Objective To study the therapeutic effect and the immune regulation of Jinyuan Decoction（Decoction for dissolving damp and clearing heat to distribute body fluid） for primary Sjogren’s syndrome（PSS）.Methods Totally 124 PSS patients were di- vided into treatment group（74 cases） and control group（50 cases） randomly

and 24 healthy subjects enrolled as the healthy control group.The treatment group was treated with Jinyuan Decoction

and the control group treated with bromhexine.The course of treat- ment was two months.The immunoglobulin and T lymphocyte subgroup of two groups were detected before and after treatment for therapeutic effect comparison.Results Before treatment

the immunoglobulin of two groups was higher but the natural killing（NK） cell and CD

4

ratio lower than those of the healthy control group.After treatment

IgG

IgM and IgA of two groups were decreased to a different degree.The difference before and after treatment was significant in the treatment group（P

<

0.01）.Both NK cell and CD

4

ratio of two groups ascended（P

<

0.05）.CD

3

of the treatment group was lower than that of the control group after treatment（P

<

0. 05）.The clinical relieve rate of treatment group was 68.92% and the control group 26%.The total effective rate was 97.3% in the treatment group and 72% in the control group.The comparison was significant（P

<

0.05 or P

<

0.01）.Conclusion The effect of Jinyuan Decoction is remarkable for PSS.