Objective: To investigate the effect of Huoxue Jiedu pill on cytokines in patients with acute mastitis. Method: The 201 patients with acute mastitis in our hospital between May 1st 2012 to May 1st 2015 were randomly divided into treatment group and control group

with 96 patients in treatment group and 105 patients in control group. Patients were treated with Huoxue Jiedu pill or placebo for 7 days on basis of antibiotic therapy. Results of routine blood test

serum and milk interleukin-6 (IL-6) and C-reactive protein (CRP) levels before and after treatment in two groups were compared. The total effective rates of two groups were compared. Result: Total effective rate was 100% in treatment group and 85.7% in control group respectively. Serum IL-6 and CRP levels were decreased significantly after treatment in both groups(P<0.05)

and the above levels in treatment group were significantly lower than those in control group after treatment(P<0.05). Human milk IL-6 and CRP levels were decreased significantly after treatment in both groups(P<0.05)

and the above levels in treatment group were significantly lower than those in control group(P<0.05). Leukocyte

neutrophil

lymphocyte and monocyte counts were decreased significantly after treatment in both groups(P<0.05). Leukocyte and monocyte counts in treatment group were significantly lower than those in control group(P<0.05). Conclusion: Huoxue Jiedu pill combined with western medicine is safe and effective for acute mastitis

thus is worthy of widespread application.