Jia Ming-Yue, Zhang Mei-Yi, Xiao Si-Yao, Yu Yang, Shao Xiang, Han Chun-Sheng, Han Gui-Ling
Department of Pulmonary and Critical Care Medicine/Department of Integrated Traditional Chinese and Western Medicine for Pulmonary Diseases Part 1, National Center for Integrative Medicine, Center of Respiratory Medicine, China-Japan Friendship Hospital; National Center for Respiratory Medicine; Institute of Respiratory Medicine, Chinese Academy of Medical Sciences, National Clinical Research Center for Respiratory Diseases, Beijing, 100029, China.
Graduate School of Beijing University of Chinese Medicine, Beijing, 100029, China.
Chin J Integr Med. 2025 Sep 9. doi: 10.1007/s11655-025-3948-0.
To observe the clinical effect and safety of Lu'e Biyan Formula (LBF) combined with loratadine in the treatment of moderate to severe allergic rhinitis (AR) patients with Fei (Lung)-qi deficiency-coldness (FQDC) syndrome.
From September 2023 to December 2024, moderate to severe AR patients with FQDC syndrome were recruited from the Outpatient Department of Integrated Traditional Chinese and Western Medicine for Pulmonary Diseases Part 1, China-Japan Friendship Hospital. Participants were randomly assigned to a test group and a control group by using a random number table at a ratio of 1:1. Both groups received oral loratadine tablets (10 mg, once daily) for 2 weeks. In addition, the test group received oral LBF (30 mL, twice daily), and the control group received a placebo of LBF. Changes in the Total Nasal Symptom Score (TNSS), Total Non-nasal Symptom Score (TNNSS), Visual Analog Scale (VAS), Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ), and Chinese medicine (CM) syndrome scores before and after treatment were compared between groups. Moreover, the total effective rates and disease recurrence rates were compared. Adverse events (AEs) during the study period were also recorded.
Totally 109 participants were recruited, and the full analysis set included 105 cases, 54 in the test group and 51 in the control group. Compared with the pre-treatment values, the scores of sneezing, runny nose, nasal obstruction, nasal itching, TNSS, TNNSS, VAS, RQLQ, and CM syndrome were significantly reduced in both groups at 1 and 2 weeks post-treatment and 12 weeks post-drug withdrawal (P<0.01). After treatment, the aforementioned scores in the test group were all markedly lower than those in the control group (P<0.01). Moreover, the total effective rate in the test group was higher than that in the control group (98.15% vs. 70.59%, P<0.01). After 12 weeks of drug withdrawal, there was no significant difference in the recurrence rate between groups (13.21% vs. 22.22%, P>0.05). No obvious AEs were observed in either group following treatment.
The combination of LBF with loratadine can effectively alleviate the symptoms of moderate to severe AR patients with FQDC syndrome, thereby improving their quality of life. This therapy demonstrated both precise effect and high safety. (Trial registration No. ITMCTR2025000589).
观察氯雷他定联合路鹅鼻炎方治疗肺气虚寒证中重度变应性鼻炎（AR）患者的临床疗效及安全性。
选取2023年9月至2024年12月中日友好医院中西医结合肺病一部门诊中重度肺气虚寒证AR患者，采用随机数字表法按1∶1比例随机分为试验组和对照组。两组均口服氯雷他定片（10 mg，每日1次），疗程2周。试验组加服路鹅鼻炎方（30 mL，每日2次），对照组服用路鹅鼻炎方安慰剂。比较两组治疗前后总鼻症状评分（TNSS）、总非鼻症状评分（TNNSS）、视觉模拟量表（VAS）、变应性鼻炎生活质量问卷（RQLQ）及中医证候评分变化。比较两组总有效率及疾病复发率。记录研究期间不良事件（AE）。
共纳入109例患者，全分析集包括105例，试验组5例，对照组51例。与治疗前比较，两组治疗后1周、2周及停药12周时喷嚏、流涕、鼻塞、鼻痒、TNSS、TNNSS、VAS、RQLQ及中医证候评分均显著降低（P<0.01）。治疗后，试验组上述评分均显著低于对照组（P<0.01）。试验组总有效率高于对照组（98.15%比70.59%，P<0.01）。停药12周后，两组复发率比较差异无统计学意义（13.21%比22.22%，P>0.05）。两组治疗后均未观察到明显AE。
路鹅鼻炎方联合氯雷他定可有效缓解肺气虚寒证中重度AR患者症状，提高其生活质量，疗效确切且安全性高。（试验注册号：ITMCTR2025000589）
