2019 年第 7 期 第 14 卷

益气养阴通络方联合硫酸羟氯喹治疗气阴两虚型原发性干燥综合征的效果及安全性

Efficacy and safty of Yiqi Yangyin Tongluo prescription combined with hydroxychloroquine sulfate in treatment of primary Sjgren′s syndrome with deficiency of Qi and Yin

作者：孙蓬远高明利

英文作者：

单位：110032沈阳，辽宁中医药大学附属医院风湿病科

英文单位：

关键词：干燥综合征；益气养阴通络方；气阴两虚硫酸羟氯喹

英文关键词：

• 摘要：

• 【摘要】目的    探讨益气养阴通络方联合免疫调节剂硫酸羟氯喹治疗气阴两虚型原发性干燥综合征（PSS）的临床效果及安全性。方法    选择辽宁中医药大学附属医院2018年9—12月门诊及住院确诊为气阴两虚型PSS患者43例，应用随机数字表法将患者分为观察组（22例）和对照组（21例），对照组给予硫酸羟氯喹联合益气养阴通络方模拟剂颗粒治疗；观察组给予硫酸羟氯喹联合益气养阴通络方颗粒治疗；2组患者均连续服药8周。比较2组患者治疗前和治疗8周后欧洲抗风湿病联盟干燥综合征患者报告指数(ESSPRI)评分、欧洲抗风湿病联盟干燥综合征疾病活动指数（ESSDAI)评分、血清球蛋白水平、滤纸潮湿长度、唾液流率及中医证候评分以及总有效率和不良反应发生率。结果    与治疗前比较，治疗8周后2组患者ESSPRI评分、ESSDAI评分、血清球蛋白水平及中医证候评分均降低，唾液流率升高，且观察组ESSPRI评分和ESSDAI评分低于对照组［(3.7±0.4)分比（5.7±1.3）分、（6.7±1.3）分比（8.6±1.1）分］，滤纸潮湿长度和唾液流率高于对照组［(6.1±1.5)mm/5 min比（5.1±0.7）mm/5 min、（1.7±1.4）ml/15 min比（1.3±0.6）ml/15 min］，差异均有统计学意义（均P＜0.05）。观察组的总有效率高于对照组［86.4%（19/22）比52.4%（11/21）］,差异有统计学意义（χ2=5.882，P=0.022）。2组患者在服药8周内均未出现严重不良反应，轻度不良反应发生率比较差异无统计学意义（P=0.730）。结论    益气养阴通络方联合免疫调节剂硫酸羟氯喹治疗气阴两虚型PSS患者总有效率优于单用免疫抑制剂硫酸羟氯喹，且不增加患者的不良反应。

• 【Abstract】Objective    To explore the efficacy and safety of Yiqi Yangyin Tongluo prescription in the treatment of primary Sjgren′s syndrome(PSS) with deficiency of Qi and Yin. Methods    A total of 43 PSS patients with Qi and Yin deficiency admitted to Affiliated Hospital of Liaoning University of Traditional Chinese Medicine from September to December 2018 were randomly divided into observation group（22 cases） and control group（21 cases）. The control group was treated with hydroxychloroquine sulfate and simulant granules of Yiqi Yangyin Tongluo prescription. The observation group was treated with hydroxychloroquine sulfate and Yiqi Yangyin Tongluo granules. Both groups were treated for 8 weeks. EULAR Sjgren′s syndrome patient reported index(ESSPRI), EULAR Sjgren′s syndrome disease activity index（ESSDAI), serum globulin level, wetting length of filter paper in Sehirmer test, saliva flow rate, traditional Chinese medicine（TCM） syndrome score, total effective rate and adverse reaction rate were analyzed. Results    After 8 weeks of treatment, ESSPRI score, ESSDAI score, serum globulin level and TCM syndrome score significantly decreased and saliva flow rate significantly increased in both groups; ESSPRI and ESSDAI scores in observation group were significantly lower than those in control group［(3.7±0.4) vs （5.7±1.3）, （6.7±1.3） vs （8.6±1.1）］; wetting length of filter paper and saliva flow rate in observation group were significantly higher than those in control group［(6.1±1.5)mm/5 min vs （5.1±0.7）mm/5 min, (1.7±1.4）ml/15 min vs （1.3±0.6）ml/15 min］（all P＜0.05）. The total clinical effective rate in observation group was significantly higher than that in observation group［86.4%（19/22） vs 52.4%（11/21）］（χ2=5.882, P=0.022）. No obvious adverse event occurred in both groups. There was no significant difference of the incidence of mild adverse reactions between groups(P=0.730). Conclusion    Yiqi Yangyin Tongluo granules combined with hydroxychloroquine sulfate treating PSS with Qi and Yin deficiency can improve the clinical efficacy without increasing adverse effect.