【目的】通过等效性随机平行对照研究比较鼻敏方（玉屏风散合补中益气汤化裁）配方颗粒与中药汤剂治疗变应性鼻炎 （AR）的疗效和安全性，并比较其化学成分的差异。【方法】选取2023 年4 月至2024 年10 月期间于广东省中医院耳鼻咽喉头颈 科门诊就诊或招募的AR 肺脾气虚证患者114 例，通过中央随机分配系统，采用随机数字表法按1∶1 比例将患者随机分为鼻 敏方配方颗粒治疗组（简称治疗组）和鼻敏方中药汤剂对照组（简称对照组），每组各57 例。治疗组给予鼻敏方配方颗粒治疗， 对照组给予鼻敏方中药汤剂治疗。2 组均以2 周为1 个疗程，共治疗6 周。分别于治疗第0、2、4、6 周及随访第1、2、3 个月 观察2 组患者的鼻部症状总分（TNSS）、眼部症状总分、鼻结膜炎生活质量调查问卷（标准版）[RQLQ（S）]总分、鼻炎控制评估 量表（RCAT）总分和药物评分以评价疗效。采用酶联免疫吸附法（ELISA）检测2 组部分患者治疗前后血清白细胞介素33 （IL-33）、白细胞介素13（IL-13）表达水平，应用UPLC-MS/MS 技术检测鼻敏方两种剂型的化学成分并作比较。【结果】（1）脱 落情况方面，2 组患者各有2 例患者脱落，最终共纳入110 例，每组各55 例。（2）结局指标方面，与基线期（治疗第0 周）比较， 2 组患者在治疗第2、4、6 周及随访第1、2、3 个月的TNSS、眼部症状总分、RQLQ（S）总分均下降（P＜0.001）；与治疗第 6 周相比，上述指标在随访期虽总体上呈上升趋势，但仍均低于基线期。2 组患者的RCAT 总分的变化趋势与上述指标相反。 2 组大部分患者治疗期及随访期的药物评分为0 分，小部分患者在随访第2 个月的药物评分略有增加，但与治疗第6 周相比， 差异无统计学意义（P＞0.05）。2 组患者上述5 个结局指标在治疗第2、4、6 周及随访第1、2、3 个月的6 个观察时点的组间 比较，差异均无统计学意义（P＞0.05）。（3）炎症细胞因子方面，鼻敏方配方颗粒与中药汤剂均可降低AR 肺脾气虚证患者血清 IL-33、IL-13 表达水平，但组间比较，差异均无统计学意义（P＞0.05）。（4）安全性方面，2 组患者均未报告严重不良反应， 治疗组的不良反应发生率为5.45%（3/55），对照组为9.09%（5/55），组间比较，差异无统计学意义（P＞0.05）。（5）化学成分方 面，鼻敏方配方颗粒与中药汤剂在正离子模式下的基峰离子（BPI）图基本一致，均鉴定出218 个化学成分。【结论】鼻敏方配 方颗粒和中药汤剂均可改善AR 患者的鼻眼症状和生活质量，较好地控制AR，减轻复发症状，减少西药用量，下调AR 相关 的炎症细胞因子，且安全性较高。两种剂型的疗效和化学成分高度相似。

Objective To compare the efficacy and safety of Bimin Formula（derived from Yupingfeng San and Buzhong Yiqi Decoction）formulated granules versus traditional decoction in treating allergic rhinitis（AR）through an equivalence randomized parallel controlled trial，and to compare their chemical compositions. Methods From April 2023 to October 2024，114 patients with AR of lung-spleen qi deficiency syndrome were selected from the Outpatient Department of Otolaryngology-Head and Neck Surgery，Guangdong Provincial Hospital of Chinese Medicine. A central randomization system was used，and patients were randomly assigned in a 1 ∶1 ratio by random number table method to receive either Bimin Formula granules（treatment group）or Bimin Formula decoction （control group），with 57 cases in each group. The treatment group received Bimin Formula granules，while the control group received Bimin Formula decoction. Both groups were treated for 6 weeks，with 2 weeks as one treatment course. The total nasal symptom score（TNSS），total ocular symptom score，total Rhinoconjunctivitis Quality of Life Questionnaire（Standardized Version）[RQLQ（S）] score，total Rhinitis Control Assessment Test （RCAT）score，and medication score were observed at weeks 0，2，4，and 6 of treatment and at months 1， 2，and 3 of follow-up to evaluate efficacy. Serum levels of interleukin-33（IL-33）and interleukin-13（IL-13） were detected by enzyme-linked immunosorbent assay（ELISA）in partial patients before and after treatment. The chemical compositions of the two dosage forms of Bimin Formula were analyzed and compared using UPLC-MS/MS. Results（1）Regarding dropout，two patients dropped out from each group，resulting in a total of 110 patients included in the final analysis，with 55 cases in each group.（2）Regarding outcome measures，compared with baseline（week 0），the TNSS，total ocular symptom score，and total RQLQ（S）score in both groups decreased at weeks 2，4，and 6 of treatment and at months 1，2，and 3 of follow-up（P＜0.001）；compared with week 6 of treatment，although the above indicators generally showed an upward trend during the follow-up period，they remained lower than baseline levels. The change trend of total RCAT score in both groups was opposite to that of the above indicators. Most patients in both groups had a medication score of 0 during the treatment and follow-up periods，with a small number of patients showing a slight increase in medication score at month 2 of follow-up， but the difference was not statistically significant compared with week 6 of treatment（P＞0.05）. There were no statistically significant differences in the above five outcome measures between the two groups at the six observation time points（weeks 2，4，and 6 of treatment and months 1，2，and 3 of follow-up）（P＞0.05）.（3）Regarding inflammatory cytokines，both Bimin Formula granules and decoction reduced the serum levels of IL-33 and IL-13 in patients with AR of lung-spleen qi deficiency syndrome，but there was no statistically significant difference between the groups（P＞0.05）.（4）Regarding safety，no serious adverse reactions were reported in either group. The incidence of adverse reactions was 5.45%（3/55）in the treatment group and 9.09%（5/55）in the control group，with no statistically significant difference between the groups（P＞0.05）.（5）Regarding chemical composition，the base peak ion（BPI）chromatograms of Bimin Formula granules and decoction in positive ion mode were essentially consistent，with 218 chemical components identified in both. Conclusion Both Bimin Formula granules and decoction can improve nasal and ocular symptoms and quality of life in AR patients， effectively control AR，alleviate recurrent symptoms，reduce the dosage of western medicine，downregulate AR related inflammatory cytokines，and exhibit a favorable safety profile. The efficacy and chemical composition of the two dosage forms are highly similar.

R276.1

国家自然科学基金资助项目（编号：81603667）；国家中医药管理局高水平中医药重点学科建设项目（编号：zyyzdxk-2023163）； 广东省基础与应用基础研究基金企业联合基金面上项目（编号：2021A1515220007）；广东省2023 年基础与应用基础研究重大项目海外名师 项目；广东省中医院中医药科学技术研究专项（编号：YN2024GZRPY024）；广东省中医院慢病管理专项课题（编号：YN2024MB020）；全国 名老中医专家传承工作室建设项目（粤中医办函〔2022〕52 号）