摘要Objective: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.Methods: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.Results: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.Conclusions: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)