摘要
目的 考察益气生津方对气阴两虚型原发性干燥综合征患者的临床疗效.方法 92例患者随机分为对照组和观察组,每组46例,对照组给予常规治疗,观察组在对照组基础上加用益气生津方,疗程8周.检测临床疗效、中医证候评分、ESSDAI评分、ESSPRI评分、唾液流率、免疫炎症指标(ESR、hs-CRP、IgG、C3、C4)、SAS评分、SDS评分、T淋巴细胞(CD4+、CD8+、Treg、Th17)、安全性指标变化.结果 观察组总有效率高于对照组(P＜0.05).治疗后,观察组中医证候评分降低(P＜0.05),并低于对照组(P＜0.05);2组ESSDAI评分、ESSPRI评分、ESR、hs-CRP、IgG、SAS 评分、SDS 评分、CD8+、Th17 降低(P＜0.05),唾液流率、C3、C4、Treg 升高(P＜0.05),以观察组更明显(CD4+除外)(P＜0.05).2组均未发现明显不良反应.结论 益气生津方可安全有效地改善气阴两虚型原发性干燥综合征患者口眼干燥症状,降低炎症指标,其机制可能与调节体内T淋巴细胞平衡有关.
Abstract
AIM To investigate the clinical effects of Yiqi Shengjin Prescription on patients with primary Sjögren's syndrome due to Dual Deficiency of Qi and Yin.METHODS Ninety-two patients were randomly assigned into control group(46 cases)for 8-week intervention of conventional treatment,and observation group(46 cases)for 8-week intervention of both Yiqi Shengjin Prescription and conventional treatment.The changes in clinical effects,TCM syndrome scores,ESSDAI score,ESSPRI score,salivary flow rate,immunoinflammatory indices(ESR,hs-CRP,IgG,C3,C4),SAS score,SDS score,T lymphocytes(CD4+,CD8+,Treg,Th17)and safety indices were detected.RESULTS The observation group demonstrated higher total effective rate than the control group(P＜0.05).After the treatment,the observation group exhibited decreased TCM syndrome scores(P＜0.05),which was lower than those in the control group(P＜0.05);the two groups displayed decreased ESSDAI score,ESSPRI score,ESR,hs-CRP,IgG,SAS score,SDS score,CD8+,Th17(P＜0.05),and increased salivary flow rate,C3,C4,Treg(P＜0.05),especially for the observation group(except for CD4+)(P＜0.05).No obvious adverse reactions were observable in the two groups.CONCLUSION For the patients with primary Sjogren's syndrome due to Deficiency of Qi and Yin,Yiqi Shengjin Prescription can safely and effectively improve dry mouth and eye symptoms,and reduce inflammatory indices,whose mechanism may contribute to the regulation of T lymphocyte balance in vivo.
基金项目
国家自然科学基金项目(82104782)
省级中医优势专科建设项目(皖中医药服务秘[2022]34号)
安徽省高校协同创新项目(GXXT-2021-085)
安徽省临床医学研究转化专项项目(20230429510702014)
安徽省临床医学研究转化专项项目(20230429510702015)
安徽省卫生健康科研重点项目(AHWJ2022a005)
安徽省黄传兵名中医工作室建设项目(中发展[2022]5号)
维普
万方数据