Objective: To observe the effect and mechanism of Wenyang Huazhuo Tongluo recipe (WYHZTLR) in treating patients with systemic sclerosis (SSc). Method: Eighty-two patients with SSc were randomly divided into two groups. Control group (41cases) was treated with methotrexate (MTX) and prednisone. Treatment group (41cases) were treated with WYHZTLR combined with MTX and prednisone. All SSc patients were treated for six months. The serum levels of B-cell activating factor (BAFF) and aminoterminal propeptide of type Ⅲ procollagen (PⅢNP) were measured by ELISA. The levels of IgG and IgM were detected by immune scatter turbidimetry. The skin score and disease activity index were assessed at the same time. Result: The treatment group was superior to the control group in efficacy

with a statically significant difference (P<0.05). The levels of BAFF

IgG

IgM and PⅢNP in two groups after treatment were significantly lower than those of before treatment (P<0.05

P<0.01). The above indexes were improved more significantly in the treatment group compared with the control group (P<0.05). Meanwhile

skin score and disease activity index significantly decreased in two groups from that of before the treatment

particularly for the the treatment group (P<0.05

P<0.01). There were positive linear correlations between BAFF and skin score

disease activity index and PⅢNP before and after treatment (P<0.01). Conclusion: WYHZTLR can reduce skin score and disease activity index and relieve clinical symptoms by reducing the serum levels of BAFF and PⅢNP and inhibiting the immunoreaction.