目的 观察芪黄健脾滋肾颗粒治疗气阴两虚型干燥综合征的临床疗效。方法 将60例气阴两虚型干燥综合征患者用随机数字表法分成治疗组和对照组，每组30例；治疗组和对照组均予以硫酸羟氯喹片（每次口服0.1 g，每日2次）和甲泼尼龙片（每次口服2 mg，每日1次），治疗组在此基础上加用芪黄健脾滋肾颗粒，每次10 g冲服，每日1次，两组的疗程均为12周。采用中医证候评分以评价两组治疗前后中医临床疗效；计算欧洲风湿病防治委员会干燥综合征患者报告指数（EULAR Sjgrens Syndrome Patient Reported Index ，ESSPRI）和欧洲风湿病防治委员会干燥综合征疾病活动指数（EULAR Sjgrens Syndrome Disease Activity Index，ESSDAI）评价患者疾病活动程度；采用治疗前后类风湿因子（rheumatoid factor，RF）、C反应蛋白（C-reactive protein，CRP）、血沉（erythrocyte sedimentation rate，ESR）、免疫球蛋白G（immunoglobulin G，IgG）、免疫球蛋白A（immunoglobulin A，IgA）、免疫球蛋白M（immunoglobulin M，IgM）、补体3（complement 3，C3）、补体4（complement 4，C4）血清学指标评价治疗前后疾病进展情况。结果 经过12周的治疗，治疗组的临床疗效明显优于对照组（P＜0.05）；治疗组患者两目干涩、口燥咽干、皮肤干燥、关节疼痛、唾液腺肿、体倦乏力评分和ESSPRI、ESSDAI评分降低程度均显著大于对照组（P<0.05）；与治疗前比较，两组患者治疗后ESR和血清RF、CRP、IgG、IgA、IgM水平均显著降低（P<0.05），C3、C4水平显著升高（P<0.05）。治疗组治疗后RF、ESR、IgG降低程度显著大于对照组（P<0.05）。结论 芪黄健脾滋肾颗粒联合基础疗法能够有效地改善干燥综合征患者的临床症状，降低外周血中ESR、IgG、RF水平，改善机体的炎症反应，能够有效缓解疾病进展，提高临床疗效。
Objective To investigate the clinical effect of Qihuang Jianpi Zishen Granule in the treatment of Sjgren's syndrome with deficiency of both Qi and Yin. Methods A total of 60 patients with Sjgrens syndrome with deficiency of both Qi and Yin were divided into treatment group and control group using a random number table, with 30 patients in each group. The patients in both groups were given oral administration of hydroxychloroquine sulfate tablets (at a dose of 0.1 g, twice a day) and methylprednisolone tablets (at a dose of 2 mg, once a day), and those in the treatment group were given Qihuang Jianpi Zishen Granule at a dose of 10 g, once a day; the course of treatment was 12 weeks for both groups. Traditional Chinese medicine (TCM) syndrome score was used to evaluate TCM clinical outcome after treatment; EULAR Sjgrens Syndrome Patient Reported Index (ESSPRI) and EULAR Sjgrens Syndrome Disease Activity Index (ESSDAI) were calculated to evaluate disease activity; related serological markers were measured before and after treatment to evaluate disease progression, including rheumatoid factor (RF), C-reactive protein (CRP), erythrocyte sedimentation rate (ESR), immunoglobulin G (IgG), immunoglobulin A (IgA), immunoglobulin M (IgM), complement 3 (C3), and complement 4 (C4). Results After 12 weeks of treatment, the treatment group had a significantly better clinical outcome than the control group (P<0.05), and compared with the control group, the treatment group had significantly greater reductions in the scores of dryness in the eyes, dry mouth and throat, dry skin, joint pain, salivary gland swelling, and body weakness and the ESSPRI and ESSDAI scores (P<0.05); after treatment, both groups had significant reductions in ESR and the serum levels of RF, CRP, IgG, IgA, and IgM (P<0.05) and significant increases in the levels of C3 and C4 (P<0.05). Compared with the control group, the treatment group had significantly greater reductions in RF, ESR, and IgG after treatment (P<0.05). Conclusion For patients with Sjgrens syndrome, Qihuang Jianpi Zishen Granule combined with basic therapy can effectively improve clinical symptoms, reduce the levels of ESR, IgG, and RF in peripheral blood, improve the bodys inflammatory response, effectively alleviate disease progression, and thus improve the clinical outcome after treatment.