目的 评价桂枝汤合玉屏风散加减治疗慢性自发性荨麻疹 （风寒袭表、营卫不和证） 的临床疗效及对辅助性 T 细胞 17 （Th17） /调节性 T 细胞 （Treg） 平衡轴的影响。方法 将 116 例慢性自发性荨麻疹患者随机分为试验组 （58 例） 和对照组 （58 例） 。对照组口服抗组胺药物 （依巴斯汀片、地氯雷他定片） ；试验组在对照组的基础上加用桂枝汤合玉屏风散加减；疗程 12 周，治疗结束后随访 8 周。检测指标：7 d 荨麻疹活动度评分 （UAS7） 、慢性荨麻疹患者生活质量评估问卷 （CUQ2oL） 、荨麻疹控制程度测试 （UCT） 达标率、中医证候评分、相关生物学指标 ［D-二聚体 （D-D） 、总免疫球蛋白 E （TIgE） 及补体 C3、C4 水平；Th17、Treg 细胞占比及 Th17/Treg 比值；白细胞介素 17 （IL-17） 、IL-23、IL-35 和转化生长因子 β （TGF-β） 水平］。采用 UAS7 评分下降指数 （SSRI）作为疗效评价标准。结果 治疗后，两组患者不同时点的 UAS7 评分均明显低于治疗前 （P＜0.05） ，且试验组明显低于同期对照组 （P＜0.05） ；在治疗后 4、8、12 周和随访 4、8 周，试验组患者的 UCT 达标率均明显高于同期对照组 （P＜0.05） 。治疗后，两组患者的 CUQ2oL 量表各因子评分及总评分均明显低于治疗前 （P＜0.05） ，外周血 D-D、TIgE 水平明显低于治疗前 （P＜0.05） ，C3、C4 水平明显高于治疗前 （P＜0.05） ；Th17 细胞水平及Th17/Treg 比值明显低于治疗前 （P＜0.05） ，Treg 细胞水平明显高于治疗前 （P＜0.05） ；IL-17、IL-23、TGF-β水平明显低于治疗前 （P＜0.05） ，IL-35 水平明显高于治疗前 （P＜0.05） ；两组患者的证候积分明显下降 （P＜0.05） ；试验组与治疗后对照组比较，差异均有统计学意义 （P＜0.05） ，以试验组效果更为明显。试验组的愈显率为 60.34% （35/58） ，明显高于对照组的 39.66% （23/58） ，差异有统计学意义 （P＜0.05） 。结论 在抗组胺药物基础上联合桂枝汤合玉屏风散加减治疗，可控制慢性自发性荨麻疹患者的疾病活动度，提高病情控制效果，改善患者生活质量，提高疗效，其作用机制可能与调节 Th17、Treg 细胞水平及相关炎症因子的表达，维持 Th17/Treg 免疫平衡有关。

Objective To evaluate the clinical effect of modified Guizhi Decoction combined with Yupingfeng Powder on chronic spontaneous urticaria（CSU）（wind-cold invading exterior，ying-wei disharmony syndrome）and its influence on Th17/Treg balance axis. Methods A total of 116 patients with CSU were randomly divided into control group（58 cases） and test group （58 cases）. The control group was treated with oral antihistamines （ebastine tablets，loratadine tablets） . The test group was additionally treated with Guizhi Decoction and modified Yupingfeng Powder on he basis of the control group. The course of treatment was 12 weeks and followed up for eight weeks. Indices detection include：the weekly score of urticaria severity （UAS7），chronic urticaria quality of life questionnaire （CUQ2oL），the standard-reaching rate of urticaria control test （UCT），TCM syndrome score，and related biological parameters [levels of D-dimer（D-D），total immunoglobulin E（TIgE），complement C3 and C4，Th17，proportion of Th17 and Treg cells，ratio of Th17/Treg，levels of interleukin （IL） -17，IL-23，IL-35，and transforming growth factor-β（TGF-β）]. UAS7 symptom score reduce index（SSRI）was used as a criterion for efficacy evaluation. Results After treatment，the UAS7 scores of the two groups at different time points were lower than those before treatment（P＜0.05），and those were significantly lower in the test group than in the control group （P＜0.05） . At 4 weeks，8 weeks and 12 weeks after treatment，and at 4 weeks and 8 weeks of follow-up，the standard-reaching rate of UCT in the test group was higher than that in the control group （P＜0.05）. After treatment，the factor scores and total scores of CUQ2oL scale of the two groups were significantly lower than those before treatment （P＜0.05），the levels of D-D and TIgE of peripheral blood were also significantly lower than those before treatment（P＜0.05）. But the levels of C3 and C4 were significantly higher than those before treatment （P＜0.05）. The levels of Th17 cells and the ratio of Th17/Treg were significantly lower than those before treatment（P＜0.05）. Treg cell level was obviously increased after treatment（P＜0.05）. In addition，the levels of IL-17，IL-23 and TGF-β were obviously decreased after treatment （P＜0.05）. IL-35 level was obviously increased after treatment（P＜0.05）. TCM syndrome score of two groups reduced obviously（P＜0.05）. The difference was statistically significant （P＜0.05） by comparison between the control group after treatment and the test group. Furthermore，the test group showed a significant effect. The cure-markedly effective rate of test group was 60.34% （35/58），which was significantly higher than that of control group [39.66%（23/58）]. The difference between groups was statistically significant （P＜0.05）. Conclusion A combination of modified Guizhi Decoction and Yupingfeng Powder therapies on the basis of antihistamines can control the disease activity of CSU patients，improve the disease control effect，improve the quality of life，and increase effectiveness. Its mechanism of action may be related to the regulation of the levels of Th17，Treg cells and the expression of related inflammasons，and the maintenance of Th17/Treg immune balance.

R275.9

海南省卫生健康行业科研项目（15A200031）