To observe the clinical efficacy of Zengse Pill (퓶취

ZSP) on patients with vitiligo of qi-stagnancy and blood-stasis syndrome type (V-QB)

and to preliminarily explore its mechanism of action. Sixty-five V-QB patients

with their diagnosis confirmed by clinical examination

were randomized by digital table method into two groups

with 31 patients in the control group and 34 in the treatment group. Cobamamide (2 tablets) was administered orally to all patients

and Psoralea tincture (a self-formulated preparation) was applied externally thrice a day. In addition

for patients in the treatment group

ZSP was given orally

at 5 pills per dose

3 times every day. The therapeutic course for both groups was 3 months. Patients were re-examined every half-month

and changes in the skin lesions were observed and recorded. The levels of lymphocyte subsets

serum immune globulin

and complement C3 and C4 in patients were determined before and after the therapeutic course and compared with the corresponding indexes determined in 21 healthy subjects. The total effective rate in the treatment group was 82.4%

which was markedly higher than that in the control group (54.8%)

showing a significant difference (P<0.05). After treatment

CD4 + percentage

CD4 +/CD8 + ratio

and blood levels of C3 and C4 increased

while CD8 + percentage decreased in the treatment group (P<0.05 or P<0.01). All these indexes remained unchanged in the control group

and the respective comparisons between groups showed significant differences (P<0.01). ZSP has a definite clinical effect on the treatment of V-QB but with no evident adverse reactions

and it can increase the CD4 + percentage

CD4 +/CD8 + ratio

and the levels of serum C3 and C4

thus regulating the immunity of the organism

which might be one of its mechanisms of action.