinitis receiving Korean Medicine treatment at two Korean Medicine hospitals from February 2025 to June 2028. Patients will be examined in three visits at 2-week intervals, followed by two additional online follow-ups at 6 and 12 months after week 4. RWD on symptom severity, quality of life, treatment administration and compliance, adverse events, and laboratory blood tests will be collected. Participation is voluntary, with no restrictions on treatment types or dosages. Statistical analyses, including propensity score matching and difference-in-difference, will be used to evaluate the effectiveness, safety, and cost-effectiveness of Korean Medicine treatment, particularly herbal decoctions. Data management ensures confidentiality and quality through a validated electronic data capture system and regular monitoring.
CONCLUSION
The findings of KOREA-R will provide insights into the effectiveness and safety of Korean Medicine treatment for allergic rhinitis, with a focus on herbal decoctions tailored to individual patient symptoms and pattern identifications. Additionally, by systematically collecting RWD for multidimensional analysis, KOREA-R will offer valuable information on the cost-utility and cost-effectiveness of herbal decoctions for both patients and healthcare policymakers.
STUDY REGISTRATION
Clinical Research Information Service, KCT0010133 (Registration date: January 13, 2025).
背景
变应性鼻炎是一种常见的免疫性疾病，对生活质量和社会经济负担有重大影响。由于临床疗效和患者偏好，韩医学疗法如草药和针灸被广泛用于治疗变应性鼻炎。特别是草药汤剂，作为韩医学治疗变应性鼻炎的关键组成部分，虽提供个性化治疗，但因难以开发安慰剂而给随机对照试验带来挑战。本研究旨在利用关于韩医学治疗变应性鼻炎的真实世界数据（RWD）建立一个登记处，重点关注草药汤剂在临床实践中的有效性、安全性和成本效益。
方法
韩国真实世界环境中变应性鼻炎韩医学登记处（KOREA-R）旨在从2025年2月至2028年6月在两家韩医学医院招募400名接受韩医学治疗的变应性鼻炎患者。患者将每隔2周接受三次检查，随后在第4周后的6个月和12个月进行另外两次在线随访。将收集关于症状严重程度、生活质量、治疗给药与依从性、不良事件以及实验室血液检查的真实世界数据。参与是自愿的，对治疗类型或剂量没有限制。将使用包括倾向得分匹配和差异中的差异在内的统计分析来评估韩医学治疗，特别是草药汤剂的有效性、安全性和成本效益。数据管理通过经过验证的电子数据捕获系统和定期监测确保保密性和质量。
结论
KOREA-R的研究结果将提供关于韩医学治疗变应性鼻炎的有效性和安全性的见解，重点是根据个体患者症状和证型识别量身定制的草药汤剂。此外，通过系统地收集真实世界数据进行多维度分析，KOREA-R将为患者和医疗保健政策制定者提供关于草药汤剂的成本效用和成本效益的有价值信息。
研究注册
临床研究信息服务，KCT0010133（注册日期：2025年1月13日）。
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