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一项关于四物汤治疗常年性变应性鼻炎的疗效和安全性的多中心研究。

A multicenter study on the efficacy and safety of So-Cheong-Ryong-Tang for perennial allergic rhinitis.

机构信息

Department of Ophthalmology, Otorhinolaryngology & Dermatology, College of Korean Medicine, Kyung Hee University, Seoul, Republic of Korea.

Department of Ophthalmology, Otorhinolaryngology & Dermatology, College of Korean Medicine, Dongguk University, Gyeongju, Republic of Korea.

出版信息

Complement Ther Med. 2019 Aug;45:50-56. doi: 10.1016/j.ctim.2019.05.018. Epub 2019 May 18.

Abstract

BACKGROUND

So-Cheong-Ryong-Tang (SCRT), also known as Xiao-Qing-Long-Tang or Sho-seiryo-to, is a mixed herbal formula that is used to treat allergic rhinitis, bronchitis, allergic asthma, and common cold in traditional Korean medicine.

OBJECTIVE

To assess the efficacy and safety of the SCRT for the treatment of allergic rhinitis.

METHODS

We conducted a double-blind, randomized, placebo-controlled, parallel-group, multicenter study of Korean adults with perennial allergic rhinitis. The trial consisted of a 4-week oral administration of SCRT or placebo, with two visits at 2-week intervals, and an 8-week follow-up period, with two visits at 4-week intervals. The primary outcome was a change in the total nasal symptoms score. The secondary outcomes included changes in the Rhinoconjunctivitis Quality of Life Questionnaire score, total serum immunoglobulin E (IgE), cytokines levels, and nasal endoscopy index.

RESULTS

SCRT improved nasal symptoms and quality of life in patients with PAR after 4 weeks medication, and these effects did not last 8 weeks after the end of medication. The level of serum IgE, eosinophil counts, and cytokines did not alter after medication. Nasal endoscopy index did not show significant difference. No serious AEs and safety assessment changes were observed in this trial.

CONCLUSION

SCRT is an effective and safe medication for patients with chronic, perennial, and moderate to severe AR. A clinical study with a >4-week period of medication use, and more participants for immune material test is needed to investigate the long-term efficacy of SCRT in relieving the symptoms of nasal obstruction and identifying the underlying mechanisms of action and indications for traditional Korean medicine.

摘要

背景

升麻鳖甲汤(So-Cheong-Ryong-Tang,简称 SCRT),又名小青龙汤或消热汤,是一种混合草药配方,用于治疗传统韩国医学中的过敏性鼻炎、支气管炎、过敏性哮喘和普通感冒。

目的

评估 SCRT 治疗过敏性鼻炎的疗效和安全性。

方法

我们进行了一项双盲、随机、安慰剂对照、平行组、多中心研究,纳入了韩国成年常年性过敏性鼻炎患者。试验包括 4 周的口服 SCRT 或安慰剂治疗,每 2 周进行 2 次就诊,8 周的随访期,每 4 周进行 2 次就诊。主要结局是总鼻部症状评分的变化。次要结局包括 Rhinoconjunctivitis Quality of Life Questionnaire 评分、总血清免疫球蛋白 E(IgE)、细胞因子水平和鼻内镜指数的变化。

结果

SCRT 在 4 周用药后改善了 PAR 患者的鼻部症状和生活质量,这些效果在停药后 8 周内并未持续。用药后血清 IgE、嗜酸性粒细胞计数和细胞因子水平没有改变。鼻内镜指数没有显示出显著差异。本试验未观察到严重不良事件和安全性评估变化。

结论

SCRT 是一种治疗慢性、常年性和中重度 AR 患者的有效且安全的药物。需要进行为期>4 周的用药期的临床研究,并纳入更多的免疫物质测试参与者,以调查 SCRT 在缓解鼻塞症状方面的长期疗效,并确定其作用机制和传统韩国医学适应证。

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