OBJECTIVETo observe the clinical efficacy of Yiqi Fumai Injection (YFI) combined hydroxychloroquine sulfate tablet in the treatment of Sjogren's syndrome patients.

METHODSEighty patients were randomly assigned to three groups. Forty patients in Group A were treated with YFI alone, 2. 6 g YFI added in 250 mL normal saline for intravenous dripping, once daily. Twenty patients in Group B took hydroxychloroquine sulfate alone, 0. 2 g each time, twice daily. Twenty patients in Group C were treated with YFI and hydroxychloroquine sulfate tablet (with the same dose and dosage as Group A and B). Fifteen days was taken as one course of treatment. The scores for dry mouth and dry eyes, the efficacy on salivary flow rate, Schirmer test, erythrocyte sedimentation rate (ESR), C-reactive protein (CRP), and IgG, and so on were compared among the three groups before and after treatment.

RESULTSThere was no significant difference in the laboratory parameters and clinical symptoms among the three groups before treatment. After treatment obvious improvement of the scores for dry mouth, the salivary flow rate, Schirmer test, ESR, CRP, and IgG was shown in all the 3 groups (P<0.05). Besides, the optimal effect was shown in Group C. Its total effective rate was 85% (17/20), better than that of Group A [80% (32/40)] and Group B [75% (15/20)], with no statistical difference (chi2 = 0.736 and 0. 695, P>0.05).

CONCLUSIONYFU combined hydroxychloroquine sulfate tablet showed better effects in treating Sjogren's syndrome patients than using Chinese medicine or Western medicine alone.