Efficacy and safty of Yiqi Yangyin Tongluo prescription combined with hydroxychloroquine sulfate in treatment of primary Sj(o)gren's syndrome with deficiency of Qi and Yin
Sun Pengyuan
Gao Mingli
Abstract：Objective To explore the efficacy and safety of Yiqi Yangyin Tongluo prescription in the treatment of primary Sj(o)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(o)gren's syndrome patient reported index (ESSPRI),EULAR Sj(o)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)](x2 =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.
Keywords：Sj(o)gren's syndromeYiqi Yangyin Tongluo prescriptionQi and Yin deficiencyHydroxychloroquine sulfate
Publication Date：2019-01-01
Online Publishing Date：2026-09-14(First online date of this platform, not the publication date of the document)
Pages：4( 1011-1014 )